A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)
Phase: PHASE3
Conditions: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms
Sponsor: Merck Sharp & Dohme LLC

Official Protocol Title:
NCT number:
Document Date:
Protocol/Amendment No.: 001-05 A Randomized 
Phase 3, Double-Blind Study of Chemotherapy 
With or Without Pembrolizumab Followed by 
Maintenance With Olaparib or Placebo for the First-
Line Treatment of BRCA non-mutated Advanced 
Epithelial Ovarian
NCT03740165
19-Aug-2025

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Title Page
THIS PROTOCOL AMENDMENT AND ALL OF THE INFORMATION RELATING 
TO IT ARE CONFIDENTIAL AND PROPRIETARY PROPERTY OF MERCK 
SHARP & DOHME LLC, RAHWAY, NJ, USA (MSD).
Protocol Title: A Randomized Phase 3, Double-Blind Study of Chemotherapy With or 
Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-
Line Treatment of BRCA non-mutated Advanced Epithelial Ovarian Cancer (EOC) 
(KEYLYNK-001 / ENGOT-ov43 / GOG-3036)
Protocol Number: 001-05/ENGOT-ov43/GOG-3036
Compound Number: MK-7339
Sponsor Name and Legal Registered Address: 
Merck Sharp & Dohme LLC
(hereafter referred to as the Sponsor or MSD)
126 East Lincoln Avenue
P.O. Box 2000
Rahway, NJ 07065 USA
Regulatory Agency Identifying Number(s): 
NCT: NCT03740165
IND NUMBER:   139,020
EU CT:
2022-502124-52
EudraCT NUMBER: 2018-001973-25
WHO/UTN: U1111-1283-3793
Approval Date: 19 August 2025
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Sponsor Signatory
Typed Name:
Title:
Date
Protocol-specific Sponsor contact information can be found in the Investigator Trial 
File Binder (or equivalent). 
Investigator Signatory
I agree to conduct this clinical study in accordance with the design outlined in this protocol 
and to abide by all provisions of this protocol.
Typed Name:
Title:
Date
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DOCUMENT HISTORY
Document
Date of Issue
Overall Rationale
Amendment 05
19-AUG-2025
To add the option of an extension study and discontinue all blood collections for ctDNA 
analysis and all PRO collections.
Amendment 04
07-NOV-2022
Recent data from studies using olaparib as front-line maintenance treatment for patients 
with HRD negative ovarian cancer have suggested a limited overall survival benefit (ie, 
PAOLA-1), which represents about 70% of all BRCAwt population. Pembrolizumab, in 
addition to chemotherapy (Arm 2), could provide added benefit over standard-of-care 
chemotherapy (Arm 3) in the HRD negative subgroup (where PARP inhibitors have shown 
limited efficacy), in particular in the CPS ≥10 population. Therefore, the multiplicity 
strategy was amended to prioritize the PFS hypothesis for the pembrolizumab arm in the 
CPS ≥10 population and to add an OS hypothesis for the pembrolizumab arm in the CPS
≥10 population.
Amendment 03
12-MAR-2021
Data from external studies in ovarian cancer have suggested an enriched treatment effect 
for programmed cell death 1 ligand 1 (PD-L1) inhibitors with increasing PD-L1 expression. 
The cutoff of combined positive score (CPS) ≥10 has been included to identify a 
population of participants that could potentially benefit more from chemotherapy with or 
without pembrolizumab (±bevacizumab) followed by maintenance with olaparib 
(±pembrolizumab) or placebo for the first-line treatment of BRCA1/2 non-mutated 
advanced epithelial ovarian cancer (EOC).
Amendment 02
20-AUG-2020
To clarify study-related procedures and assessments, to add ctDNA collections, and to 
allow docetaxel for participants who cannot tolerate paclitaxel following Sponsor 
consultation.
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Document
Date of Issue
Overall Rationale
Amendment 01
02-MAY-2019
Multiple updates were incorporated, including:
Extending period from primary debulking surgery to start of lead-in chemotherapy; 
extending the Screening Period to better reflect the standard of care across many countries; 
allowing additional time for recovery from toxicities associated with lead-in chemotherapy 
following Sponsor consultation; allowing participants to start maintenance earlier if they 
cannot tolerate 6 cycles of treatment following Sponsor consultation; revision of 
hemoglobin levels required for study entry; and clarification of discontinuation criteria 
based on clinical progression as determined by CA-125 and concurrent malignant bowel 
obstruction.
Original protocol
28-AUG-2018
N/A
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PROTOCOL AMENDMENT SUMMARY OF CHANGES
Amendment: 05
Overall Rationale for the Amendment:
To add the option of an extension study and discontinue all blood collections for ctDNA 
analysis and all PRO collections.
Summary of Changes Table
Section Number and 
Name
Description of Change
Brief Rationale
Primary Reason for Amendment
Section 6.7, Treatment 
After the End of the Study 
Duration of Participation: Added the possibility of 
an extension study.
To address a change in strategy by 
providing the option of an 
extension study.
Section Number and 
Name
Description of Change
Brief Rationale
Additional Changes
Title Page  
Added NCT, EU CT, and WHO/UTN numbers.
To include current trial registry 
information.
Section 1.1, Synopsis
Overall Design: Updated the estimated duration of 
the study from 6 years to 7 years.
To align with the current estimated 
duration between first patient 
enrolled and last patient, last visit. 
Duration of Participation: Noted that all blood 
collections for ctDNA analysis and all PRO 
collections will be discontinued.
To discontinue nonessential 
assessments.
Section 1.3.1, SoA –
Adjuvant Treatment Period 
With Primary Debulking 
Followed by Maintenance
Discontinued all PRO collections. 
See Section 1.1 rationale, 
nonessential assessments.
Discontinued all blood collections for ctDNA 
analysis.
See Section 1.1 rationale, 
nonessential assessments.
Section 1.3.2, SoA –
Neoadjuvant/Adjuvant 
Treatment Period With
Interval Debulking 
Followed by Maintenance
Discontinued all PRO collections. 
See Section 1.1 rationale, 
nonessential assessments.
Discontinued all blood collections for ctDNA 
analysis.
See Section 1.1 rationale, 
nonessential assessments.
Section 4.1, Overall 
Design
Noted that all blood collections for ctDNA 
analysis and all PRO collections will be 
discontinued.
See Section 1.1 rationale, 
nonessential assessments.
Added the option of an extension study.
See rationale for Section 1.1, 
Duration of Participation - strategy, 
extension study.
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Section Number and 
Name
Description of Change
Brief Rationale
Section 4.2.1.3, Patient-
reported Outcomes 
Noted that all PRO collections will be 
discontinued. 
See Section 1.1 rationale, 
nonessential assessments.
Section 4.4, Beginning and 
End of Study Definition
Refined the definitions of start and end of study.
To align with the EU CTR.
Added text regarding the estimated maximum 
duration of the study to attain final assessment.
See above rationale pertaining to the 
EU CTR.
Section 6.7, Treatment 
After the End of the Study  
Added extension study language for intervention  
after the end of the current study.
See rationale for Section 1.1, 
Duration of Participation - strategy, 
extension study.
Section 8, Study 
Assessments and 
Procedures
Added a statement to specify that the Sponsor will 
provide ample notification to investigators should 
additional procedures/assessments be discontinued 
in the future.
To allow the Sponsor the option of 
discontinuing future 
procedures/assessments if needed.
Section 8.2.4, Quality-of-
Life Assessment
Noted that all PRO collections will be 
discontinued. 
See Section 1.1 rationale, 
nonessential assessments.
Section 8.4.1, Time Period 
and Frequency for 
Collecting AE, SAE, and 
Other Reportable Safety 
Event Information
Added text about collecting safety event 
information in an extension study.
See rationale for Section 1.1, 
Duration of Participation - strategy, 
extension study.
Table 10: Revised text for Pregnancy/Lactation 
Exposure row.
To add details not previously 
specified.
Table 10: Updated periods and duration for 
potential DILI events meeting biochemical criteria 
of Hy’s Law.
To maintain continued regulatory 
reporting compliance in alignment 
with new health authority DILI 
reporting requirements.
Table 10: Revised text for ECI (requiring 
regulatory reporting) row.
For consistency with language in 
Section 8.4.3.
Section 8.4.3, Follow-up 
of AE, SAE, and Other 
Reportable Safety Event 
Information
Added potential DILI events meeting biochemical 
criteria of Hy’s Law to list of other reportable 
safety events.
See Section 8.4.1 rationale, DILI
reporting requirements.
Section 8.4.4, Regulatory 
Reporting Requirements 
for SAE
Added a statement describing the process for 
reporting SUSARs.
See Section 4.4 rationale pertaining 
to the EU CTR. 
Section 8.4.7, Events of 
Clinical Interest
ECIs updated to include potential DILI meeting
biochemical criteria of Hy’s Law, with associated 
reporting requirements.
See Section 8.4.1 rationale, DILI
reporting requirements.
Section 10.1, Appendix 1: 
Regulatory, Ethical and 
Study Oversight 
Considerations
Added numbering (10.1.3.1 through 10.1.10) to 
subheadings where missing.
To streamline the flow of content.
Section 10.1.1, Code of 
Conduct for Clinical Trials
Updated wording to include reference to additional 
standards and regulations.
See Section 4.4 rationale pertaining 
to the EU CTR.
Section 10.1.3, Data 
Protection
Added text regarding Sponsor’s EU-approved 
Binding Corporate Rules.
See Section 4.4 rationale pertaining 
to the EU CTR.
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Section Number and 
Name
Description of Change
Brief Rationale
Section 10.1.6, 
Compliance With Study 
Registration and Results 
Posting Requirements
Updated referenced EU regulation and added a 
submission website link.
See Section 4.4 rationale pertaining 
to the EU CTR.
Section 10.1.7, 
Compliance with Law, 
Audit, and Debarment
Added text for investigators located in countries 
with serious breach reporting requirements. 
See Section 4.4 rationale pertaining 
to the EU CTR.
Section 10.1.8, Data 
Quality Assurance
Added the EU CTR requirement for a 25-year 
retention period for records and documents.
See Section 4.4 rationale pertaining 
to the EU CTR.
Section 10.3, Appendix 3: 
Contraceptive Guidance 
and Pregnancy Testing
Added numbering (10.3.1 through 10.3.3) to 
subheadings.
See Section 10.1 rationale.
Section 10.4, Appendix 4: 
Adverse Events: 
Definitions and Procedures 
for Recording, Evaluating, 
Follow-up, and Reporting
Added numbering (10.4.1 through 10.4.7) to 
subheadings.
See Section 10.1 rationale.
Section 10.4.3, Definition 
of SAE
Added potential DILI events meeting biochemical 
criteria of Hy’s Law to definition of SAE.
See Section 8.4.1 rationale, DILI 
reporting requirements.
Section 10.4.4, Definition 
of a Suspected Unexpected 
Serious Adverse Reaction 
(SUSAR)
Added this section.
See Section 8.4.1 rationale, details 
not previously specified.
Section 10.6, Appendix 6: 
Collection and 
Management of Specimens 
for Future Biomedical 
Research
Added numbering (10.6.1 through 10.6.8) to 
subheadings.
See Section 10.1 rationale.
Section 10.10, Appendix 
10: Weighted Parametric 
Group Sequential Design
Removed multiple pages of code at the end of this 
section.
To meet journal publication 
requirements.
Updated Figure 5 by replacing study intervention 
names with the respective study arm (#) and 
adding list of abbreviations.
To align with the otherwise identical 
Figure 4 in Section 9.8. 
Throughout document
Minor administrative, formatting, grammatical, 
and/or typographical changes were made 
throughout the document.
To ensure clarity and accurate 
interpretation of the intent of the 
protocol.
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TABLE OF CONTENTS
DOCUMENT HISTORY ........................................................................................................3
PROTOCOL AMENDMENT SUMMARY OF CHANGES...............................................5
1.
PROTOCOL SUMMARY ............................................................................................18
SYNOPSIS............................................................................................................18
SCHEMA..............................................................................................................26
SCHEDULE OF ACTIVITIES (SOA)...............................................................31
SoA – Adjuvant Treatment Period With Primary Debulking Followed 
by Maintenance............................................................................................31
SoA – Neoadjuvant/Adjuvant Treatment Period With Interval 
Debulking Followed by Maintenance..........................................................47
Imaging Assessments for Primary Debulking Followed by Adjuvant 
Treatment and Maintenance.........................................................................65
Imaging Assessments for Neoadjuvant / Adjuvant Treatment Period 
With Interval Debulking Followed by Maintenance ...................................66
Imaging Assessments for Neoadjuvant / Adjuvant Treatment Period 
Without Interval Debulking Followed by Maintenance ..............................68
2.
INTRODUCTION..........................................................................................................70
STUDY RATIONALE.........................................................................................70
BACKGROUND ..................................................................................................71
Pembrolizumab ............................................................................................71
Olaparib........................................................................................................72
Pharmaceutical and Therapeutic Background .............................................72
Inhibition of PD-1 as a Target for Cancer .........................................72
Inhibition of PARP as a Target for Cancer........................................73
Combined Use of an Anti-PD-1 Monoclonal Antibody and PARP 
Inhibitor for the Treatment of Cancer................................................74
Overview of Epithelial Ovarian Cancer.............................................75
Current Standard of Care and Unmet Medical Need.........................75
Preclinical and Clinical Studies ...................................................................76
Ongoing Clinical Studies.............................................................................76
Information on Other Study-related Therapy ..............................................77
BENEFIT/RISK ASSESSMENT........................................................................77
3.
OBJECTIVES/HYPOTHESES AND ENDPOINTS..................................................78
4.
STUDY DESIGN............................................................................................................82
OVERALL DESIGN ...........................................................................................82
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Data Monitoring Committee........................................................................85
Interim Analyses ..........................................................................................85
SCIENTIFIC RATIONALE FOR STUDY DESIGN.......................................85
Rationale for Endpoints ...............................................................................85
Efficacy Endpoints.............................................................................85
RECIST 1.1..............................................................................85
Modified RECIST 1.1 for Immune-based Therapeutics..........85
Safety Endpoints................................................................................86
..........................................................86
..................................................................87
.............................................................87
............................................................................87
.......................................88
...........................................................89
Rationale for the Use of Comparator/Placebo .............................................90
JUSTIFICATION FOR DOSE...........................................................................90
Rationale for Pembrolizumab Dosing Regimen ..........................................90
Rationale for Olaparib Dosing Regimen......................................................90
Rationale for Chemotherapy and Bevacizumab Dosing Regimen ..............90
BEGINNING AND END OF STUDY DEFINITION.......................................90
Clinical Criteria for Early Study Termination .............................................91
5.
STUDY POPULATION ................................................................................................91
INCLUSION CRITERIA....................................................................................91
EXCLUSION CRITERIA...................................................................................94
LIFESTYLE CONSIDERATIONS....................................................................98
Meals and Dietary Restrictions....................................................................98
Activity Restrictions ....................................................................................98
SCREEN FAILURES..........................................................................................98
PARTICIPANT REPLACEMENT STRATEGY.............................................98
6.
STUDY INTERVENTION............................................................................................98
TREATMENTS ADMINISTERED...................................................................98
PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY ..............100
Dose Preparation........................................................................................100
Handling, Storage, and Accountability......................................................100
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND 
BLINDING .........................................................................................................101
Method of Treatment Assignment .............................................................101
Stratification.....................................................................................101
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Blinding......................................................................................................101
TREATMENT COMPLIANCE.......................................................................101
Pembrolizumab, Pembrolizumab Placebo, Carboplatin, Paclitaxel (or 
Docetaxel), and Bevacizumab Compliance...............................................102
Olaparib Compliance .................................................................................102
CONCOMITANT THERAPY..........................................................................102
Prohibited Concomitant Medications ........................................................103
Acceptable Concomitant Medications .......................................................104
Rescue Medications and Supportive Care .................................................105
DOSE MODIFICATION (ESCALATION/TITRATION/OTHER).............105
Immune-related Events and Dose Modification (Withhold, Treat, 
Discontinue)...............................................................................................105
Dose Modification and Toxicity Management for Immune-related 
AEs Associated with Pembrolizumab..............................................105
Dose Modification and Toxicity Management of Infusion-
Reactions Related to Pembrolizumab or Pembrolizumab Placebo..110
Other Pembrolizumab or Pembrolizumab Placebo Dose 
Interruptions.....................................................................................113
Olaparib Dosing Modifications..................................................................113
Olaparib Dose Reduction.................................................................113
Management of Hematological Toxicity .........................................113
Management of Prolonged Hematological Toxicities .....................115
Management of Non-Hematological Toxicity.................................116
Management of New or Worsening Pulmonary Symptoms ..116
Management of Nausea and Vomiting ..................................116
Management of Renal Impairment ........................................117
Interruptions for Intercurrent Non-Toxicity-Related Events...........117
Dose Reductions for Concurrent CYP3A4 Inhibitor Use................118
Management of Overlapping Toxicities ....................................................118
Chemotherapy and Bevacizumab Dose Modifications..............................118
Lead-in Period..................................................................................118
Treatment Period..............................................................................118
TREATMENT AFTER THE END OF THE STUDY....................................119
CLINICAL SUPPLIES DISCLOSURE ..........................................................119
STANDARD POLICIES ...................................................................................120
7.
DISCONTINUATION OF STUDY TREATMENT AND PARTICIPANT 
WITHDRAWAL..........................................................................................................120
DISCONTINUATION OF STUDY TREATMENT.......................................120
PARTICIPANT WITHDRAWAL FROM THE STUDY..............................122
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LOST TO FOLLOW-UP ..................................................................................122
8.
STUDY ASSESSMENTS AND PROCEDURES......................................................123
ADMINISTRATIVE AND GENERAL PROCEDURES...............................123
Informed Consent.......................................................................................123
General Informed Consent...............................................................124
Consent and Collection of Specimens for Future Biomedical 
Research...........................................................................................124
Inclusion/Exclusion Criteria ......................................................................124
Participant Identification Card...................................................................124
Medical History .........................................................................................125
Ovarian Cancer History ...................................................................125
Debulking Surgery.....................................................................................125
Tumor Tissue Biopsy and Sample Collection .................................126
Prior and Concomitant Medications Review.............................................126
Prior Medications.............................................................................126
Concomitant Medications................................................................126
Subsequent Anticancer Therapy ......................................................126
Assignment of Screening Number.............................................................126
Assignment of Treatment/Randomization Number...................................127
Treatment Administration..........................................................................127
Timing of Dose Administration.......................................................127
Pembrolizumab or Pembrolizumab Placebo..........................128
Paclitaxel (or Docetaxel)........................................................128
Carboplatin.............................................................................129
Bevacizumab..........................................................................129
Olaparib or Olaparib Placebo.................................................130
Antiemetic Therapy ...............................................................131
Discontinuation and Withdrawal ...............................................................131
Discontinuation of Study Treatment Due to Progressive Disease 
Prior to Interval Debulking..............................................................131
Withdrawal From Future Biomedical Research ..............................131
Participant Blinding/Unblinding................................................................132
Non-Emergency Unblinding............................................................133
Calibration of Equipment...........................................................................133
Tumor Tissue .............................................................................................133
Tumor Tissue for PD-L1 and BRCA1/2 Status................................133
Tumor Tissue for Biomarker Analyses............................................133
EFFICACY ASSESSMENTS ...........................................................................134
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Tumor Imaging ..........................................................................................134
Initial Tumor Imaging......................................................................134
Tumor Imaging During the Study....................................................135
Imaging for Participants Eligible for Primary Debulking......135
Imaging for Participants Eligible for Interval Debulking......136
Response Evaluation Following Debulking Surgery.............136
Imaging for Eligibility to Continue Olaparib/Olaparib 
Placebo at 2 Years..................................................................137
End of Treatment and Follow-up Tumor Imaging...........................137
RECIST 1.1 Assessment of Disease................................................137
iRECIST Assessment of Disease.....................................................138
Pathological Tumor Assessment................................................................141
Tumor Marker Assessment........................................................................141
Quality-of-Life Assessment.......................................................................141
SAFETY ASSESSMENTS................................................................................142
Physical Examinations...............................................................................142
Vital Signs..................................................................................................142
Electrocardiograms ....................................................................................142
Clinical Safety Laboratory Assessments ...................................................143
Bone Marrow or Blood Cytogenetic Samples .................................143
Performance Assessments..........................................................................143
Eastern Cooperative Oncology Group Performance Status.............143
ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, AND OTHER 
REPORTABLE SAFETY EVENTS ................................................................144
Time Period and Frequency for Collecting AE, SAE, and Other 
Reportable Safety Event Information ........................................................144
Method of Detecting AEs, SAEs, and Other Reportable Safety Events....146
Follow-up of AE, SAE and Other Reportable Safety Event Information..147
Regulatory Reporting Requirements for SAE ...........................................147
Disease-related Events and/or Disease-related Outcomes Not Qualifying 
as AEs or SAEs..........................................................................................147
Pregnancy and Exposure During Breastfeeding ........................................148
Events of Clinical Interest (ECIs)..............................................................148
TREATMENT OF OVERDOSE......................................................................149
PHARMACOKINETICS..................................................................................149
PHARMACODYNAMICS................................................................................149
BIOMARKERS..................................................................................................149
FUTURE BIOMEDICAL RESEARCH SAMPLE COLLECTION ............150
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MEDICAL RESOURCE UTILIZATION AND HEALTH ECONOMICS.150
VISIT REQUIREMENTS.................................................................................150
Screening....................................................................................................150
Treatment Period........................................................................................151
Posttreatment Visits ...................................................................................151
Safety Follow-up Visit.....................................................................151
Efficacy Follow-up Visits................................................................151
Survival Follow-up Assessments.....................................................152
Survival Status .................................................................................152
9.
STATISTICAL ANALYSIS PLAN ...........................................................................152
STATISTICAL ANALYSIS PLAN SUMMARY ...........................................152
RESPONSIBILITY FOR ANALYSES/IN-HOUSE BLINDING..................155
HYPOTHESES/ESTIMATION .......................................................................155
ANALYSIS ENDPOINTS.................................................................................155
ANALYSIS POPULATIONS ...........................................................................157
Efficacy Analysis Population.....................................................................157
Safety Analysis Population........................................................................157
PRO Analysis Population ..........................................................................157
STATISTICAL METHODS .............................................................................157
Statistical Methods for Efficacy Analyses.................................................157
Progression-free Survival.................................................................158
Overall Survival...............................................................................160
Statistical Methods for Safety Analyses ....................................................161
Statistical Methods for PRO Analyses.......................................................162
Summaries of Baseline Characteristics and Demographics.......................163
...................................................................................163
...........................................................................163
.......................................................................163
.............................................................................................165
...................................................................................166
..............................................................166
..............................................................................168
Safety Analyses..........................................................................................170
SAMPLE SIZE AND POWER CALCULATIONS........................................170
SUBGROUP ANALYSES.................................................................................172
COMPLIANCE (MEDICATION ADHERENCE).........................................172
EXTENT OF EXPOSURE................................................................................172
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10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS...................................................................................................173
APPENDIX 1:  REGULATORY, ETHICAL AND STUDY OVERSIGHT 
CONSIDERATIONS.........................................................................................173
Code of Conduct for Clinical Trials...........................................................173
Financial Disclosure...................................................................................175
Data Protection...........................................................................................175
Confidentiality of Data ....................................................................176
Confidentiality of Participant Records.............................................176
Confidentiality of IRB/IEC Information..........................................176
Committees Structure.................................................................................176
Steering Committee .........................................................................176
Executive Oversight Committee......................................................177
Data Monitoring Committee............................................................177
Publication Policy......................................................................................177
Compliance With Study Registration and Results Posting Requirements 177
Compliance With Law, Audit, and Debarment .........................................178
Data Quality Assurance .............................................................................179
Source Documents .....................................................................................179
Study and Site Closure...............................................................................180
APPENDIX 2:  COLLECTION AND MANAGEMENT OF SPECIMENS 
FOR FUTURE BIOMEDICAL RESEARCH.................................................181
APPENDIX 3:  CONTRACEPTIVE GUIDANCE AND PREGNANCY 
TESTING............................................................................................................186
Definitions..................................................................................................186
Contraception Requirements......................................................................186
Pregnancy Testing......................................................................................187
APPENDIX 4: ADVERSE EVENTS:  DEFINITIONS AND 
PROCEDURES FOR RECORDING, EVALUATING, FOLLOW-UP, 
AND REPORTING............................................................................................188
Definitions of Medication Error, Misuse, and Abuse................................188
Definition of AE ........................................................................................188
Definition of SAE ......................................................................................189
Definition of a Suspected Unexpected Serious Adverse Reaction 
(SUSAR)....................................................................................................191
Additional Events Reported in the Same Manner as SAE.........................191
Recording AE and SAE .............................................................................191
Reporting of AEs, SAEs, and Other Reportable Safety Events to the 
Sponsor ......................................................................................................195
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APPENDIX 5:  CLINICAL LABORATORY TESTS ...................................196
APPENDIX 6:  DESCRIPTION OF THE IRECIST PROCESS FOR 
ASSESSMENT OF DISEASE PROGRESSION ............................................198
Assessment at Screening and Prior to RECIST 1.1 Progression ...............198
Assessment and Decision at RECIST 1.1 Progression..............................198
Assessment at the Confirmatory Imaging..................................................199
Confirmation of Disease Progression ........................................................199
Persistent iUPD..........................................................................................199
Resolution of iUPD....................................................................................200
Management Following the Confirmatory Imaging ..................................200
Detection of Progression at Visits After Pseudoprogression Resolves .....200
APPENDIX 7:  COUNTRY-SPECIFIC REQUIREMENTS ........................202
Germany.....................................................................................................202
United Kingdom.........................................................................................205
France.........................................................................................................208
Japan ..........................................................................................................211
APPENDIX 8:  ABBREVIATIONS.................................................................212
APPENDIX 9: ASSESSMENT OF RESPONSE IN OVARIAN CANCER 
BY GYNECOLOGIC CANCER INTERGROUP (CGIG) CRITERIA.......217
................................................................................218
11. REFERENCES.............................................................................................................225
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LIST OF TABLES
Table 1
Adequate Organ Function Laboratory Values.............................................93
Table 2
Study Treatment(s).......................................................................................99
Table 3
Dose Modification and Toxicity Management Guidelines for Immune-
related Adverse Events Associated With Pembrolizumab Monotherapy, 
Coformulations or IO Combinations.........................................................107
Table 4
Pembrolizumab or Pembrolizumab Placebo Infusion Reaction Dose 
Modification and Treatment Guidelines....................................................111
Table 5
Management of Anemia.............................................................................114
Table 6
Management of Neutropenia, Leukopenia, and Thrombocytopenia .........115
Table 7
Dose Reduction of Olaparib or Olaparib Placebo to Manage Moderate 
Renal Impairment......................................................................................117
Table 8
Dose Reduction of Olaparib or Olaparib Placebo With a Strong or 
Moderate CYP3A4 Inhibitor.....................................................................118
Table 9
Imaging and Treatment After First Radiologic Evidence of PD ...............140
Table 10
Reporting Periods and Time Frames for Adverse Events and Other 
Reportable Safety Events ..........................................................................145
Table 11
Censoring Rules for Primary and Secondary Analyses of PFS.................159
Table 12
Efficacy Analysis Methods for Key Efficacy Endpoints...........................160
Table 13
Analysis Strategy for Safety Parameters....................................................162
Table 14
Summary of Interim and Final Analyses ...................................................164
Table 15
 
.....167
Table 16
....169
Table 17
Highly Effective Contraception Methods..................................................187
Table 18
Protocol-required Safety Laboratory Assessments....................................196
Table 19
............................220
Table 20
.220
Table 21
........222
Table 22
.....223
Table 23
....224
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LIST OF FIGURES
Figure 1
Study Diagram .............................................................................................27
Figure 2
Study Intervals for Participants Eligible for Primary Debulking.................28
Figure 3
Study Intervals for Participants Eligible for Interval Debulking.................29
Figure 4
.........166
Figure 5
.........219
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1. Protocol Summary
Synopsis
Protocol Title:
A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without 
Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the 
First-Line Treatment of BRCA non-mutated Advanced Epithelial Ovarian 
Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)
Short Title:
First-line chemotherapy plus pembrolizumab and olaparib for BRCA non-mutated
advanced EOC (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)
Objectives/Hypotheses and Endpoints:
In participants with previously untreated BRCA1/2 non-mutated advanced EOC treated 
with pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab 
treatment plus olaparib maintenance (Arm 1) or pembrolizumab plus 
carboplatin/paclitaxel followed by continued pembrolizumab treatment (Arm 2) versus 
carboplatin/paclitaxel alone (Arm 3):
Objective/Hypothesis
Endpoint
Primary
•
Objective:  To compare the 
progression-free survival (PFS) as 
assessed by the investigator according 
to Response Evaluation Criteria in 
Solid Tumors version 1.1 
(RECIST 1.1)
Hypothesis (H1): The combination of 
pembrolizumab plus 
carboplatin/paclitaxel followed by 
continued pembrolizumab treatment 
and olaparib maintenance (Arm 1) is 
superior to carboplatin/paclitaxel alone 
(Arm 3) with respect to PFS per 
•
PFS, the time from the date of 
randomization until either the earliest 
date of documented disease 
progression or death due to any cause, 
whichever occurs first
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RECIST 1.1 in participants with 
PD-L1 positive tumors (CPS ≥10).
Hypothesis (H2): The combination of 
pembrolizumab plus 
carboplatin/paclitaxel followed by 
continued pembrolizumab treatment 
and olaparib maintenance (Arm 1) is 
superior to carboplatin/paclitaxel alone 
(Arm 3) with respect to PFS per 
RECIST 1.1 in All Participants.
Hypothesis (H3):  The combination of 
pembrolizumab plus 
carboplatin/paclitaxel followed by 
continued pembrolizumab treatment 
(Arm 2) is superior to 
carboplatin/paclitaxel alone (Arm 3)
with respect to PFS per RECIST 1.1 in 
participants with PD-L1 positive 
tumors (CPS ≥10).
Hypothesis (H4): The combination of 
pembrolizumab plus 
carboplatin/paclitaxel followed by 
continued pembrolizumab treatment 
(Arm 2) is superior to 
carboplatin/paclitaxel alone (Arm 3) 
with respect to PFS per RECIST 1.1 in 
All Participants.
Secondary
•
Objective:  To compare the overall 
survival (OS)
Hypothesis (H5):  The combination of 
pembrolizumab plus 
carboplatin/paclitaxel followed by 
continued pembrolizumab treatment 
and olaparib maintenance (Arm 1) is 
superior to carboplatin/paclitaxel alone 
(Arm 3) with respect to OS in All 
Participants.
Hypothesis (H6):  The combination of 
pembrolizumab plus 
carboplatin/paclitaxel followed by 
•
OS, the time from the date of 
randomization to death due to any 
cause
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continued pembrolizumab treatment 
(Arm 2) is superior to 
carboplatin/paclitaxel alone (Arm 3) 
with respect to OS in All Participants.
Hypothesis (H7):  The combination of 
pembrolizumab plus 
carboplatin/paclitaxel followed by 
continued pembrolizumab treatment 
(Arm 2) is superior to 
carboplatin/paclitaxel alone (Arm 3) 
with respect to OS in participants with 
PD-L1 positive tumors (CPS ≥10).
•
Objective:  To compare the PFS as 
assessed by blinded independent 
central review according to
RECIST 1.1 in participants with 
PD-L1 positive tumors (CPS ≥10) and 
in All Participants.
•
PFS
•
Objective:  To compare the PFS after 
second-line treatment as determined by 
the investigator according to the local 
standard of clinical practice (PFS2)
following discontinuation of study 
treatment administration in participants 
with PD-L1 positive tumors (CPS ≥10)
and in All Participants.
•
PFS2, the time from date of 
randomization until disease 
progression (clinical or radiological) 
after second-line treatment or death 
due to any cause, whichever occurs 
first
•
Objective: To evaluate the safety and 
tolerability of pembrolizumab 
administered with chemotherapy and 
olaparib maintenance
•
Adverse events (AEs)
•
Study treatment discontinuation due to 
AEs
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•
Objective: To compare the mean 
change from baseline of Global Health 
Status/Quality-of-Life (GHS/QoL) 
score using the European Organisation 
for Research and Treatment of Cancer 
(EORTC) Quality-of-Life 
Questionnaire Core 30 (QLQ-C30) and 
abdominal and gastrointestinal 
(abdominal/GI) symptoms using the 
EORTC Ovarian Cancer-Specific 
Quality-of-Life Questionnaire (QLQ-
OV28) abdominal/GI symptom scale
Change from baseline in:
•
EORTC QLQ-C30 GHS/QoL score
•
EORTC QLQ-OV28 abdominal/GI 
symptom scale
•
Objective: To compare time to 
deterioration (TTD) of GHS/QoL score 
using EORTC QLQ-C30 and 
abdominal/GI symptoms using 
EORTC QLQ-OV28
Time to deterioration in:
•
EORTC QLQ-C30 GHS/QoL score
•
EORTC QLQ-OV28 abdominal/GI 
symptom scale
•
Objective:  To compare the time to 
first subsequent anticancer treatment 
(TFST), the time to second subsequent 
anticancer treatment (TSST), and the 
time to discontinuation of study 
treatment or death (TDT)
•
TFST, the time from the date of 
randomization to initiation of first 
subsequent anticancer treatment or 
death due to any cause, whichever 
occurs first
•
TSST, the time from the date of 
randomization to initiation of second 
subsequent anticancer treatment or 
death due to any cause, whichever 
occurs first
•
TDT, the time from the date of 
randomization to discontinuation of 
study treatment or death due to any 
cause, whichever occurs first
•
Objective:  To compare the rate of 
locally determined pathological 
complete response (pCR) of 
pembrolizumab in combination with 
carboplatin/paclitaxel versus 
carboplatin/paclitaxel alone when 
administered as neoadjuvant therapy
•
pCR, all surgical specimens collected 
during the interval debulking surgery 
are microscopically negative for 
malignancy
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Overall Design:
Study Phase
Phase 3
Clinical Indication
First-line treatment of advanced EOC
Population
Participants with BRCA1/2 non-mutated advanced EOC
Study Type
Interventional
Type of Design
Multi-site, randomized, parallel, 3 arm
Type of Control
Placebo-control
Study Blinding
Double-blind
Estimated Duration of 
Study
The Sponsor estimates that the study will require 
approximately 7 years from the time the first participant 
provides documented informed consent until the last 
participant’s last study-related telephone call or visit. 
Number of Participants:
Approximately 1284 participants will be randomized.
Treatment Groups and Duration:
Treatment Groups
Following a Lead-in Period, during which all participants 
will receive a single cycle of carboplatin/paclitaxel*, 
participants will be randomly assigned in a 1:1:1 ratio to 
the following treatment arms:
Arm 1
Treatment: Carboplatin/paclitaxel* for 5 cycles plus 
pembrolizumab 200 mg every 3 weeks (Q3W) for up to 35 
infusions
Maintenance: Olaparib 300 mg (twice daily [BID])
Arm 2
Treatment: Carboplatin/paclitaxel* for 5 cycles plus 
pembrolizumab 200 mg Q3W for up to 35 infusions
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Maintenance: Olaparib placebo (BID)
Arm 3
Treatment: Carboplatin/paclitaxel* for 5 cycles plus 
pembrolizumab placebo Q3W for up to 35 infusions
Maintenance: Olaparib placebo (BID)
Crossover between treatment arms is not permitted.
*At the investigator’s discretion and determined prior to 
the participant being randomly assigned to study 
treatment, 1 of the following regimens may be selected:
•
Carboplatin area under the concentration-time curve 
(AUC)5 or AUC6 Q3W plus paclitaxel 175 mg/m2
Q3W
•
Carboplatin AUC5 or AUC6 Q3W plus paclitaxel 
80 mg/m2 every week (QW)
•
Carboplatin AUC2 or AUC2.7 QW plus paclitaxel 
60 mg/m2 QW
Docetaxel may be considered for participants who 
experience either a severe hypersensitivity reaction to 
paclitaxel or an AE requiring discontinuation of paclitaxel 
only after consultation with the Sponsor. The recommended 
dose, as determined by the SGCTG group [Vasey, P. A., et 
al 2004], is as follows:
•
Docetaxel 75 mg/m2 Q3W plus carboplatin AUC 5 
Q3W
Note: At the investigator’s discretion, bevacizumab may be 
used, but the investigator must decide on the use of 
bevacizumab prior to the participant being randomly 
assigned to study treatment. For participants eligible for 
interval debulking surgery, bevacizumab, if using, should 
be started with lead-in chemotherapy, stopped following 
Cycle 1 (prior to surgery), and resumed in Cycle 4 (after 
surgery). For participants eligible for primary debulking 
surgery, bevacizumab, if using, should be initiated in Cycle 
1. The investigator may wait to administer the first dose of 
bevacizumab, as long as it is administered by Cycle 4 (but 
it may be started sooner). Any delay in restarting/starting 
bevacizumab beyond what is defined in the protocol
requires Sponsor approval.
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Duration of 
Participation
Each participant will participate in the study from the time 
the participant signs the Informed Consent Form through 
the final protocol-specified contact.
After the Screening/Lead-in Period, each participant will 
be randomly assigned to receive study treatment until any 
of the following occur:
• Disease progression is radiographically documented per
RECIST 1.1 by the investigator, and when clinically 
appropriate, confirmed by the site per modified RECIST 
1.1 for immune-based therapeutics (iRECIST)
• Clinical progression without radiographic disease
progression defined by elevated CA-125 (based on GCIG 
criteria [see Appendix 9]) in conjunction with any of the 
following criteria for malignant bowel obstruction:

Any of the following: new or worsening abdominal 
pain, nausea, or vomiting

Abdominal distension, constipation, and/or diarrhea 

No evidence of metabolic or electrolyte 
abnormalities leading to impaired intestinal motility
Note: Symptoms must be assessed as not related to study 
treatment and/or concomitant medication AND other non-
malignant causes must be excluded by supplementary 
diagnostic measures
Note: Participants who discontinue study treatment due to 
clinical progression will have posttreatment follow-up 
imaging to evaluate disease status until disease 
progression is radiographically documented per 
RECIST 1.1 by the investigator 
• Initiation of a new anticancer treatment
• Unacceptable AEs
• Intercurrent illness that prevents further administration of 
study treatment
• Investigator’s decision to discontinue the participant
• The participant has received 35 infusions of either 
pembrolizumab or pembrolizumab placebo 
(approximately 2 years), the participant has received 
2 years of olaparib or olaparib placebo, or the participant 
has received the maximum duration of bevacizumab per 
the approved label or local practice
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Note: Only participants with no evidence of disease will 
stop treatment with olaparib or olaparib placebo following 
2 years of treatment. The total duration of treatment is 
calculated starting with the first dose of olaparib or 
olaparib placebo.
Additional discontinuation criteria are outlined in 
Section 7.1. After the end of study treatment, each 
participant will be followed for the occurrence of AEs and 
spontaneously reported pregnancy as described under 
Section 8.4.1.
Participants who discontinue for reasons other than 
radiographic disease progression will have posttreatment 
follow-up imaging to evaluate disease status until disease 
progression is radiographically documented per 
RECIST 1.1 by the investigator, and when clinically 
appropriate, confirmed by the site per iRECIST, initiating a 
new anticancer treatment, withdrawal of consent, becoming 
lost to follow-up, pregnancy, or death. All participants will 
be followed by telephone for OS until death, withdrawal of 
consent, or the end of the study.
Upon study completion, participants are to be discontinued,
and those who remain on study treatment upon study 
completion may be enrolled in an extension study to 
continue treatment as per the current study.
As of Amendment 05, all blood collections for ctDNA 
analysis and all PRO collections will be discontinued.
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Study Governance:
Study Governance 
Committees
Committee
Included in this study?
Steering Committee
Yes
Executive Oversight 
Committee
Yes
Data Monitoring Committee
Yes
Clinical Adjudication 
Committee
No
Study governance considerations are outlined in Appendix 1.
A list of abbreviations used in this document can be found in Appendix 8.
Schema
The study design is depicted in Figure 1. A schematic detailing the intervals for screening 
and debulking surgery for participants eligible for primary and interval debulking is 
presented in Figure 2 and Figure 3, respectively.
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Figure 2
Study Intervals for Participants Eligible for Primary Debulking
PDS=primary debulking surgery; W=week.
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Figure 3
Study Intervals for Participants Eligible for Interval Debulking
A) Screening/Lead-in
C1D1=Cycle 1, Day 1; C2D1=Cycle, 2 Day 1; C3D1=Cycle 3, Day 1; IDS=interval debulking surgery; W=week.
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B) Interval Debulking Surgery
C1D1=Cycle 1 Day 1; C2D1=Cycle 2 Day 1, C2D15=Cycle 2 Day 15; C3D1=Cycle 3 Day 1; QW=once weekly; Q3W=every 3 weeks.
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Schedule of Activities (SoA)
SoA – Adjuvant Treatment Period With Primary Debulking Followed by Maintenance
Primary Debulking Followed by Adjuvant Treatment and Maintenance
Study Period
Screening
+ Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screenb
Lead-
In
1
2
3
4
5
6
7+
DC
Safety 
FUc
Efficacy
FUd
Survival 
FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or
following lead-in chemotherapy. 
Maintenance is for participants 
without radiographic disease 
progression; participants must have 
SD, PR, CR, or non-PD.
Scheduling 
Window (Days):
–56 to 
start of 
lead-in
Start 
of lead-
in to –1
–3
±
3
±
3
± 3
± 3
±
3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W,
or 
Q24W
post DC 
(± 7)
Q12W 
(± 7)
Administrative Procedures
ICF
X
Consent must be obtained prior to 
performing any protocol-specific 
procedures. If the signature falls 
outside of the 56-day screening 
window, the participant does not need 
to be reconsented.
Participant must be reconsented prior 
to continuing study treatment after 
initial disease progression.
FBR ICF (optional)
X
Participants may participate in main 
study without signing FBR ICF.
Inclusion /Exclusion
Participant ID Card
X
X
Distribute at screening and add 
randomization number at C1D1.
Demographics and 
Medical History
X
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Primary Debulking Followed by Adjuvant Treatment and Maintenance
Study Period
Screening
+ Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screenb
Lead-
In
1
2
3
4
5
6
7+
DC
Safety 
FUc
Efficacy
FUd
Survival 
FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or
following lead-in chemotherapy. 
Maintenance is for participants 
without radiographic disease 
progression; participants must have 
SD, PR, CR, or non-PD.
Scheduling 
Window (Days):
–56 to 
start of 
lead-in
Start 
of lead-
in to –1
–3
±
3
±
3
± 3
± 3
±
3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W,
or 
Q24W
post DC 
(± 7)
Q12W 
(± 7)
Ovarian Cancer 
History
X
Assess and record presurgery tumor 
burden per imaging and postsurgery 
tumor burden per imaging and 
surgical report.
R0 and R1 will be determined based 
on the outcome of surgery; however, 
radiological findings at the baseline 
imaging (postsurgery) needs to be 
considered when defining R0.
History of Blood 
Transfusions
X
Include history of blood transfusion 
within previous 120 days from start of 
study intervention and the reasons, eg, 
bleeding or myelosuppression.
Prior/Concomitant 
Medication Review
X
X
X
X
X
X
X
X
X
X
Record medications taken within 
56 days prior to randomization. 
Concomitant medications will be 
recorded for 30 days after last dose 
(or for up to 90 days after last dose 
for SAEs).
Include blood transfusions during 
review of concomitant medications. 
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Primary Debulking Followed by Adjuvant Treatment and Maintenance
Study Period
Screening
+ Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screenb
Lead-
In
1
2
3
4
5
6
7+
DC
Safety 
FUc
Efficacy
FUd
Survival 
FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or
following lead-in chemotherapy. 
Maintenance is for participants 
without radiographic disease 
progression; participants must have 
SD, PR, CR, or non-PD.
Scheduling 
Window (Days):
–56 to 
start of 
lead-in
Start 
of lead-
in to –1
–3
±
3
±
3
± 3
± 3
±
3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W,
or 
Q24W
post DC 
(± 7)
Q12W 
(± 7)
Primary Debulking 
Surgery
X
Primary debulking surgery does not 
need to be performed within the 56-
day Screening Period. 
Surgery must occur up to 7 weeks 
(maximum) prior to the start of lead-
in chemotherapy.
Rationale for 
Carboplatin
X
Investigator must provide rationale 
for not choosing cisplatin prior to 
randomization.
Randomization
(using IRT)
X
Randomization via IRT may occur up 
to 3 days prior to C1D1. 
Subsequent 
Anticancer Therapy 
Review
X
X
X
X
Survival Status
X
Upon Sponsor request, participants 
may be contacted to assess survival 
status at any point during the study.
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Primary Debulking Followed by Adjuvant Treatment and Maintenance
Study Period
Screening
+ Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screenb
Lead-
In
1
2
3
4
5
6
7+
DC
Safety 
FUc
Efficacy
FUd
Survival 
FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or
following lead-in chemotherapy. 
Maintenance is for participants 
without radiographic disease 
progression; participants must have 
SD, PR, CR, or non-PD.
Scheduling 
Window (Days):
–56 to 
start of 
lead-in
Start 
of lead-
in to –1
–3
±
3
±
3
± 3
± 3
±
3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W,
or 
Q24W
post DC 
(± 7)
Q12W 
(± 7)
Study Treatment Administration
Lead-in Carboplatin
/ Paclitaxel
X
Lead-in chemotherapy should start 
when clinically appropriate but no 
longer than 7 weeks after primary 
debulking surgery.
Investigator’s choice of 3 regimens:
1)
Carboplatin AUC5 or AUC6 + 
paclitaxel 175 mg/m2 Q3W, or
2)
Carboplatin AUC5 or AUC6 
Q3W + paclitaxel 80 mg/m2
QW, or
3)
Carboplatin AUC2 or AUC2.7 
QW + paclitaxel 60 mg/m2 QW
Q3W dosing on Day 1 and QW 
dosing on Days 1, 8, and 15 of each 
cycle.
Docetaxel (75 mg/m2 Q3W) may be 
considered for participants who either 
experience a severe hypersensitivity
reaction or an AE that requires 
discontinuation of paclitaxel only 
after Sponsor consultation
08XTLZ

Product: MK-7339 
35
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Primary Debulking Followed by Adjuvant Treatment and Maintenance
Study Period
Screening
+ Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screenb
Lead-
In
1
2
3
4
5
6
7+
DC
Safety 
FUc
Efficacy
FUd
Survival 
FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or
following lead-in chemotherapy. 
Maintenance is for participants 
without radiographic disease 
progression; participants must have 
SD, PR, CR, or non-PD.
Scheduling 
Window (Days):
–56 to 
start of 
lead-in
Start 
of lead-
in to –1
–3
±
3
±
3
± 3
± 3
±
3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W,
or 
Q24W
post DC 
(± 7)
Q12W 
(± 7)
Carboplatin / 
Paclitaxel
X
X
X
X
X
Investigator’s choice of 3 regimens:
1)
Carboplatin AUC5 or AUC6 + 
paclitaxel 175 mg/m2 Q3W, or
2)
Carboplatin AUC5 or AUC6 
Q3W + paclitaxel 80 mg/m2
QW, or
3)
Carboplatin AUC2 or AUC2.7 
QW + paclitaxel 60 mg/m2 QW
Q3W dosing on Day 1 and QW 
dosing on Days 1, 8 and 15 of each 
cycle.
Day 1 of Cycle 1 must be at least 
20 days after the first dose of lead-in 
chemotherapy.
Docetaxel (75 mg/m2 Q3W) may be 
considered for participants who either 
experience a severe hypersensitivity
reaction or an AE that requires 
discontinuation of paclitaxel only 
after Sponsor consultation.
08XTLZ

Product: MK-7339 
36
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Primary Debulking Followed by Adjuvant Treatment and Maintenance
Study Period
Screening
+ Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screenb
Lead-
In
1
2
3
4
5
6
7+
DC
Safety 
FUc
Efficacy
FUd
Survival 
FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or
following lead-in chemotherapy. 
Maintenance is for participants 
without radiographic disease 
progression; participants must have 
SD, PR, CR, or non-PD.
Scheduling 
Window (Days):
–56 to 
start of 
lead-in
Start 
of lead-
in to –1
–3
±
3
±
3
± 3
± 3
±
3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W,
or 
Q24W
post DC 
(± 7)
Q12W 
(± 7)
Bevacizumab 
(optional)
X
X
X
X
X
X
X
Bevacizumab use must be selected in 
IRT prior to randomization.
Day 1 of Cycle 1 must be at least 
20 days after the first dose of lead-in 
chemotherapy.
The investigator may wait to 
administer the first dose of 
bevacizumab, as long as the first dose 
is administered by Cycle 4 (but it may 
be started as early as Cycle 1). 
Pembrolizumab / 
Placebo
X
X
X
X
X
X
X
200 mg Q3W / normal saline or 
dextrose Q3W. Participant may 
receive up to 35 infusions.
Day 1 of Cycle 1 must be at least 
20 days after the first dose of lead-in 
chemotherapy.
08XTLZ

Product: MK-7339 
37
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Primary Debulking Followed by Adjuvant Treatment and Maintenance
Study Period
Screening
+ Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screenb
Lead-
In
1
2
3
4
5
6
7+
DC
Safety 
FUc
Efficacy
FUd
Survival 
FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or
following lead-in chemotherapy. 
Maintenance is for participants 
without radiographic disease 
progression; participants must have 
SD, PR, CR, or non-PD.
Scheduling 
Window (Days):
–56 to 
start of 
lead-in
Start 
of lead-
in to –1
–3
±
3
±
3
± 3
± 3
±
3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W,
or 
Q24W
post DC 
(± 7)
Q12W 
(± 7)
Olaparib / Placebo
Xa
300 mg BID / placebo BID. 
Participants with no evidence of 
disease after 2 years of treatment with 
olaparib or olaparib placebo will stop 
olaparib or olaparib placebo at the 
next scheduled visit following 
radiographic assessment of CR or 
NED. 
Participants with continued evidence 
of disease after 2 years of treatment 
with olaparib or olaparib placebo and 
without evidence of disease 
progression may continue olaparib or 
olaparib placebo until any one of the 
discontinuation criteria is met.
Efficacy Procedures
Tumor Imaging
X
X
X
X
Refer to Section 1.3.3.
Bone imaging
X
X
X
X
Refer to Section 1.3.3.
Brain imaging
X
X
X
X
Refer to Section 1.3.3.
08XTLZ

Product: MK-7339 
38
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Primary Debulking Followed by Adjuvant Treatment and Maintenance
Study Period
Screening
+ Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screenb
Lead-
In
1
2
3
4
5
6
7+
DC
Safety 
FUc
Efficacy
FUd
Survival 
FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or
following lead-in chemotherapy. 
Maintenance is for participants 
without radiographic disease 
progression; participants must have 
SD, PR, CR, or non-PD.
Scheduling 
Window (Days):
–56 to 
start of 
lead-in
Start 
of lead-
in to –1
–3
±
3
±
3
± 3
± 3
±
3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W,
or 
Q24W
post DC 
(± 7)
Q12W 
(± 7)
Safety Procedures (during treatment visits safety assessments and procedures must be done prior to treatment administration)e
AE Monitoring
X
X
X
X
X
X
X
X
X
X
Report all AEs through 30 days 
following last dose of study treatment. 
Report SAEs through 90 days 
following last dose of study treatment
(or 30 days following last dose if 
participant initiates new anticancer
therapy, whichever is earlier).
Complete PE
X
X
Directed PE
X
X
X
X
X
X
X
X
X
Perform as clinically indicated.
Weight
X
X
X
X
X
X
X
X
X
X
Perform within 7 days prior to starting 
lead-in chemotherapy.
Vital Signs
X
X
X
X
X
X
X
X
X
X
Assess BP, heart rate, RR, 
temperature. Height only assessed 
once prior to starting lead-in 
chemotherapy.
Perform within 7 days prior to starting 
lead-in chemotherapy.
12-lead ECG
X
X
Additional ECGs may be performed 
as clinically indicated.
Perform within 7 days prior to starting 
lead-in chemotherapy.
08XTLZ

Product: MK-7339 
39
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Primary Debulking Followed by Adjuvant Treatment and Maintenance
Study Period
Screening
+ Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screenb
Lead-
In
1
2
3
4
5
6
7+
DC
Safety 
FUc
Efficacy
FUd
Survival 
FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or
following lead-in chemotherapy. 
Maintenance is for participants 
without radiographic disease 
progression; participants must have 
SD, PR, CR, or non-PD.
Scheduling 
Window (Days):
–56 to 
start of 
lead-in
Start 
of lead-
in to –1
–3
±
3
±
3
± 3
± 3
±
3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W,
or 
Q24W
post DC 
(± 7)
Q12W 
(± 7)
PT or INR and 
aPTT/PTT
X
Perform within 7 days prior to starting
lead-in chemotherapy.
PT or INR and aPTT/PTT should be 
monitored more closely in 
participants receiving anticoagulant 
therapy during treatment and Safety 
Follow-up Period. 
Chemistry
X
X
X
X
X
X
X
X
X
X
Perform within 7 days prior to starting 
lead-in chemotherapy and again 
within 3 days prior to C1D1
treatment.
Hematology
X
X
X
X
X
X
X
X
X
X
Perform within 7 days prior to starting 
lead-in chemotherapy and again 
within 3 days prior to C1D1
treatment.
Urinalysis (dipstick
or laboratory 
analysis)
X
X
X
X
X
X
Perform within 7 days prior to starting
lead-in chemotherapy and again 
within 3 days prior to C1D1
treatment.
Continue to perform urinalysis testing 
every 4 cycles starting with Cycle 4
(ie, Cycles 8, 12, 16 etc).
08XTLZ

Product: MK-7339 
40
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Primary Debulking Followed by Adjuvant Treatment and Maintenance
Study Period
Screening
+ Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screenb
Lead-
In
1
2
3
4
5
6
7+
DC
Safety 
FUc
Efficacy
FUd
Survival 
FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or
following lead-in chemotherapy. 
Maintenance is for participants 
without radiographic disease 
progression; participants must have 
SD, PR, CR, or non-PD.
Scheduling 
Window (Days):
–56 to 
start of 
lead-in
Start 
of lead-
in to –1
–3
±
3
±
3
± 3
± 3
±
3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W,
or 
Q24W
post DC 
(± 7)
Q12W 
(± 7)
Urinalysis (dipstick
or laboratory 
analysis) –
Participants 
Receiving 
Bevacizumab
X
X
X
X
X
X
X
X
X
X
Perform within 7 days prior to starting 
lead-in chemotherapy.
Participants receiving bevacizumab 
require urinalysis at every dosing 
cycle while receiving bevacizumab.
T3 or FT3 / FT4 / 
TSH
X
X
X
X
X
X
X
Perform within 7 days prior to starting 
lead-in chemotherapy. 
Perform every other cycle (C2, C4, 
C6, C8, etc).
Cortisol Levels
X
Perform within 7 days prior to starting 
lead-in chemotherapy.
CA-125
X
X
X
Perform within 7 days prior to starting 
lead-in chemotherapy.
Sample to be collected at the time of 
each tumor imaging assessment
(±14 days of scheduled imaging 
assessment) (Section 1.3.3). An 
optional sample may be collected at 
the time of unscheduled imaging at 
the investigator’s discretion.
All CA-125 testing will be performed 
locally.
08XTLZ

Product: MK-7339 
41
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Primary Debulking Followed by Adjuvant Treatment and Maintenance
Study Period
Screening
+ Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screenb
Lead-
In
1
2
3
4
5
6
7+
DC
Safety 
FUc
Efficacy
FUd
Survival 
FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or
following lead-in chemotherapy. 
Maintenance is for participants 
without radiographic disease 
progression; participants must have 
SD, PR, CR, or non-PD.
Scheduling 
Window (Days):
–56 to 
start of 
lead-in
Start 
of lead-
in to –1
–3
±
3
±
3
± 3
± 3
±
3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W,
or 
Q24W
post DC 
(± 7)
Q12W 
(± 7)
Urine or serum 
pregnancy test -
WOCBP only
X
X
X
X
X
X
X
Xa
X
X
WOCBP require a negative pregnancy 
test within either 24 hours (urine) or 
72 hours (serum) prior to starting 
lead-in chemotherapy and again 
within either 24 hours (urine) or 
72 hours (serum) prior to C1D1 
treatment as outlined in Appendix 3.
A pregnancy test must be performed
at the cycle the participant enters 
maintenance and then test at each 
cycle that olaparib/olaparib placebo is 
administered.
More frequent pregnancy testing may 
be performed if required by local 
regulations or if clinically indicated.
Refer to Appendix 7 for country-
specific requirements.
Serum Follicle-
Stimulating 
Hormone (FSH) -
WOCBP only
Only to be determined once for 
women <45 years old with no menses 
for ≥1 year (12 months) prior to 
screening and not currently on HRT 
or hormonal contraception.
08XTLZ

Product: MK-7339 
42
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Primary Debulking Followed by Adjuvant Treatment and Maintenance
Study Period
Screening
+ Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screenb
Lead-
In
1
2
3
4
5
6
7+
DC
Safety 
FUc
Efficacy
FUd
Survival 
FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or
following lead-in chemotherapy. 
Maintenance is for participants 
without radiographic disease 
progression; participants must have 
SD, PR, CR, or non-PD.
Scheduling 
Window (Days):
–56 to 
start of 
lead-in
Start 
of lead-
in to –1
–3
±
3
±
3
± 3
± 3
±
3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W,
or 
Q24W
post DC 
(± 7)
Q12W 
(± 7)
HIV / HBV / HCV
Testing is only required once at 
screening if mandated by local health 
authority.
Refer to Appendix 7 for country-
specific requirements.
ECOG Performance 
Status
X
X
X
X
X
X
X
X
X
Perform within 7 days prior to starting 
lead-in chemotherapy and again 
within 3 days prior to C1D1 
treatment.
As of Amendment 05, all PRO
collections will be discontinued. 
Original protocol text in this section 
has been retained for historical 
perspective.
Administer PROs on Day 1 of the 
following cycles:
C1, C2, C3, C4, every 3 cycles 
through C16 (C7, C10, C13, C16), 
and every 4 cycles thereafter in the 
second year (C20, C24, C28, C32, 
C36) for as long as participant is 
receiving study treatment.
CCI
CCI
08XTLZ

Product: MK-7339 
43
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Primary Debulking Followed by Adjuvant Treatment and Maintenance
Study Period
Screening
+ Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screenb
Lead-
In
1
2
3
4
5
6
7+
DC
Safety 
FUc
Efficacy
FUd
Survival 
FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or
following lead-in chemotherapy. 
Maintenance is for participants 
without radiographic disease 
progression; participants must have 
SD, PR, CR, or non-PD.
Scheduling 
Window (Days):
–56 to 
start of 
lead-in
Start 
of lead-
in to –1
–3
±
3
±
3
± 3
± 3
±
3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W,
or 
Q24W
post DC 
(± 7)
Q12W 
(± 7)
Biomarker Sample Collection
Biomarker samples may be 
collected up to 3 days prior to 
C1D1.
Blood for Genetic 
Analysis 
X
Collect prior to administration of 
study treatment. Refer to Section 8.9 
for additional collection information.
Blood for Plasma 
Biomarker Analysis
X
X
X
X
X
Collect prior to administration of 
study treatment.
A sample needs to be collected at the 
cycle the participants enters 
maintenance (C7 or earlier); no 
additional on-treatment samples are 
required following this collection.
Blood for Serum 
Biomarker Analysis
X
X
X
X
X
Collect prior to administration of 
study treatment.
A sample needs to be collected at the 
cycle the participants enters 
maintenance (C7 or earlier); no 
additional on-treatment samples are 
required following this collection.
08XTLZ

Product: MK-7339 
44
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Primary Debulking Followed by Adjuvant Treatment and Maintenance
Study Period
Screening
+ Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screenb
Lead-
In
1
2
3
4
5
6
7+
DC
Safety 
FUc
Efficacy
FUd
Survival 
FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or
following lead-in chemotherapy. 
Maintenance is for participants 
without radiographic disease 
progression; participants must have 
SD, PR, CR, or non-PD.
Scheduling 
Window (Days):
–56 to 
start of 
lead-in
Start 
of lead-
in to –1
–3
±
3
±
3
± 3
± 3
±
3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W,
or 
Q24W
post DC 
(± 7)
Q12W 
(± 7)
Blood for RNA 
Analysis
X
X
X
X
X
Collect prior to administration of 
study treatment.
A sample needs to be collected at the 
cycle the participants enters 
maintenance (C7 or earlier); no 
additional on-treatment samples are 
required following this collection.
Blood for ctDNA
Analysis
X
X
X
X
X
X
As of Amendment 05, all blood 
collections for ctDNA will be 
discontinued. Original protocol text 
in this section has been retained for 
historical perspective.
Collect prior to administration of 
study treatment.
A sample needs to be collected at the 
cycle the participants enters 
maintenance (C7 or earlier); during 
maintenance, a sample to be collected 
every second regularly scheduled 
imaging assessment (±14 days). A 
sample may be collected at the time 
of unscheduled imaging (±14 days) at 
the investigator’s discretion. Refer to 
imaging timing outlined in Section 
1.3.3.
08XTLZ

Product: MK-7339 
45
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Primary Debulking Followed by Adjuvant Treatment and Maintenance
Study Period
Screening
+ Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screenb
Lead-
In
1
2
3
4
5
6
7+
DC
Safety 
FUc
Efficacy
FUd
Survival 
FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or
following lead-in chemotherapy. 
Maintenance is for participants 
without radiographic disease 
progression; participants must have 
SD, PR, CR, or non-PD.
Scheduling 
Window (Days):
–56 to 
start of 
lead-in
Start 
of lead-
in to –1
–3
±
3
±
3
± 3
± 3
±
3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W,
or 
Q24W
post DC 
(± 7)
Q12W 
(± 7)
PD-L1 Status
X
Required for stratification; results 
must be available prior to 
randomization.
Sponsor consultation is required to 
delay randomization if the results are 
not available at the planned time of 
randomization.
BRCA1/2 Status
X
Required for stratification; results 
must be available prior to 
randomization and must be BRCA1/2
non-mutated.
Sponsor consultation is required to 
delay randomization if the results are 
not available at the planned time of 
randomization.
Submission of 
Newly obtained 
Tissue Collection 
X
Newly obtained tissue must be 
obtained prior to the administration of 
systemic cytotoxic treatment for the 
treatment of current ovarian cancer. If 
a diagnostic biopsy is performed prior 
to surgery and submitted, the biopsy 
should not be collected more than 8
weeks prior to primary debulking 
surgery.
08XTLZ

Product: MK-7339 
46
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Primary Debulking Followed by Adjuvant Treatment and Maintenance
Study Period
Screening
+ Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screenb
Lead-
In
1
2
3
4
5
6
7+
DC
Safety 
FUc
Efficacy
FUd
Survival 
FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or
following lead-in chemotherapy. 
Maintenance is for participants 
without radiographic disease 
progression; participants must have 
SD, PR, CR, or non-PD.
Scheduling 
Window (Days):
–56 to 
start of 
lead-in
Start 
of lead-
in to –1
–3
±
3
±
3
± 3
± 3
±
3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W,
or 
Q24W
post DC 
(± 7)
Q12W 
(± 7)
Tumor Biopsy
X
A core or excisional biopsy to be 
collected from visual tumor upon 
confirmed PD, if possible.
AE=adverse event; aPTT=activated partial thromboplastin time; AUC=area under the concentration-time curve; BICR=blinded independent central review; BID=twice daily; 
BRCA1/2=breast cancer susceptibility gene 1/2; C1D1=Cycle 1, Day 1; C5D1=Cycle 5, Day 1; C7=Cycle 7; CA-125=cancer antigen-125; CR=complete response; 
ctDNA=circulating tumor DNA; DBP=diastolic blood pressure; DC=discontinuation; ECG=electrocardiogram; ECOG=Eastern Cooperative Cancer Group
FT3=free triiodothyronine; FT4=free thyroxine; HBV=hepatitis B virus; HCV=hepatitis C virus; HIV=human immunodeficiency virus; 
HRT=hormone replacement therapy; ICF=informed consent form; ID=identification; INR=International Normalized Ratio; iRECIST=modified Response Evaluation 
Criteria in Solid Tumors 1.1 for immune-based therapeutics; IRT=interactive response technology; NED=no evidence of disease; pCR=pathological complete response; 
PD=progressive disease; PD-L1=programmed cell death ligand 1; PR=partial response; PRO=patient-reported outcome; PT=prothrombin time; PTT=partial thromboplastin 
time; Q3W=every 3 weeks; Q9W=every 9 weeks; Q12W=every 12 weeks; Q24W=every 24 weeks; QW=once weekly; RECIST=Response Evaluation Criteria in Solid 
Tumors; RR=respiratory rate; SBP=systolic blood pressure; SD=stable disease; SOC=standard of care; T3=triiodothyronine; TSH=thyroid-stimulating hormone; 
WOCBP=women of childbearing potential.
a.
Following consultation with the Sponsor, participants who are unable to complete 6 treatment cycles (including lead-in) of chemotherapy due to toxicity, may be eligible to 
start the Maintenance Period earlier.
b.
All screening procedures should be performed prior to starting lead-in chemotherapy unless otherwise noted. The Lead-in Period occurs within the 56-day window. The
optional recovery period, if needed, should not exceed 7 days between cycles (weekly chemotherapy regimen) or at the end of lead-in chemotherapy. Randomization should 
occur within 7 days of completing lead-in chemotherapy; a delay of an additional 2 weeks (up to 3 weeks total) may be granted upon consultation with the Sponsor.
c.
If the DC visit occurs ≥30 days from last dose of study treatment, a Safety Follow-up Visit is not required.
d.
For participants who DC for reasons other than radiographic PD, imaging continues until radiographically documented PD by the investigator (and, when clinically 
appropriate, confirmed by iRECIST), initiation of a new anticancer treatment, withdrawal of consent, becoming lost to follow-up, pregnancy, or death, whichever occurs 
first. Efficacy follow-up visits may be scheduled to coincide with follow-up imaging. Refer to Section 1.3.3 for the imaging schedule during the treatment and 
posttreatment Efficacy Follow-up Period.
e.
All procedures and laboratory testing should be conducted on the day of, or within the specified window, but prior to dosing. Laboratory results must be assessed by a 
qualified investigator prior to dosing; thyroid function testing is an exception as outlined in Appendix 5.
CCI
CCI
CCI
08XTLZ

Product: MK-7339 
47
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
SoA – Neoadjuvant/Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Neoadjuvant / Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Study Period
Screening
+Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Surviva
l FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is for participants 
without radiographic disease 
progression; participants must 
have SD, PR or CR, or non-PD.
Scheduling 
Window (Days):
-56 to 
start of 
lead-in
Start 
of 
lead-
in
to -1
-3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)
Q12W 
(± 7)
Administrative Procedures
ICF
X
Consent must be obtained prior to 
performing any protocol-specific 
procedures. If the signature falls 
outside of the 56-day screening 
window, the participant does not 
need to be reconsented.
Participant must be reconsented prior 
to continuing study treatment after 
initial disease progression.
FBR ICF 
(optional)
X
Participants may participate in main 
study without signing FBR ICF.
Inclusion 
/Exclusion
Participant ID 
Card
X
X
Distribute at screening and add 
randomization number at C1D1.
Demographics and 
Medical History
X
Ovarian Cancer 
History
X
Assess and record tumor burden per 
imaging.
08XTLZ

Product: MK-7339 
48
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Neoadjuvant / Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Study Period
Screening
+Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Surviva
l FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is for participants 
without radiographic disease 
progression; participants must 
have SD, PR or CR, or non-PD.
Scheduling 
Window (Days):
-56 to 
start of 
lead-in
Start 
of 
lead-
in
to -1
-3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)
Q12W 
(± 7)
History of Blood 
Transfusion
X
Include history of blood transfusion 
within previous 120 days from start 
of study intervention and the reasons, 
eg, bleeding or myelosuppression.
Prior/Concomitant 
Medication 
Review
X
X
X
X
X
X
X
X
X
X
X
Record medications taken within 
56 days prior to randomization. 
Concomitant medications will be 
recorded for 30 days after last dose 
(or for up to 90 days after last dose 
for SAEs).
Include blood transfusions during 
review of concomitant medications. 
Interval Debulking 
Surgery (if 
indicated)
X
Surgery should occur:
Between 3 to 6 weeks following 
C2D1 for participants on Q3W 
chemotherapy regimen; or 
Between 1 to 4 weeks following 
C2D15 for participants on QW 
chemotherapy regimen.
The last dose of pembrolizumab/ 
pembrolizumab placebo should be 
administered at least 3 weeks before 
surgery. Study treatment may resume 
when clinically appropriate but no 
later than 7 weeks following surgery.
08XTLZ

Product: MK-7339 
49
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Neoadjuvant / Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Study Period
Screening
+Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Surviva
l FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is for participants 
without radiographic disease 
progression; participants must 
have SD, PR or CR, or non-PD.
Scheduling 
Window (Days):
-56 to 
start of 
lead-in
Start 
of 
lead-
in
to -1
-3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)
Q12W 
(± 7)
Rationale for 
Carboplatin
X
Investigator must provide rationale 
for not choosing cisplatin prior to 
randomization.
Randomization
(using IRT)
X
Randomization via IRT may occur 
up to 3 days prior to C1D1. 
Subsequent 
Anticancer
Therapy Review
X
X
X
X
Survival Status
X
Upon Sponsor request, participants 
may be contacted to assess survival 
status at any point during the study.
08XTLZ

Product: MK-7339 
50
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Neoadjuvant / Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Study Period
Screening
+Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Surviva
l FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is for participants 
without radiographic disease 
progression; participants must 
have SD, PR or CR, or non-PD.
Scheduling 
Window (Days):
-56 to 
start of 
lead-in
Start 
of 
lead-
in
to -1
-3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)
Q12W 
(± 7)
Study Treatment Administration
Lead-in 
Carboplatin/ 
Paclitaxel
X
Investigator’s choice of 3 regimens:
1)
Carboplatin AUC5 or AUC6 + 
paclitaxel 175 mg/m2 Q3W, or
2)
Carboplatin AUC5 or AUC6   
Q3W + paclitaxel 80 mg/m2
QW, or
3)
Carboplatin AUC2 or AUC2.7 
QW + paclitaxel 60 mg/m2 QW
Q3W dosing on Day 1 and QW 
dosing on Days 1, 8 and 15 of each 
cycle.
Docetaxel (75 mg/m2 Q3W) may be 
considered for participants who 
either experience a severe 
hypersensitivity reaction or an AE 
that requires discontinuation of 
paclitaxel only after Sponsor 
consultation.
08XTLZ

Product: MK-7339 
51
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Neoadjuvant / Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Study Period
Screening
+Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Surviva
l FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is for participants 
without radiographic disease 
progression; participants must 
have SD, PR or CR, or non-PD.
Scheduling 
Window (Days):
-56 to 
start of 
lead-in
Start 
of 
lead-
in
to -1
-3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)
Q12W 
(± 7)
Carboplatin / 
Paclitaxel
X
X
X
X
X
Investigator’s choice of 3 regimens:
1)
Carboplatin AUC5 or AUC6  + 
paclitaxel 175 mg/m2 Q3W, or
2)
Carboplatin AUC5 or AUC6   
Q3W + paclitaxel 80 mg/m2
QW, or
3)
Carboplatin AUC2 or AUC2.7 
QW + paclitaxel 60 mg/m2 QW
Q3W dosing on Day 1 and QW 
dosing on Days 1, 8 and 15 of each 
cycle.
Day 1 of Cycle 1 must be at least 
20 days after the first dose of lead-in 
chemotherapy.
Docetaxel (75 mg/m2 Q3W) may be 
considered for participants who 
either experience a severe 
hypersensitivity reaction or an AE 
that requires discontinuation of 
paclitaxel only after Sponsor 
consultation.
08XTLZ

Product: MK-7339 
52
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Neoadjuvant / Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Study Period
Screening
+Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Surviva
l FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is for participants 
without radiographic disease 
progression; participants must 
have SD, PR or CR, or non-PD.
Scheduling 
Window (Days):
-56 to 
start of 
lead-in
Start 
of 
lead-
in
to -1
-3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)
Q12W 
(± 7)
Bevacizumab 
(optional)
X
X
X
X
X
X
Bevacizumab use must be selected in 
IRT prior to randomization.
Day 1 of Cycle 1 must be at least 
20 days after the first dose of lead-in 
chemotherapy.
The investigator may wait to 
administer the first dose of 
bevacizumab, as long as the first 
dose is administered by Cycle 4 (but 
it may be started with lead-in).
Pembrolizumab / 
Placebo
X
X
X
X
X
X
X
200 mg Q3W / normal saline or 
dextrose Q3W. Participant may 
receive up to 35 infusions.
Day 1 of Cycle 1 must be at least 
20 days after the first dose of lead-in 
chemotherapy.
08XTLZ

Product: MK-7339 
53
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Neoadjuvant / Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Study Period
Screening
+Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Surviva
l FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is for participants 
without radiographic disease 
progression; participants must 
have SD, PR or CR, or non-PD.
Scheduling 
Window (Days):
-56 to 
start of 
lead-in
Start 
of 
lead-
in
to -1
-3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)
Q12W 
(± 7)
Olaparib / Placebo
Xa
300 mg BID / placebo BID. 
Participants with no evidence of 
disease after 2 years of treatment 
with olaparib or olaparib placebo will 
stop olaparib or olaparib placebo at 
the next scheduled visit following 
radiographic assessment of CR or 
NED.
Participants with continued evidence 
of disease after 2 years of treatment 
with olaparib or olaparib placebo and 
without evidence of disease 
progression may continue olaparib or 
olaparib placebo until any one of the 
discontinuation criteria is met.
Efficacy Procedures
Pathological 
Tumor Assessment
X
Detailed pathological assessment of 
all tumor tissue collected during 
interval debulking for determination 
of pCR.
Tumor Imaging
X
X
X
X
Refer to Sections 1.3.4 and 1.3.5
Bone imaging
X
X
X
X
Refer to Sections 1.3.4 and 1.3.5
Brain Imaging
X
X
X
X
Refer to Sections 1.3.4 and 1.3.5
08XTLZ

Product: MK-7339 
54
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Neoadjuvant / Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Study Period
Screening
+Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Surviva
l FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is for participants 
without radiographic disease 
progression; participants must 
have SD, PR or CR, or non-PD.
Scheduling 
Window (Days):
-56 to 
start of 
lead-in
Start 
of 
lead-
in
to -1
-3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)
Q12W 
(± 7)
Safety Procedures (during treatment visits safety assessments and procedures must be done prior to treatment administration)e
AE Monitoring
X
X
X
X
X
X
X
X
X
X
X
Report all AEs through 30 days 
following last dose of study 
treatment. Report SAEs through 
90 days following last dose of study 
treatment (or 30 days following last 
dose if participant initiates new 
anticancer therapy, whichever is 
earlier).
Complete PE
X
X
Directed PE
X
X
X
X
X
X
X
X
X
Perform as clinically indicated.
Weight
X
X
X
X
X
X
X
X
X
X
Perform within 7 days prior to
starting lead-in chemotherapy.
Vital Signs
X
X
X
X
X
X
X
X
X
X
Assess BP, heart rate, RR, 
temperature. Height only assessed 
once prior to starting lead-in 
chemotherapy.
Perform within 7 days prior to 
starting lead-in chemotherapy.
12-lead ECG
X
X
Additional ECGs may be performed 
as clinically indicated.
Perform within 7 days prior to 
starting lead-in chemotherapy.
08XTLZ

Product: MK-7339 
55
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Neoadjuvant / Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Study Period
Screening
+Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Surviva
l FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is for participants 
without radiographic disease 
progression; participants must 
have SD, PR or CR, or non-PD.
Scheduling 
Window (Days):
-56 to 
start of 
lead-in
Start 
of 
lead-
in
to -1
-3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)
Q12W 
(± 7)
PT or INR and 
aPTT/PTT
X
Perform within 7 days prior to 
starting lead-in chemotherapy.
PT or INR and aPTT/PTT should be 
monitored more closely in 
participants receiving anticoagulant 
therapy during treatment and Safety 
Follow-up Period.
Chemistry
X
X
X
X
X
X
X
X
X
X
Perform within 7 days prior to 
starting lead-in chemotherapy and 
again within 3 days prior to C1D1
treatment.
Hematology
X
X
X
X
X
X
X
X
X
X
Perform within 7 days prior to 
starting lead-in chemotherapy and 
again within 3 days prior to C1D1
treatment.
Urinalysis
(dipstick or 
laboratory 
analysis)
X
X
X
X
X
X
Perform within 7 days prior to 
starting lead-in chemotherapy and 
again within 3 days prior to C1D1
treatment.
Continue to perform urinalysis 
testing every 4 cycles starting with 
Cycle 4 (ie, Cycles 8, 12, 16 etc).
08XTLZ

Product: MK-7339 
56
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Neoadjuvant / Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Study Period
Screening
+Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Surviva
l FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is for participants 
without radiographic disease 
progression; participants must 
have SD, PR or CR, or non-PD.
Scheduling 
Window (Days):
-56 to 
start of 
lead-in
Start 
of 
lead-
in
to -1
-3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)
Q12W 
(± 7)
Urinalysis 
(dipstick or 
laboratory 
analysis) –
Participants 
Receiving 
Bevacizumab
X
X
X
X
X
X
X
X
Perform within 7 days prior to 
starting lead-in chemotherapy.
Participants receiving bevacizumab 
require urinalysis at every dosing 
cycle while receiving bevacizumab.
T3 or free T3 / 
FT4 / TSH
X
X
X
X
X
X
X
Perform within 7 days prior to 
starting lead-in chemotherapy. 
Perform at every other cycle (C2, C4, 
C6, C8, etc).
Cortisol Levels
X
X
X
X
Perform within 7 days prior to 
starting lead-in chemotherapy.
Perform within 7 days prior to 
surgery and within 7 days prior to 
administration of study treatment for 
the 2 treatment cycles following 
surgery.
08XTLZ

Product: MK-7339 
57
Protocol/Amendment No.:  001-05/ENGOT-ov43/GOG-3036
MK-7339-001-05/ENGOT-ov43/GOG-3036 Final Protocol
19-Aug-2025
Confidential
Neoadjuvant / Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Study Period
Screening
+Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Surviva
l FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is for participants 
without radiographic disease 
progression; participants must 
have SD, PR or CR, or non-PD.
Scheduling 
Window (Days):
-56 to 
start of 
lead-in
Start 
of 
lead-
in
to -1
-3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)
Q12W 
(± 7)
CA-125
X
X
X
Perform within 7 days prior to 
starting lead-in chemotherapy. 
Sample to be collected at the time of 
each tumor imaging assessment 
(±14 days of scheduled imaging 
assessment) (Section 1.3.4 and 
1.3.5). An optional sample may be 
collected at the time of unscheduled 
imaging at the investigator’s 
discretion.
All CA-125 testing will be performed 
locally.
CEA
X
Perform within 7 days prior to 
starting lead-in chemotherapy.
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Neoadjuvant / Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Study Period
Screening
+Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Surviva
l FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is for participants 
without radiographic disease 
progression; participants must 
have SD, PR or CR, or non-PD.
Scheduling 
Window (Days):
-56 to 
start of 
lead-in
Start 
of 
lead-
in
to -1
-3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)
Q12W 
(± 7)
Urine or serum 
pregnancy test -
WOCBP only
X
X
X
X
X
X
X
Xa
X
X
WOCBP require a negative 
pregnancy test within either 24 hours 
(urine) or 72 hours (serum) prior to 
starting lead-in chemotherapy and 
again within either 24 hours (urine) 
or 72 hours (serum) prior to C1D1 
treatment as outlined in Appendix 3.
A pregnancy test must be performed 
at the cycle the participant enters 
maintenance and test at each cycle
that olaparib/olaparib placebo is 
administered.
More frequent pregnancy testing may 
be performed if required by local 
regulations or if clinically indicated.
Refer to Appendix 7 for country-
specific requirements.
Serum Follicle-
Stimulating 
Hormone (FSH) -
WOCBP only
Only to be determined once for 
women <45 years old with no 
menses for ≥1 year (12 months) prior 
to screening and not currently on 
HRT or hormonal contraception.
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Confidential
Neoadjuvant / Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Study Period
Screening
+Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Surviva
l FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is for participants 
without radiographic disease 
progression; participants must 
have SD, PR or CR, or non-PD.
Scheduling 
Window (Days):
-56 to 
start of 
lead-in
Start 
of 
lead-
in
to -1
-3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)
Q12W 
(± 7)
HIV / HBV / HCV
Testing is only required once at 
screening if mandated by local health 
authority.
Refer to Appendix 7 for country-
specific requirements.
ECOG 
Performance 
Status
X
X
X
X
X
X
X
X
X
Perform within 7 days prior to 
starting lead-in chemotherapy and 
again within 3 days prior to C1D1 
treatment.
As of Amendment 05, all PRO
collections will be discontinued.
Original protocol text in this 
section has been retained for
historical perspective.
Administer PROs on Day 1 of the 
following cycles:
C1, C2, C3, C4, every 3 cycles 
through C16 (C7, C10, C13, C16), 
and every 4 cycles thereafter in the 
second year (C20, C24, C28, C32, 
C36) for as long as participant is 
receiving study treatment.
CCI
CCI
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Confidential
Neoadjuvant / Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Study Period
Screening
+Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Surviva
l FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is for participants 
without radiographic disease 
progression; participants must 
have SD, PR or CR, or non-PD.
Scheduling 
Window (Days):
-56 to 
start of 
lead-in
Start 
of 
lead-
in
to -1
-3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)
Q12W 
(± 7)
Biomarker Sample Collection
Biomarker samples may be 
collected up to 3 days prior to 
C1D1.
Blood for Genetic 
Analysis 
X
Collect prior to administration of 
study treatment. Refer to Section 8.9 
for additional collection information.
Blood for Plasma 
Biomarker 
Analysis
X
X
X
X
X
Collect prior to administration of 
study treatment.
A sample needs to be collected at the 
cycle the participants enters 
maintenance (C7 or earlier); no 
additional on-treatment samples are 
required following this collection.
Blood for Serum 
Biomarker 
Analysis
X
X
X
X
X
Collect prior to administration of 
study treatment.
A sample needs to be collected at the 
cycle the participants enters 
maintenance (C7 or earlier); no 
additional on-treatment samples are 
required following this collection.
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Confidential
Neoadjuvant / Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Study Period
Screening
+Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Surviva
l FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is for participants 
without radiographic disease 
progression; participants must 
have SD, PR or CR, or non-PD.
Scheduling 
Window (Days):
-56 to 
start of 
lead-in
Start 
of 
lead-
in
to -1
-3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)
Q12W 
(± 7)
Blood for RNA 
Analysis
X
X
X
X
X
Collect prior to administration of 
study treatment.
A sample needs to be collected at the 
cycle the participants enters 
maintenance (C7 or earlier); no 
additional on-treatment samples are 
required following this collection.
Blood for ctDNA
Analysis
X
X
X
X
X
X
As of Amendment 05, all blood 
collections for ctDNA will be 
discontinued. Original protocol 
text in this section has been 
retained for historical perspective.
Collect prior to administration of 
study treatment.
A sample needs to be collected at the 
cycle the participants enters 
maintenance (C7 or earlier); during 
maintenance, a sample to be 
collected every second regularly 
scheduled imaging assessment
(±14 days). A sample may be 
collected at the time of unscheduled 
imaging (±14 days) at the 
investigator’s discretion. Refer to 
imaging timing outlined in Sections 
1.3.4 and 1.3.5.
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Confidential
Neoadjuvant / Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Study Period
Screening
+Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Surviva
l FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is for participants 
without radiographic disease 
progression; participants must 
have SD, PR or CR, or non-PD.
Scheduling 
Window (Days):
-56 to 
start of 
lead-in
Start 
of 
lead-
in
to -1
-3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)
Q12W 
(± 7)
PD-L1 Status
X
Required for stratification; results 
must be available prior to 
randomization.
Sponsor consultation is required to 
delay randomization if the results are 
not available at the planned time of 
randomization.
BRCA1/2 Status
X
Required for stratification; results 
must be available prior to 
randomization and must be BRCA1/2
non-mutated.
Sponsor consultation is required to 
delay randomization if the results are 
not available at the planned time of 
randomization.
Submission of 
Newly obtained 
Tissue Collection
X
Newly obtained tissue must be 
obtained within 8 weeks prior to the 
administration of systemic cytotoxic 
treatment for the treatment of current 
ovarian cancer.
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Confidential
Neoadjuvant / Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Study Period
Screening
+Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Surviva
l FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is for participants 
without radiographic disease 
progression; participants must 
have SD, PR or CR, or non-PD.
Scheduling 
Window (Days):
-56 to 
start of 
lead-in
Start 
of 
lead-
in
to -1
-3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)
Q12W 
(± 7)
Tumor Biopsy
X
X
If possible, a core or excisional 
biopsy should be obtained at the 
following time points and submitted 
to the central lab:
1) Tumor tissue removed during 
interval debulking 
2) If participant is unable to 
undergo interval debulking
3) Visual tumor upon confirmed 
PD
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Confidential
Neoadjuvant / Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Study Period
Screening
+Lead-in
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Surviva
l FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is for participants 
without radiographic disease 
progression; participants must 
have SD, PR or CR, or non-PD.
Scheduling 
Window (Days):
-56 to 
start of 
lead-in
Start 
of 
lead-
in
to -1
-3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)
Q12W 
(± 7)
AE=adverse event; aPTT=activated partial thromboplastin time; AUC=area under the concentration-time curve; BICR=blinded independent central review; BID=twice daily; 
BRCA1/2=breast cancer susceptibility gene 1/2; C1D1=Cycle 1, Day 1; C2=Cycle 2; C5D1=Cycle 5, Day 1; C7=Cycle 7; CA-125=cancer antigen-125; CEA=cancer 
embryonic antigen; CR=complete response; ctDNA=circulating tumor DNA; DBP=diastolic blood pressure; DC=discontinuation; ECG=electrocardiogram; ECOG=Eastern 
Cooperative Cancer Group;
FT3=free triiodothyronine; FT4=free thyroxine; HBV=hepatitis B virus; HCV=hepatitis C virus; HIV=human 
immunodeficiency virus; HRT=hormone replacement therapy; ICF=informed consent form; ID=identification; INR=International Normalized Ratio; iRECIST=modified 
Response Evaluation Criteria in Solid Tumors 1.1 for immune-based therapeutics; IRT=interactive response technology; NED=no evidence of disease; pCR=pathological 
complete response; PD=progressive disease; PD-L1=programmed cell death ligand 1; PR=partial response; PRO=patient-reported outcome; PT=prothrombin time; 
PTT=partial thromboplastin time; Q3W=every 3 weeks; Q9W=every 9 weeks; Q12W=every 12 weeks; Q24W=every 24 weeks; QW=once weekly; RECIST=Response 
Evaluation Criteria in Solid Tumors; RR=respiratory rate; SBP=systolic blood pressure; SD=stable disease; SOC=standard of care; T3=triiodothyronine; TSH=thyroid-
stimulating hormone; WOCBP=women of childbearing potential.
a.
Following consultation with the Sponsor, participants who are unable to complete 6 treatment cycles (including lead-in) of chemotherapy due to toxicity, may be eligible to 
start the Maintenance Period earlier.
b.
All screening procedures should be performed prior to starting lead-in chemotherapy unless otherwise noted. The Lead-in Period occurs within the 56-day window. The
optional recovery period, if needed, should not exceed 7 days between cycles (weekly chemotherapy regimen) or at the end of lead-in chemotherapy. Randomization should 
occur within 7 days of completing lead-in chemotherapy; a delay of an additional 2 weeks (up to 3 weeks total) may be granted upon consultation with the Sponsor.
c.
If the DC visit occurs ≥30 days from last dose of study treatment, a Safety Follow-up Visit is not required.
d.
For participants who DC for reasons other than radiographic PD, imaging continues until radiographically documented PD by the investigator (and, when clinically 
appropriate, confirmed by iRECIST), initiation of a new anticancer therapy, withdrawal of consent, becoming lost to follow-up, pregnancy, or death, whichever occurs first. 
Efficacy Follow-up Visits may be scheduled to coincide with follow-up imaging. Refer to Sections 1.3.4 and 1.3.5 for the imaging schedule during the treatment and 
posttreatment Efficacy Follow-up Period.
e.
All procedures and laboratory testing should be conducted on the day of, or within the specified window, but prior to dosing. Laboratory results must be assessed by a 
qualified investigator prior to dosing; thyroid function testing is an exception as outlined in Appendix 5.
CCI
CCI
CCI
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Confidential
Imaging Assessments for Primary Debulking Followed by Adjuvant Treatment 
and Maintenance
Primary Debulking Followed by Adjuvant Treatment and Maintenance
Imaging Visit
Description
Baseline
Perform imaging after primary debulking surgery and within 28 days prior to 
starting lead-in chemotherapy.
Treatment Period
Imaging performed 9 weeks (63 days ± 7) from the date of randomization.
Maintenance Eligibility
To confirm SD, PR, CR, or non-PD, imaging must be performed: 

A minimum of 21 days following C5D1 (for Q3W regimen) or a
minimum of 7 days following C5D15 (for QW regimen) and prior to 
starting olaparib or olaparib placebo in the Maintenance Period (for 
participants completing 6 cycles of chemotherapy [including lead-in 
dose])
OR

A minimum of 21 days after Day 1 of the last cycle of chemotherapy 
(if discontinued due to toxicity) and prior to starting olaparib or 
olaparib placebo in the Maintenance Period. Imaging obtained within 4 
weeks (28 days) prior to the planned start of maintenance may be used 
as the maintenance eligibility scan following Sponsor approval.
Participants with radiographic evidence of PD (but clinically stable) can start 
the Maintenance Period (pembrolizumab/pembrolizumab placebo only) and 
must have PD ruled out per iRECIST (Section 8.2.1.5) prior to starting olaparib 
or olaparib placebo in the Maintenance Period.
Maintenance
Imaging is to be performed Q9W (63 days ± 7 days) from the date of the 
maintenance eligibility assessment through Week 54, Q12W (84 days ± 7 days) 
through Week 156, and Q24 weeks (168 days ± 7 days) thereafter. Week 54 and 
Week 156 are calculated from the date of randomization.
Imaging For Eligibility to 
Continue Olaparib/ 
Olaparib Placebo at 
2 years
Imaging should be performed within 4 weeks prior to reaching 2 years of 
maintenance with olaparib/olaparib placebo:
• If at this scan, the participant has CR or NED, this is the final tumor imaging 
in the Maintenance Phase and the participant must discontinue 
olaparib/olaparib placebo. Note: the participant will continue to have 
imaging in the Efficacy Follow-up Phase (see below and Section 8.11.3.2).
• If at this scan the participant does not have a CR and is not NED, the 
participant may continue olaparib/olaparib placebo until CR or NED by 
RECIST 1.1. Note: Thereafter, the participant will continue to have imaging 
in the Efficacy Follow-up Phase (see below and Section 8.11.3.2).
Posttreatment Efficacy 
Follow-up Imaging
Participants who discontinue study treatment without documented disease 
progression should continue monitoring disease status by tumor imaging Q9W 
(63 days ± 7) through Week 54, Q12W (84 days ± 7 days) through Week 156, 
and Q24 weeks (168 days ± 7 days) thereafter or until meeting discontinuation 
criteria. Week 54 and Week 156 are calculated from the date of randomization.
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Confidential
Primary Debulking Followed by Adjuvant Treatment and Maintenance
Imaging Visit
Description
End of Treatment
Imaging performed at the time of treatment discontinuation (±4 weeks) and 
prior to starting a new anticancer treatment. If previous imaging was obtained 
within 4 weeks (28 days) before the date of discontinuation, then imaging at 
treatment discontinuation is not mandatory.
For participants who discontinue study treatment due to documented PD
(Table 9), this is the final required tumor imaging if the investigator elects not 
to implement iRECIST.
CR=complete response; CxDx=Cycle 1, Day 1; iRECIST=modified Response Evaluation Criteria in Solid Tumors 1.1 
for immune-based therapeutics; NED=no evidence of disease; PD=progressive disease; PR=partial response; 
QW=every week; QxW=every x weeks; SD=stable disease.
Note: Chest, abdomen, and pelvis imaging - required at baseline and every timepoint according to the schedule above.
Note: Bone imaging – required at baseline for participants with a history of bone metastases or who are clinically 
symptomatic. If positive for bone metastases at baseline, perform bone imaging according to the schedule above.
Note: Brain imaging – required at baseline for participants with a history of brain metastases (to confirm stability) or who 
are clinically symptomatic (to rule out brain metastases). If positive for brain metastases but eligible per exclusion 
criterion 7, perform brain imaging according to the schedule above.
Note: Unscheduled imaging may be performed as clinically indicated.
Imaging Assessments for Neoadjuvant / Adjuvant Treatment Period With
Interval Debulking Followed by Maintenance
Neoadjuvant / Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Imaging Visit
Description
Baseline
Perform imaging within 28 days prior to starting lead-in chemotherapy.
Peri-surgery

Presurgery: Imaging performed a minimum of 21 days after C2D1

Postsurgery: Imaging performed prior to resuming treatment at C3D1
Note: If surgery is attempted but not performed (with or without biopsy 
collection), continue imaging as specified here.
Maintenance Eligibility
To confirm SD, PR, CR, or non-PD, imaging must be performed:

A minimum of 21 days following C5D1 (for Q3W regimen) or a
minimum of 7 days following C5D15 (for QW regimen) and prior to 
starting olaparib or olaparib placebo the Maintenance Period (for 
participants completing 6 cycles of chemotherapy [including lead-in 
dose]).
OR

A minimum of 21 days after Day 1 of the last cycle of chemotherapy 
(if discontinued due to toxicity) and prior to starting olaparib or 
olaparib placebo in the Maintenance Period. Imaging obtained within 4 
weeks (28 days) prior to the planned start of maintenance, including 
postsurgery imaging, may be used as the maintenance eligibility scan 
following Sponsor approval.
Participants with radiographic evidence of PD (but clinically stable) can start 
the Maintenance Period (pembrolizumab/pembrolizumab placebo only) and 
must have PD ruled out per iRECIST (Section 8.2.1.5) prior to starting olaparib 
or olaparib placebo in the Maintenance Period.
Maintenance
Imaging is to be performed Q9W (63 days ± 7) from the date of the 
maintenance eligibility assessment through Week 54, Q12W (84 days ± 7 days) 
through Week 156, and Q24 weeks (168 days ± 7 days) thereafter or until 
meeting discontinuation criteria. Week 54 and Week 156 are calculated from 
the date of randomization.
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Neoadjuvant / Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Imaging Visit
Description
Imaging For Eligibility to 
Continue Olaparib/ 
Olaparib Placebo at 
2 years
Imaging should be performed within 4 weeks prior to reaching 2 years of 
maintenance with olaparib/olaparib placebo:
• If at this scan, the participant has CR or NED, this is the final tumor imaging 
in the Maintenance Phase and the participant must discontinue 
olaparib/olaparib placebo. Note: the participant will continue to have 
imaging in the Efficacy Follow-up Phase (see below and Section 8.11.3.2).
• If at this scan the participant does not have a CR and is not NED, the 
participant may continue olaparib/olaparib placebo until CR or NED by 
RECIST 1.1. Note: Thereafter, the participant will continue to have imaging 
in the Efficacy Follow-up Phase (see below and Section 8.11.3.2).
Posttreatment Efficacy 
Follow-up Imaging
Participants who discontinue study treatment without documented disease 
progression should continue monitoring disease status by tumor imaging Q9W 
(63 days ± 7) through Week 54, Q12W (84 days ± 7 days) through Week 156, 
and Q24 weeks (168 days ± 7 days) thereafter. Week 54 and Week 156 are 
calculated from the date of randomization.
End of Treatment
Imaging performed at the time of treatment discontinuation (±4 weeks) and 
prior to starting a new anticancer treatment. If previous imaging was obtained 
within 4 weeks (28 days) before the date of discontinuation, then imaging at 
treatment discontinuation is not mandatory.
For participants who discontinue study treatment due to documented PD
(Table 9), this is the final required tumor imaging if the investigator elects not 
to implement iRECIST.
CR=complete response; CxDx=Cycle x, Day x; iRECIST=modified Response Evaluation Criteria in Solid Tumors 1.1 
for immune-based therapeutics; NED=no evidence of disease; PD=progressive disease; PR=partial response; 
QW=every week; QxW=every x weeks; SD=stable disease.
Note: Chest, abdomen, and pelvis imaging - required at baseline and every timepoint according to the schedule above.
Note: Bone imaging – required at baseline for participants with a history of bone metastases or who are clinically 
symptomatic. If positive for bone metastases at baseline, perform bone imaging according to the schedule above.
Note: Brain imaging – required at baseline for participants with a history of brain metastases (to confirm stability) or who 
are clinically symptomatic (to rule out brain metastases). If positive for brain metastases, but eligible per exclusion 
criterion 7, perform brain imaging according to the schedule above.
Note: Unscheduled imaging may be performed as clinically indicated.
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Imaging Assessments for Neoadjuvant / Adjuvant Treatment Period Without 
Interval Debulking Followed by Maintenance
Neoadjuvant / Adjuvant Treatment Period Without Interval Debulking Followed by Maintenance
Imaging Visit
Description
Baseline
Perform imaging within 28 days prior to starting lead-in chemotherapy.
Treatment Period
Imaging performed 9 weeks (63 days ± 7) from the date of randomization.
If surgery is not performed (with or without biopsy collection), continue 
imaging as specified here.
Maintenance Eligibility
To confirm SD, PR, CR, or non-PD, imaging must be performed:

A minimum of 21 days following C5D1 (for Q3W regimen) or a
minimum of 1 week following C5D15 (for QW regimen) and prior to 
starting olaparib or olaparib placebo in the Maintenance Period (for 
participants completing 6 cycles of chemotherapy [including lead-in 
dose])
OR

A minimum of 21 days after Day 1 of the last cycle of chemotherapy 
(if discontinued due to toxicity) and prior to starting olaparib or 
olaparib placebo in the Maintenance Period. Imaging obtained within 4 
weeks (28 days) prior to the planned start of maintenance may be used 
as the maintenance eligibility scan following Sponsor approval
Participants with radiographic evidence of PD (but clinically stable) can start 
the Maintenance Period (pembrolizumab/pembrolizumab placebo only) and 
must have PD ruled out per iRECIST (Section 8.2.1.5) prior to starting olaparib 
or olaparib placebo in the Maintenance Period.
Maintenance
Imaging is to be performed Q9W (63 days ± 7) from the date of the 
maintenance eligibility assessment through Week 54, Q12W (84 days ± 7 days) 
through Week 156, and Q24 weeks (168 days ± 7 days) thereafter. Week 54 and 
Week 156 are calculated from the date of randomization.
Imaging For Eligibility to 
Continue Olaparib/ 
Olaparib Placebo at 
2 years
Imaging should be performed within 4 weeks prior to reaching 2 years of 
maintenance with olaparib/olaparib placebo:
• If at this scan, the participant has CR or NED, this is the final tumor imaging 
in the Maintenance Phase and the participant must discontinue 
olaparib/olaparib placebo. Note: the participant will continue to have 
imaging in the Efficacy Follow-up Phase (see below and Section 8.11.3.2).
• If at this scan the participant does not have a CR and is not NED, the 
participant may continue olaparib/olaparib placebo until CR or NED by 
RECIST 1.1. Note: Thereafter, the participant will continue to have imaging 
in the Efficacy Follow-up Phase (see below and Section 8.11.3.2).
Posttreatment Efficacy 
Follow-up Imaging
Participants who discontinue study treatment without documented disease 
progression should continue monitoring disease status by tumor imaging Q9W 
(63 days ± 7) through Week 54, Q12W (84 days ± 7 days) through Week 156, 
and Q24 weeks (168 days ± 7 days) thereafter or until meeting discontinuation 
criteria. Week 54 and Week 156 are calculated from the date of randomization.
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Neoadjuvant / Adjuvant Treatment Period Without Interval Debulking Followed by Maintenance
Imaging Visit
Description
End of Treatment
Imaging performed at the time of treatment discontinuation (±4 weeks) and 
prior to starting a new anticancer treatment. If previous imaging was obtained 
within 4 weeks (28 days) before the date of discontinuation, then imaging at 
treatment discontinuation is not mandatory.
For participants who discontinue study treatment due to documented PD (Table
9), this is the final required tumor imaging if the investigator elects not to 
implement iRECIST.
CR=complete response; CxDx=Cycle x, Day x; iRECIST=modified Response Evaluation Criteria in Solid Tumors 1.1 
for immune-based therapeutics; NED=no evidence of disease; PD=progressive disease; PR=partial response; 
QW=every week; QxW=every x weeks; SD=stable disease.
Note: Chest, abdomen, and pelvis imaging - required at baseline and every timepoint according to the schedule above.
Note: Bone imaging – required at baseline for participants with a history of bone metastases or who are clinically 
symptomatic. If positive for bone metastases at baseline, perform bone imaging according to the schedule above.
Note: Brain imaging – required at baseline for participants with a history of brain metastases (to confirm stability) or who 
are clinically symptomatic (to rule out brain metastases). If positive for brain metastases, but eligible per exclusion 
criterion 7, perform brain imaging according to the schedule above.
Note: Unscheduled imaging may be performed as clinically indicated.
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2. Introduction
Study Rationale
Treatment of newly diagnosed, advanced OC is determined by the stage and risk of disease
recurrence at diagnosis. Treatment options include either cytoreductive surgery followed by 
adjuvant chemotherapy (most likely platinum- and taxane-based) or chemotherapy alone. 
Alternatively, when the removal of all cancer during the initial surgery would be problematic 
due to tumor size, chemotherapy may be administered before surgery (neoadjuvant 
chemotherapy) to shrink the tumor, with additional chemotherapy after surgery (adjuvant 
chemotherapy). Clinically, complete remission is achieved in most newly diagnosed patients 
through a combination of cytoreductive surgery and chemotherapy; however, 10% of patients 
might not respond to first-line chemotherapeutic treatment and, of those who do respond, 
between 55% and 75% will relapse within 2 years [du Bois, A., et al 2009] [Ledermann, J. 
A., et al 2013] [Edwards, S. J., et al 2015]. The overall 5-year survival rate for EOC remains 
poor, ranging from 28% to 57% depending on age at diagnosis [Edwards, S. J., et al 2015] 
[Eisenhauer, E. L., et al 2012]; in addition, toxicity is high with the current SOC
chemotherapeutic regimens, urgently requiring novel therapies to be identified for women 
with OC.
PARP inhibitors have been recently approved as maintenance treatment in the front-line
setting for patients with OC HRD positive (ie, based on PAOLA-1) or irrespective of HRR 
status (ie, based on PRIMA); however, BRCA1/2 non-mutated patient population still 
represents high unmet need, particularly in patients with homologous recombination 
proficiency. OS data from PAOLA-1 presented at ESMO 2022 have shown HR=1.18 for 
olaparib plus bevacizumab in the HRD-negative subgroup, confirming limited efficacy of 
PARP inhibitors in these patient populations. HRD-negative OC represents about 70% of all 
BRCAwt OC and remains an area of high unmet clinical need. 
The PD-1 antibody pembrolizumab has shown efficacy as monotherapy in patients with 
several advanced cancers and has a non-overlapping toxicity profile with chemotherapy. A 
recently published report of a randomized, controlled clinical study demonstrated that the 
addition of pembrolizumab to carboplatin and pemetrexed improved efficacy and had a 
favorable benefit-to-risk profile in patients with chemotherapy-naïve, advanced non-
squamous NSCLC [Langer, C. J., et al 2016]. These are the first published data to 
prospectively show a benefit of the addition of a PD-1 pathway inhibitor to platinum-based
doublet chemotherapy in front-line advanced non-squamous NSCLC. Ongoing studies, in 
several different tumor types, are currently investigating the benefit of the addition of 
pembrolizumab to other front-line platinum-based chemotherapies. Data from KEYNOTE-
100, in participants with recurrent OC, suggest improved efficacy for pembrolizumab 
monotherapy in those participants whose tumors express PD-L1 with the cutoff of CPS ≥10.
In addition, recent data from a Phase 3 study of atezolizumab in combination with 
carboplatin, paclitaxel, and bevacizumab in front-line advanced OC failed to demonstrate an 
advantage in PFS and OS over standard chemotherapy (IMAGYN50) [Moore, K., et al 
2020]. However, a trend favoring atezolizumab was shown in the PD-L1 positive population. 
IMAGYN50 data suggest prevalence of PD-L1 positive cases ~60% (measured by SP142 at 
IC1% cutoff). Given that the prevalence of PD-L1 positivity at IC1% cutoff is slightly higher 
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compared with CPS ≥10, we would expect the prevalence at CPS ≥10 to be ~50%. These 
results are in-line with those of JAVELIN 200 Ovarian, which tested avelumab alone or in 
combination with PLD versus PLD in platinum refractory or resistant OC. Despite being 
overall a negative study, JAVELIN 200 demonstrated a trend favoring the combination of 
PLD and avelumab in the PD-L1 positive population. In addition, the Kaplan-Meier Curve
for PFS from JAVELIN 200 shows a late separation of the curves for PLD plus avelumab 
versus PLD, indicating that data maturity may be important to demonstrate an 
immunotherapy effect in this patient population.
Similarly, the final PFS analysis of IMAGYN050 was conducted with relatively immature 
data (~50% of events in each arm), and it was estimated that the study would have achieved 
the PFS endpoint in PD-L1 positive patients if they were to have more mature data (ie, more 
events [~70%]). A similar issue was considered as one of the main reasons the JAVELIN 
study failed at the interim analysis with immature data and limited number of events. The 
overall follow-up was also 19 months, and there was not a PARP inhibitor used in 
IMAGYN50, which also is an important aspect to consider along with the inclusion of 
patients with BRCA1/2 mutated (BRCAmut) as well as those with BRCA non-mutated tumors 
in the study. All of these were considered when revising the SAP for this amendment.
The combination of immune checkpoint inhibitor pembrolizumab plus the PARP inhibitor 
niraparib has shown efficacy in participants with platinum-resistant, relapsed OC following 
initial treatment (TOPACIO/KEYNOTE-162), with responses documented irrespective of 
BRCA1/2 status [Konstantinopoulos, P. A., et al 2018]. In addition, data recently presented 
from the MEDIOLA study, in participants with BRCA non-mutated, platinum-sensitive
recurrent OC, comparing the triple combination of durvalumab + olaparib + bevacizumab
with the doublet combination of durvalumab + olaparib, demonstrated a high ORR,
particularly in triple combination arm (ORR ~87%) vs doublet (ORR ~34%) [Pujade-
Lauraine, E., et al 2019]. Olaparib is currently approved for second-line maintenance in 
platinum-sensitive, recurrent OC, regardless of BRCA1/2 status and is currently being 
investigated as maintenance treatment after response to front-line chemotherapy (SOLO-1 
study) in BRCAmut OC patients. Based on the promising results from the 
TOPACIO/KEYNOTE-162 and MEDIOLA studies [Konstantinopoulos, P. A., et al 2018] 
[Drew, Y., et al 2018], the present study has been designed to compare carboplatin/paclitaxel 
alone with the novel combinations of either carboplatin/paclitaxel plus pembrolizumab or 
carboplatin/paclitaxel plus pembrolizumab with olaparib maintenance as a first-line treatment 
for BRCA1/2 non-mutated advanced EOC. This novel combination will likely provide 
significant benefit for women with newly diagnosed advanced OC.
Background
Pembrolizumab
Pembrolizumab is a potent humanized Ig G4 monoclonal antibody with high specificity of 
binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and PD-L2. Based on 
preclinical in vitro data, pembrolizumab has high affinity and potent receptor blocking 
activity for PD-1. Pembrolizumab has an acceptable preclinical safety profile and is in 
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clinical development as an IV immunotherapy for advanced malignancies. KEYTRUDA®
(pembrolizumab) is indicated for the treatment of patients across a number of indications.
Refer to the IB/approved labeling for detailed background information on pembrolizumab.
Olaparib
Olaparib (AZD2281, KU-0059436) is a potent PARP inhibitor (PARP-1, -2 and -3) that is 
being developed as an oral therapy, both as a monotherapy (including maintenance) and for 
combination with chemotherapy and other anticancer agents.
PARP inhibition is a novel approach to targeting tumors with deficiencies in DNA repair 
mechanisms. PARP enzymes are essential for repairing DNA SSBs. Inhibiting PARPs leads 
to the persistence of SSBs, which are then converted to the more serious DNA DSBs during 
the process of DNA replication. During the process of cell division, DSBs can be efficiently 
repaired in normal cells by HRR. Tumors with HRD, such as OCs in patients with BRCA1/2
mutations, cannot accurately repair the DNA damage, which may become lethal to cells as it 
accumulates. In such tumor types, olaparib may offer a potentially efficacious and less toxic 
cancer treatment compared with currently available chemotherapy regimens.
Refer to the IB/approved labeling for detailed background information on olaparib.
Pharmaceutical and Therapeutic Background
Inhibition of PD-1 as a Target for Cancer
The importance of intact immune surveillance in controlling outgrowth of neoplastic 
transformation has been known for decades [Disis, M. L. 2010]. Accumulating evidence 
shows a correlation between TILs in cancer tissue and favorable prognosis in various 
malignancies. In particular, the presence of CD8+ T-cells and the ratio of CD8+ effector T-
cells/FoxP3+ regulatory T-cells correlates with improved prognosis and long-term survival in 
solid malignancies, such as ovarian, colorectal, and pancreatic cancer; hepatocellular 
carcinoma; malignant melanoma; and renal cell carcinoma. TILs can be expanded ex vivo 
and reinfused, inducing durable objective tumor responses in cancers such as melanoma 
[Dudley, M. E., et al 2005] [Hunder, N. N., et al 2008].
The PD-1 receptor-ligand interaction is a major pathway hijacked by tumors to suppress 
immune control. The normal function of PD-1, expressed on the cell surface of activated 
T-cells under healthy conditions, is to down-modulate unwanted or excessive immune 
responses, including autoimmune reactions. PD-1 (encoded by the gene Pdcd1) is an Ig 
superfamily member related to CD28 and CTLA-4 that has been shown to negatively 
regulate antigen receptor signaling upon engagement of its ligands (PD-L1 and/or PD-L2) 
[Greenwald, R. J., et al 2005] [Okazaki, T., et al 2001].
The structure of murine PD-1 has been resolved [Zhang, X., et al 2004]. PD-1 and its family 
members are type I transmembrane glycoproteins containing an extracellular Ig-variable-type 
domain responsible for ligand binding and a cytoplasmic tail responsible for the binding of 
signaling molecules. The cytoplasmic tail of PD-1 contains 2 tyrosine-based signaling motifs, 
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an immunoreceptor tyrosine-based inhibition motif, and an immunoreceptor tyrosine-based 
switch motif. Following T-cell stimulation, PD-1 recruits the tyrosine phosphatases, Src 
homology region 2 domain-containing phosphatase-1 (SHP-1) and SHP-2, to the 
immunoreceptor tyrosine-based switch motif within its cytoplasmic tail, leading to the 
dephosphorylation of effector molecules such as CD3 zeta, protein kinase C-theta, and zeta-
chain-associated protein kinase, which are involved in the CD3 T-cell signaling cascade 
[Okazaki, T., et al 2001] [Chemnitz, J. M., et al 2004] [Sheppard, K-A, et al 2004] [Riley, J. 
L. 2009]. The mechanism by which PD-1 down-modulates T-cell responses is similar to, but 
distinct from, that of CTLA-4, because both molecules regulate an overlapping set of 
signaling proteins [Parry, R. V., et al 2005] [Francisco, L. M., et al 2010]. As a consequence, 
the PD-1/PD-L1 pathway is an attractive target for therapeutic intervention in EOC.
Inhibition of PARP as a Target for Cancer
PARP1 and PARP2 are zinc-finger DNA-binding enzymes that play a critical role in DNA 
repair [Ame, J. C., et al 2004] by sensing DNA damage and converting it into intracellular 
signals that activate the base excision repair and SSB repair pathways. When a break in DNA 
occurs, PARP enzymes are recruited to and bind at the end of the broken DNA strands, 
activating their enzymatic activity. PARP subsequently catalyzes the addition of long 
polymers of ADP-ribose onto several other proteins associated with chromatin (eg, PARP, 
histones, DNA repair proteins), resulting in chromatin relaxation, rapid recruitment of DNA 
repair proteins, and efficient repair of the break.
Under normal conditions, HRR is the preferred pathway for repairing DNA damage as it is 
associated with a lower rate of errors compared with other forms of DNA repair [Prakash, R., 
et al 2015]. During DNA replication (S phase), pre-existing SSBs are converted to DSBs as 
the replication machinery passes [Fong, Peter C., et al 2009], which are ultimately repaired 
by HRR. Cells unable to perform HRR (eg, due to inactivation of genes required for the 
process, such as BRCA1 or BRCA2) are more likely to use the error-prone NHEJ or 
alternative NHEJ pathways to repair these DSBs and are at risk for accumulating multiple 
lesions or loss of heterozygosity. Over time, the buildup of excessive DNA errors in 
combination with the inability to complete S phase (because of stalled replication forks) 
contributes to cell death.
Clinical studies have shown that PARP inhibitors are most effective in patients with recurrent 
OC who are either platinum-sensitive or platinum-resistant and harbor mutations of BRCA1/2
[George, A., et al 2017]. PARP inhibitors have demonstrated effectiveness in patients 
without germline BRCAmut (gBRCAmut), although the magnitude has been smaller [Fong, 
Peter C., et al 2009] [Gelmon, K. A., et al 2011] [Ledermann, J., et al 2012]. For example, 
median PFS was significantly longer for patients with platinum-sensitive, relapsed OC and
gBRCAmut who were treated with olaparib as maintenance therapy compared with placebo 
(19.1 months versus 5.5 months; HR: 0.30, p<0.001) [Pujade-Lauraine, E., et al 2017]. 
Similarly, median PFS was significantly longer in patients with platinum-sensitive, relapsed 
OC and any BRCA1/2 status compared with placebo (8.4 months versus 4.8 months; HR: 
0.35, p<0.001). Additionally, these patients had a median OS of 29.8 months compared with 
27.8 months for placebo (HR: 0.73) [Ledermann, J., et al 2012].
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In summary, treatment with PARP1/2 inhibitors represents a novel opportunity to selectively 
kill a subset of cancer cell types by exploiting their deficiencies in DNA repair. Human 
cancers exhibit genomic instability and an increased mutation rate due to underlying defects 
in DNA repair. These deficiencies render cancer cells more dependent on the remaining 
DNA repair pathways, and targeting these pathways is expected to have a much greater 
impact on the survival of the tumor cells than on normal cells.
Combined Use of an Anti-PD-1 Monoclonal Antibody and PARP Inhibitor for 
the Treatment of Cancer
Over recent years, research has revealed the importance of TILs in controlling the clinical 
progression of various cancers and their presence in a tumor is associated with response to 
immune checkpoint inhibitors [Fridman, W. H., et al 2012]. In OC, intraepithelial CD8+ T-
cells correlated with the presence of mutation or loss of expression of BRCA1 through 
promoter methylation [Clarke, B., et al 2009]. Patients with OC that were sensitive to agents 
targeting defects in DNA repair are likely to overlap with those tumors with an active, yet 
checkpoint-blocked, immune response.
Despite promising activity of PD-1 inhibitors observed in some types of cancer, including 
melanoma and NSCLC [Barbee, M. S., et al 2015], activity in OC has been modest [Disis, 
M. L., et al 2015] [Varga, A., et al 2015] [Matulonis, U. A., et al 2018]. In KEYNOTE-028, 
the confirmed ORR was 11.5% following pembrolizumab monotherapy in participants with 
advanced ovarian epithelial, fallopian tube, or primary peritoneal carcinoma who had failed 
prior therapy [Disis, M. L., et al 2015]. In KEYNOTE-100, the ORR was 9% for all 
participants with epithelial ovarian, fallopian tube, or primary peritoneal cancer and
confirmed recurrence following front-line platinum-based therapy [Matulonis, U. A., et al 
2018]. ORR was higher in participants who had elevated levels of PD-L1 expression: 14% in 
participants with a combined positive score (CPS) ≥1% and 25% in participants with a CPS 
≥10% [Matulonis, U. A., et al 2018].
While the ORR of PARP inhibitors in unselected patients with OC (ie, with and without 
gBRCAmut) has been modest to date [Gelmon, K. A., et al 2011] [Ledermann, J., et al 2012] 
[Sandhu, S. K., et al 2013], PARP inhibition has significantly prolonged PFS when used as 
either monotherapy or in combination with chemotherapy [Ledermann, J., et al 2014] [Oza, 
A. M., et al 2015] [Mirza, M. R., et al 2016]. Additionally, synergistic interactions have been 
observed between immune checkpoint inhibitors and PARP inhibitors. Nonclinical 
experiments in syngeneic mouse models have shown an increased response rate to the 
combination of anti-PD-1 and a PARP inhibitor over either agent alone, providing additional 
support to investigate this combination in patients [Higuchi, T., et al 2015] [Huang, J., et al 
2015]. A Phase 1 dose-finding combination study of pembrolizumab and a PARP inhibitor
(ie, niraparib) is currently ongoing in participants with platinum-resistant recurrent OC 
treated with ≤5 prior lines of chemotherapy and having responded with CR or PR to first-line 
platinum-based chemotherapy (TOPACIO/KEYNOTE-162). In preliminary results, 4 of 
8 participants with OC responded (based on RECIST 1.1), 3 of whom were gBRCAmut
negative. No significant overlapping toxicity was noted with the combination of 
pembrolizumab and the PARP inhibitor, and the combination was generally well tolerated
[Konstantinopoulos, P. A., et al 2018].
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Exposure of a tumor in vivo to a PARP inhibitor results in increased cancer cell death by 
2 independent mechanisms. First, through the mechanism of synthetic lethality, the PARP 
inhibitor can kill HRD tumors through apoptosis. Second, the PARP inhibitor can increase 
the number of CD8+ T cells and natural killer cells, as well as their production of interferon-
gamma and tumor necrosis factor-alpha, resulting in an improved response to checkpoint 
blockade [Huang, J., et al 2015]. Furthermore, a wide array of biomarkers will be explored in 
this protocol to investigate tumor cell death, genomic changes, apoptosis, and immune 
response. Given the non-overlapping safety and metabolic profile (see the current IB for 
pembrolizumab and olaparib, respectively, for details) and preclinical data suggesting 
possible synergistic interaction between immune checkpoint inhibitors and PARP inhibitors 
along with a potential overlap for PD-1 and PARP-sensitive patient populations, this study is 
designed to evaluate pembrolizumab and the combination of pembrolizumab plus olaparib 
maintenance when added to the current SOC as a front-line treatment for the treatment of 
advanced EOC.
Overview of Epithelial Ovarian Cancer
OC is the most lethal gynecologic cancer and one of the top -leading causes of cancer death 
among women. In 2017, the estimated number of new cases and deaths from OC in the US is 
22,440 and 14,080, respectively [Siegel, R. L., et al 2017]. Worldwide, OC represents one of 
the 10 most common cancer diagnoses and leading causes of cancer-related deaths in women 
[Torre, L. A., et al 2015]. Due to lack of tumor-specific signs and symptoms and effective
screening tests for early detection, over 75% of OC patients are first diagnosed at advanced 
stages. Based on the US data from 2006 to 2012, at initial diagnosis, 60% had distant 
metastasis, 19% had regional disease and only 15% had localized disease. The overall 5-year 
survival rate of OC is approximately 46% counting all stages; the 5-year survival rate in 
patients with distant metastasis is only 29% [Siegel, R. L., et al 2017].
OC is a heterogeneous disease, with distinct histopathologic features, genetic alterations, and 
clinical behaviors. EOC is the most common (>90% of OCs) and most lethal of the 
gynecologic malignancies [Gilks, C. B. and Prat, J. 2009]. Currently, EOCs are classified 
into 5 main subtypes based on histopathology, immunohistochemistry, and molecular-genetic 
characteristics: HGSC (~ 70% of EOCs), endometrioid carcinoma (~ 10% of EOCs), clear 
cell carcinoma (~ 10% of EOCs), mucinous carcinoma (~ 3% of EOCs), and low-grade 
serous carcinoma (5% EOC) [Gilks, C. B. and Prat, J. 2009] [Prat, J. and FIGO Committee 
on Gynecologic Oncology 2014]. The distinction of EOC subtype at diagnosis/staging is a 
critical factor that will guide treatment, as each tumor type responds differently to 
chemotherapy [Gilks, C. B. and Prat, J. 2009]. Primary peritoneal carcinoma and fallopian 
tube carcinoma, while rare and distinct tumor types, have typically been managed and 
studied together with EOC as they share similar clinical and pathological characteristics with 
HGSC [Cannistra, S. A., et al 2011].
Current Standard of Care and Unmet Medical Need
The current SOC for advanced EOC (FIGO Stage II to Stage IV) includes primary 
cytoreductive/debulking surgery followed by postoperative front-line (ie, adjuvant) systemic 
treatment with IV carboplatin and paclitaxel administered Q3W for 6 cycles. However, 
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weekly paclitaxel has also been frequently used to replace Q3W paclitaxel. In addition, 
where locally approved for front-line treatment, IV bevacizumab can be added to IV 
carboplatin and paclitaxel for up to 6 cycles and then continued as a single agent. In suitable 
cases, postoperative chemotherapy, usually cisplatin plus paclitaxel, can be delivered via the 
intraperitoneal route. Finally, in cases with bulky disease that is initially inoperable, 3 cycles 
of standard platinum/taxane-based chemotherapy can be administered as neoadjuvant therapy 
prior to cytoreductive/debulking surgery (ie, interval cytoreductive/debulking surgery) 
followed by an additional 3 cycles of standard platinum/taxane-based chemotherapy 
[Morgan, R. J ., et al 2016] [Ledermann, J. A., et al 2013].
The goal of cytoreductive/debulking surgery is to achieve resection of all macroscopically 
visible tumors, while the goals of postoperative first-line chemotherapy are: 1) to help 
achieve complete remission in those with residual disease, and 2) to prevent disease 
recurrence for those with complete tumor resection. However, after these primary treatments, 
only a small proportion of patients will achieve long-term disease-free and survival status. A 
meta-analysis on data from 3 randomized studies following the standard primary treatment 
with surgery and platinum/taxane-based chemotherapy (N = 3126), showed that only 24% of 
patients were recurrence-free after a median follow-up time of 53.9 months. The remaining 
76% had recurrent disease (17.2%) or had died (58.8%) [du Bois, A., et al 2009].
Recently (29-APR-2020), niraparib was approved by the FDA for the maintenance treatment 
of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal 
cancer who are in a CR or PR to first-line platinum-based chemotherapy. On 08-MAY-2020, 
the combination of olaparib with bevacizumab for first-line maintenance treatment of adult 
patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who 
are in complete or PR to first-line platinum-based chemotherapy and whose cancer is 
associated with HRD positive status defined by either a deleterious or suspected deleterious 
BRCA mutation, and/or genomic instability was approved by the FDA. FDA also approved 
the Myriad myChoice® CDx (Myriad Genetic Laboratories, Inc.) as a companion diagnostic 
for olaparib.
While the current SOC is initially effective for the treatment of EOC, approximately 70% of 
patients will experience a relapse within 3 years of treatment cessation [du Bois, A., et al 
2009] [Ledermann, J. A., et al 2013]. Thus, there is an unmet medical need for therapies that, 
when used in combination with the current SOC, significantly increases the proportion of 
patients with complete remission and prevents disease recurrence in patients with advanced 
EOC.
Preclinical and Clinical Studies
For a summary of preclinical and clinical study data for pembrolizumab and olaparib, refer to 
their respective IBs.
Ongoing Clinical Studies
For a summary of ongoing clinical study data for pembrolizumab and olaparib, refer to their
respective IBs.
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Information on Other Study-related Therapy
For additional information on carboplatin, paclitaxel, docetaxel, and bevacizumab, refer to 
their respective approved product labels.
Benefit/Risk Assessment
It cannot be guaranteed that participants in clinical studies will directly benefit from 
treatment during participation, as clinical studies are designed to provide information about 
the safety and effectiveness of an investigational medicine.
As discussed in Section 2.2.3.3, the combination of pembrolizumab and a PARP inhibitor has 
shown preliminary efficacy in heavily pretreated participants with platinum-resistant OC 
(TOPACIO/KEYNOTE-168). Given the high rate of relapse following initial treatment for 
OC [Ledermann, J. A., et al 2013], there is an unmet medical need for an effective and 
tolerable first-line treatment regimen. The existing data suggest that a combination of PD-1 
blockade with PARP inhibition, when added to carboplatin/paclitaxel, is a promising 
therapeutic strategy and the benefit risk assessment for participants included in this study is 
expected to be favorable.
Additional details regarding specific benefits and risks for participants participating in this 
clinical study may be found in the accompanying IB and Informed Consent documents.
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3. Objectives/Hypotheses and Endpoints
In participants with previously untreated BRCA1/2 non-mutated advanced EOC treated with 
pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab treatment 
plus olaparib maintenance (Arm 1) or pembrolizumab plus carboplatin/paclitaxel followed by 
continued pembrolizumab treatment (Arm 2) versus carboplatin/paclitaxel alone (Arm 3):
Objective/Hypothesis
Endpoint
Primary
•
Objective:  To compare the progression-
free survival (PFS) as assessed by the 
investigator according to Response 
Evaluation Criteria in Solid Tumors 
version 1.1 (RECIST 1.1)
Hypothesis (H1): The combination of 
pembrolizumab plus 
carboplatin/paclitaxel followed by 
continued pembrolizumab treatment and 
olaparib maintenance (Arm 1) is 
superior to carboplatin/paclitaxel alone 
(Arm 3) with respect to PFS per 
RECIST 1.1 in participants with PD-L1 
positive tumors (CPS ≥10).
Hypothesis (H2): The combination of 
pembrolizumab plus 
carboplatin/paclitaxel followed by 
continued pembrolizumab treatment and 
olaparib maintenance (Arm 1) is 
superior to carboplatin/paclitaxel alone 
(Arm 3) with respect to PFS per 
RECIST 1.1 in All Participants.
Hypothesis (H3):  The combination of 
pembrolizumab plus 
carboplatin/paclitaxel followed by 
continued pembrolizumab treatment 
(Arm 2) is superior to 
carboplatin/paclitaxel alone (Arm 3) 
with respect to PFS per RECIST 1.1 in 
participants with PD-L1 positive tumors 
(CPS ≥10).
Hypothesis (H4): The combination of 
pembrolizumab plus 
•
PFS, the time from the date of 
randomization until either the earliest 
date of documented disease progression 
or death due to any cause, whichever 
occurs first
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Objective/Hypothesis
Endpoint
carboplatin/paclitaxel followed by 
continued pembrolizumab treatment 
(Arm 2) is superior to 
carboplatin/paclitaxel alone (Arm 3) 
with respect to PFS per RECIST 1.1 in 
All Participants.
Secondary
•
Objective:  To compare the overall 
survival (OS) 
Hypothesis (H5): The combination of 
pembrolizumab plus 
carboplatin/paclitaxel followed by 
continued pembrolizumab treatment and 
olaparib maintenance (Arm 1) is 
superior to carboplatin/paclitaxel alone 
(Arm 3) with respect to OS in All 
Participants.
Hypothesis (H6):  The combination of 
pembrolizumab plus 
carboplatin/paclitaxel followed by 
continued pembrolizumab treatment 
(Arm 2) is superior to 
carboplatin/paclitaxel alone (Arm 3) 
with respect to OS in All Participants.
Hypothesis (H7):  The combination of 
pembrolizumab plus 
carboplatin/paclitaxel followed by 
continued pembrolizumab treatment 
(Arm 2) is superior to 
carboplatin/paclitaxel alone (Arm 3) 
with respect to OS in participants with 
PD-L1 positive tumors (CPS ≥10).
•
OS, the time from the date of 
randomization to death due to any cause
•
Objective:  To compare the PFS as 
assessed by blinded independent central 
review (BICR) per RECIST 1.1 in 
participants with PD-L1 positive tumors 
(CPS ≥10) and in All Participants.
•
PFS
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Objective/Hypothesis
Endpoint
•
Objective:  To compare the PFS after 
second-line treatment as determined by 
the investigator according to the local 
standard of clinical practice (PFS2)
following discontinuation of study 
treatment administration in participants 
with PD-L1 positive tumors (CPS ≥10)
and in All Participants.
•
PFS2, the time from the date of 
randomization until disease progression 
(clinical or radiological) after second-
line treatment or death due to any cause, 
whichever occurs first
•
Objective: To evaluate the safety and 
tolerability of pembrolizumab 
administered with chemotherapy and 
olaparib maintenance
•
Adverse events (AEs)
•
Study treatment discontinuation due to 
AEs
•
Objective: To compare the mean change 
from baseline of Global Health 
Status/Quality-of-Life (GHS/QoL) score 
using the European Organisation for 
Research and Treatment of Cancer 
(EORTC) Quality-of-Life Questionnaire 
Core 30 (QLQ-C30) and abdominal and 
gastrointestinal (abdominal/GI) 
symptoms using the EORTC Ovarian 
Cancer-Specific Quality-of-Life 
Questionnaire (QLQ-OV28) 
abdominal/GI symptom scale
Change from baseline in:
•
EORTC QLQ-C30 GHS/QoL score
•
EORTC QLQ-OV28 abdominal/GI 
symptom scale
•
Objective: To compare time to 
deterioration (TTD) of GHS/QoL score 
using EORTC QLQ-C30 and 
abdominal/GI symptoms using EORTC 
QLQ-OV28
Time to deterioration in:
•
EORTC QLQ-C30 GHS/QoL score
•
EORTC QLQ-OV28 abdominal/GI 
symptom scale
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Objective/Hypothesis
Endpoint
•
Objective:  To compare the time to first 
subsequent anticancer treatment (TFST), 
the time to second subsequent 
anticancer treatment (TSST), and the 
time to discontinuation of study 
treatment (TDT)
•
TFST, the time from the date of 
randomization to initiation of first 
subsequent anticancer treatment or death 
due to any cause, whichever occurs first
•
TSST, the time from the date of 
randomization to initiation of second 
subsequent anticancer treatment or death 
due to any cause, whichever occurs first
•
TDT, the time from the date of 
randomization to discontinuation of 
study treatment or death due to any 
cause, whichever occurs first
•
Objective:  To compare the rate of 
locally determined pathological 
complete response (pCR) of 
pembrolizumab in combination with 
carboplatin/paclitaxel versus 
carboplatin/paclitaxel alone when 
administered as neoadjuvant therapy
•
pCR, all surgical specimens collected 
during the interval debulking surgery
are microscopically negative for 
malignancy
Tertiary/Exploratory
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Objective/Hypothesis
Endpoint
4. Study Design
Overall Design
This is a Phase 3, randomized, placebo-controlled, parallel-group, multi-site, double-blind 
study to evaluate chemotherapy with or without pembrolizumab followed by maintenance 
with olaparib or placebo for the first-line treatment of BRCA1/2 non-mutated advanced EOC.
Following a Lead-in Period during which all participants will receive a single cycle of 
carboplatin/paclitaxel*, approximately 1284 participants will be randomly assigned in a 
1:1:1 ratio to 1 of 3 treatment arms. Prior to randomization, participants will be stratified by 
surgery (planned interval debulking versus R0 [no macroscopic residual disease (0 cm) intra-
or extra-abdominal (metastatic) following primary debulking] versus R1 [>0 cm macroscopic 
residual disease intra- or extra-abdominal (metastatic) following primary debulking]), 
bevacizumab use (yes versus no), and PD-L1 positivity (CPS <10 versus CPS ≥10).
Arm 1: Treatment: carboplatin/paclitaxel* for 5 cycles plus pembrolizumab 200 mg 
Q3W for up to 35 infusions 
Maintenance: olaparib 300 mg twice daily (BID)
Arm 2: Treatment: carboplatin/paclitaxel* for 5 cycles plus pembrolizumab 200 mg 
Q3W for up to 35 infusions
Maintenance: olaparib placebo BID
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Arm 3: Treatment: carboplatin/paclitaxel* for 5 cycles plus pembrolizumab placebo 
Q3W for up to 35 infusions
Maintenance: olaparib placebo BID
Crossover between treatment arms is not permitted.
*At the investigator’s discretion and determined prior to the participant being randomly 
assigned to study treatment, one of the following regimens should be administered:
•
Carboplatin area under the concentration-time curve (AUC)5 or AUC6 Q3W plus 
paclitaxel 175 mg/m2 Q3W
•
Carboplatin AUC5 or AUC6 Q3W plus paclitaxel 80 mg/m2 once weekly (QW)
•
Carboplatin AUC2 or AUC2.7 QW plus paclitaxel 60 mg/m2 QW
Docetaxel may be considered for participants who experience either a severe hypersensitivity
reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation 
with the Sponsor. The recommended dose, as determined by the SGCTG group [Vasey, P. A., 
et al 2004], is as follows:
•
Docetaxel 75 mg/m2 Q3W plus carboplatin AUC 5 Q3W
Note:  At the investigator’s discretion, bevacizumab may be used. Use of bevacizumab 
must be decided prior to randomization as it is a stratification factor. For participants 
eligible for interval debulking, bevacizumab (if using) should be started with 
carboplatin/paclitaxel during the Lead-in Period, stopped following Cycle 1 (prior to 
surgery), and resumed in Cycle 4. For participants eligible for primary debulking surgery, 
bevacizumab (if using) should be initiated in Cycle 1. The investigator may wait to 
administer the first dose of bevacizumab, as long as it is administered by Cycle 4 (but it 
may be started sooner). Any delay in starting/restarting bevacizumab beyond what is 
defined in the protocol require Sponsor approval. If using, bevacizumab should be
continued with chemotherapy and study treatment as per the local SOC and approved 
product label. 
Participants must be candidates for either primary or interval debulking surgery. Primary 
debulking surgery may be, but does not need to be, performed within the 56-day Screening 
Period. Participants should initiate lead-in chemotherapy when clinically appropriate but no 
longer than 7 weeks following primary debulking surgery. (Figure 2). Participants having 
primary debulking surgery should receive 6 treatment cycles (including lead-in) of adjuvant 
carboplatin/paclitaxel plus either pembrolizumab or pembrolizumab placebo. Alternatively, 
participants who are candidates for interval debulking surgery will receive 2 cycles of 
carboplatin/paclitaxel plus either pembrolizumab or pembrolizumab placebo prior to surgery 
(neoadjuvant treatment) and another 3 cycles of carboplatin/paclitaxel plus either 
pembrolizumab or pembrolizumab placebo after surgery (adjuvant treatment). Participants 
should resume study treatment when clinically appropriate but no longer than 7 weeks 
following interval debulking surgery (Figure 3).
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Participants with stable disease (SD), PR, CR, or non-progressive disease (PD) will enter the 
Maintenance Period. Participants with disease progression will be discontinued from the 
study (Section 7.1). The Maintenance Period (continued pembrolizumab treatment plus 
olaparib maintenance [Arm 1], continued pembrolizumab treatment plus olaparib placebo 
[Arm 2], or continued pembrolizumab placebo plus olaparib placebo [Arm 3]) will start at 
Cycle 7. Participants who are not able to complete 6 treatment cycles (including lead-in) of 
chemotherapy due to toxicity, may be eligible to start the Maintenance Period as early as 
Cycle 2 following consultation with the Sponsor. Note: participants may be able to start the 
Maintenance Period and receive only pembrolizumab or pembrolizumab placebo following 
consultation with the Sponsor.
Pembrolizumab and pembrolizumab placebo may continue for up to 35 infusions 
(approximately 2 years starting with the first infusion in Cycle 1) or until meeting criteria for 
discontinuation of study treatment (Section 7.1). Participants who have no evidence of 
disease (NED) will stop olaparib or olaparib placebo after 2 years, calculated from the first 
dose of olaparib or olaparib placebo. Participants who continue to have evidence of disease
without evidence of disease progression at this time will continue olaparib or olaparib 
placebo until meeting criteria for discontinuation of study treatment (Section 7.1).
Participants will be evaluated with radiographic imaging to assess response to treatment at 
regular intervals during the study (Section 8.2.1). Participants will continue with imaging 
until disease progression is radiographically documented by the investigator per RECIST 1.1
(Section 8.2.1.4), and when clinically appropriate, confirmed by the site per modified 
RECIST 1.1 for immune-based therapeutics (iRECIST), initiating a new anticancer
treatment, withdrawal of consent, becoming lost to follow-up, pregnancy or death
(Section 8.2.1.5). All imaging obtained on study will be submitted to the central imaging 
vendor for retrospective assessment of PFS per RECIST 1.1 by BICR.
Tumor marker data (ie, CA-125) will not be used for defining PD to evaluate progression-
related primary and secondary objectives; however, CA-125 may be used to make clinical 
decisions, including the decision to discontinue a participant from study treatment
(Section 7.1). Clinical criteria such as the Gynecologic Cancer Intergroup criteria (see 
Appendix 9) will also be considered for the management of clinical events (eg, bowel 
obstruction) without radiographic disease progression. Participants who discontinue due to 
CA-125 increase and concurrent malignant bowel obstruction will have posttreatment follow-
up imaging to evaluate disease status until disease progression is radiographically 
documented per RECIST 1.1 by the investigator as outlined in Section 8.2.1.3.
AE monitoring will be ongoing throughout the study and graded in severity according to the 
guidelines outlined in the NCI CTCAE version 4.03 (v4). AEs will be reported by the 
investigator or delegate through 30 days following cessation of study treatment. Serious AEs
(SAEs) will be reported by the investigator or delegate through 90 days following cessation 
of study treatment or 30 days following cessation of study treatment if the participant 
initiates new anticancer therapy, whichever is earlier.
As of Amendment 05, all blood collections for ctDNA analysis and all PRO collections 
will be discontinued.
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Specific procedures to be performed during the study, as well as their prescribed times and 
associated visit windows, are outlined in the SoA, Section 1.3. Details of each procedure are 
provided in Section 8.
After the final analysis, participants may be transitioned to an extension study, if available.
Data Monitoring Committee
This study will use an independent, external data monitoring committee (eDMC) to monitor 
safety and efficacy (Section 9.7). The eDMC will review unblinded safety data at regular 
intervals throughout the study and efficacy data at prespecified interim analyses, as outlined 
in the eDMC charter.
Interim Analyses
Scientific Rationale for Study Design
Rationale for Endpoints
Efficacy Endpoints
This study will use PFS as the primary endpoint and OS as a key secondary endpoint as 
outlined in Section 3.
This study will use PFS based on RECIST 1.1 criteria as assessed by the investigator as the 
primary endpoint. PFS is an acceptable measure of clinical benefit for a late stage study that 
demonstrates superiority of a new antineoplastic therapy, especially if the magnitude of the 
effect is large and the therapy has an acceptable risk/benefit profile. Additionally, as a 
secondary objective, images will be read by a central imaging vendor blinded to treatment 
assignment to minimize bias in the response assessments.
OS has been recognized as the gold standard for the demonstration of superiority of a new 
antineoplastic therapy in randomized clinical studies.
RECIST 1.1
RECIST 1.1 will be used by the investigator when assessing images for primary efficacy 
(Section 8.2.1.4). Although traditional RECIST 1.1 references a maximum of 5 target lesions 
in total and 2 per organ, this protocol has implemented an adjustment to RECIST 1.1 to allow 
a maximum of 10 target lesions in total and 5 per organ.
Modified RECIST 1.1 for Immune-based Therapeutics
RECIST 1.1 will be adapted to account for the unique tumor response seen following 
treatment with pembrolizumab (Section 8.2.1.5). Immunotherapeutic agents such as 
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pembrolizumab may produce antitumor effects by potentiating endogenous cancer-specific 
immune responses. The response patterns seen with such an approach may extend beyond the 
typical time course of responses seen with cytotoxic agents, and patients treated with 
pembrolizumab may manifest a clinical response after an initial increase in tumor burden or 
even the appearance of new lesions. 
Thus, standard RECIST 1.1 may not provide an accurate response assessment of 
immunotherapeutic agents such as pembrolizumab. Based on an analysis of participants with 
melanoma enrolled in KEYNOTE-001 (KN001), 7% of evaluable participants experienced 
delayed or early tumor pseudoprogression. Of note, participants who had PD by RECIST 1.1 
but not by the immune-related response criteria [Wolchok, J. D., et al 2009], had longer OS 
than participants with PD by both criteria [Hodi, F. S., et al 2014]. Additionally, the data 
suggest that RECIST 1.1 may underestimate the benefit of pembrolizumab in approximately 
15% of participants. These findings support the need to apply a modification to RECIST 1.1 
that takes into account the unique patterns of atypical response in immunotherapy and enable 
treatment beyond initial radiographic progression, if the participant is clinically stable. 
iRECIST assessment has been developed and published by the RECIST Working Group, 
with input from leading experts from industry and academia, along with participation from 
the US FDA and the European Medicines Agency (EMA) [Seymour, L., et al 2017]. The 
unidimensional measurement of target lesions, qualitative assessment of non-target lesions, 
and response categories are identical to RECIST 1.1, until progression is seen by 
RECIST 1.1. However, if a participant is clinically stable, additional imaging may be 
performed to confirm radiographic progression. iRECIST will be used by investigators to 
assess tumor response and progression and make treatment decisions, as well as for 
exploratory efficacy analyses where specified.
Safety Endpoints
Safety parameters commonly used for evaluating investigational systemic anticancer
treatments include, but are not limited to, the incidence of, causality, and outcome of 
AEs/SAEs; and changes in vital sign measurements and laboratory values. AEs will be 
assessed as defined by NCI CTCAE v4.03.
Patient-reported Outcomes
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Rationale for the Use of Comparator/Placebo
Carboplatin and paclitaxel represent the current SOC for the first-line treatment of advanced 
EOC. Docetaxel may be considered for participants who either experience a severe 
hypersensitivity reaction or an AE that requires discontinuation of paclitaxel only after 
Sponsor consultation. The use of a placebo for pembrolizumab and olaparib will ensure the 
objectivity of investigator- and centrally-assessed progression and safety, as well as any 
decisions to interrupt/discontinue therapy.
Justification for Dose
Rationale for Pembrolizumab Dosing Regimen
The planned dose of pembrolizumab for this study is 200 mg Q3W. Based on the totality of 
data generated in the KEYTRUDA development program, 200 mg Q3W is the appropriate 
dose of pembrolizumab for adults across all indications and regardless of tumor type.
Rationale for Olaparib Dosing Regimen
The dose of olaparib used in this study is 300 mg BID (tablet formulation) and is the current 
approved dose.
Rationale for Chemotherapy and Bevacizumab Dosing Regimen
The dosing regimens of carboplatin and paclitaxel that will be used in this study are 
reflective of current clinical practice. The dose of docetaxel, if approved by the Sponsor, 
reflects the recommended dose for OC as determined by the SGCTG group [Vasey, P. A., et 
al 2004]. The use of bevacizumab is allowed at the investigator’s discretion, where approved 
for the front-line treatment of EOC, as per the local SOC and approved product label.
Beginning and End of Study Definition
The overall study begins when the first participant (or their legally acceptable representative) 
provides documented informed consent. The overall study ends when the last participant 
completes the last study-related contact, withdraws consent, or is lost to follow-up (Section 
7.3). For purposes of analysis and reporting, the overall study ends when the Sponsor 
receives the last laboratory test result or at the time of final contact with the last participant, 
whichever comes last.
If the study includes countries in the EEA, the local start of the study in the EEA is defined 
as FSR in any Member State.
The Sponsor estimates that the maximum duration of the study from first participant entered 
through long-term follow-up will be approximately 7 years to attain the final assessment of 
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the study (eg, to evaluate safety and/or long-term efficacy) for all evaluable participants. 
Refer to the Synopsis, Section 1.1, for the duration of participation of participants.
Clinical Criteria for Early Study Termination
The clinical study may be terminated early if the extent (incidence and/or severity) of 
emerging effects/clinical endpoints is such that the risk/benefit ratio to the study population 
as a whole is unacceptable. In addition, further recruitment in the study or at (a) particular 
study site(s) may be stopped due to insufficient compliance with the protocol, Good Clinical 
Practice (GCP) and/or other applicable regulatory requirements, procedure-related problems 
or the number of discontinuations for administrative reasons is too high.
5. Study Population
Female participants of at least 18 years of age with EOC, fallopian tube cancer, or primary 
peritoneal cancer will be enrolled in this study.
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted.
As stated in the Code of Conduct for Clinical Trials (Section 10.1.1), this study uses 
participants of varying age (as applicable), race, and ethnicity. The collection and use of 
these demographic data will follow all local laws and participant confidentiality guidelines 
while supporting the study of the disease, its related factors, and the IMP under investigation.
Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Type of Participant and Disease Characteristics
1. Participant has histologically confirmed FIGO Stage III or Stage IV EOC (high-grade 
predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with 
high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal 
cancer, or fallopian tube cancer.
Note:  Enrollment of participants with low-grade serous OC will be capped at 4% of the 
total population.
2. Participant has just completed primary debulking surgery or is eligible for primary
debulking surgery or is a potential candidate for interval debulking surgery.
3. Participant is a candidate for carboplatin and paclitaxel chemotherapy, to be administered 
in the adjuvant or neoadjuvant setting.
4. Participant that is a candidate for neoadjuvant chemotherapy has a CA-125 
(kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25 
[Vergote, I., et al 2010].
Note: if the serum CA-125/CEA ratio is less than 25, then a workup should be negative 
for the presence of a non-OC to determine eligibility (eg, breast or gastrointestinal
cancers [including CRC]).
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5. Participant is able to provide a newly obtained core or excisional biopsy of a tumor lesion
for prospective testing of BRCA1/2 and PD-L1 status prior to randomization.
Note: Newly obtained tissue may be obtained at any time prior to the administration of 
systemic cytotoxic treatment for the treatment of current OC. Both formalin-fixed 
paraffin-embedded (FFPE) tumor blocks and slides are acceptable. If submitting 
unstained cut slides, freshly cut slides should be submitted to the testing laboratory 
within 14 days from the date the slides are cut.
Demographics
6. Participant is female and at least 18 years of age on the day of signing informed consent.
7. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 
0 or 1, as assessed within 7 days prior to initiating chemotherapy in the Lead-in Period 
and within 3 days prior to Day 1 of Cycle 1.
Female participants:
8. A female participant is eligible to participate if she is not pregnant or breastfeeding, and 
at least 1 of the following conditions applies:
•
Is not a woman of childbearing potential (WOCBP)
OR
•
Is a WOCBP and using a contraceptive method that is highly effective (with a failure 
rate of <1% per year), with low user dependency, or be abstinent from heterosexual 
intercourse as their preferred and usual lifestyle (abstinent on a long-term and 
persistent basis), as described in Appendix 3 during the Treatment Period and for at 
least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) 
and bevacizumab (if administered), at least 180 days following the last dose of 
olaparib (or olaparib placebo), and at least 210 days following the last dose of 
chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store 
for her own use for the purpose of reproduction during this period. The investigator 
should evaluate the potential for contraceptive method failure (ie, noncompliance, 
recently initiated) in relationship to the first dose of study treatment. Refer to 
Appendix 7 for country-specific requirements.
•
A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as 
required by local regulations) within either 24 hours (urine) or 72 hours (serum) 
before the first dose of study treatment.
•
If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum 
pregnancy test is required. In such cases, the participant must be excluded from 
participation if the serum pregnancy result is positive.
•
Additional requirements for pregnancy testing during and after study treatment are 
located in Appendix 3.
•
The investigator is responsible for review of medical history, menstrual history, and 
recent sexual activity to decrease the risk for inclusion of a woman with an early 
undetected pregnancy.
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•
Contraceptive use by women should be consistent with local regulations regarding the 
methods of contraception for those participating in clinical studies. If the 
contraception requirements in the local label for any of the study interventions is 
more stringent than the requirements above, the local label requirements are to be 
followed.
Informed Consent
9. The participant (or legally acceptable representative if applicable) provides written
informed consent for the study. The participant may also provide consent for future 
biomedical research; however, the participant may participate in the main study without 
participating in future biomedical research.
Laboratory Values
10. Participant has adequate organ function as defined in Table 1; all screening laboratory 
tests should be performed within 7 days prior to starting chemotherapy in the Lead-in 
Period.
Table 1
Adequate Organ Function Laboratory Values
System
Laboratory Value
Hematological
Absolute neutrophil count (ANC)
≥1500/µL
Platelets
≥100 000/µL
Hemoglobin
≥9.0 g/dL or ≥5.6 mmol/La
Renal
Creatinine OR
Measured or calculatedb creatinine clearance
(GFR can also be used in place of creatinine or 
CrCl)
≤1.5 × ULN OR
≥51 mL/min for participant with creatinine levels 
>1.5 × institutional ULN
Hepatic
Total bilirubin
≤1.5 ×ULN OR direct bilirubin ≤ULN for 
participants with total bilirubin levels >1.5 × ULN
AST (SGOT) and ALT (SGPT)
≤2.5 × ULN (≤5 × ULN for participants with liver 
metastases)
Coagulation
International normalized ratio (INR) OR 
prothrombin time (PT)
Activated partial thromboplastin time (aPTT) or 
partial thromboplastin time (PTT)c
≤1.5 × ULN unless participant is receiving 
anticoagulant therapy as long as PT or aPTT is 
within therapeutic range of intended use of 
anticoagulants
ALT (SGPT)=alanine aminotransferase (serum glutamic-pyruvic transaminase); AST (SGOT)=aspartate 
aminotransferase (serum glutamic-oxaloacetic transaminase); CrCl=creatinine clearance; GFR=glomerular filtration 
rate; ULN=upper limit of normal.
Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements 
should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.
a.
Criteria must be met without erythropoietin dependency. Transfusion of packed red blood cells is allowed.
b.
Creatinine clearance (CrCl) should be calculated per institutional standard.
c.
PTT may be performed if the local lab is unable to perform aPTT.
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Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions 
1. Participant has mucinous, germ cell, or borderline tumor of the ovary.
2. Participant has a known or suspected deleterious mutation (germline or somatic) in either 
BRCA1 or BRCA2.
3. Participant has a history of non-infectious pneumonitis that required treatment with 
steroids or currently has pneumonitis.
4. Participant either has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) 
or has features suggestive of MDS/AML.
5. Participant has a known additional malignancy that is progressing or has required active 
treatment in the last 3 years.
Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the 
skin, or carcinoma in situ (eg, ductal carcinoma in situ, cervical carcinoma in situ) that 
has undergone potentially curative therapy are not excluded.
Note: Participants with synchronous primary endometrial cancer or a past history of 
primary endometrial cancer that met the following conditions are not excluded: Stage not 
greater than I-A; no more than superficial myometrial invasion, without vascular or 
lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear 
cell or other FIGO Grade 3 lesions.
6. Participant has ongoing Grade 3 or Grade 4 toxicity, excluding alopecia, following 
chemotherapy administered during the Lead-in Period.
7. Participant has known active central nervous system metastases and/or carcinomatous 
meningitis. Participants with brain metastases may participate provided they were 
previously treated (except with chemotherapy) and are radiologically stable, clinically 
stable, and no steroids were used for the management of symptoms related to brain 
metastases within 14 days prior to randomization. Stable brain metastases should be 
established prior to the first dose of lead-in chemotherapy.
Note: Participants with known untreated, asymptomatic brain metastases (ie, no 
neurological symptoms, no requirement for corticosteroids, no or minimal surrounding 
edema, and no lesion >1.5 cm) may participate but will require regular imaging of the 
brain as a site of disease. 
8. Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid 
therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other form of 
immunosuppressive therapy within 7 days prior to randomization.
9. Participant has an active autoimmune disease that has required systemic treatment in the 
past 2 years (ie, with use of disease modifying agents, corticosteroids or 
immunosuppressive drugs).
Note: Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid 
replacement therapy for adrenal or pituitary insufficiency) is not considered a form of 
systemic treatment and is allowed.
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10. Participant has a known history of active tuberculosis (TB; Bacillus Tuberculosis).
11. Participant has an active infection requiring systemic therapy.
12. Participant has a history or current evidence of any condition (eg, cytopenia, transfusion-
dependent anemia, or thrombocytopenia), therapy, or laboratory abnormality that might 
confound the results of the study, interfere with the participant’s involvement for the full 
duration of the study, or is not in the best interest of the participant to be involved, in the 
opinion of the treating investigator.
13. Participant has received colony-stimulating factors (eg, granulocyte colony-stimulating 
factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF] or 
recombinant erythropoietin) within 4 weeks (28 days) prior to receiving chemotherapy 
during the Lead-in Period.
14. Participant is considered to be of poor medical risk due to a serious, uncontrolled medical 
disorder, non-malignant systemic disease or active, uncontrolled infection. Examples 
include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 
3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal 
cord compression, superior vena cava syndrome, or extensive interstitial bilateral lung 
disease on high-resolution computed tomography (HRCT) scan.
15. Participant has had surgery <6 months prior to screening to treat borderline tumors, early-
stage EOC or early-stage fallopian tube cancer.
16. Participant has a known psychiatric or substance abuse disorder that would interfere with 
the ability to cooperate with the requirements of the study.
17. Participant has a known history of human immunodeficiency virus (HIV) infection. HIV 
testing is required at screening only if mandated by local health authority. Refer to 
Appendix 7 for country-specific requirements.
18. Participant has a known history of hepatitis B (defined as hepatitis B surface antigen 
[HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] 
is detected) infection. Testing for hepatitis B or hepatitis C is required at screening only if 
mandated by local health authority. Refer to Appendix 7 for country-specific 
requirements.
Note: Participants with a history of hepatitis B but who are HBsAg negative are eligible 
for the study.
19. Participant is either unable to swallow orally administered medication or has a 
gastrointestinal disorder affecting absorption (eg, gastrectomy, partial bowel obstruction, 
malabsorption).
20. Participant has uncontrolled hypertension.
Note:  This applies only to participants who will receive bevacizumab during the Lead-in 
Period and should be confirmed prior to the first administration of bevacizumab. Use of 
antihypertensive medications to control blood pressure is allowed.
21. Participant has current, clinically relevant bowel obstruction (including sub-occlusive 
disease), abdominal fistula or gastrointestinal perforation, related to underlying EOC.
Note: This applies only to participants who will receive bevacizumab.
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22. Participant has a history of hemorrhage, hemoptysis or active gastrointestinal bleeding 
within 6 months prior to randomization.
Note: This applies only to participants who will receive bevacizumab.
23. A WOCBP who has a positive urine pregnancy test within 72 hours before the first dose 
of chemotherapy in the Lead-in Period and within 72 hours prior to Day 1 of Cycle 1 (see 
Appendix 3), is pregnant or breastfeeding, or is expecting to conceive children within the 
projected duration of the study, starting with screening through 120 days following the 
last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if 
administered), at least 180 days following the last dose of olaparib (or olaparib placebo),
and at least 210 days following the last dose of chemotherapy. 
Note:  If the urine test cannot be confirmed as negative, a serum pregnancy test is 
required. In such cases, the participant must be excluded from participation if the serum 
pregnancy result is positive.
Prior/Concomitant Therapy
24. Participant has received prior treatment for any stage of OC, including radiation or 
systemic anticancer therapy (eg, chemotherapy, hormonal therapy, immunotherapy, 
investigational therapy).
Note:  Treatment with 1 cycle of standard of care chemotherapy (lead-in dose) for EOC, 
fallopian tube cancer, or primary peritoneal cancer prior randomization in the study is 
allowed.
25. Participant has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 
agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, 
CTLA-4, OX 40, CD137).
26. Participant has received prior therapy with either olaparib or any other PARP inhibitor.
27. Is a participant for whom intraperitoneal chemotherapy is planned or has been 
administered as first-line therapy.
28. Participant has received a live vaccine within 30 days prior to the first dose of study 
treatment on Day 1 of Cycle 1. Examples of live vaccines include, but are not limited to, 
the following:  measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, 
rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza 
vaccines for injection are generally killed virus vaccines and are allowed; however, 
intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not 
allowed.
29. Participant has severe hypersensitivity (≥Grade 3) to pembrolizumab, olaparib, 
carboplatin, paclitaxel, or bevacizumab (if using) and/or any of their excipients.
Note: If severe hypersensitivity to paclitaxel occurs during lead-in, docetaxel may be 
considered instead of paclitaxel after consultation with the Sponsor.
30. Participant is currently receiving either strong (eg, itraconazole, telithromycin, 
clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, 
saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg. ciprofloxacin, 
erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 
(CYP)3A4 that cannot be discontinued prior to starting olaparib or olaparib placebo and 
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for the duration of the study. The required washout period prior to starting olaparib is 2 
weeks.
Note: A current list of strong/moderate inhibitors of CYP3A4 can be found at the 
following website: https://www.fda.gov/drugs/drug-interactions-labeling/drug-
development-and-drug-interactions-table-substrates-inhibitors-and-inducers
31. Participant is currently receiving either strong (eg, phenobarbital, phenytoin, rifampicin, 
rifabutin, rifapentine, carbamazepine, nevirapine, and St John’s Wort) or moderate (eg. 
bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued prior to 
starting olaparib or olaparib placebo and for the duration of the study. The required 
washout period prior to starting olaparib is 5 weeks for phenobarbital and 3 weeks for 
other agents.
Note: A current list of strong/moderate inducers of CYP3A4 can be found at the following 
website: https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-
drug-interactions-table-substrates-inhibitors-and-inducers
Prior/Concurrent Clinical Study Experience
32. Participant is currently participating or has participated in a study of an investigational 
agent or has used an investigational device within 4 weeks (28 days) of starting 
chemotherapy in the Lead-in Period.
Note: Participants who have entered the follow-up phase of an investigational study may 
participate as long as it has been 4 weeks (28 days) after the last dose of the previous 
investigational agent.
Diagnostic Assessments
33. Participant has resting electrocardiogram (ECG) indicating uncontrolled, potentially 
reversible cardiac conditions, as judged by the investigator (eg, unstable ischemia, 
uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation 
>500 ms, electrolyte disturbances, etc.), or participant has congenital long QT syndrome.
Other Exclusions
34. Participant has had an allogenic tissue/solid organ transplant, has received previous 
allogenic bone marrow transplant, or has received double umbilical cord transplantation.
35. Participant either had major surgery within 3 weeks of randomization or has not 
recovered from any effects of any major surgery.
Note: Participants can start chemotherapy during the Lead-in Period as soon as 
clinically relevant after primary debulking, provided they have adequately recovered.
36. Participant, in the judgement of the investigator, is unlikely to comply with the study 
procedures, restrictions, and requirements of the study.
Refer to Appendix 7 for additional country-specific requirements.
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Lifestyle Considerations
Meals and Dietary Restrictions
During the Maintenance Period, participants should avoid grapefruit, grapefruit juice, Seville 
oranges, Seville orange juice, and St. John’s Wort (tablet or tea) while receiving study 
treatment. Otherwise, participants should maintain a normal diet unless modifications are 
required to manage an AE such as diarrhea, nausea, or vomiting.
Activity Restrictions
AEs related to olaparib may include asthenia, fatigue and dizziness. Therefore, participants 
should be advised to use caution while driving or using machinery if these symptoms occur.
Screen Failures
Screen failures are defined as participants who consent to participate in the clinical study but 
are not subsequently randomized. A minimal set of screen failure information is required to 
ensure transparent reporting of screen failure participants to meet the Consolidated Standards 
of Reporting Trials (CONSORT) publishing requirements and to respond to queries from 
regulatory authorities. Minimal information includes demography, screen failure details, 
eligibility criteria, and any AEs or SAEs meeting reporting requirements as outlined in the 
data entry guidelines.
Participant Replacement Strategy
A participant who is discontinued from study treatment or withdraws from the study will not 
be replaced.
6. Study Intervention
Study treatment is defined as any investigational treatment(s), marketed product(s), placebo,
or medical device(s) intended to be administered to a study participant according to the study 
protocol.
Clinical supplies [study treatment(s) provided by the Sponsor] will be packaged to support 
enrollment. Clinical supplies will be affixed with a clinical label in accordance with 
regulatory requirements.
Treatments Administered
The study treatment(s) to be used in this study are outlined below in Table 2.
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Table 2
Study Treatment(s)
Study Treatment 
Name
Dose 
Formulation
Unit Dose 
Strength(s)
Dosage 
Level(s)
Route of 
Administration
Regimen/Treatment 
Period/Vaccination 
Regimen
Use
IMP or 
NIMP/AxMP
Sourcing
Pembrolizumab
Solution for 
infusion
25 mg/mL
200 mg
IV
Q3W; Day 1 of each 3-
week cycle
Test product
IMP
Central
Placebo for 
pembrolizumab 
(normal saline or 
dextrose)
Solution for 
infusion
N/A
N/A
IV
Q3W; Day 1 of each 3-
week cycle
Placebo
IMP
Local
Olaparib
Tablet
150 mg
100 mg
300 mg
Oral
BID 
during 
each 
treatment cycle
Test product
IMP
Central
Placebo for olaparib
Tablet
N/A
N/A
Oral
BID 
during 
each 
treatment cycles
Placebo
IMP
Central
Carboplatin
Solution for 
infusion
10 mg/mL
(60 mL)
AUC5-AUC6 
IV
Q3W; Day 1 of each 3-
week cycle
Background 
therapy
NIMP/AxMP
Local or 
Central
AUC2-
AUC2.7
QW; Day 1, 8, and 15 
of each 3-week cycle
Paclitaxel
Solution for 
infusion
6 mg/mL
(16.7 mL)
175 mg/m2
IV
Q3W; Day 1 of each 
cycle
Background 
therapy
NIMP/AxMP
Local or 
central
80 mg/m2
QW; Day 1, 8, and 15 
of each 3-week cycle
60 mg/m2
QW; Day 1, 8, and 15 
of each 3-week cycle
Docetaxel
Solution for 
infusion
20 mg/mL
75 mg/m2
IV
Q3W, Day 1 of each 
cycle
Background 
therapy
NIMP/AxMP
Local or 
central
Bevacizumab
Solution for 
infusion
25 mg/mL
(4 mL)
Variable
IV
Q3W; Day 1 of each 3-
week cycle
Background 
therapy
NIMP/AxMP
Local
AUC=area under the concentration-time curve; BID=twice daily; EEA=European Economic Area; IMP=Investigational Medicinal Product; IV=intravenous; N/A=not 
applicable; NIMP/AxMP=Noninvestigational Medicinal Product/auxiliary medicinal product; Q3W=every 3 weeks; QW=every week; SOC=standard of care.
Note: The classification of IMP and NIMP/AxMP is based on guidance issued by the European Commission and applies to countries in the EEA. Country differences with 
respect to the classification/definition of IMP and NIMP/AxMP may exist. In these circumstances, local legislation is followed.
Note: In this protocol, placebo for pembrolizumab is diluent alone (normal saline and/or dextrose); diluent is used for blinding purposes and does not contain active ingredients.
Note: The 300 mg dose of olaparib should be made up of 2 × 150 mg tablets; 100 mg tablets are provided for dose reductions as outlined in Section 6.6.2.
Note: Docetaxel may only be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel 
only after consultation with the Sponsor.
Note: The unit dose strength of chemotherapy may vary depending on market availability.
Note: Carboplatin and paclitaxel (or docetaxel) administered during the Lead-in Period will be sourced locally.
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Placebo for olaparib was created to match the active product.
All supplies indicated in Table 2 will be provided per the ‘Sourcing’ column depending upon 
local country operational requirements. Every attempt should be made to source these 
supplies from a single lot/batch number.
Refer to Section 8.1.9 for details regarding administration of the study treatment.
Refer to Appendix 7 for country-specific requirements.
Preparation/Handling/Storage/Accountability
Dose Preparation
The Pharmacy Manual contains specific instructions for pembrolizumab and pembrolizumab 
placebo reconstitution, preparation of the infusion fluid, and administration. 
Olaparib and olaparib placebo are tablets for oral administration; no preparation is required. 
Olaparib and matching placebo will be provided in high-density polyethylene bottles with 
child-resistant closures. Each bottle will be labeled in accordance with Good Manufacturing 
Practice Annex 13 and per country regulatory requirement.
Carboplatin, paclitaxel, docetaxel, and bevacizumab should be prepared per local and 
institutional guidelines according to the approved product labels.
Handling, Storage, and Accountability
The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study treatment received and any discrepancies are reported 
and resolved before use of the study treatment.
Only participants enrolled in the study may receive study treatment and only authorized site 
staff may supply or administer study treatment. All study treatments must be stored in a 
secure, environmentally controlled, and monitored (manual or automated) area in accordance 
with the labeled storage conditions with access limited to the investigator and authorized site 
staff.
The investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study treatment accountability, reconciliation, and record maintenance (ie, 
receipt, reconciliation, and final disposition records).
For all study sites, the local country Sponsor personnel or designee will provide appropriate 
documentation that must be completed for drug accountability and return, or local discard 
and destruction if appropriate. Where local discard and destruction is appropriate, the 
investigator is responsible for ensuring that a local discard/destruction procedure is 
documented.
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The study site is responsible for recording the lot number, manufacturer, and expiry date for 
any locally purchased product (if applicable) as per local guidelines unless otherwise 
instructed by the Sponsor.
The investigator shall take responsibility for and shall take all steps to maintain appropriate 
records and ensure appropriate supply, storage, handling, distribution and usage of study 
treatments in accordance with the protocol and any applicable laws and regulations.
Measures to Minimize Bias: Randomization and Blinding
Method of Treatment Assignment
Treatment allocation/randomization will occur centrally using an interactive response 
technology (IRT) system. There are 3 study treatment arms. Participants will be assigned 
randomly in a 1:1:1 ratio to Arm 1, Arm 2, or Arm 3, respectively.
Stratification
Treatment allocation/randomization will be stratified according to the following factors:
1. Surgery: planned interval debulking versus R0 following primary debulking versus R1 
following primary debulking
2. Bevacizumab use (yes versus no)
3. PD-L1 status (CPS <10 versus CPS ≥10)
Blinding
A double-blinding technique with in-house blinding will be used. Pembrolizumab and 
pembrolizumab placebo will be prepared and/or dispensed in a blinded fashion by an 
unblinded pharmacist or other qualified site personnel. Olaparib and olaparib placebo will be 
supplied as either 150-mg or matching tablets and will be administered orally BID 
continuously starting in the Maintenance Period. Additionally, either 100-mg or matching 
tablets will be provided for dose reductions as outlined in Section 6.6.2. The participant, the 
investigator and Sponsor personnel or delegate(s) who are involved in the study treatment 
administration or clinical evaluation of the participants are unaware of the group 
assignments.
See Section 8.1.11 for a description of the method of unblinding a participant during the 
study, should such action be warranted.
Treatment Compliance
If there are interruptions in the study intervention schedule, the details of and reason for any 
interruption of study intervention will be documented in the participant’s medical record.
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Pembrolizumab, Pembrolizumab Placebo, Carboplatin, Paclitaxel (or 
Docetaxel), and Bevacizumab Compliance
Administration of IV pembrolizumab, pembrolizumab placebo, carboplatin, paclitaxel (or 
docetaxel), and bevacizumab (if using) will be monitored by the investigator and/or study 
staff. The total volume of study treatment infused will be compared with the total volume 
prepared to determine compliance with each dose administered. 
Pembrolizumab/pembrolizumab placebo, chemotherapy, and bevacizumab (if using) can be 
administered on an out-patient basis.
Interruptions from either the protocol-specified pembrolizumab/pembrolizumab placebo or 
carboplatin/paclitaxel (or docetaxel), and bevacizumab (if using) treatment plan require 
consultation between the investigator and the Sponsor and written documentation of the 
collaborative decision on participant management (Section 7.1):
•
Pembrolizumab or pembrolizumab placebo is interrupted for greater than 3 weeks for 
situations other than treatment-related AEs such as medical/surgical events or logistical 
reasons not related to study treatment
•
Pembrolizumab or pembrolizumab placebo is interrupted for greater than 12 weeks for
treatment-related AEs
•
Carboplatin and paclitaxel (or docetaxel) or bevacizumab are interrupted for greater than 
6 consecutive weeks
•
Carboplatin and paclitaxel (or docetaxel) are discontinued
Olaparib Compliance
Interruptions from the protocol-specified treatment plan for ≥4 weeks (28 days) will require 
consultation between the investigator and the Sponsor and written documentation of the 
collaborative decision on participant management. 
Participants should be given clear instructions on how and when to take their study 
intervention. Participants will self-administer olaparib or olaparib placebo except when a 
clinic visit is scheduled. Study site staff will make tablet counts at regular intervals during 
treatment. After the tablet count has been performed, the remaining tablets will not be 
returned to the participant but will be retained by the investigative site until reconciliation is 
completed by the study monitor. All participants must return their bottle(s) of 
olaparib/olaparib placebo at the appropriate scheduled visit, when a new bottle will be 
dispensed. Participants will be instructed to notify study site personnel of missed doses.
Interruptions from the protocol-specified olaparib/olaparib placebo treatment plan for
>28 consecutive days require consultation between the investigator and the Sponsor and 
written documentation of the collaborative decision on participant management.
Concomitant Therapy
Medications or vaccinations specifically prohibited in the exclusion criteria are not allowed 
during the ongoing study. If there is a clinical indication for any medication or vaccination 
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specifically prohibited, discontinuation from study treatment may be required. The 
investigator should discuss any questions regarding this with the Sponsor Clinical Director. 
The final decision on any supportive therapy or vaccination rests with the investigator and/or 
the participant's primary physician. However, the decision to continue the participant on 
study treatment requires the mutual agreement of the investigator, the Sponsor and the 
participant.
All medications received within 56 days prior to randomization and up to 30 days after the 
last dose of study treatment should be recorded. If a participant experiences an SAE or event 
of clinical interest (as defined in Section 8.4.7), all concomitant medications administered 
30 days after the last dose of study treatment are to be recorded.
Prohibited Concomitant Medications
Listed below are specific restrictions for concomitant therapy or vaccination that are not 
permitted during the study (exceptions noted):
1. Antineoplastic systemic chemotherapy or biological therapy not specified in this 
protocol.
2. Immunotherapy not specified in this protocol.
3. Investigational agents other than pembrolizumab and olaparib.
4. Anticancer hormonal therapy (eg, antiestrogens).
•
Note: Hormone replacement therapy is allowed.
5. Radiation therapy for disease control.
•
Note: Palliative radiation therapy to symptomatic lesions may be allowed following 
Sponsor consultation after assessment of disease progression has been determined.
6. Live or live attenuated vaccines within 30 days prior to the first dose of study treatment
on Day 1 of Cycle 1, while participating in the study, and within 30 days of the last dose 
of study medication. Refer to Appendix 7 for country-specific requirements.
•
Examples of live vaccines include, but are not limited to, the following: measles, 
mumps, rubella, chickenpox, yellow fever, intranasal seasonal influenza, rabies, 
BCG, and typhoid (oral).
•
Note: Seasonal influenza vaccines for injection are generally killed virus vaccines 
and are allowed.
•
Note:  Any licensed COVID-19 vaccine (including for Emergency Use) in a 
particular country is allowed in the study as long as they are mRNA, replication-
incompetent adenoviral vaccines, or inactivated vaccines. These vaccines will be 
treated just as any other concomitant therapy.
Investigational vaccines (ie, those not licensed or approved for Emergency Use) are 
not allowed.
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7. Systemic glucocorticoids for any purpose other than to modulate symptoms from an AE
that is suspected to have an immunologic etiology. 
•
Note:  physiologic doses of corticosteroids not exceeding 10 mg daily of prednisone 
equivalent may be used during the study. Inhaled steroids for the management of 
asthma and prophylactic corticosteroids to avoid allergic reactions or to premedicate 
for chemotherapy and/or bevacizumab may be used during the study
8. Prophylactic cytokines (eg, G-CSF or GM-CSF) should not be administered within 
4 weeks (28 days) prior to the first dose of chemotherapy administered during the Lead-in 
Period, but may be administered in subsequent cycles.
9. Strong and moderate inducers or inhibitors of CYP3A that cannot be discontinued prior 
to starting olaparib or olaparib placebo and for the duration of the study (see Section 5.2).
•
Note: A current list of strong/moderate inducers/inhibitors of CYP3A4 can be found 
at the following website:  https://www.fda.gov/drugs/drug-interactions-labeling/drug-
development-and-drug-interactions-table-substrates-inhibitors-and-inducers
•
Note: Exceptions are outlined in Section 6.6.2.6.
Participants who, in the assessment by the investigator, require the use of any of the 
aforementioned treatments for clinical management should be discontinued from study 
treatment but continue in the study for assessment of disease status and survival.
The exclusion criteria (Section 5.2) describe other medications which are prohibited in this 
study.
There are no prohibited therapies during the Posttreatment Efficacy Follow-up Phase.
Acceptable Concomitant Medications
All treatments that the investigator considers necessary for a participant’s welfare may be 
administered at the discretion of the investigator in keeping with the community standards of 
medical care. All concomitant medication will be recorded on the electronic case report form 
(eCRF) including all prescription, over-the-counter, herbal supplements, and IV medications 
and fluids. If changes occur during the study period, documentation of drug dosage 
frequency, route, and date will also be included on the eCRF.
Based on limited in vitro data, olaparib may increase the exposure to substrates of CYP3A4, 
organic-anion-transporting polypeptide 1B1, organic cation transporter 1/2/3, and multidrug 
and toxic compound extrusion 1/2 and reduce exposure to substrates of CYP2B6. Caution 
should be observed if substrates of these isoenzymes or transporter proteins are co-
administered. A current list of substrates can be found at the following website:
https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-
interactions-table-substrates-inhibitors-and-inducers
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Rescue Medications and Supportive Care
Participants should receive appropriate supportive care measures as deemed necessary by the 
treating investigator. Suggested supportive care measures for the management of AEs with 
potential immunologic etiology are outlined along with the dose modification guidelines in 
Table 3. Where appropriate, these guidelines include the use of oral or IV treatment with 
corticosteroids, as well as additional anti-inflammatory agents if symptoms do not improve 
with administration of corticosteroids. Note that several courses of steroid tapering may be 
necessary as symptoms may worsen when the steroid dose is decreased. For each disorder, 
attempts should be made to rule out other causes such as metastatic disease or bacterial or 
viral infection, which might require additional supportive care. The treatment guidelines are 
intended to be applied when the investigator determines the events to be related to 
pembrolizumab or pembrolizumab placebo. 
Note: If after the evaluation of the event, it is determined not to be related to 
pembrolizumab/pembrolizumab placebo, the investigator does not need to follow the 
treatment guidance. Refer to Table 3 for guidelines regarding dose modification and 
supportive care. 
It may be necessary to perform conditional procedures such as bronchoscopy, endoscopy, or 
skin photography as part of evaluation of the event.
Dose Modification (Escalation/Titration/Other)
Immune-related Events and Dose Modification (Withhold, Treat, Discontinue)
Dose Modification and Toxicity Management for Immune-related AEs 
Associated with Pembrolizumab
AEs associated with pembrolizumab exposure may represent an immune-related response. 
These irAEs may occur shortly after the first dose or several months after the last dose of 
pembrolizumab treatment and may affect more than one body system simultaneously. 
Therefore, early recognition and initiation of treatment is critical to reduce complications. 
Based on existing clinical study data, most irAEs were reversible and could be managed with 
interruptions of pembrolizumab, administration of corticosteroids and/or other supportive 
care. For suspected irAEs, ensure adequate evaluation to confirm etiology or exclude other 
causes. Additional procedures or tests such as bronchoscopy, endoscopy, skin biopsy may be 
included as part of the evaluation. Based on the severity of irAEs, withhold or permanently 
discontinue pembrolizumab and administer corticosteroids. 
Dose modification and toxicity management guidelines for irAEs associated with 
pembrolizumab monotherapy, coformulations, or IO combinations are provided in Table 3.
If pembrolizumab or pembrolizumab placebo is interrupted or discontinued during either the 
adjuvant/neoadjuvant or Maintenance Period, dosing with either chemotherapy or 
olaparib/olaparib placebo, respectively, may continue if the criteria as outlined in 
Section 6.6.2 and Section 6.6.3 have not been met. If both carboplatin and paclitaxel (or 
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docetaxel) are interrupted, pembrolizumab or pembrolizumab placebo should be continued. 
Refer to Appendix 7 for country-specific requirements.
The reason for interruption or discontinuation of pembrolizumab or pembrolizumab placebo 
should be recorded in the eCRF.
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Table 3
Dose Modification and Toxicity Management Guidelines for Immune-related Adverse Events Associated With 
Pembrolizumab Monotherapy, Coformulations or IO Combinations
General instructions:
1. Severe and life-threatening irAEs should be treated with IV corticosteroids followed by oral steroids. Other immunosuppressive treatment should begin if the irAEs are not 
controlled by corticosteroids.
2. Pembrolizumab monotherapy, coformulations or IO combinations must be permanently discontinued if the irAE does not resolve or the corticosteroid dose is not ≤10 mg/day 
within 12 weeks of the last treatment. 
3. The corticosteroid taper should begin when the irAE is ≤ Grade 1 and continue at least 4 weeks.
4. If pembrolizumab monotherapy, coformulations or IO combinations have been withheld, treatment may resume after the irAE decreased to ≤Grade 1 after corticosteroid 
taper.
irAEs
Toxicity Grade 
(CTCAEv4.0)
Action With 
Pembrolizumab 
Monotherapy, 
Coformulations or 
IO Combinations
Corticosteroid and/or Other 
Therapies
Monitoring and Follow-up
Pneumonitis 
Grade 2
Withhold 
•
Administer corticosteroids 
(initial dose of 1-2 mg/kg 
prednisone or equivalent) 
followed by taper
•
Monitor participants for signs and symptoms of 
pneumonitis
•
Evaluate participants with suspected pneumonitis 
with radiographic imaging and initiate 
corticosteroid treatment
•
Add prophylactic antibiotics for opportunistic 
infections
Recurrent Grade 2 
or Grade 3 or 4 
Permanently 
discontinue
Diarrhea / Colitis 
Grade 2 or 3
Withhold
•
Administer corticosteroids 
(initial dose of 1-2 mg/kg 
prednisone or equivalent) 
followed by taper
•
Monitor participants for signs and symptoms of 
enterocolitis (ie, diarrhea, abdominal pain, blood 
or mucus in stool with or without fever) and of 
bowel perforation (ie, peritoneal signs and ileus)
•
Participants with ≥Grade 2 diarrhea suspecting 
colitis should consider GI consultation and 
performing endoscopy to rule out colitis
•
Participants with diarrhea/colitis should be advised 
to drink liberal quantities of clear fluids. If 
sufficient oral fluid intake is not feasible, fluid and 
electrolytes should be substituted via IV infusion.
Recurrent Grade 3 
or Grade 4
Permanently 
discontinue
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irAEs
Toxicity Grade 
(CTCAEv4.0)
Action With 
Pembrolizumab 
Monotherapy, 
Coformulations or 
IO Combinations
Corticosteroid and/or Other 
Therapies
Monitoring and Follow-up
AST / ALT 
Elevation or 
Increased 
Bilirubin
Grade 2
Withhold
•
Administer corticosteroids 
(initial dose of 0.5-1 mg/kg 
prednisone or equivalent) 
followed by taper
•
Monitor with liver function tests (consider weekly 
or more frequently until liver enzyme value 
returned to baseline or is stable)
Grade 3 or 4 
Permanently 
discontinue
•
Administer corticosteroids 
(initial dose of 1-2 mg/kg 
prednisone or equivalent) 
followed by taper
T1DM or 
Hyperglycemia
New onset T1DM 
or 
Grade 3 or 4 
hyperglycemia 
associated with 
evidence of β-cell 
failure
Withhold a
•
Initiate insulin replacement 
therapy for participants 
with T1DM
•
Administer anti-
hyperglycemic in 
participants with 
hyperglycemia
•
Monitor participants for hyperglycemia or other 
signs and symptoms of diabetes
Hypophysitis
Grade 2
Withhold
•
Administer corticosteroids 
and initiate hormonal 
replacements as clinically 
indicated
•
Monitor for signs and symptoms of hypophysitis
(including hypopituitarism and adrenal 
insufficiency)
Grade 3 or 4
Withhold or 
permanently 
discontinue a
Hyperthyroidism 
Grade 2
Continue
•
Treat with non-selective 
beta-blockers (eg, 
propranolol) or 
thionamides as appropriate
•
Monitor for signs and symptoms of thyroid 
disorders
Grade 3 or 4
Withhold or 
Permanently 
discontinue a
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irAEs
Toxicity Grade 
(CTCAEv4.0)
Action With 
Pembrolizumab 
Monotherapy, 
Coformulations or 
IO Combinations
Corticosteroid and/or Other 
Therapies
Monitoring and Follow-up
Hypothyroidism
Grade 2-4
Continue
•
Initiate thyroid 
replacement hormones (eg, 
levothyroxine or 
liothyronine) per standard 
of care
•
Monitor for signs and symptoms of thyroid 
disorders
Nephritis and 
renal dysfunction
Grade 2
Withhold
•
Administer corticosteroids 
(prednisone 1-2 mg/kg or 
equivalent) followed by 
taper
•
Monitor changes of renal function
Grade 3 or 4
Permanently 
discontinue
Myocarditis
Grade 1 
Withhold
•
Based on severity of AE 
administer corticosteroids
•
Ensure adequate evaluation to confirm etiology 
and/or exclude other causes
Grade 2, 3 or 4
Permanently 
discontinue
All Other irAEs
Persistent Grade 2
Withhold
•
Based on severity of AE 
administer corticosteroids
•
Ensure adequate evaluation to confirm etiology or 
exclude other causes
Grade 3
Withhold or 
discontinue b
Recurrent Grade 3 
or Grade 4 
Permanently 
discontinue
AE(s)=adverse event(s); ALT=alanine aminotransferase; AST=aspartate aminotransferase; CTCAE=Common Terminology Criteria for Adverse Events; DRESS=Drug Rash 
with Eosinophilia and Systemic Symptom; GI=gastrointestinal; IO=immune-oncology; ir=immune related; IV=intravenous; SJS=Stevens-Johnson Syndrome; T1DM=type 
1 diabetes mellitus; TEN=Toxic Epidermal Necrolysis; ULN=upper limit of normal.
Note: Non-irAE will be managed as appropriate, following clinical practice recommendations.
a.
The decision to withhold or permanently discontinue pembrolizumab monotherapy, coformulations or IO combinations is at the discretion of the investigator or treating 
physician. If control achieved or ≤ Grade 2, pembrolizumab monotherapy, coformulations or IO combinations may be resumed.
b.
Events that require discontinuation include, but are not limited to: Guillain-Barre Syndrome, encephalitis, myelitis, DRESS, SJS, TEN and other clinically important irAEs 
(eg, vasculitis and sclerosing cholangitis).
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Dose Modification and Toxicity Management of Infusion-Reactions Related to 
Pembrolizumab or Pembrolizumab Placebo
Pembrolizumab may cause severe or life-threatening infusion-reactions, including severe 
hypersensitivity or anaphylaxis. Signs and symptoms usually develop during or shortly after 
drug infusion and generally resolve completely within 24 hours of completion of infusion. 
Dose modification and toxicity management guidelines on pembrolizumab- or 
pembrolizumab placebo-associated infusion reaction are provided in Table 4.
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Table 4
Pembrolizumab or Pembrolizumab Placebo Infusion Reaction Dose Modification and Treatment Guidelines
NCI CTCAE Grade
Treatment
Premedication at Subsequent Dosing
Grade 1
Mild reaction; infusion 
interruption not indicated; 
intervention not indicated
Increase monitoring of vital signs as medically indicated until the participant 
is deemed medically stable in the opinion of the investigator.
None
Grade 2
Requires therapy or infusion 
interruption but responds 
promptly to symptomatic 
treatment (e.g., antihistamines, 
NSAIDs, narcotics, IV fluids); 
prophylactic medications 
indicated for ≤24 hrs
Stop Infusion.
Additional appropriate medical therapy may include but is not limited to:

IV fluids

Antihistamines

NSAIDs

Acetaminophen

Narcotics
Increase monitoring of vital signs as medically indicated until the participant 
is deemed medically stable in the opinion of the investigator.
If symptoms resolve within 1 hour of stopping drug infusion, the infusion may 
be restarted at 50% of the original infusion rate (e.g. from 100 mL/hr to 50 
mL/hr). Otherwise dosing will be held until symptoms resolve and the 
participant should be premedicated for the next scheduled dose.
Participants who develop Grade 2 toxicity despite adequate 
premedication should be permanently discontinued from further study 
drug treatment
Participant may be premedicated 1.5 h (± 
30 minutes) prior to infusion of 
pembrolizumab or pembrolizumab 
placebo with:

Diphenhydramine 50 mg PO (or 
equivalent dose of antihistamine).

Acetaminophen 500-1000 mg PO (or 
equivalent dose of analgesic).
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NCI CTCAE Grade
Treatment
Premedication at Subsequent Dosing
Grades 3 or 4
Grade 3:
Prolonged (ie, not rapidly 
responsive to symptomatic 
medication and/or brief 
interruption of infusion); 
recurrence of symptoms 
following initial improvement; 
hospitalization indicated for 
other clinical sequelae (e.g., 
renal impairment, pulmonary 
infiltrates)
Grade 4:
Life-threatening; pressor or 
ventilatory support indicated
Stop Infusion.
Additional appropriate medical therapy may include but is not limited to:

Epinephrine**

IV fluids

Antihistamines

NSAIDs

Acetaminophen

Narcotics

Oxygen

Pressors

Corticosteroids
Increase monitoring of vital signs as medically indicated until the participant 
is deemed medically stable in the opinion of the investigator.
Hospitalization may be indicated.
**In cases of anaphylaxis, epinephrine should be used immediately.
Participant is permanently discontinued from further study drug 
treatment.
No subsequent dosing
CTCAE=Common Terminology Criteria for Adverse Events; IV=intravenous; NCI=National Cancer Institute; NSAIDs=nonsteroidal anti-inflammatory drugs; PO=by mouth
Note: Appropriate resuscitation equipment should be available at the bedside and a physician readily available during the period of drug administration.
Note: For further information, please refer to the CTCAE v4.0 at http://ctep.cancer.gov.
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Other Pembrolizumab or Pembrolizumab Placebo Dose Interruptions
Pembrolizumab or pembrolizumab placebo may be interrupted for situations other than 
treatment-related AEs such as medical/surgical events or logistical reasons not related to 
study treatment. However, study treatment is to be restarted within 3 weeks (21 days) of the
originally schedule dose and within 42 days of the previously administered dose, unless 
otherwise discussed with the Sponsor. The reason for interruption should be documented in 
the participant’s study record.
Olaparib Dosing Modifications
Olaparib Dose Reduction
The dose of olaparib can be reduced to 250 mg BID initially and then to 200 mg BID as 
needed. If the 200 mg BID dose is not tolerable, no further dose reduction is allowed and 
study treatment should be discontinued. Once dose is reduced, escalation is not permitted 
(except following concomitant treatment with CYP3A4 inhibitors [Table 8]).
The reason for the dose interruption or reduction should be captured on the appropriate 
eCRF. If either olaparib or olaparib placebo is discontinued during the maintenance phase 
due to toxicity, the participant may continue pembrolizumab or pembrolizumab placebo if 
the criteria outlined in Section 6.6.1 have not been met.
Management of Hematological Toxicity
Any hematological toxicity observed during the study could be managed by a brief 
interruption of study treatment or a dose reduction of olaparib or olaparib placebo (Table 5
and Table 6). Repeated interruptions, not exceeding 4 weeks (28 days) duration, are allowed 
as required. If the interruption is any longer, the study team must be informed.
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Table 5
Management of Anemia
Toxicity
NCI CTCAE Grade
Action Taken
Hemoglobin (Hb)
Grade 2
(<10 but ≥8 g/dL)
First Occurrence:
Give appropriate supportive treatment and investigate 
causality.

Investigator judgement to either continue 
olaparib/olaparib placebo with supportive treatment (eg,
transfusion) or interrupt olaparib/olaparib placebo dosing 
for a maximum of 4 weeks (28 days). Treatment can be 
restarted if Hb has recovered to >9 g/dL.
Subsequent Recurrence:

Hb <9 but ≥8 g/dL: Interrupt olaparib/olaparib placebo 
for a maximum of 4 weeks (28 days) until Hb improves 
to >9 g/dL. Upon recovery, reduce the dose of 
olaparib/olaparib placebo to 250 mg/matching tablet
BID. A second dose reduction to 200 mg/matching tablet
BID may be considered if additional decreases in Hb 
occur
Grade 3
(<8 g/dL)
Give appropriate supportive treatment (eg, transfusion) and 
investigate causality.

Interrupt olaparib/olaparib placebo, for a maximum of 
4 weeks (28 days), until Hb improves to ≥9 g/dL.

Upon recovery, reduce the dose of olaparib/olaparib 
placebo to 250 mg/matching tablet BID. A second dose 
reduction to 200 mg/matching tablet BID may be 
considered if additional decreases in Hb occur.
BID=twice daily; CTCAE=Common Terminology Criteria for Adverse Events; Hb=hemoglobin; NCI=National Cancer 
Institute.
Note: Common treatable causes of anemia (eg, iron, vitamin B12 or folate deficiencies and hypothyroidism) should be 
investigated and appropriately managed. In some cases management of anemia may require blood transfusions. 
The management of prolonged hematological toxicities is detailed in Section 6.6.2.3.
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Table 6
Management of Neutropenia, Leukopenia, and Thrombocytopenia
Toxicity
NCI CTCAE Grade
Action Taken
Neutropenia, 
Leukopenia, or
Thrombocytopenia
Grades 1 or 2
Investigator judgement to either continue 
olaparib/olaparib placebo or interrupt dosing
for a maximum of 4 weeks (28 days). Give 
appropriate supportive treatment and 
investigate causality.
Grades 3 or 4

Interrupt olaparib/olaparib placebo, for a 
maximum of 4 weeks (28 days), until event 
recovers to ≤Grade 1.

Repeated incidence: reduce the dose of
olaparib/olaparib placebo to 
250 mg/matching tablet BID. A second 
dose reduction to 200 mg/matching tablet
BID may be considered if additional Grade 
3 or 4 events occur.
BID=twice daily; CTCAE=Common Terminology Criteria for Adverse Events; G-CSF=granulocyte colony-stimulating 
factor; NCI=National Cancer Institute.
Note: AEs of neutropenia and leukopenia should be managed as deemed appropriate by the investigator with close 
follow-up and interruption of study treatment if CTCAE Grade 3 or worse neutropenia occurs.
Note: Primary prophylaxis with G-CSF is not recommended; however, if a participant develops febrile neutropenia, study 
treatment should be interrupted and appropriate management including G-CSF should be given according to local 
hospital guidelines. Please note that G-CSF should not be used within at least 24 hours (7 days for pegylated G-
CSF) of the last dose of study treatment unless absolutely necessary.
Note: Platelet transfusions, if indicated, should be done according to local hospital guidelines. 
Note: The management of prolonged hematological toxicities is detailed in Section 6.6.2.3.
Management of Prolonged Hematological Toxicities
If a participant develops prolonged hematological toxicity such as:
•
≥2-week interruption/delay in olaparib/olaparib placebo due to NCI CTCAE Grade 3 or 
worse anemia and/or the development of blood transfusion dependence
•
≥2-week interruption/delay in olaparib/olaparib placebo due to NCI CTCAE Grade 3 or 
worse neutropenia (absolute neutrophil count <1 × 109/L)
•
≥2-week interruption/delay in olaparib/olaparib placebo due to NCI CTCAE Grade 3 or 
worse thrombocytopenia and/or development of platelet transfusion dependence (platelets 
<50 × 109/L)
Differential blood count, including reticulocytes and peripheral blood smear, should be 
checked weekly. If any blood parameters remain clinically abnormal after the dosing of 
olaparib/olaparib placebo has been interrupted for 4 weeks (28 days), the participant should 
be referred to hematologist for further investigations. Bone marrow analysis and/or blood 
cytogenetic analysis should be considered, according to local regulation and/or standard 
institutional hematological practice. Olaparib/olaparib placebo should be discontinued if 
blood counts do not recover to NCI CTCAE Grade 1 or better within 4 weeks (28 days) of 
dose interruption.
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Development of confirmed MDS or other clonal blood disorder should be reported as an SAE 
and full reports must be provided by the investigator to the Sponsor as outlined in 
Section 8.4.4. Olaparib/olaparib placebo treatment should be discontinued for confirmed 
MDS and/or AML (Section 7.1).
Management of Non-Hematological Toxicity
Repeat dose interruptions, not exceeding 4 weeks (28 days) duration, are allowed as required. 
If toxicity reoccurs following rechallenge with olaparib/olaparib placebo, and where further 
dose interruptions are considered inadequate for management of toxicity, either a dose 
reduction should be considered (Section 6.6.2.1) or the participant must permanently 
discontinue study treatment.
Treatment must be interrupted if any NCI CTCAE Grade 3 or 4 AE occurs that the 
investigator considers to be related to administration of olaparib/olaparib placebo.
Management of New or Worsening Pulmonary Symptoms
If new or worsening pulmonary symptoms (eg, dyspnea) or radiological abnormalities occur 
in the absence of a clear diagnosis, an interruption in study treatment is recommended and 
further diagnostic workup (including a high-resolution CT scan) should be performed to 
exclude pneumonitis.
Following investigation, if no evidence of abnormality is observed on CT imaging and 
symptoms resolve, then study treatment may be restarted, if deemed appropriate by the 
investigator. If significant pulmonary abnormalities are identified, these need to be discussed 
with the Clinical Director.
Management of Nausea and Vomiting
Events of nausea and vomiting are known to be associated with olaparib treatment. These 
events are generally mild to moderate (NCI CTCAE Grade 1 or 2) in severity, intermittent, 
and manageable on continued treatment. The first onset generally occurs in the first month of 
treatment for nausea and within the first 6 months of treatment for vomiting. For nausea, the 
incidence generally plateaus at around 9 months, and for vomiting at around 6 to 7 months.
No routine prophylactic antiemetic treatment is required at the start of dosing with 
olaparib/olaparib placebo; however, participants should receive appropriate antiemetic 
treatment at the first onset of nausea or vomiting and as required thereafter, in accordance 
with local regulations or institutional guidelines. Alternatively, olaparib/olaparib placebo
tablets can be taken with a light meal/snack (eg, 2 pieces of toast or a couple of biscuits).
As per international guidance on antiemetic use in cancer patients (European Society for 
Medical Oncology, National Comprehensive Cancer Network), generally a single-agent 
antiemetic should be considered (eg, dopamine receptor antagonist, antihistamines, or 
dexamethasone).
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Management of Renal Impairment
If subsequent to study entry and while still on study therapy, a participant’s estimated 
creatinine clearance (CrCl) falls below the threshold for study inclusion (≥51 mL/min), 
retesting should be performed promptly.
A dose reduction is recommended for participants who develop moderate renal impairment 
(calculated CrCl between 31 and 50 mL/min as calculated by either Cockcroft-Gault equation 
or based on a 24-hour urine test) for any reason during the course of the study (Table 7).
Table 7
Dose Reduction of Olaparib or Olaparib Placebo to Manage Moderate Renal 
Impairment
Initial Dose
Moderate Renal Impairmenta
300 mg/matching tablet BID
200 mg/matching tablet BID
BID=twice daily.
a.
Creatinine clearance of 31 to 50 mL/min as calculated by either Cockcroft-Gault equation or based on 24-hour urine 
test.
Because the CrCl determination is only an estimate of renal function, in instances where the 
CrCl falls to between 31 and 50 mL/min, the investigator should use his or her discretion in 
determining whether a dose change or discontinuation of therapy is warranted.
Olaparib has not been studied in participants with severe renal impairment (CrCl 
≤30 mL/min) or end-stage renal disease; if participants develop severe impairment or end-
stage disease, it is recommended that olaparib/olaparib placebo be discontinued.
Interruptions for Intercurrent Non-Toxicity-Related Events
Olaparib/olaparib placebo dose interruption for conditions other than toxicity resolution 
should be kept as short as possible. If a participant cannot restart study treatment within 
4 weeks (28 days) for resolution of intercurrent conditions not related to disease progression 
or toxicity, the case should be discussed with the Clinical Director, and approved via a 
Sponsor Communication Form.
Participants will be instructed to notify the study site personnel of missed doses. All dose 
reductions and interruptions (including any missed doses), and the reasons for the 
reductions/interruptions, per drug accountability and participant feedback reconciliation, are 
to be recorded in the eCRF. 
Olaparib/olaparib placebo should be stopped at least 3 days prior to planned surgery and can
be restarted when the wound has healed. It is not required to stop olaparib/olaparib placebo 
for any needle biopsy procedure.
Olaparib/olaparib placebo should be discontinued for a minimum of 3 days before a 
participant undergoes radiation treatment and should be restarted within 4 weeks (28 days) as 
long as any bone marrow toxicity has recovered.
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Dose Reductions for Concurrent CYP3A4 Inhibitor Use
Strong or moderate CYP3A inhibitors should not be taken with olaparib/olaparib placebo. If, 
at any time after starting olaparib/olaparib placebo in the Maintenance Period, there is no 
suitable alternative concomitant medication then the dose of olaparib/olaparib placebo should 
be reduced for the period of concomitant administration as described in Table 8. After the 
washout of the inhibitor is complete (outlined in Section 5.2), the olaparib dose can be re-
escalated. The dose reduction of olaparib/olaparib placebo should be recorded in the eCRF 
with the reason documented as concomitant CYP3A inhibitor use.
Table 8
Dose Reduction of Olaparib or Olaparib Placebo With a Strong or Moderate 
CYP3A4 Inhibitor
Initial Dose
Strong CYP3A Inhibitor
Moderate CYP3A Inhibitor
300 mg BID
100 mg BID
150 mg BID
BID=twice daily; CYP=Cytochrome P450.
Management of Overlapping Toxicities
Both olaparib and pembrolizumab treatment may be associated with the development of 
pneumonitis and renal toxicity. 
For renal dysfunction, follow the dose modification guidelines provided in Table 3
(pembrolizumab) and Table 7 (olaparib). A kidney biopsy is strongly recommended to help 
to determine etiology of renal dysfunction.
Treatment with olaparib/olaparib placebo must be held for any grade of pneumonitis. 
Treatment with pembrolizumab/pembrolizumab placebo must be held for pneumonitis 
≥Grade 2 (Table 3). When the pneumonitis resolves to <Grade 2, then 
pembrolizumab/pembrolizumab placebo may be resumed as per guidelines in Table 3. 
Olaparib/olaparib placebo may be restarted once pneumonitis has completely resolved. Study 
treatment must be discontinued for recurrent Grade 2 pneumonitis (Table 3).
Chemotherapy and Bevacizumab Dose Modifications
Lead-in Period
Dose modifications of chemotherapy are not allowed during the Lead-in Period; all 
participants must receive the full dose of chemotherapy to be eligible to move into the 
Treatment Period.
Treatment Period
Carboplatin and/or paclitaxel (or docetaxel) may be reduced, interrupted, or discontinued at 
the investigator’s discretion per the approved product labels, local regulations, and/or 
institutional standards. If chemotherapy (either carboplatin or paclitaxel [or docetaxel] or 
both) is interrupted or discontinued, pembrolizumab or pembrolizumab placebo should be 
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continued. If pembrolizumab or pembrolizumab placebo is interrupted or discontinued, 
chemotherapy should be continued. 
Bevacizumab, if using, may be interrupted, or discontinued at the investigator’s discretion 
per the approved product label and local regulations. If bevacizumab is interrupted or 
discontinued, pembrolizumab/pembrolizumab placebo and olaparib/olaparib placebo may be 
continued. If pembrolizumab/pembrolizumab placebo or olaparib/olaparib placebo is 
interrupted or discontinued, bevacizumab may be continued as per the approved product 
label, local regulations, and/or institutional standards.
Interruptions from either carboplatin and paclitaxel (or docetaxel) or bevacizumab of greater 
than 6 weeks (42 days) from the originally scheduled dose require consultation between the 
investigator and the Sponsor. Discontinuation of both carboplatin and paclitaxel (or 
docetaxel) require consultation between the investigator and the Sponsor and written 
documentation of the collaborative decision on participant management.
Supportive care measures (eg. G-CSF, erythropoietin, blood transfusion) should be used 
according to local standards to manage chemotherapy-induced myelosuppression, including 
to prevent severe infections linked to febrile neutropenia. In order to minimize dose 
reductions, interruptions, and discontinuations of chemotherapy, these supportive care 
measures should be used before implementing dose modifications, when appropriate.
Treatment After the End of the Study
The study is complete upon consent of the last active treatment participant for an extension 
study, if available, in which participants can continue treatment as per the current study.  
All study-related procedures and data collection as defined per protocol will be terminated at 
study completion. In addition, follow-up will be stopped upon study completion as defined in 
Section 4.4. For participants who enroll in an extension study, if available, investigators will 
follow the SoA of the extension study protocol.
Clinical Supplies Disclosure
The emergency unblinding call center will use the treatment/randomization schedule for the 
study to unblind participants and to unmask study treatment identity. The emergency 
unblinding call center should only be used in cases of emergency (see Section 8.1.11). In the 
event that the emergency unblinding call center is not available for a given site in this study, 
the central electronic treatment allocation/randomization system (IRT) should be used in 
order to unblind participants and to unmask study treatment identity. The Sponsor will not 
provide random code/disclosure envelopes or lists with the clinical supplies.
See Section 8.1.11 for a description of the method of unblinding a participant during the 
study, should such action be warranted.
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Standard Policies
For studies using controlled substances, all federal, state, province, country, etc. regulations 
must be adhered to in regard to the shipping, storage, handling and dispensing of controlled 
substances. Additionally, the investigator should have the appropriate controlled drug 
license(s) as mandated by federal, state, province, country, etc. laws in which the study is 
being conducted.
At the close of the study after unblinding, a letter is to be sent by the investigator to those 
participants who received placebos in the image of the competitor’s product to provide the 
following advice: 
“You have participated in a study conducted by the Sponsor. This is to advise you that you 
were among those who received either an infusion prepared at the investigational site or a 
look-alike tablet created to resemble the drugs pembrolizumab or olaparib as much as 
possible. You did not receive the active drug pembrolizumab or olaparib as manufactured by 
the Sponsor or Astra Zeneca, respectively.”
7. Discontinuation of Study Treatment and Participant Withdrawal
Discontinuation of Study Treatment
Discontinuation of study treatment does not represent withdrawal from the study.
As certain data on clinical events beyond study treatment discontinuation may be important 
to the study, they must be collected through the participant’s last scheduled follow-up, even 
if the participant has discontinued study treatment. Therefore, all participants who 
discontinue study treatment prior to completion of the protocol-specified treatment period 
will still continue to participate in the study as specified in Section 1.3 and Section 8.11.3.
Participants may discontinue study treatment at any time for any reason or be discontinued 
from the study treatment at the discretion of the investigator should any untoward effect 
occur. In addition, a participant may be discontinued from study treatment by the investigator 
or the Sponsor if study treatment is inappropriate, the study plan is violated, or for 
administrative and/or other safety reasons. Specific details regarding procedures to be 
performed at study treatment discontinuation are provided in Section 8.1.10.
A participant must be discontinued from study treatment but continue to be monitored in the 
study for any of the following reasons:
•
The participant or participant’s legally acceptable representative requests to discontinue 
study treatment.
•
Radiographic disease progression documented by the investigator per RECIST 1.1, and 
when clinically appropriate, confirmed by the site per iRECIST (Section 8.2.1.5).
Note: An exception to continue study treatment beyond confirmed PD per iRECIST
(iCPD) may be considered after obtaining the informed consent addendum and 
consultation with the Sponsor (Section 8.2.1.5).
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•
Clinical progression without radiographic disease progression defined by elevated 
CA-125 (based on GCIG criteria [see Appendix 9]) in conjunction with any of the 
following criteria for malignant bowel obstruction:
-
Any of the following: new or worsening abdominal pain, nausea, or vomiting
-
Abdominal distension, constipation, and/or diarrhea 
-
No evidence of metabolic or electrolyte abnormalities leading to impaired intestinal 
motility
Note: Symptoms must be assessed as not related to study treatment and/or concomitant 
medication AND other non-malignant causes must be excluded by supplementary 
diagnostic measures
Note: Participants who discontinue study treatment due to clinical progression will have 
posttreatment follow-up imaging to evaluate disease status until disease progression is 
radiographically documented per RECIST 1.1 by the investigator (Section 8.2.1.4).
•
Any progression or recurrence of any malignancy, or any occurrence of another 
malignancy that requires active systemic treatment.
•
The participant interrupts pembrolizumab or pembrolizumab placebo administration for 
more than 12 consecutive weeks for an AE/toxicity or for more than 3 consecutive weeks 
for administrative reasons without Sponsor consultation.
•
The participant interrupts olaparib or olaparib placebo for more than 4 consecutive weeks 
(>28 consecutive days) without Sponsor consultation.
•
The participant interrupts chemotherapy (both carboplatin and paclitaxel [or docetaxel])
or bevacizumab for more than 6 consecutive weeks without Sponsor consultation.
Note: Participants who are not able to complete 6 treatment cycles (including lead-in) of 
chemotherapy due to toxicity, may be eligible to start the Maintenance Period as early as 
Cycle 2 following consultation with the Sponsor.
Note: Docetaxel may be considered for participants who experience either a severe 
hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel 
only after consultation with the Sponsor.
•
The participant has a medical condition or personal circumstance which, in the opinion of 
the investigator and/or Sponsor, placed the participant at unnecessary risk from continued 
administration of study treatment.
•
The participant has a confirmed positive serum pregnancy test.
•
Any study treatment-related toxicity specified as a reason for permanent discontinuation 
as defined in the guidelines for dose modifications due to AEs in Section 6.6.
•
Unacceptable AEs.
•
Bone marrow findings consistent with MDS or AML.
•
If a participant with liver metastasis has Grade 2 AST or ALT at the start of study 
treatment, and the AST or ALT value increases by ≥50% relative to baseline and lasts for 
≥1 week, then the participant should permanently discontinue study treatment.
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•
Completion of 35 infusions (approximately 2 years) with pembrolizumab/pembrolizumab
placebo (calculated from first dose), completion of approximately 2 years of treatment 
with olaparib or olaparib placebo, or the participant has received the maximum duration 
of bevacizumab per the approved label or local practice.
Note: Only participants with NED will stop treatment with olaparib or olaparib placebo 
following 2 years of treatment. The total duration of treatment is calculated starting with 
the first dose of olaparib or olaparib placebo.
For participants who are discontinued from study treatment but continue to be monitored in 
the study, all visits and procedures, as outlined in the SoA, should be completed.
Discontinuation from study treatment is “permanent.” Once a participant is discontinued, 
he/she shall not be allowed to restart study treatment. 
Participant Withdrawal From the Study
A participant must be withdrawn from the study if the participant or participant’s legally 
acceptable representative withdraws consent from the study.
If a participant withdraws from the study, they will no longer receive study treatment or be 
followed at scheduled protocol visits.
Specific details regarding procedures to be performed at the time of withdrawal from the 
study, as well as specific details regarding withdrawal from future biomedical research are 
outlined in Section 8.1.10. Participants who wish to withdraw from treatment and/or imaging 
may retain consent specifically for the noninvasive Survival Follow-up Phase of the study. 
All participants are encouraged to be followed for survival status until death or the closure of 
the study, if they consent to do so. The procedures to be performed should a participant 
repeatedly fail to return for scheduled visits and/or if the study site is unable to contact the 
participant are outlined in Section 7.3.
Lost to Follow-up
If a participant fails to return to the clinic for a required study visit and/or if the site is unable 
to contact the participant, the following procedures are to be performed:
•
The site must attempt to contact the participant and reschedule the missed visit. If the 
participant is contacted, the participant should be counseled on the importance of 
maintaining the protocol-specified visit schedule.
•
The investigator or designee must make every effort to regain contact with the participant 
at each missed visit (eg, telephone calls and/or a certified letter to the participant’s last 
known mailing address or locally equivalent methods). These contact attempts should be 
documented in the participant’s medical record.
•
Note:  A participant is not considered lost to follow-up until the last scheduled visit for 
the individual participant. The missing data for the participant will be managed via the 
prespecified statistical data handling and analysis guidelines.
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8. Study Assessments and Procedures
•
Study procedures and their timing are summarized in the SoA. 
•
If it is determined that a study procedure and/or assessment no longer needs to be 
performed, the Sponsor or its designee will provide ample notification to participating 
investigator sites so appropriate adjustments can be made.
•
Adherence to the study design requirements, including those specified in the SoA, is 
essential and required for study conduct.
•
The investigator is responsible for assuring that procedures are conducted by 
appropriately qualified or trained staff. Delegation of study site personnel responsibilities 
will be documented in the Investigator Trial File Binder (or equivalent).
•
All study-related medical decisions must be made by an investigator who is a qualified 
physician.
•
All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable. 
•
Procedures conducted as part of the participant’s routine clinical management (eg, blood 
count) and obtained before signing of ICF may be utilized for screening or baseline 
purposes provided the procedures meet the protocol-specified criteria and were 
performed within the time frame defined in the SoA.
•
Additional evaluations/testing may be deemed necessary by the investigator and or the 
Sponsor for reasons related to participant safety. In some cases, such evaluation/testing 
may be potentially sensitive in nature (eg, HIV, hepatitis C, etc.), and thus local 
regulations may require that additional informed consent be obtained from the 
participant. In these cases, such evaluations/testing will be performed in accordance with 
those regulations.
Repeat or unscheduled samples may be taken for safety reasons or for technical issues with 
the samples.
Administrative and General Procedures
Informed Consent
The investigator or medically qualified designee (consistent with local requirements) must 
obtain documented consent from each potential participant or each participant’s legally 
acceptable representative prior to participating in a clinical study or future biomedical 
research. If there are changes to the participant’s status during the study (eg, health or age of 
majority requirements), the investigator or medically qualified designee must ensure the 
appropriate consent is in place. 
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General Informed Consent
Consent must be documented by the participant’s dated signature or by the participant’s 
legally acceptable representative’s dated signature on a consent form along with the dated 
signature of the person conducting the consent discussion. 
A copy of the signed and dated consent form should be given to the participant before 
participation in the study.
The initial ICF, any subsequent revised written ICF and any written information provided to 
the participant must receive the Institutional Review Board/Independent Ethics Committee’s
(IRB/IEC’s) approval/favorable opinion in advance of use. The participant or his/her legally 
acceptable representative should be informed in a timely manner if new information becomes 
available that may be relevant to the participant’s willingness to continue participation in the 
study. The communication of this information will be provided and documented via a revised 
consent form or addendum to the original consent form that captures the participant’s dated 
signature or by the participant’s legally acceptable representative’s dated signature.
The participant or his/her legally acceptable representative will be asked to sign consent at 
the point of initial radiographic disease progression.
Specifics about a study and the study population will be added to the consent form template 
at the protocol level. 
The informed consent will adhere to IRB/IEC requirements, applicable laws and regulations 
and Sponsor requirements.
Note: If primary debulking surgery is performed within the Screening Period, the main study 
ICF may be signed prior to surgery.
Consent and Collection of Specimens for Future Biomedical Research
The investigator or medically qualified designee will explain the future biomedical research 
consent to the participant, answer all of his/her questions, and obtain written informed 
consent before performing any procedure related to future biomedical research. A copy of the 
informed consent will be given to the participant.
Inclusion/Exclusion Criteria
All inclusion and exclusion criteria will be reviewed by the investigator who is a qualified 
physician to ensure that the participant qualifies for the study.
Participant Identification Card
All participants will be given a Participant Identification Card identifying them as 
participants in a research study. The card will contain study site contact information 
(including direct telephone numbers) to be utilized in the event of an emergency. The 
investigator or qualified designee will provide the participant with a Participant Identification 
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Card immediately after the participant provides written informed consent. At the time of 
treatment allocation/randomization, site personnel will add the treatment/randomization 
number to the Participant Identification Card.
The Participant Identification Card also contains contact information for the emergency 
unblinding call center so that a health care provider can obtain information about study 
treatment in emergency situations where the investigator is not available.
Medical History
A medical history will be obtained by the investigator or qualified designee. The medical 
history will collect all active conditions and any condition diagnosed within the prior 
10 years that the investigator considers to be clinically significant. Details regarding the 
disease for which the participant has enrolled in this study will be recorded separately and 
not listed as medical history.
Ovarian Cancer History
The investigator or qualified designee will obtain prior and current details regarding the 
participant’s OC, including investigator-determined tumor size per RECIST 1.1.
Debulking Surgery
All eligible participants will undergo debulking surgery (primary or interval) per the local 
SOC. Primary debulking surgery can occur up to 7 weeks (49 days) prior to starting 
chemotherapy during the Lead-in Period (Figure 2); all participants eligible for primary 
debulking surgery may sign the main study ICF prior to surgery (Section 8.1.1). Interval 
debulking surgery should be performed between 3 to 6 weeks following Day 1 Cycle 2 for 
participants on a Q3W chemotherapy regimen or between 1 to 4 weeks following Day 15 of 
Cycle 2 for participants on a weekly chemotherapy regimen (Figure 3); any delay to interval 
debulking surgery (eg, due to an AE) requires approval from the Sponsor. The last dose of 
pembrolizumab or pembrolizumab placebo should be administered no less than 3 weeks 
before surgery. Participants should resume study treatment when clinically appropriate but no 
longer than 7 weeks following surgery. Details regarding the date of surgery, surgical 
findings, residual tumor postsurgery, surgical pathology, etc. will be recorded in the 
appropriate eCRF. All tumor tissue will be reviewed by the local pathologist for pathological 
CR (pCR) following interval debulking surgery (Section 8.2.2). Debulking surgery may be 
performed at a hospital/surgical unit separate from the investigator site.
If the investigator determines that a participant has inoperable disease following the 
3 neoadjuvant treatment cycles (including lead-in), the participant may continue treatment in 
the study without undergoing the interval debulking surgery. For these participants, a tumor 
biopsy should be collected, if possible (Section 8.1.5.1). Participants should resume study 
treatment when clinically appropriate but no longer than 6 weeks following the last dose of 
study treatment.
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Tumor Tissue Biopsy and Sample Collection
All tumor tissue collected during interval debulking will be sent for detailed pathological 
assessment (Section 8.2.2). A separate core or excisional biopsy will be collected from the 
tumor tissue at the time of debulking surgery. For those participants who do not undergo 
interval debulking surgery, a core or excisional biopsy should be collected, if possible, prior 
to resuming study medication in Cycle 3.
An optional core or excisional biopsy may be collected at the time of PD, if possible 
(Section 1.3).
All biopsies should be obtained and prepared according to the instructions outlined in the 
Procedure Manual for this study. If feasible, at least 2 separate core biopsies should be 
obtained. These tumor tissues will be submitted to the designated central laboratory.
Prior and Concomitant Medications Review
Prior Medications
The investigator or qualified designee will review prior medication use, including any 
protocol-specified washout requirement, and record prior medication taken by the participant 
within 56 days before randomization.
Treatment for the disease for which the participant has enrolled in this study will be recorded 
separately and not listed as a prior medication.
Concomitant Medications
The investigator or qualified designee will record medication (including blood transfusions), 
if any, taken by the participant during the study (Section 6.5). Additionally, the investigator 
or qualified designee will record medication, if any, taken by the participant following PD.
Subsequent Anticancer Therapy
Details of subsequent therapies for cancer and/or details of surgery for the treatment of the 
cancer, after discontinuation of treatment, will be collected. Reasons for starting subsequent 
anticancer therapies including access to other PD-1/PD-L1 inhibitors, PARP inhibitors, or 
investigational drugs will be collected.
Assignment of Screening Number
All consented participants will be given a unique screening number that will be used to 
identify the participant for all procedures that occur prior to randomization. Each participant 
will be assigned only one screening number. Screening numbers must not be re-used for 
different participants.
Any participant who is screened multiple times will retain the original screening number 
assigned at the initial screening visit.
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Specific details on the screening visit requirements (screening/rescreening) are provided in 
Section 8.11.1. 
Assignment of Treatment/Randomization Number
All eligible participants will be randomly allocated and will receive a 
treatment/randomization number. The treatment/randomization number identifies the 
participant for all procedures occurring after treatment allocation/randomization. Once a 
treatment/randomization number is assigned to a participant, it can never be re-assigned to 
another participant.
A single participant cannot be assigned more than 1 treatment/randomization number.
The investigator must provide the rationale for not choosing cisplatin prior to randomization.
Treatment Administration
Carboplatin, paclitaxel (or docetaxel), bevacizumab (if using), and 
pembrolizumab/pembrolizumab placebo will be administered by the investigator and/or 
study staff according to the specifications within the Pharmacy Manual. Olaparib/olaparib 
placebo will be administered by the investigator and/or study staff on Day 1 of the first cycle
in the Maintenance Period. Participants will then self-administer olaparib/olaparib placebo
orally for the remainder of the 21-day treatment cycle (Section 8.1.9.1.5).
Study Treatment should begin within 3 days of randomization.
Note: There must be a minimum of 20 days between the start of lead-in chemotherapy and 
Day 1 of Cycle 1.
Timing of Dose Administration
Treatment With Chemotherapy:
Participants will receive pembrolizumab 200 mg (Day 1) or pembrolizumab placebo (Day 1) 
together with investigator’s choice of carboplatin + paclitaxel regimen for 5 treatment cycles 
(± bevacizumab):
•
Carboplatin AUC5 or 6 Q3W plus paclitaxel 175 mg/m2 Q3W
•
Carboplatin AUC5 or 6 Q3W plus paclitaxel 80 mg/m2 QW
•
Carboplatin AUC2 or 2.7 QW plus paclitaxel 60 mg/m2 QW
Note: Docetaxel may be considered for participants who experience either a severe 
hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only 
after consultation with the Sponsor. The recommended dose of docetaxel [Vasey, P. A., et al 
2004] is 75 mg/m2 Q3W plus carboplatin AUC 5.
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Note: the maximum duration of treatment with chemotherapy is not to exceed 6 cycles (this 
includes the Lead-in Period).
Between Chemotherapy and Maintenance (for assessment of eligibility for 
maintenance):
Participants will receive pembrolizumab 200 mg (Day 1) or pembrolizumab placebo (Day 1) 
(± bevacizumab).
Maintenance:
Participants will continue with pembrolizumab 200 mg (Day 1) or pembrolizumab placebo 
(Day 1) and maintenance therapy with olaparib 300 mg or olaparib placebo BID 
(± bevacizumab).
Treatment Sequencing:
Depending on which individual components of the regimen are being administered during 
any given cycle, administer in the following order:
1. Olaparib or olaparib placebo (starting in maintenance)
2. Pembrolizumab or pembrolizumab placebo
3. Paclitaxel (or docetaxel)
4. Carboplatin
5. Bevacizumab
Note: local practice for drug administration sequence can be followed if preferred. The date
and dose of administration must be captured in the eCRF.
On Day 1 of each cycle, study treatment should be administered after all procedures and 
assessments have been completed. Study treatment can be administered ± 3 days of the 
targeted Day 1 for each cycle.
Pembrolizumab or Pembrolizumab Placebo
Pembrolizumab or pembrolizumab placebo will be administered as a 30-minute IV infusion 
Q3W. Sites should make every effort to target infusion timing to be as close to 30 minutes as 
possible. However, given the variability of infusion pumps from site to site, a window 
of -5 minutes and + 10 minutes is permitted (ie, infusion time is 30 minutes:  -5 minutes/
+10 minutes).
Paclitaxel (or Docetaxel)
Paclitaxel (175 mg/m2 Q3W, 80 mg/m2 QW, or 60 mg/m2 QW) will be administered as an IV 
infusion for 6 treatment cycles (including lead-in) as per local practice and labels. For Q3W 
and QW infusions of paclitaxel, the infusion time should follow local practice and labels. All 
participants should be premedicated with oral or IV steroid and antihistamines according to 
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the approved product label and/or standard practice. Additional premedications should be 
administered as per standard practice.
Docetaxel (75 mg/m2 Q3W), if approved by the Sponsor, will be administered as an IV 
infusion as per local practice and labels. The infusion time should follow local practice and 
labels. All participants should be premedicated with an oral steroid according to the approved 
product label and/or standard practice. Additional premedications should be administered as 
per standard practice.
Carboplatin
Carboplatin (AUC5-6 mg/mL•min Q3W or AUC2-2.7 mg/mL•min QW) will be 
administered as an IV infusion for 6 treatment cycles (including lead-in) as per local practice 
and labels. The infusion time of carboplatin should follow local practice and labels. The 
carboplatin dose should be calculated using Calvert formula (see below) and should not
exceed 900 mg.
Calvert Formula:
Total Dose (mg) = target AUC × (GFR + 25)
The estimated GFR used in the Calvert formula should not exceed 125 mL/min to calculate 
the maximum carboplatin dose (mg): 
Target AUC 6 (mg/mL•min) × (125 + 25) = 6 × 150 mL/min = 900 mg
Bevacizumab
If bevacizumab is used, it should be administered, as per local practice and label, on Day 1 of 
each treatment cycle administered, after carboplatin. The local practice for drug 
administration sequence can be followed if preferred. The date and dose of bevacizumab 
administered will be recorded in the eCRF.
Note: Bevacizumab may be used at the investigator’s discretion as per the local SOC and 
approved product label:
•
Participants eligible for primary debulking may receive bevacizumab starting with 
Cycle 1.
•
Participants eligible for interval debulking may receive bevacizumab starting with the 
lead-in dose of chemotherapy but must NOT be dosed with bevacizumab at Cycle 2 or 
Cycle 3. Dosing with bevacizumab should resume in Cycle 4 OR after the wound has 
healed, whichever is longer.
Note: If, following Sponsor consultation, surgery is delayed, bevacizumab should be 
interrupted at least 4 weeks prior to the planned date of surgery. Bevacizumab should 
resume 4 weeks after surgery OR after the wound has healed, whichever is longer.
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•
For any participant who will receive bevacizumab, the investigator may wait to 
administer the first dose of bevacizumab, as long as it is administered by Cycle 4.
Note: For all participants who will start bevacizumab after lead-in chemotherapy, blood 
pressure measurements need to be performed to ensure that the participant does not have 
uncontrolled hypertension (Section 8.3.2). Blood pressure must be controlled prior to 
starting bevacizumab. 
Note: Any delay in restarting/starting bevacizumab beyond what is defined in the 
protocol requires Sponsor approval.
Olaparib or Olaparib Placebo
Participants must complete 1 lead-in cycle with chemotherapy and 5 treatment cycles on
study and have NED progression (CR, PR, SD, or non-PD) prior to starting either olaparib or 
olaparib placebo in the Maintenance Period (Cycle 7). Participants who are unable to 
complete 6 treatment cycles (including lead-in) of chemotherapy due to toxicity, may still be 
eligible to start the Maintenance Period earlier following consultation with the Sponsor.
Participants should begin olaparib/olaparib placebo in the Maintenance Period as soon as 
clinically appropriate (ie, no ongoing toxicities, completed maintenance eligibility imaging 
[Section 8.2.1.2], and accounting for the washout period for CYP3A4 inhibitors/inducers 
[Section 5.2]) but no later than 9 weeks from Day 1 of the last cycle of chemotherapy. If 
olaparib/olaparib placebo is started ≥9 weeks from Day 1 of the last cycle of chemotherapy, 
Sponsor consultation is required.
If iRECIST is implemented (Section 8.2.1.5), olaparib/olaparib placebo should not be started 
in the Maintenance Period until it is determined that the participant has persistent 
unconfirmed progression (with an overall response of iUPD), or as showing disease stability 
or response (iSD/iPR/iCR) (Appendix 6). 
Prior to starting the recommended dose of olaparib (300 mg BID) or olaparib placebo, the 
participants CrCl must be ≥51 mL/min. Sponsor consultation is required for any participants 
with CrCl <51 mL/min. In addition, investigators should confirm that the participant does not 
meet any of the dose modification criteria of olaparib or olaparib placebo described in 
Section 6.6.2. Sponsor consultation is required for any participants with a condition meeting 
the dose modification criteria to initiate olaparib or olaparib placebo at a reduced dose.
Participants will self-administer olaparib/olaparib placebo except on Day 1 of each cycle, 
when the dose will be given at the study site clinic prior to the infusion of either 
pembrolizumab or pembrolizumab placebo. Olaparib/olaparib placebo tablets should be 
taken with one glass of water twice a day at the same time each day, approximately 12 hours 
between doses. The tablets should be swallowed whole and not chewed, crushed, dissolved 
or divided. Olaparib/olaparib placebo tablets can be taken with or without food. 
If vomiting occurs shortly after the olaparib/olaparib placebo tablets are swallowed, the dose 
should only be replaced if all of the intact tablets can be seen and counted. Should any
participant enrolled in the study miss a scheduled dose for any reason (eg, as a result of 
forgetting to take the tablets or vomiting), the participant will be allowed to take the 
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scheduled dose up to a maximum of 2 hours after that scheduled dose time. If greater than 
2 hours after the scheduled dose time, the missed dose is not to be taken and the participant 
should take their allotted dose at the next scheduled time.
Participants with no evidence of disease after 2 years of treatment with olaparib or olaparib 
placebo will stop olaparib or olaparib placebo at the next scheduled visit after radiographic 
assessment of CR or NED. Participants with continued evidence of disease after 2 years of 
treatment with olaparib or olaparib placebo and without evidence of disease progression may 
continue olaparib or olaparib placebo until any one of the discontinuation criteria is met.
Antiemetic Therapy
The use of antiemetic therapy should follow Multinational Association of Supportive Care in 
Cancer guidelines [Roila, F., et al 2016]. For the first 6 treatment cycles (including lead-in), 
antiemetic therapy should include a 5-HT3 receptor antagonist, and/or dexamethasone (or 
equivalent) [Roila, F., et al 2016]. Aprepitant use is allowed during the Treatment Period 
(through the last dose of chemotherapy); however, it is not allowed during the Maintenance 
Period as it is a moderate inhibitor of CYP3A4.
Discontinuation and Withdrawal
Participants who discontinue study treatment prior to completion of the Treatment Period 
should be encouraged to continue to be followed for all remaining study visits.
When a participant withdraws from participation in the study, all applicable activities 
scheduled for the final study visit should be performed (at the time of withdrawal). Any AEs
which are present at the time of withdrawal should be followed in accordance with the safety 
requirements outlined in Section 8.4.
Discontinuation of Study Treatment Due to Progressive Disease Prior to 
Interval Debulking
Due to the mechanism of action of pembrolizumab, some participants may experience a 
transient tumor flare within the first few months of starting treatment and then experience 
subsequent disease response. Because this is a double-blind study, the Sponsor, investigators, 
other study site personnel, and participants will be blinded to pembrolizumab versus 
pembrolizumab placebo administration. Therefore, if the initial imaging assessment prior to 
interval debulking surgery suggests PD by RECIST 1.1 (Section 8.2.1.4), investigators are 
encouraged to implement iRECIST (Section 8.2.1.5) prior to discontinuation of study 
treatment in participants that are clinically stable.
Withdrawal From Future Biomedical Research
Participants may withdraw their consent for future biomedical research. Participants may 
withdraw consent at any time by contacting the principal investigator for the main study. If 
medical records for the main study are still available, the investigator will contact the 
Sponsor using the designated mailbox (clinical.specimen.management@MSD.com). 
Subsequently, the participant’s consent for future biomedical research will be withdrawn. A 
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letter will be sent from the Sponsor to the investigator confirming the withdrawal. It is the 
responsibility of the investigator to inform the participant of completion of withdrawal. Any 
analyses in progress at the time of request for withdrawal or already performed prior to the 
request being received by the Sponsor will continue to be used as part of the overall research 
study data and results. No new analyses would be generated after the request is received.
In the event that the medical records for the main study are no longer available (eg, if the 
investigator is no longer required by regulatory authorities to retain the main study records) 
or the specimens have been completely anonymized, there will no longer be a link between 
the participant’s personal information and their specimens. In this situation, the request for 
specimen withdrawal cannot be processed.
Participant Blinding/Unblinding
STUDY INTERVENTION IDENTIFICATION INFORMATION IS TO BE UNMASKED 
ONLY IF NECESSARY FOR THE WELFARE OF THE PARTICIPANT. EVERY 
EFFORT SHOULD BE MADE NOT TO UNBLIND.
For emergency situations where the investigator or medically qualified designee (consistent 
with local requirements) needs to identify the intervention used by a participant and/or the 
dosage administered, he/she will contact the emergency unblinding call center by telephone 
and make a request for emergency unblinding. As requested by the investigator or medically 
qualified designee, the emergency unblinding call center will provide the information to 
him/her promptly and report unblinding to the Sponsor. Before contacting the emergency 
unblinding call center to request unblinding of a participant’s intervention assignment, the 
investigator who is a qualified physician should make reasonable attempts to enter the 
toxicity grade of the AEs observed, the relation to study intervention, the reason thereof, etc, 
in the medical record. If it is not possible to record this assessment in the medical record 
before the unblinding, the unblinding should not be delayed.
If unblinding has occurred, the circumstances around the unblinding (eg, date, reason, and 
person performing the unblinding) must be documented promptly, and the Sponsor Clinical 
Director notified as soon as possible.
Participants whose treatment assignment has been unblinded by the investigator or medically 
qualified designee and/or nonstudy treating physician should continue to be monitored in the 
study.
Additionally, the investigator or medically qualified designee must go into the IRT system 
and perform the unblind in the IRT system to update drug disposition. In the event that the 
emergency unblinding call center is not available for a given site in this study, the IRT
system should be used for emergency unblinding in the event that this is required for 
participant safety.
At the end of the study, random code/disclosure envelopes or lists and unblinding logs are to 
be returned to the Sponsor or designee.
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Non-Emergency Unblinding
Unblinding to study treatment (pembrolizumab/pembrolizumab placebo and/or 
olaparib/olaparib placebo) administration may occur on an individual participant basis and 
only after consultation with the Sponsor under the following circumstances:
•
PD with discontinuation of study treatment and the participant is considered for 
enrollment on an alternate immune-oncology protocol that requires knowledge of prior 
treatment with pembrolizumab and/or olaparib.
•
AE necessitating discontinuation of treatment and unblinding required for appropriate 
clinical management of complications. Prior to unblinding any participant in this 
situation, the Sponsor’s Clinical Director must be consulted to review individual requests 
for unblinding using Sponsor consultation form with reasons to unblind clearly 
documented.
Note: in some instances, unblinding to study treatment may be needed for appropriate 
clinical management of the complications but may not necessitate discontinuation of 
study treatment. The Sponsor’s Clinical Director must be consulted to review individual 
requests for unblinding using Sponsor consultation form with reasons to unblind and 
decision to remain on study treatment clearly documented.
Calibration of Equipment
The investigator or qualified designee has the responsibility to ensure that any device or 
instrument used for a clinical evaluation/test during a clinical study that provides information 
about inclusion/exclusion criteria and/or safety or efficacy parameters shall be suitably 
calibrated and/or maintained to ensure that the data obtained is reliable and/or reproducible. 
Documentation of equipment calibration must be retained as source documentation at the 
study site.
Tumor Tissue
Tumor Tissue for PD-L1 and BRCA1/2 Status
Participants are required to have an excisional or core biopsy performed during the Screening 
Period for the central determination of PD-L1 and BRCA1/2 status. The results of central 
testing to assess BRCA1/2 status will yield information about other genes, including those
potentially involved in HRR, and will support exploratory translational science objectives.
Tumor Tissue for Biomarker Analyses
Participation in this study will be dependent upon participants supplying tumor tissue for
biomarker analysis. A newly obtained core or excision biopsy of a tumor lesion is preferred. 
Submission of either FFPE tumor blocks or unstained slides is acceptable. For participants 
eligible for primary debulking surgery, newly obtained tissue must be obtained prior to the 
administration of systemic cytotoxic treatment for the treatment of current OC. If a 
diagnostic biopsy is performed prior to surgery and submitted, the biopsy should not be 
collected more than 8 weeks prior to primary debulking surgery  For participants eligible for 
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interval debulking surgery, newly obtained tissue must be obtained within 8 weeks prior to 
the administration of systemic cytotoxic treatment for the treatment of current OC.
If submitting unstained cut slides, freshly cut slides should be submitted to the testing 
laboratory within 14 days from the date the slides are cut, otherwise a new sample will be 
requested.
Participants must sign the main study ICF prior to submitting existing tissue samples and/or 
undergoing a new biopsy.
Efficacy Assessments
Tumor Imaging
The process for image collection and transmission to the central imaging vendor can be 
found in the site imaging manual. Tumor imaging is strongly preferred to be acquired by CT. 
For the abdomen and pelvis, contrast-enhanced magnetic resonance imaging (MRI) may be 
used when CT with iodinated contrast is contraindicated, or when mandated by local 
practice. The same imaging technique regarding modality (ideally the same scanner) and use 
of contrast should be used in a participant throughout the study to optimize the
reproducibility of the assessment of existing and new tumor burden and to improve the 
accuracy of the assessment of response or progression based on imaging.
Participant eligibility will be determined using local assessment (investigator assessment) 
based on RECIST 1.1. All scheduled images for all study participants from the sites will be 
submitted to the central imaging vendor. In addition, images (including via other modalities) 
that are obtained at an unscheduled time point to determine disease progression, as well as 
imaging obtained for other reasons, but which demonstrate radiologic progression, should 
also be submitted to the central imaging vendor.
If the investigator considers the participant has progressed, but elects to implement iRECIST, 
the investigator will assess for confirmation of progression by iRECIST at subsequent time 
points (Section 8.2.1.5). Images should continue to be submitted to the central imaging 
vendor.
Note: For the purposes of assessing tumor imaging, the term “investigator” refers to the local 
investigator at the site and/or the radiological reviewer located at the site or at an offsite 
facility.
Initial Tumor Imaging
Initial tumor imaging at screening must be performed within 28 days prior to administration 
of chemotherapy during the Lead-in Period. The screening images must be submitted to the 
central imaging vendor for retrospective review.
Tumor imaging performed as part of routine clinical management are acceptable for use as 
screening tumor imaging if it is of diagnostic quality and performed within 28 days prior to 
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the administration of chemotherapy during the Lead-in Period and can be assessed by the 
central imaging vendor.
If brain imaging is performed to document the stability of existing metastases, MRI is 
preferred; however, CT imaging will be acceptable if MRI is medically contraindicated.
Bone scans are required at baseline for participants with a history of bone metastases or who 
are clinically symptomatic. Any supplemental imaging done to support a positive or negative 
bone scan, such as plain X-rays acquired for correlation, should be submitted to the central 
imaging vendor.
Tumor Imaging During the Study
Imaging for Participants Eligible for Primary Debulking
For participants eligible for primary debulking surgery, imaging during the Treatment Period 
will be performed as detailed in Section 1.3.3 and outlined below. An imaging assessment to 
confirm eligibility (ie, CR, PR, SD, or non-PD) for the Maintenance Period will be 
performed as follows:
•
A minimum of 21 days following Day 1 of Cycle 5 (for Q3W regimen) or a minimum of 
7 days following C5D15 (for QW regimen) and prior to initiating treatment with olaparib 
or olaparib placebo in Cycle 7; or
•
A minimum of 21 days after Day 1 of the last cycle of chemotherapy for participants who 
cannot complete 6 treatment cycles (including lead-in) of chemotherapy due to toxicity
but are deemed eligible for maintenance following Sponsor consultation
Note: Imaging obtained within 4 weeks (28 days) prior to the planned start of 
maintenance may be used as the maintenance eligibility scan following Sponsor approval.
When determining eligibility for the Maintenance Period, the imaging assessment obtained 
prior to starting the Maintenance Period should be compared with the baseline imaging 
assessment to assess CR, PR, SD, or non-PD. Subsequent tumor imaging should be 
performed every 9 weeks (63 days ± 7 days) from the maintenance eligibility assessment or 
more frequently if clinically indicated. After approximately 1 year (after Week 54), 
participants who remain on treatment will have imaging performed every 12 weeks (84 days
± 7 days). After approximately 3 years (after Week 156), participants who remain on study
will have imaging performed every 24 weeks (168 days ± 7 days). Week 54 and Week 156 
are calculated from the date of randomization.
Other than the imaging assessment to determine eligibility for maintenance and eligibility to 
continue olaparib/olaparib placebo beyond 2 years, imaging timing should follow calendar 
days and should not be adjusted for delays in cycle starts. Imaging should continue to be 
performed until PD is identified by the investigator, the start of new anticancer treatment, 
withdrawal of consent, pregnancy, or death, whichever occurs first; however, if the 
investigator elects to continue treatment and follow iRECIST after initial radiographic PD, 
imaging should continue, and images should be submitted to the central imaging vendor. All 
supplemental imaging must be submitted to the central imaging vendor.
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Imaging for Participants Eligible for Interval Debulking
For participants eligible for interval debulking surgery, the first on-study imaging assessment 
should be performed at least 21 days after Day 1 of Cycle 2 and prior to the debulking 
surgery. An imaging assessment should be performed after debulking surgery and prior to 
dosing in Cycle 3 (Day 1, Cycle 3). Imaging assessments following surgery will be 
performed as detailed in Section 1.3.4. If surgery is not performed, the imaging assessment 
prior to Cycle 3 is not required and subsequent tumor imaging should be performed as 
detailed in Section 1.3.5. An imaging assessment to confirm eligibility (ie, non-PD) for the 
Maintenance Period will be performed as follows:
•
A minimum of 21 days following Day 1 of Cycle 5 (for Q3W regimen) or a minimum of 
7 days following C5D15 (for QW regimen) and prior to initiating treatment with olaparib 
or olaparib placebo in Cycle 7; or  
•
A minimum of 21 days following Day 1 of the last cycle of chemotherapy for participants 
who cannot complete 6 treatment cycles (including lead-in) of chemotherapy due to 
toxicity but are deemed eligible for maintenance following Sponsor consultation
Note: Imaging obtained within 4 weeks (28 days) prior to the planned start of 
maintenance, including postsurgery imaging, may be used as the maintenance eligibility 
scan following Sponsor approval.
When determining eligibility for the Maintenance Period, the imaging assessment obtained 
prior to starting the Maintenance Period should be compared with the baseline imaging 
assessment to assess non-PD. Subsequent tumor imaging should be performed every 9 weeks 
(63 days ± 7 days) from the maintenance eligibility assessment or more frequently if 
clinically indicated. After approximately 1 year (after Week 54), participants who remain on
treatment will have imaging performed every 12 weeks (84 days ± 7 days). After 
approximately 3 years (after Week 156), participants who remain on study will have imaging 
performed every 24 weeks (168 days ± 7 days). Week 54 and Week 156 are calculated from 
the date of randomization. 
Other than the image assessments pre/post debulking surgery, to determine eligibility for 
maintenance, and eligibility to continue olaparib/olaparib placebo beyond 2 years imaging 
timing should follow calendar days and should not be adjusted for delays in cycle starts. 
Imaging should continue to be performed until PD is identified by the investigator, the start 
of new anticancer treatment, withdrawal of consent, pregnancy, or death, whichever occurs 
first; however, if the investigator elects to continue treatment and follow iRECIST after 
initial radiographic PD, imaging should continue, and images should be submitted to the 
central imaging vendor. All supplemental imaging must be submitted to the central imaging 
vendor.
Response Evaluation Following Debulking Surgery
Following debulking surgery, tumor may still be present. PD is defined as the growth of the 
primary tumor or appearance of any new tumors following debulking surgery as assessed by 
the investigator per RECIST 1.1 and iRECIST as outlined in Section 8.2.1.4 and 
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Section 8.2.1.5, respectively. For those participants with NED following debulking surgery, 
progression is defined as the detection of new lesions on follow-up radiological assessments.
Per iRECIST (Section 8.2.1.5), PD should be confirmed by the site 4 to 8 weeks after 
verification of the site-assessed first radiologic evidence of PD in clinically stable 
participants. Participants who have unconfirmed PD may continue on treatment at the 
discretion of the investigator until progression is confirmed by the site per iRECIST,
provided they have met the conditions detailed in Section 8.2.1.5. Participants who receive
confirmatory imaging do not need to undergo the next scheduled tumor imaging if it is less 
than 4 weeks (28 days) later; tumor imaging may resume at the subsequent scheduled 
imaging time point if clinically stable. Participants who have confirmed PD by iRECIST, as 
assessed by the site, will discontinue study treatment unless treatment beyond confirmed 
progression is approved by the Sponsor as detailed in Section 8.2.1.5.
Imaging for Eligibility to Continue Olaparib/Olaparib Placebo at 2 Years
Imaging should be performed within 4 weeks prior to reaching 2 years of maintenance with 
olaparib/olaparib placebo:
•
If at this scan, the participant has CR or NED, this is the final tumor imaging in the 
Maintenance Phase and the participant must discontinue olaparib/olaparib placebo. Note: 
The participant will continue to have imaging in the Efficacy Follow-up Phase (Section 
8.11.3.2).
•
If at this scan the participant does not have a CR and is not NED, the participant may 
continue olaparib/olaparib placebo until CR or NED by RECIST 1.1. Note: Thereafter, 
the participant will continue to have imaging in the Efficacy Follow-up Phase (Section 
8.11.3.2).
End of Treatment and Follow-up Tumor Imaging
For participants who discontinue study treatment, tumor imaging should be performed at the 
time of treatment discontinuation (± 4-week window) and prior to starting a new anticancer 
treatment. If a previous imaging was obtained within 4 weeks (28 days) prior to the date of 
discontinuation, then imaging at treatment discontinuation is not mandatory. For participants
who discontinue study treatment due to documented PD, this is the final required tumor 
imaging if the investigator elects not to implement iRECIST.
For participants who discontinue study treatment without documented disease progression, 
every effort should be made to continue monitoring disease status by tumor imaging using 
the same imaging schedule used while on treatment (every 9 weeks in Year 1 or every 
12 weeks after Year 1) until the start of a new anticancer treatment, disease progression, 
pregnancy, death, withdrawal of consent, or the end of the study, whichever occurs first.
RECIST 1.1 Assessment of Disease
RECIST 1.1 will be used by the investigator as the primary measure for assessment of tumor 
response, date of PD, and as a basis for all protocol guidelines related to disease status (eg, 
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discontinuation of treatment). Although RECIST 1.1 references a maximum of 5 target 
lesions in total and 2 per organ, this protocol allows a maximum of 10 target lesions in total 
and 5 per organ, if clinically relevant to enable a broader sampling of tumor burden.
Initial tumor imaging showing site-assessed PD should also be submitted to the central 
imaging vendor.
iRECIST Assessment of Disease
iRECIST is based on RECIST 1.1, but adapted to account for the unique tumor response seen 
with immunotherapeutic drugs. iRECIST will be used by the investigator to assess tumor 
response and progression, and make treatment decisions. 
When clinically stable, participants should not be discontinued until progression is confirmed 
by the investigator, working with local radiology, according to the rules outlined in 
Appendix 6. This allowance to continue treatment despite initial radiologic PD takes into 
account the observation that some participants can have a transient tumor flare in the first 
few months after the start of immunotherapy, and then experience subsequent disease 
response. This data will be collected in the clinical database.
Clinical stability is defined as the following: 
•
Absence of symptoms and signs indicating clinically significant progression of disease
•
No decline in ECOG performance status 
•
No requirements for intensified management, including increased analgesia, radiation, or 
other palliative care
Any participant deemed clinically unstable should be discontinued from study treatment at 
site-assessed first radiologic evidence of PD, and is not required to have repeat tumor 
imaging for confirmation of PD by iRECIST.
If the investigator decides to continue treatment, the participant may continue to receive 
study treatment and the tumor assessment should be repeated 4 to 8 weeks later to confirm 
PD by iRECIST, per investigator assessment. For participants eligible for interval debulking 
surgery, the tumor assessment should be repeated 4 to 8 weeks later to confirm PD by 
iRECIST, but prior to debulking surgery. Images should continue to be sent in to the central 
imaging vendor for potential retrospective BICR. 
If repeat imaging does not confirm PD per iRECIST, as assessed by the investigator, and the 
participant continues to be clinically stable, study treatment may continue and follow the 
regular imaging schedule. If PD is confirmed, participants will be discontinued from study 
treatment.
If a participant has radiographic iCPD as defined in Appendix 6, study treatment should be 
discontinued; however, if the participant is achieving a clinically meaningful benefit, an 
exception to continue study treatment may be considered following consultation with the 
Sponsor. In this case, if study treatment is continued, tumor imaging should continue to be 
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performed following the intervals as outlined in Section 1.3 and submitted to the central 
imaging vendor.
A description of the adaptations and iRECIST process is provided in Appendix 6, with 
additional detail in the iRECIST publication [Seymour, L., et al 2017]. A summary of 
imaging and treatment requirements after first radiologic evidence of progression is provided 
in Table 9.
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Table 9
Imaging and Treatment After First Radiologic Evidence of PD
Clinically Stable
Clinically Unstable
Imaging
Treatment
Imaging
Treatment
First radiologic evidence 
of PD by RECIST 1.1
Repeat imaging at 4 to 
8 weeks to confirm PD
May continue study
treatment at investigator’s 
discretion while awaiting 
confirmatory tumor imaging 
by site by iRECIST
Repeat imaging at 4 to 8 weeks 
to confirm PD per 
investigator’s discretion only
Discontinue treatment
Repeat tumor imaging 
confirms PD (iCPD) by 
iRECIST per investigator
assessment
No additional imaging 
required
Discontinue treatment 
(exception is possible upon 
consultation with Sponsor)
No additional imaging required
Not applicable
Repeat tumor imaging 
shows iUPD by iRECIST 
per investigator assessment
Repeat imaging at 4 to 
8 weeks to confirm PD. May 
occur at next regularly 
scheduled visit
Continue study treatment at 
the investigator’s discretion
Repeat imaging at 4 to 8 weeks 
to confirm PD per 
investigator’s discretion only
Discontinue treatment
Repeat tumor imaging 
shows iSD, iPR, or iCR by 
iRECIST per investigator’s 
assessment
Continue regularly 
scheduled imaging 
assessments
Continue study treatment at 
the investigator’s discretion
Continue regularly scheduled 
imaging assessments
May restart study treatment if 
condition has improved and/or 
clinically stable per 
investigator’s discretion. Next 
tumor imaging should occur 
according to the regular 
imaging schedule
iCPD=iRECIST confirmed progressive disease; iCR=iRECIST confirmed complete response; iPR=iRECIST confirmed partial response; iRECIST=modified Response 
Evaluation Criteria in Solid Tumors 1.1 for immune-based therapeutics; iSD=iRECIST confirmed stable disease; iUPD=iRECIST unconfirmed progressive disease; 
PD=progressive disease; RECIST 1.1=Response Evaluation Criteria in Solid Tumors 1.1.
Note: If progression has been verified by the site, further management is by the site, based on iRECIST. Any further imaging should still be submitted to the central imaging 
vendor. If RECIST 1.1 disease progression has not been verified by the site, ideally the site should continue treatment. Whether or not treatment continues, imaging 
should be collected and submitted to the central imaging vendor until RECIST 1.1 progression is verified by the site.
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Pathological Tumor Assessment
Following interval debulking surgery, detailed pathological assessment will be performed by 
the local pathologist on all tumor tissue removed during the surgery and recorded in the 
appropriate eCRF. A redacted copy of the detailed pathological assessment will be requested 
following review of pCR worksheet. A pCR is defined as the disappearance of all known 
disease noted prior to surgery; all biopsies (and peritoneal washings if performed) collected 
during the interval debulking surgery are microscopically negative for malignancy.
All pathologists reviewing and interpreting surgical specimens for assessment of pCR will be 
blinded to treatment assignment.
Any leftover tissue will be archived for future biomedical research if the participant has 
documented the optional informed consent for future biomedical research as specified in 
Section 8.1.1.2.
Tumor Marker Assessment
Tumor markers alone cannot be used to assess response. However, some disease-specific and 
validated tumor markers (eg, CA-125 for OC) can be integrated as non-target disease 
markers. An increase in markers coincident with a decline in clinical stability and other signs 
of disease progression could indicate clinical progression (Section 7.1). For CA-125, this 
would be an increase of either ≥2 × the normal value or ≥2 × the lowest level it has been 
[Pepin, K., et al 2014] [Rustin, G. J., et al 2011].
Blood samples for tumor markers (ie, CA-125) will be obtained at time points indicated in 
Section 1.3, as clinically appropriate for the participant. Additional assessments may be done 
if clinically indicated (eg, suspected progression). CA-125 will be assessed by a local
laboratory.
Quality-of-Life Assessment
As of Amendment 05, all PRO collections will be discontinued. Original protocol text in 
this section has been retained for historical perspective.
For patient-reported outcomes (PROs), the EQ-5D-5L, EORTC QLQ-C30, and EORTC 
QLQ-OV28 questionnaires will be administered by trained study site personnel and 
completed by the participants themselves.
It is strongly recommended that PROs are administered prior to other study procedures 
assessments including drug administration, AE evaluation, and disease status notification. 
The PROs are completed in the following order: EQ-5D-5L first, then EORTC QLQ-C30, 
and lastly EORTC QLQ-OV28 at the time points specified in the Section 1.3 and briefly 
summarized below. 
The PROs will be completed on Day 1 of C1, C2, C3, C4, every 3 cycles through C16 (C7, 
C10, C13, C16), and every 4 cycles thereafter in the second year (C20, C24, C28, C32, C36) 
for as long as participant is receiving study treatment. The PROs will also be completed at 
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the treatment discontinuation visit and 30-day Safety Follow-up Visit. If the participant does 
not complete the PROs for any reason, the “Miss Mode” form must be completed to capture 
the reason the assessment was not performed.
Safety Assessments
Details regarding specific safety procedures/assessments to be performed in this study are 
provided below. The total amount of blood to be drawn over the course of the study (from 
prestudy to poststudy visits), including approximate blood volumes drawn by visit and by 
sample type per participant can be found in the Procedure Manual. Safety monitoring and 
assessments should be performed in accordance with the approved product labels and local 
practice for paclitaxel (or docetaxel), carboplatin and bevacizumab.
Planned time points for all safety assessments are provided in the SoA.
Physical Examinations
A complete physical examination will be conducted by an investigator or medically qualified 
designee (consistent with local requirements) as per institutional standard during the 
Screening Period. Height and weight will also be measured and recorded.
A brief directed physical examination will be conducted by an investigator or medically 
qualified designee (consistent with local requirements) as per institutional standard as 
clinically indicated, prior to administration of study treatment. Weight will also be measured 
and recorded.
Clinically significant abnormal findings should be recorded as medical history. After the first 
dose of chemotherapy in the Lead-in Period, new clinically significant abnormal findings 
should be recorded as AEs.
The time points for complete and directed physical examinations are described in the SoA 
(Section 1.3). Investigators should pay special attention to clinical signs related to previous 
serious illnesses.
Vital Signs
The investigator or qualified designee will measure vital signs at the time points specified in 
the SoA (Section 1.3) and will include temperature, systolic and diastolic blood pressure, 
heart rate, and respiratory rate. For participants who will start bevacizumab after the Lead-in 
Period, blood pressure must be measured prior to the first administration of bevacizumab to 
ensure the participant does not have uncontrolled hypertension.
Electrocardiograms
A standard 12-lead ECG will be obtained and reviewed by an investigator or medically 
qualified designee (consistent with local requirements) at the time points specified in the SoA 
(Section 1.3). Clinically significant abnormal findings at Screening should be recorded as 
medical history. An additional ECG should be performed when clinically necessary.
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Clinical Safety Laboratory Assessments
Refer to Appendix 5 for the list of clinical laboratory tests to be performed and to the SoA for 
the timing and frequency. 
•
The investigator or medically qualified designee (consistent with local requirements)
must review the laboratory report, document this review, and record any clinically 
relevant changes occurring during the study in the AE section of the CRF. The laboratory 
reports must be filed with the source documents. Clinically significant abnormal 
laboratory findings are those which are not associated with the underlying disease, unless 
judged by the investigator to be more severe than expected for the participant’s condition.
•
All protocol-required laboratory assessments, as defined in Appendix 5, must be 
conducted in accordance with the SoA.
•
If laboratory values from non-protocol-specified laboratory assessments performed at the 
institution’s local laboratory require a change in study participant management or are 
considered clinically significant by the investigator (eg, SAE or AE or dose 
modification), then the results must be recorded in the appropriate CRF (eg, SLAB).
•
For any laboratory tests with values considered clinically significantly abnormal during 
participation in the study or within 30 days after the last dose of study treatment, every 
attempt should be made to perform repeat assessments until the values return to normal or 
baseline or if a new baseline is established as determined by the investigator. 
The total amount of blood to be drawn/collected over the course of the study (from prestudy 
to poststudy visits), including approximate blood volumes drawn/collected by visit and by 
sample type per participant can be found in the Procedures Manual. Refer to the SoA 
(Section 1.3) for the timing of laboratory assessments.
Bone Marrow or Blood Cytogenetic Samples
Bone marrow or blood cytogenetic samples may be collected for participants with prolonged 
hematological toxicities as defined in Section 6.6.2.3.
Bone marrow analysis should include an aspirate for cellular morphology, cytogenetic 
analysis and flow cytometry, and a core biopsy for bone marrow cellularity. If it is not 
possible to conduct cytogenetic analysis or flow cytometry on the bone marrow aspirate, then 
attempts should be made to carry out the tests on a blood sample.
Performance Assessments
Eastern Cooperative Oncology Group Performance Status
The investigator or qualified designee will assess ECOG status at screening and prior to the 
administration of each dose of study treatment as specified in the SoA (Section 1.3).
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Adverse Events, Serious Adverse Events, and Other Reportable Safety Events 
The definitions of an AE or SAE, as well as the method of recording, evaluating, and 
assessing causality of AE and SAE and the procedures for completing and transmitting AE, 
SAE, and other reportable safety event reports can be found in Appendix 4.
Progression of the cancer under study is not considered an AE as described in Section 8.4.5 
and Appendix 4.
AE, SAEs, and other reportable safety events will be reported by the participant (or, when 
appropriate, by a caregiver, surrogate, or the participant’s legally authorized representative). 
The investigator and any designees are responsible for detecting, documenting, and reporting 
events that meet the definition of an AE or SAE as well as other reportable safety events.
Investigators need to document if an SAE was associated with a medication error, misuse, or 
abuse. Investigators remain responsible for following up AE, SAEs, and other reportable 
safety events for outcome according to Section 8.4.3.
The investigator, who is a qualified physician, will assess events that meet the definition of 
an AE or SAE as well as other reportable safety events with respect to seriousness, 
intensity/toxicity and causality.
AEs will not be collected for participants during the prescreening period (for determination 
of archival tissue status) as long as that participant has not undergone any protocol-specified 
procedure or intervention. If the participant requires a blood draw, fresh tumor biopsy etc., 
the participant is first required to provide consent to the main study and AEs will be captured 
according to guidelines for standard AE reporting.
Time Period and Frequency for Collecting AE, SAE, and Other Reportable 
Safety Event Information
•
All AEs, SAEs, and other reportable safety events that occur after the consent form is 
signed but before treatment allocation/randomization must be reported by the investigator 
if the participant is receiving placebo run-in or other run-in treatment, if the event causes 
the participant to be excluded from the study, or is the result of a protocol-specified 
intervention, including but not limited to washout or discontinuation of usual therapy, 
diet, or a procedure. 
•
All AEs from the time of treatment allocation/randomization through 30 days following 
cessation of study treatment must be reported by the investigator. 
•
All AEs meeting serious criteria, from the time of treatment allocation/randomization 
through 90 days following cessation of study treatment, or 30 days following cessation of 
study treatment if the participant initiates new anticancer therapy, whichever is earlier 
must be reported by the investigator. 
•
All pregnancies and exposure during breastfeeding, from the time of treatment 
allocation/randomization through 180 days following cessation of study treatment, or 
30 days following cessation of study treatment if the participant initiates new anticancer 
therapy must be reported by the investigator. 
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•
Additionally, any SAE brought to the attention of an investigator at any time outside of 
the time period specified above must be reported immediately to the Sponsor if the event 
is considered to be drug related.
•
Any SAE of MDS/AML or new primary malignancy occurring ≥30 days after the last 
dose of olaparib/olaparib placebo should be reported regardless of the investigator’s 
assessment of causality or knowledge of the treatment arm.
Investigators are not obligated to actively seek AE or SAE or other reportable safety events 
in former study participants. However, if the investigator learns of any SAE, including a 
death, at any time after a participant has been discharged from the study, and he/she 
considers the event to be reasonably related to the study treatment or study participation, the 
investigator must promptly notify the Sponsor.
If an extension study is available and a participant has been consented for the extension 
study, then safety events, including those considered related to study intervention, will be 
collected as instructed in the extension study. 
All initial and follow-up AEs, SAEs and other reportable safety events will be recorded and 
reported to the Sponsor or designee within the time frames as indicated in Table 10.
Table 10
Reporting Periods and Time Frames for Adverse Events and Other Reportable 
Safety Events
Type of Event
Reporting Period:
Consent to 
Randomization/
Allocation
Reporting Period:
Randomization/
Allocation 
Through Protocol-
specified AE 
Collection Period
Reporting 
Period:
After the 
Protocol-
specified AE 
Collection 
Period
Time Frame to Report 
Event and Follow-up 
Information to Sponsor
NSAE
Report if:
–
due to protocol-
specified 
intervention
–
causes 
exclusion
–
participant is 
receiving placebo 
run-in or other run-
in treatment
Report all
Not required
Per data entry guidelines
SAE, Cancer, or 
Overdose
Report if:
–
due to protocol-
specified 
intervention
–
causes 
exclusion
–
participant is 
receiving placebo 
run-in or other run-
in treatment
Report all
Report if:
– drug related
(Follow ongoing 
to outcome)
Within 24 hours of 
learning of event
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Type of Event
Reporting Period:
Consent to 
Randomization/
Allocation
Reporting Period:
Randomization/
Allocation 
Through Protocol-
specified AE 
Collection Period
Reporting 
Period:
After the 
Protocol-
specified AE 
Collection 
Period
Time Frame to Report 
Event and Follow-up 
Information to Sponsor
Pregnancy/Lactation 
Exposure
Report if:
–
participant has 
been exposed to any 
protocol-specified 
intervention (eg, 
procedure, washout, 
or run-in treatment 
including placebo 
run-in)
Exception: A 
positive pregnancy 
test at the time of 
initial screening is 
not a reportable 
event.
Report all
Previously 
reported 
– Follow to 
completion/
termination; 
report outcome
Within 24 hours of 
learning of event
Potential DILI events 
meeting biochemical 
criteria of Hy’s Law 
(requiring regulatory 
reporting)
Report if:
–
due to 
intervention
–
causes 
exclusion
Report
- regardless of 
suspected etiology -
to be reported as an 
ECI and SAE with 
OME criteria in the 
absence of other 
serious criteria
Previously 
reported –
Follow to 
completion/
termination; 
report outcome
Within 24 hours of 
learning of event
ECI (requiring 
regulatory reporting)
Report if:
–
due to 
intervention
–
causes 
exclusion
Report if: 
–
requiring 
regulatory 
reporting
Previously 
reported –
Follow to 
completion/
termination; 
report outcome
Within 24 hours of 
learning of event
ECI (does not require 
regulatory reporting)
Report if:
–
due to 
intervention
–
causes 
exclusion
Report
–
those not 
requiring regulatory 
reporting
Not required
Within 5 calendar days of 
learning of event (unless 
an SAE)
Abbreviations: DILI=drug-induced liver injury; ECI=event of clinical interest; NSAE=nonserious adverse event; 
OME=other important medical event; SAE=serious adverse event.
Method of Detecting AEs, SAEs, and Other Reportable Safety Events
Care will be taken not to introduce bias when detecting AE and/or SAE and other reportable 
safety events. Open-ended and nonleading verbal questioning of the participant is the 
preferred method to inquire about AE occurrence.
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Follow-up of AE, SAE and Other Reportable Safety Event Information
After the initial AE/SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. SAEs and other reportable safety events, including 
potential DILI events meeting biochemical criteria of Hy’s Law, pregnancy and exposure 
during breastfeeding, ECIs, cancer, and overdose will be followed until resolution, 
stabilization, until the event is otherwise explained, or the participant is lost to follow-up (as 
defined in Section 7.3). The investigator will also make every attempt to follow all 
nonserious AEs that occur in randomized participants for outcome. Further information on 
follow-up procedures is given in Appendix 4.
Regulatory Reporting Requirements for SAE
•
Prompt notification (within 24 hours) by the investigator to the Sponsor of SAE is 
essential so that legal obligations and ethical responsibilities towards the safety of 
participants and the safety of a study treatment under clinical investigation are met. 
•
The Sponsor has a legal responsibility to notify both the local regulatory authority and 
other regulatory agencies about the safety of a study treatment under clinical 
investigation. All AEs will be reported to regulatory authorities, IRB/IECs and 
investigators in accordance with all applicable global laws and regulations, ie, per ICH 
Topic E6 (R2) Guidelines for GCP.
•
Investigator safety reports must be prepared for suspected unexpected serious adverse 
reactions according to local regulatory requirements and Sponsor policy and forwarded to 
investigators as necessary.
•
An investigator who receives an investigator safety report describing an SAE or other 
specific safety information (eg, summary or listing of SAE) from the Sponsor will file it 
along with the IB and will notify the IRB/IEC, if appropriate according to local 
requirements.
Note: To meet EU CTR requirements, the Sponsor will report SUSARs to the Eudravigilance 
database via E2B(R3) electronic ICSR form in compliance with CTR 536/2014.
Disease-related Events and/or Disease-related Outcomes Not Qualifying as AEs 
or SAEs
Efficacy endpoints as outlined in this section will not be reported to the Sponsor as described 
in Section 8.4.1. 
Specifically, the suspected/actual events covered in this exception include any event that is 
disease progression of the cancer under study.
The Sponsor will monitor unblinded aggregated efficacy endpoint events and safety data to 
ensure the safety of the participants in the study. Any suspected endpoint which upon review 
is not progression of the cancer under study will be forwarded to Global Pharmacovigilance
as an SAE within 24 hours of determination that the event is not progression of the cancer 
under study.
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Pregnancy and Exposure During Breastfeeding
Although pregnancy and infant exposure during breastfeeding are not considered AEs, any 
pregnancy or infant exposure during breastfeeding in a participant (spontaneously reported to 
the investigator or their designee) that occurs during the study are reportable to the Sponsor.
All reported pregnancies must be followed to the completion/termination of the pregnancy. 
Pregnancy outcomes of spontaneous abortion, missed abortion, benign hydatidiform mole, 
blighted ovum, fetal death, intrauterine death, miscarriage and stillbirth must be reported as 
serious events (Important Medical Events). If the pregnancy continues to term, the outcome 
(health of infant) must also be reported.
Events of Clinical Interest (ECIs)
Selected nonserious and serious AEs are also known as ECIs and must be reported to the 
Sponsor.
All potential DILI events meeting biochemical criteria of Hy’s Law will be reported to the 
Sponsor, regardless of suspected etiology, as both an ECI and SAE, with OME criteria in the 
absence of other SAE criteria, within 24 hours of learning of the event. Potential DILI events 
are defined as:
•
An elevated AST or ALT laboratory value that is greater than or equal to 3× the ULN 
and,
•
An elevated total bilirubin laboratory value that is greater than or equal to 2× the ULN 
and, 
•
At the same time, an alkaline phosphatase laboratory value that is less than 2× the ULN, 
determined by way of protocol-specified laboratory testing or unscheduled laboratory 
testing.*
*Note: These criteria are based on available regulatory guidance documents. The purpose 
of the criteria is to specify a threshold of abnormal hepatic tests that may require an 
additional evaluation for an underlying etiology. The study site guidance for assessment 
and follow-up of these criteria can be found in the Investigator Study File Binder (or 
equivalent).
Additional ECIs for this study include:
1. An overdose of study intervention, as defined in Section 8.5, that is not associated with 
clinical symptoms or abnormal laboratory results.
2. Any event of MDS/AML, new primary malignancy, or pneumonitis should be reported 
whether it is considered a nonserious AE (eg, non-melanoma skin cancer) or SAE and 
regardless of investigator’s assessment of causality as defined in Section 8.4.1.
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Treatment of Overdose
For this study, an overdose of pembrolizumab will be defined as any dose of 1000 mg or 
greater (≥5 times the indicated dose). Olaparib must only be used in accordance with the 
dosing recommendations in this protocol. Any dose or frequency of dosing that exceeds the 
dosing regimen specified in this protocol should be reported as an overdose.
No specific information is available on the treatment of overdose of pembrolizumab, 
chemotherapy, bevacizumab, or olaparib. In the event of overdose, the participant should be 
observed closely for signs of toxicity. Appropriate supportive treatment should be provided if 
clinically indicated.
Pharmacokinetics
PK parameters will not be evaluated in this study.
Pharmacodynamics
Pharmacodynamic parameters will not be evaluated in this study.
Biomarkers
To identify novel biomarkers, the following biospecimens to support exploratory analyses of 
cellular components (eg, protein, RNA, DNA, metabolites) and other circulating molecules 
will be collected from all participants in this study as specified in the SoA:
•
Blood for genetic analysis
•
Blood for RNA analysis
•
Blood for plasma biomarker analysis
•
Blood for serum biomarker analysis
•
Blood for circulating tumor DNA
•
Newly obtained tissue collection
•
Tumor tissue
Sample collection, storage and shipment instructions for the exploratory biomarker 
specimens will be provided in the Procedure Manual.
The sample for genetic analysis should be drawn for planned exploratory biomarker research. 
This sample will not be collected at the site if there is either a local law or regulation 
prohibiting collection, or if the IRB/IEC does not approve the collection of the sample for 
these purposes. If the sample is collected, leftover extracted DNA will be stored for future 
biomedical research if the participant signs the future biomedical research consent. If the 
genetic sample collection is not approved, but future biomedical research is approved and 
consent is given, this sample will be collected for the purpose of future biomedical research.
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Future Biomedical Research Sample Collection
If the participant signs the future biomedical research consent, leftover samples listed in 
Section 8.8 will be obtained as part of future biomedical research.
Medical Resource Utilization and Health Economics
Medical resource utilization and health economics data, associated with medical encounters, 
will be collected in the CRF by the investigator and study site personnel for all participants 
throughout the study. Protocol-mandated procedures, tests, and encounters are excluded.
The data collected may be used to conduct exploratory economic analyses and will include:
•
All-cause hospitalizations and emergency room visits, from the time of treatment 
allocation/randomization through 90 days following cessation of study treatment, or 30 
days following cessation of study treatment, if the participant initiates new anticancer
therapy, whichever is earlier.
Visit Requirements
Visit requirements are outlined in Section 1.3. Specific procedure-related details are provided 
above in Section 8.
Screening
Within 56 days prior to randomization, potential participants will be evaluated to determine 
that they fulfill the entry requirements as set forth in Section 5.
Written consent must be obtained prior to performing any protocol-specific procedure. 
Results of a test performed prior to the participant signing consent as part of routine clinical 
management are acceptable in lieu of a screening test if performed within the specified time 
frame. Screening procedures are to be completed within 56-day Screening Period, except for 
the following:
•
Laboratory tests are to be performed within 7 days prior to the initiating chemotherapy in 
the Lead-in Period. An exception is HIV and hepatitis testing which may be done up to 
56 days prior to randomization if required by the local health authority. Refer to 
Appendix 7 for country-specific requirements.
•
Baseline imaging to be performed within 28 days prior to starting lead-in chemotherapy 
administration.
•
Clinical chemistry and hematological parameters are to be reassessed within 3 days of 
Cycle 1 Day 1.
•
Evaluation of ECOG is to be performed within 7 days prior to initiating chemotherapy in 
the Lead-in Period and within 3 days of Cycle 1 Day 1.
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•
For WOCBP, a pregnancy test (urine or serum) will be performed within either 24 hours 
(urine) or 72 hours (serum) prior to initiating chemotherapy during the Lead-in Period
and within either 24 hours (urine) or 72 hours (serum) prior to Day 1 of Cycle 1. If urine 
pregnancy results cannot be confirmed as negative, a serum pregnancy test will be 
required (performed by the local study site laboratory). Refer to Appendix 7 for country-
specific requirements.
•
Newly obtained tissue may be obtained at any time prior to the administration of systemic 
cytotoxic treatment for the treatment of current OC.
Participants may be rescreened after initially failing to meet the inclusion/exclusion criteria. 
Results from assessments during the initial Screening Period are acceptable in lieu of a repeat 
screening test if performed within the specified time frame and the corresponding 
inclusion/exclusion criteria is met. Participants who are rescreened will retain their original 
screening number.
Treatment Period
Visit requirements are outlined in the SoA (Section 1.3). Specific procedure-related details 
are provided in Section 8.
Posttreatment Visits
Safety Follow-up Visit
The mandatory Safety Follow-up Visit should be conducted 30 days (+7 days) after the last 
dose of study treatment or before the initiation of a new anticancer treatment, whichever 
comes first. If the discontinuation visit occurs ≥30 days from last dose of study intervention, 
a Safety Follow-up Visit is not required.
Efficacy Follow-up Visits
Participants who complete the protocol-required cycles of study intervention or who 
discontinue study treatment for a reason other than PD will begin the Efficacy Follow-up 
Phase and should be assessed approximately every 9 weeks (63 days ± 7 days) during the 
first year (through Week 54), approximately every 12 weeks (84 days ± 7 days) through 
Week 156, and Q24 weeks (168 days ± 7 days) thereafter by radiologic imaging to monitor 
disease status. Every effort should be made to collect information regarding disease status 
until the start of new anticancer therapy, disease progression, pregnancy, death, or the end of 
study. 
Information regarding poststudy anticancer treatment will be collected if new treatment is 
initiated. Participants who will not have further efficacy assessments must enter the Survival 
Follow-up Phase.
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Survival Follow-up Assessments
Participant survival follow-up status will be assessed approximately every 12 weeks to assess 
for survival status until death, withdrawal of consent, or the end of the study, whichever 
occurs first.
The first survival follow-up assessment should be scheduled as detailed below:
•
For participants who discontinue study treatment and who will not enter the Efficacy 
Follow-up Phase, the first survival follow-up contact will be scheduled 12 weeks after the 
discontinuation visit and/or Safety Follow-up Visit (whichever is last).
•
For participants who entered but are no longer being assessed during the Efficacy 
Follow-up Phase, the first survival follow-up contact will be scheduled 12 weeks after the 
last efficacy assessment follow-up visit has been performed.
Investigators should ask during survival follow-up assessments if the participant has 
developed MDS/AML or a new primary malignancy and prompted to report any such cases.
Survival Status
To ensure current and complete survival data is available at the time of database locks, 
updated survival status may be requested during the course of the study by the Sponsor. For 
example, updated survival status may be requested prior to but not limited to an eDMC 
review, interim and/or final analysis. Upon Sponsor notification, all participants who do 
not/will not have a scheduled study visit or study contact during the Sponsor defined time 
period will be contacted for their survival status.
9. Statistical Analysis Plan
This section outlines the statistical analysis strategy and procedures for the study. If, after the 
study has begun, changes are made to primary and/or key secondary hypotheses, or the 
statistical methods related to those hypotheses, then the protocol will be amended (consistent 
with ICH Guideline E-9). Changes to exploratory or other non-confirmatory analyses made 
after the protocol has been finalized, but prior to the conduct of any analysis, will be 
documented in a supplemental Statistical Analysis Plan (sSAP) and referenced in the Clinical 
Study Report (CSR) for the study. A separate biomarker analysis plan will be provided. 
Posthoc exploratory analyses will be clearly identified in the CSR. The PRO analysis plan 
will also be included in the sSAP.
Statistical Analysis Plan Summary
Key elements of the Statistical Analysis Plan are summarized below. The comprehensive 
plan is provided in Sections 9.2 through 9.12.
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Key Elements of the Statistical Analysis Plan
Study Design Overview
A Randomized Phase 3, Double-Blind Study of Chemotherapy With or 
Without Pembrolizumab Followed by Maintenance With Olaparib or 
Placebo for the First-Line Treatment of BRCA non-mutated Advanced 
Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / 
GOG-3036)
Treatment Assignment
Approximately 1284 participants will be randomized in a 1:1:1 ratio between 
3 treatment arms: 

Arm 1:
Treatment: carboplatin/paclitaxel for 5 cycles plus pembrolizumab Q3W 
for up to 35 infusions.
Maintenance: olaparib BID

Arm 2:
Treatment: carboplatin/paclitaxel Q3W for 5 cycles plus pembrolizumab 
Q3W for up to 35 infusions
Maintenance: olaparib placebo BID

Arm 3 (control Arm):
Treatment: carboplatin/paclitaxel plus pembrolizumab placebo Q3W for 
5 cycles plus pembrolizumab placebo Q3W for up to 35 infusions. 
Maintenance: olaparib placebo BID
Stratification factors are as follows:
1.
Surgery (planned interval debulking versus R0 following primary 
debulking versus R1 following primary debulking)
2.
Bevacizumab use (yes versus no)
3.
PD-L1 status (CPS <10 versus CPS ≥10)
Analysis Populations
Efficacy: Intention-to-Treat (ITT)
Safety: All Participants as Treated (APaT)
Primary Endpoints

Progression-free survival (PFS) based on RECIST 1.1 as assessed by 
investigator in participants with PD-L1 positive tumors (CPS ≥10)

PFS per RECIST 1.1 assessed by investigator in all participants.
Key Secondary 
Endpoints

Overall survival (OS) in participants with PD-L1 positive tumors
(CPS ≥10)

OS in all participants
Statistical Methods for
Key Efficacy Analyses
The primary and key secondary hypotheses will be evaluated by comparing the 
treatment arms (Arm 1 vs Arm 3 and Arm 2 vs Arm 3) with respect to PFS and 
OS using a stratified log-rank test. The hazard ratio [HR] will be estimated
using a stratified Cox regression model. Event rates over time will be estimated 
within each treatment group using the Kaplan-Meier method. 
Statistical Methods for
Key Safety Analyses
The analysis of safety results will follow a tiered approach. The tiers differ with 
respect to the analyses that will be performed. There are no events of interest 
that warrant elevation to Tier 1 events in this study. Tier 2 parameters will be 
assessed via point estimates with 95% confidence intervals (CIs) provided for 
between-group comparisons; only point estimates by treatment group are 
provided for Tier 3 safety parameters. The 95% CIs for the between-treatment 
differences in percentages will be provided using the Miettinen and Nurminen 
method.
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CCI
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Responsibility for Analyses/In-house Blinding
The statistical analysis of the data obtained from this study will be the responsibility of the 
Clinical Biostatistics department of the Sponsor.
This study will be conducted as a double-blind study in-house blinding procedures. The 
official, final database will not be unblinded until medical/scientific review has been 
performed, protocol deviations have been identified, and data has been declared final and 
complete. 
The Sponsor will generate the randomized allocation schedule for study treatment 
assignment for this protocol and the randomization will be implemented in IRT.
Blinding issues related to the planned interim analyses are described in Section 9.7.
Hypotheses/Estimation
Objectives and hypotheses of the study are stated in Section 3.
Analysis Endpoints
Efficacy, safety and PRO endpoints that will be evaluated for within- and/or between-
treatment differences are listed below. Other endpoints will be described in the sSAP.
CCI
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Primary
PFS: The time from randomization to the first documented PD as assessed by the 
investigator according to RECIST 1.1, or death due to any cause, whichever occurs first.
Secondary
OS:  The time from randomization to death due to any cause. 
PFS: The time from randomization to the first documented PD as assessed by BICR 
according to RECIST 1.1, or death due to any cause, whichever occurs first.
PFS2: The time from randomization to subsequent disease progression (clinical or 
radiological) after second-line therapy, or death from any cause, whichever first. 
TFST: The time from the date of randomization until initiation of first subsequent anticancer
therapy or death due to any cause, whichever occurs first.
TSST: The time from the date of randomization until initiation of second subsequent 
anticancer therapy or death due to any cause, whichever occurs first.
TDT: The time from the date of randomization to discontinuation of study treatment or death 
due to any cause, whichever occurs first.
pCR: The disappearance of all known disease noted prior to surgery; all biopsies (and 
peritoneal washings if performed) collected during the interval debulking surgery are 
microscopically negative for malignancy.
PRO: Change from baseline and time to deterioration in EORTC QLQ-C30 GHS/QoL
(items 29 and 30), and the abdominal/GI symptom subscale (items 31 to 36) from EORTC 
QLQ-OV28 will be evaluated as secondary endpoints. 
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Analysis Populations
Efficacy Analysis Population
The Intention-to-Treat (ITT) population will serve as the population for the primary efficacy 
analyses. All randomized participants will be included in this population. Participants will be 
analyzed in the treatment group to which they are randomized.
The analysis population for ORR consists of all randomly assigned participants with 
measurable disease.
Safety Analysis Population
The All Participants as Treated (APaT) population will be used for the analysis of safety data 
in this study. The APaT population consists of all randomized/allocated participants who 
received at least 1 dose of study treatment. Participants will be included in the treatment 
group corresponding to the study treatment they actually received for the analysis of safety 
data using the APaT population. This will be the treatment group to which they are 
randomized except for participants who take incorrect study treatment for the entire 
Treatment Period; such participants will be included in the treatment group corresponding to 
the study treatment actually received.
At least 1 laboratory, vital sign, or ECG measurement obtained subsequent to at least 1 dose 
of study treatment is required for inclusion in the analysis of the respective safety parameter. 
To assess change from baseline, a baseline measurement is also required.
Details on the approach to handling safety analyses are provided in Section 9.6.
PRO Analysis Population
The PRO analyses are based on the PRO Full Analysis Set (PRO FAS) population, defined as 
all randomized participants who have at least 1 PRO assessment available for the specific 
endpoint and have received at least 1 dose of the study intervention. Participants will be 
analyzed in the treatment group to which they are randomized.
Statistical Methods
Statistical Methods for Efficacy Analyses
Statistical testing and inference for safety analyses are described in Section 9.6.2. Efficacy 
results that will be deemed to be statistically significant after consideration of the Type-I 
error control strategy are described in Section 9.8. Nominal p-values will be computed for 
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other efficacy analyses, but should be interpreted with caution due to potential issues of 
multiplicity.
Progression-free Survival
The non-parametric Kaplan-Meier method will be used to estimate the PFS curve in each 
treatment group. The treatment difference in PFS will be assessed by the stratified log-rank 
test. A stratified Cox proportional hazard model with Efron's method of tie handling will be 
used to assess the magnitude of the treatment difference (ie, the HR) between the treatment 
arms. The HR and its 95% CI from the stratified Cox model with Efron's method of tie 
handling and with a single treatment covariate will be reported. The stratification factors used 
for randomization (Section 6.3.1.1) will be applied to both the stratified log-rank test and the 
stratified Cox model. Median PFS and its 95% confidence intervals (CIs) will be updated 
post the second interim analysis; however, no formal statistical test will be performed.
Since disease progression is assessed periodically, PD can occur any time in the time interval 
between the last assessment where PD was not documented and the assessment when PD is 
documented. The true date of disease progression will be approximated by the date of the 
first assessment at which PD is objectively documented per RECIST 1.1 (based on 
investigator for primary analysis). Death is always considered as a confirmed PD event. 
Participants who do not experience a PFS event will be censored at the last disease 
assessment.
In order to evaluate the robustness of the PFS endpoint per RECIST 1.1 based on investigator
assessment, 1 primary and 2 sensitivity analyses with a different set of censoring rules will be 
performed. For the primary analysis, if the events (PD or death) are immediately after more 
than 1 missed disease assessment, the data are censored at the last disease assessment prior to 
missing visits. Also, data after new anticancer therapy are censored at the last disease 
assessment prior to the initiation of new anticancer therapy. The first sensitivity analysis 
follows the complete follow-up intention-to-treat principle. That is, PDs/deaths are counted 
as events regardless of missed study visits or initiation of new anticancer therapy. The second 
sensitivity analysis, it considers discontinuation of treatment or initiation of an anticancer
treatment subsequent to discontinuation of study-specified treatments, whichever occurs 
later, to be a PD event for participants without documented PD or death. If a participant
meets multiple criteria for censoring, the censoring criterion that occurs earliest will be 
applied. The censoring rules for primary and sensitivity analyses are summarized in 
Table 11.
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Table 11
Censoring Rules for Primary and Secondary Analyses of PFS
Situation
Primary Analysis
Sensitivity
Analysis 1
Sensitivity
Analysis 2
PD or death 
documented after 
≤1 missed disease 
assessment, and before 
new anticancer therapy, 
if any
Progressed at date of 
documented PD or 
death
Progressed at date of 
documented PD or death
Progressed at date of 
documented PD or death
PD or death 
documented 
immediately after 
≥2 consecutive missed 
disease assessments or 
after new anticancer
therapy, if any
Censored at last disease 
assessment prior to 
the earlier date of 
≥2 consecutive missed 
disease assessment and 
new anticancer therapy, 
if any
Progressed at date of 
documented PD or death
Progressed at date of 
documented PD or death
No PD and no death; 
and new anticancer
treatment is not 
initiated
Censored at last disease 
assessment 
Censored at last disease 
assessment 
Progressed at treatment 
discontinuation due to 
reasons other than complete 
response; otherwise 
censored at last disease 
assessment if still on study 
or completed study 
treatment.
No PD and no death; 
new anticancer
treatment is initiated
Censored at last disease 
assessment before new 
anticancer treatment 
Censored at last disease 
assessment
Progressed at date of new 
anticancer treatment 
Abbreviation: PD = progressive disease.
Similar analyses will be performed for the secondary endpoint of PFS per RECIST 1.1 by 
BICR assessment. Only the primary censoring rule will be applied for the analysis of PFS by 
BICR assessment.
An analysis of PFS2, defined as the time from randomization to subsequent disease 
progression after second-line therapy, or death from any cause, whichever first, will be 
carried out. Participants alive and for whom a disease progression following initiation of new 
anticancer treatment has not been observed will be censored at the third-line therapy start 
date if any or the last time the participant was known to be alive and without second disease 
progression. The same stratified Cox proportional hazard model will be used to estimate the 
HR and its 95% CI.
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Overall Survival
The non-parametric Kaplan-Meier method will be used to estimate the survival curves. The 
treatment difference in survival will be assessed by the stratified log-rank test (based on the 
stratification factors defined in Section 6.3.1.1). A stratified Cox proportional hazard model 
with Efron's method of tie handling will be used to assess the magnitude of the treatment 
difference (ie, the HR). The HR and its 95% CI from the stratified Cox model with a single 
treatment covariate will be reported. The stratification factors used for randomization 
(Section 6.3.1.1) will be applied to both the stratified log-rank test and the stratified Cox 
model. Participants without documented death at the time of analysis will be censored at the 
date of last known contact. The Restricted Mean Survival Time method may be conducted 
for OS to account for the possible non-proportional hazards effect.
A summary of the primary analysis strategy for the key efficacy endpoints is provided in 
Table 12.
Table 12
Efficacy Analysis Methods for Key Efficacy Endpoints
Endpoint/Variable
Statistical Method
Analysis 
Population
Missing Data Approach
Primary Analyses:
PFS (RECIST 1.1)
by investigator
Testing: Stratified log-rank test
Estimation: Stratified Cox 
model with Efron's tie handling 
method 
ITT (in 
participants
with CPS ≥10
and in all 
participants)
Censored according to rules in 
Table 11.
Secondary Analyses:
OS
Testing: Stratified log-rank test
Estimation: Stratified Cox 
model with Efron's tie handling 
method
ITT (in 
participants
with CPS ≥10
and in all 
participants)
Censored at last known alive 
date
PFS (RECIST 1.1)
by BICR
Estimation: Stratified Cox 
model with Efron's tie handling 
method 
ITT (in 
participants
with CPS ≥10
and in all 
participants)
Primary censoring rule in 
Table 11.
PFS2
Estimation: Stratified Cox 
model with Efron's tie handling 
method
ITT (in 
participants
with CPS ≥10
and in all 
participants)
Participants alive and for whom 
no secondary disease 
progression has been served 
will be censored at the third-
line therapy start date, if any, or
the last time known to be alive 
and without second disease 
progression.
Abbreviations: BICR = blinded independent central review; CPS = combined positive score; ITT = intention-to-treat; 
OS = overall survival; PFS = progression-free survival; PFS2 = progression-free survival after next-line treatment; 
RECIST 1.1 = Response Evaluation Criteria in Solid Tumors version 1.1.
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Statistical Methods for Safety Analyses
Safety and tolerability will be assessed by clinical review of all relevant parameters including 
AEs, laboratory tests, vital signs, and ECG measurements.
The analysis of safety results will follow a tiered approach (Table 13). The tiers differ with 
respect to the analyses that will be performed. AEs (specific terms as well as system organ 
class terms) and events that meet predefined limits of change (PDLCs) in laboratory values, 
vital signs, and ECG parameters are either prespecified as “Tier 1” endpoints, or will be 
classified as belonging to "Tier 2" or "Tier 3" based on the observed proportions of 
participants with an event. 
Tier 1 Events
Safety parameters that are identified a priori constitute “Tier 1” safety endpoints that will be 
subject to inferential testing for statistical significance. AEs of special interest that are 
immune-mediated or potentially immune-mediated are well documented and will be 
evaluated separately; however, these events have been characterized consistently throughout 
the pembrolizumab clinical development program and determination of statistical 
significance is not expected to add value to the safety evaluation. Additionally, there are no 
known AEs associated with participants for which determination of a p-value is expected to 
impact the safety assessment. Therefore, there are no Tier 1 events in this study.
Tier 2 Events
Tier 2 parameters will be assessed via point estimates with 95% CIs provided for differences 
in the proportion of participants with events (via the Miettinen and Nurminen method 
[1985]).
Membership in Tier 2 requires that at least 10% of participants in any treatment group exhibit 
the event; all other AEs and predefined limits of change will belong to Tier 3. The threshold 
of at least 10% of participants was chosen for Tier 2 events because the population enrolled 
in this study is in critical condition and usually experiences various AEs of similar types 
regardless of treatment; events reported less frequently than 10% of participants would 
obscure the assessment of the overall safety profile and add little to the interpretation of 
potentially meaningful treatment differences. In addition, Grade 3 to 5 AEs (≥5% of 
participants in 1 of the treatment groups) and SAEs (≥5% of participants in 1 of the treatment 
groups) will be considered Tier 2 endpoints. Because many 95% CIs may be provided 
without adjustment for multiplicity, the CIs should be regarded as a helpful descriptive 
measure to be used in safety review, not as a formal method for assessing the statistical 
significance of the between-group differences.
Tier 3 Events
Safety endpoints that are not Tier 1 or 2 events are considered Tier 3 events. The broad AE 
categories consisting of the proportion of participants with any AE, a drug-related AE, a 
serious AE, an AE which is both drug related and serious, a Grade 3-5 AE, a drug-related 
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Grade 3-5 AE, and discontinuation due to an AE will be considered Tier 3 endpoints. Only 
point estimates by treatment group are provided for Tier 3 safety parameters.
Continuous Safety Measures 
For continuous measures such as changes from baseline in laboratory, vital signs, and ECG 
parameters, summary statistics for baseline, on-treatment, and change from baseline values 
will be provided by treatment group in table format.
Table 13
Analysis Strategy for Safety Parameters
Safety Tier
Safety Endpoint
95% CI for 
Treatment 
Comparison
Descriptive 
Statistics
Tier 2
Grade 3-5 AE (incidence ≥5% of participants in one of 
the treatment groups)
X
X
Serious AE (incidence ≥5% of participants in one of the 
treatment groups)
X
X
AEs (incidence ≥10% of participants in one of the 
treatment groups)
X
X
Tier 3
Any AE
X
Any Grade 3-5 AE
X
Any Serious AE 
X
Any Drug-Related AE
X
Any Serious and Drug-Related AE
X
Any Grade 3-5 and Drug-Related AE
X
Discontinuation due to AE
X
Death
X
Specific AEs, SOCs (incidence <10% of participants in 
all of the treatment groups)
X
Change from Baseline Results (lab toxicity shift, vital 
signs)
X
Abbreviations: AE=adverse event; CI=confidence interval; SOC=system organ class.
Statistical Methods for PRO Analyses
To evaluate the treatment effect on the HRQoL outcomes at prespecified time points, a 
constrained longitudinal data analysis model will be applied, with the PRO score as the 
response variable, and the treatment by time interaction and stratification factors as 
covariates. Least square mean (lsmean) change from baseline will be summarized. Group-
wise comparisons will be performed and the model-based lsmean score will be provided by 
treatment group and study visit.
A difference of 10 points in PRO score on the 100-point scale is perceived to be clinically 
meaningful to participants according to previous research. Correspondingly, a participant’s 
postbaseline PRO score will be classified as “improvement”, “stable”, or “deterioration” 
according to a 10-point or greater change for EORTC QLQ-C30 GHS/QoL and EORTC 
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QLQ-OV28 abdominal/GI symptom scale. The number and proportion of participants with 
“improved”, “stable”, or “deteriorated” scales will be summarized by treatment arm.
The Kaplan-Meier method will be used to estimate times to deterioration survival curve for 
each treatment arm and the Cox proportional hazards regression model will be used to 
estimate the magnitude of treatment difference.
Details of other PRO analyses will be described in the sSAP.
Summaries of Baseline Characteristics and Demographics
The comparability of the treatment groups for each relevant characteristic will be assessed by 
the use of tables and/or graphs. No statistical hypothesis tests will be performed on these 
characteristics. The number and percentage of participants randomized, and the primary 
reason for discontinuation will be displayed. Demographic variables (such as age) and 
baseline characteristics will be summarized by treatment either by descriptive statistics or 
categorical tables. The reasons for exclusion from the ITT population (if any) will be 
summarized.
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Safety Analyses
The eDMC has responsibility for assessment of overall risk/benefit. When prompted by 
safety concerns, the eDMC can request corresponding efficacy data. eDMC review of 
efficacy data to assess the overall risk/benefit to study participants will not require a 
multiplicity adjustment typically associated with a planned efficacy interim analysis. 
However, to account for any multiplicity concerns raised by the eDMC review of unplanned 
efficacy data when prompted by safety concerns, a sensitivity analysis for OS adopting a 
conservative multiplicity adjustment will be prespecified in the sSAP.
Sample Size and Power Calculations
The study plans to randomize ~1284 participants with
in a 1:1:1 ratio into the 
3 arms. Of note, the assumption of
was made in the sample size and power calculations. 
PFS is the primary endpoint and OS is the key secondary endpoint for the study.
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For PFS in participants with CPS ≥10 of Arm 1 versus Arm 3 comparison,
the study has ~ 85% power to detect a HR of 0.70
For PFS in all participants of Arm 1 versus Arm 3 comparison,
the study has ~ 93% power to detect a HR of 0.72 at the initially allocated 
α=0.005 (1-sided). 
For PFS in participants with CPS ≥10 of Arm 2 versus Arm 3 comparison
the study has ~ 87% power to detect a HR of 0.70 at the 
α=0.025 (1-sided). 
For OS in participants with CPS ≥10 of Arm 2 versus Arm 3 comparison,
he study has ~ 74% power to detect a HR of 0.70 at the 
α=0.025 (1-sided).
For PFS in all participants of Arm 2 versus Arm 3 comparison,
the study has ~ 98% power to detect a HR of 0.72 at the α=0.025 (1-
sided). 
For OS in all participants for both comparisons (Arm 2 versus Arm 3 and Arm 1 versus 
Arm 3),
the study has ~ 85% power to 
detect a HR of 0.75 at the α=0.025 (1-sided). 
Note that the above power calculations are based on a constant HR assumption. The interim 
analysis timing and spending have been designed to ensure the final alpha available is 
maximized to make testing most sensitive when follow-up is available across both early and 
late parts of the survival and PFS distributions.
The above sample size and power calculations for PFS and OS assume the following:
•
PFS follows an exponential distribution with a median of 16 months for the control 
group. 
•
OS follows an exponential distribution with a median of 46 months for the control group.
The sample size and power calculations were performed using R (“gsDesign” package). 
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Subgroup Analyses
To determine whether the treatment effect is consistent across various subgroups, the 
between-group treatment effect for PFS and OS (with a nominal 95% CI) will be estimated 
and plotted by treatment group within each category of the following classification variables:
•
Stratification factors
-
Surgery (planned interval debulking versus R0 following primary debulking versus
R1 following primary debulking)
-
Bevacizumab use (yes versus no)
-
PD-L1 status (CPS <10 versus CPS ≥10)
•
Race (white, non-white)
•
ECOG performance status (0, 1)
A Forest plot will be produced, which provides the point estimates and CIs for the treatment 
effect across the categories of subgroups listed above. The consistency of the treatment effect 
will be assessed descriptively via summary statistics by category for the classification 
variables listed above.
Compliance (Medication Adherence)
Drug accountability data for study treatment will be collected during the study. Any 
deviation from protocol-directed administration will be reported.
Extent of Exposure
Extent of exposure for a participant is defined as number of cycles in which the participant 
receives the study treatment infusion for pembrolizumab/pembrolizumab placebo, and the 
number of days in which the participant receives olaparib/olaparib placebo. Summary 
statistics will be provided on the extent of exposure for pembrolizumab/pembrolizumab 
placebo and olaparib/olaparib placebo, separately, for the APaT population.
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10. Supporting Documentation and Operational Considerations
Appendix 1: Regulatory, Ethical and Study Oversight Considerations
Code of Conduct for Clinical Trials
Merck Sharp & Dohme LLC, Rahway, NJ, USA (MSD)
Code of Conduct for Interventional Clinical Trials
I.
Introduction
A. Purpose
MSD, through its subsidiaries, conducts clinical trials worldwide to evaluate the safety and effectiveness of our 
products. As such, we are committed to designing, implementing, conducting, analyzing, and reporting these trials in 
compliance with the highest ethical and scientific standards. Protection of participants in clinical trials is the overriding
concern in the design of clinical trials. In all cases, MSD clinical trials will be conducted in compliance with MSD’s 
global standards, local and/or national regulations (including all applicable data protection laws and regulations), 
Regulation (EU) 536/2014, the International Council for Harmonisation Good Clinical Practice (ICH-GCP) E6 and 
ICH General Considerations for Clinical Studies E8, and in accordance with the ethical principles that have their origin 
in the Declaration of Helsinki. 
B. Scope
Highest ethical and scientific standards shall be endorsed for all clinical interventional investigations sponsored by 
MSD irrespective of the party (parties) employed for their execution (e.g., contract research organizations, 
collaborative research efforts). This Code is not intended to apply to trials which are observational in nature, or which 
are retrospective. Further, this Code does not apply to investigator-initiated trials, which are not under the full control 
of MSD.
II.
Scientific Issues
A. Trial Conduct
1.  Trial Design
Except for pilot or estimation trials, clinical trial protocols will be hypothesis-driven to assess safety, efficacy 
and/or pharmacokinetic or pharmacodynamic indices of MSD or comparator products. Alternatively, MSD may 
conduct outcomes research trials, trials to assess or validate various endpoint measures, or trials to determine 
patient preferences, etc.
The design (i.e., participant population, duration, statistical power) must be adequate to address the specific 
purpose of the trial. Participants must meet protocol entry criteria to be enrolled in the trial.
2.  Site Selection
MSD selects investigative sites based on medical expertise, access to appropriate participants, adequacy of 
facilities and staff, previous performance in clinical trials, as well as budgetary considerations. Prior to trial 
initiation, sites are evaluated by MSD personnel to assess the ability to successfully conduct the trial. 
3.  Site Monitoring/Scientific Integrity
Investigative trial sites are monitored to assess compliance with the trial protocol and general principles of Good
Clinical Practice (GCP). MSD reviews clinical data for accuracy, completeness, and consistency. Data are verified 
versus source documentation according to standard operating procedures. Per MSD policies and procedures, if 
fraud, scientific/research misconduct or serious GCP-non-compliance is suspected, the issues are investigated. 
When necessary, the clinical site will be closed, the responsible regulatory authorities and ethics review 
committees notified.
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B.  Publication and Authorship
Regardless of trial outcome, MSD commits to publish the primary and secondary results of its registered trials of 
marketed products in which treatment is assigned, according to the prespecified plans for data analysis. To the extent 
scientifically appropriate, MSD seeks to publish the results of other analyses it conducts that are important to patients, 
physicians, and payers. Some early phase or pilot trials are intended to be hypothesis-generating rather than hypothesis 
testing; in such cases, publication of results may not be appropriate since the trial may be underpowered and the 
analyses complicated by statistical issues such as multiplicity.
MSD’s policy on authorship is consistent with the recommendations published by the International Committee of 
Medical Journal Editors (ICMJE). In summary, authorship should reflect significant contribution to the design and 
conduct of the trial, performance or interpretation of the analysis, and/or writing of the manuscript. All named authors 
must be able to defend the trial results and conclusions. MSD funding of a trial will be acknowledged in publications.
III. Participant Protection
A.  Ethics Committee Review (Institutional Review Board [IRB]/Independent Ethics Committee [IEC])
All clinical trials will be reviewed and approved by an IRB/IEC before being initiated at each site. Significant changes 
or revisions to the protocol will be approved by the ethics committee prior to implementation, except changes required 
urgently to protect participant safety that may be enacted in anticipation of ethics committee approval. For each site, the 
ethics committee and MSD will approve the participant informed consent form. 
B.  Safety
The guiding principle in decision-making in clinical trials is that participant welfare is of primary importance. Potential 
participants will be informed of the risks and benefits of, as well as alternatives to, trial participation. At a minimum, 
trial designs will take into account the local standard of care. 
All participation in MSD clinical trials is voluntary. Participants enter the trial only after informed consent is obtained. 
Participants may withdraw from an MSD trial at any time, without any influence on their access to, or receipt of, 
medical care that may otherwise be available to them.
C.  Confidentiality
MSD is committed to safeguarding participant confidentiality, to the greatest extent possible. Unless required by law, 
only the investigator, Sponsor (or representative), ethics committee, and/or regulatory authorities will have access to 
confidential medical records that might identify the participant by name.
D.  Genomic Research
Genomic research will only be conducted in accordance with a protocol and informed consent authorized by an ethics 
committee.
IV. Financial Considerations
A.  Payments to Investigators
Clinical trials are time- and labor-intensive. It is MSD’s policy to compensate investigators (or the sponsoring 
institution) in a fair manner for the work performed in support of MSD trials. MSD does not pay incentives to enroll 
participants in its trials. However, when enrollment is particularly challenging, additional payments may be made to 
compensate for the time spent in extra recruiting efforts.
MSD does not pay for participant referrals. However, MSD may compensate referring physicians for time spent on 
chart review to identify potentially eligible participants.
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B.  Clinical Research Funding 
Informed consent forms will disclose that the trial is sponsored by MSD, and that the investigator or sponsoring 
institution is being paid or provided a grant for performing the trial. However, the local ethics committee may wish to 
alter the wording of the disclosure statement to be consistent with financial practices at that institution. As noted above, 
all publications resulting from MSD trials will indicate MSD as a source of funding.
C.  Funding for Travel and Other Requests
Funding of travel by investigators and support staff (e.g., to scientific meetings, investigator meetings, etc.) will be 
consistent with local guidelines and practices. 
V.
Investigator Commitment
Investigators will be expected to review MSD’s Code of Conduct as an appendix to the trial protocol, and in signing the 
protocol, agree to support these ethical and scientific standards.
Financial Disclosure
Financial disclosure requirements are outlined in the US Food and Drug Administration 
Regulations, financial disclosure by Clinical Investigators (21 CFR Part 54). It is the 
Sponsor's responsibility to determine, based on these regulations, whether a request for 
financial disclosure information is required. It is the investigator's/subinvestigator's 
responsibility to comply with any such request. 
The investigator/subinvestigator(s) agree, if requested by the Sponsor in accordance with 21 
CFR Part 54, to provide his/her financial interests in and/or arrangements with the Sponsor to 
allow for the submission of complete and accurate certification and disclosure statements. 
The investigator/subinvestigator(s) further agree to provide this information on a 
Certification/Disclosure Form, commonly known as a financial disclosure form, provided by 
the Sponsor. The investigator/subinvestigator(s) also consent to the transmission of this 
information to the Sponsor in the United States for these purposes. This may involve the 
transmission of information to countries that do not have laws protecting personal data.
Data Protection
Participants will be assigned a unique identifier by the Sponsor. Any participant records or 
datasets that are transferred to the Sponsor will contain the identifier only; participant names 
or any information which would make the participant identifiable will not be transferred. 
The participant must be informed that his/her personal study-related data will be used by the 
Sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant. 
The participant must be informed that his/her medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the Sponsor, by 
appropriate IRB/IEC members, and by inspectors from regulatory authorities.
The Sponsor has EU-approved Binding Corporate Rules since 2017, covering all aspects of 
its Global Privacy Program (Corporate Policy 20), and is self-certified pursuant to the EU-US 
Data Privacy Framework.
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Confidentiality of Data
By signing this protocol, the investigator affirms to the Sponsor that information furnished to 
the investigator by the Sponsor will be maintained in confidence, and such information will 
be divulged to the IRB, IEC, or similar or expert committee; affiliated institution and 
employees, only under an appropriate understanding of confidentiality with such board or 
committee, affiliated institution and employees. Data generated by this study will be 
considered confidential by the investigator, except to the extent that it is included in a 
publication as provided in the Publications section of this protocol.
Confidentiality of Participant Records
By signing this protocol, the investigator agrees that the Sponsor (or Sponsor representative), 
IRB/IEC, or regulatory authority representatives may consult and/or copy study documents in 
order to verify worksheet/CRF data. By signing the consent form, the participant agrees to 
this process. If study documents will be photocopied during the process of verifying 
worksheet/CRF information, the participant will be identified by unique code only; full 
names/initials will be masked prior to transmission to the Sponsor.
By signing this protocol, the investigator agrees to treat all participant data used and 
disclosed in connection with this study in accordance with all applicable privacy laws, rules 
and regulations.
Confidentiality of IRB/IEC Information
The Sponsor is required to record the name and address of each IRB/IEC that reviews and 
approves this study. The Sponsor is also required to document that each IRB/IEC meets 
regulatory and ICH-GCP requirements by requesting and maintaining records of the names 
and qualifications of the IRB/IEC members and to make these records available for 
regulatory agency review upon request by those agencies.
Committees Structure
Steering Committee
This study will be conducted in consultation with a Steering Committee. The Steering 
Committee may be comprised of some or all of the following members:
•
Sponsor personnel,
•
Investigators participating in the study, and
•
Consulting therapeutic area experts and clinical trialists.
The Steering Committee will provide guidance on the operational aspects of the study and 
evaluate recommendations from the DMC.
Specific details regarding responsibilities and governance of the Steering Committee will be 
described in a separate charter.”
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Executive Oversight Committee
The Executive Oversight Committee is comprised of members of Sponsor Senior 
Management. The Executive Oversight Committee will receive and decide upon any 
recommendations made by the DMC regarding the study.
Data Monitoring Committee
To supplement the routine study monitoring outlined in this protocol, an external DMC will 
monitor the interim data from this study. The voting members of the committee are external 
to the Sponsor. The members of the DMC must not be involved with the study in any other 
way (eg, they cannot be study investigators) and must have no competing interests that could 
affect their roles with respect to the study. 
The DMC will make recommendations to the Executive Oversight Committee regarding 
steps to ensure both participant safety and the continued ethical integrity of the study. Also, 
the DMC will review interim study results, consider the overall risk and benefit to study 
participants (see Section 9.7 [Interim Analyses]) and recommend to the Executive Oversight 
Committee whether the study should continue in accordance with the protocol.
Specific details regarding composition, responsibilities, and governance, including the roles 
and responsibilities of the various members and the Sponsor protocol team; meeting 
facilitation; the study governance structure; and requirements for and proper documentation 
of DMC reports, minutes, and recommendations will be described in the DMC charter that is 
reviewed and approved by all the DMC members.
Publication Policy
The results of this study may be published or presented at scientific meetings. The Sponsor 
will comply with the requirements for publication of study results. In accordance with 
standard editorial and ethical practice, the Sponsor will generally support publication of 
multicenter studies only in their entirety and not as individual site data. In this case, a 
coordinating investigator will be designated by mutual agreement.
If publication activity is not directed by the Sponsor, the investigator agrees to submit all 
manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect 
proprietary information and to provide comments. 
Authorship will be determined by mutual agreement and in-line with International 
Committee of Medical Journal Editors authorship requirements.
Compliance With Study Registration and Results Posting Requirements
Under the terms of the FDAAA of 2007 and the EMA clinical trials Regulation 536/2014, the 
Sponsor of the study is solely responsible for determining whether the study and its results 
are subject to the requirements for submission to http://www.clinicaltrials.gov, 
www.clinicaltrialsregister.eu, https://euclinicaltrials.eu, or other local registries. MSD, as 
Sponsor of this study, will review this protocol and submit the information necessary to 
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fulfill these requirements. For studies conducted under the EMA Clinical Trials Regulation 
546/2014, a summary of the study results will be submitted in compliance with the 
regulation. MSD entries are not limited to FDAAA or the EMA clinical trials Regulation 
536/2014 mandated trials. Information posted will allow participants to identify potentially 
appropriate studies for their disease conditions and pursue participation by calling a central 
contact number for further information on appropriate study locations and site contact 
information. 
By signing this protocol, the investigator acknowledges that the statutory obligations under 
FDAAA, the EMA clinical trials directive or other locally mandated registries are that of the 
Sponsor and agrees not to submit any information about this study or its results to those 
registries.
Compliance With Law, Audit, and Debarment
By signing this protocol, the investigator agrees to conduct the study in an efficient and 
diligent manner and in conformance with this protocol; generally accepted standards of GCP
(eg, International Conference for Harmonisation of Technical Requirements for Registration 
of Pharmaceuticals for Human Use Good Clinical Practice: Consolidated Guideline and other 
generally accepted standards of GCP); and all applicable federal, state and local laws, rules 
and regulations relating to the conduct of the clinical study.
The Code of Conduct, a collection of goals and considerations that govern the ethical and 
scientific conduct of clinical investigations sponsored by MSD, is provided in this appendix 
under the Code of Conduct for Clinical Trials.
The investigator agrees not to seek reimbursement from participants, their insurance 
providers or from government programs for procedures included as part of the study
reimbursed to the investigator by the Sponsor.
The investigator will promptly inform the Sponsor of any regulatory authority inspection 
conducted for this study.
The investigator agrees to provide the Sponsor with relevant information from inspection 
observations/findings to allow the Sponsor to assist in responding to any citations resulting 
from regulatory authority inspection, and will provide the Sponsor with a copy of the 
proposed response for consultation before submission to the regulatory authority. 
Persons debarred from conducting or working on clinical studies by any court or regulatory 
authority will not be allowed to conduct or work on this Sponsor’s studies. The investigator 
will immediately disclose in writing to the Sponsor if any person who is involved in 
conducting the study is debarred or if any proceeding for debarment is pending or, to the best 
of the investigator’s knowledge, threatened.
For investigators located in countries with serious breach reporting requirements, the 
investigator will promptly report to the Sponsor any serious breach or suspected serious 
breach that occurs in compliance with those requirements. Unless more specifically defined 
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in the applicable requirements, a serious breach is any breach of the applicable clinical trial 
regulation or of the clinical trial protocol that is likely to affect to a significant degree: (i) the 
safety or rights of a trial participant, or (ii) the reliability and robustness of the data generated 
in the clinical trial.
Data Quality Assurance
All participant data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the Sponsor or designee electronically (eg, laboratory data). The investigator 
or qualified designee is responsible for verifying that data entries are accurate and correct by 
physically or electronically signing the CRF. 
Detailed information regarding data management procedures for this protocol will be 
provided separately.
The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF. 
The investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source data documents. 
Study documentation will be promptly and fully disclosed to the Sponsor by the investigator 
upon request and also shall be made available at the study site upon request for inspection, 
copying, review and audit at reasonable times by representatives of the Sponsor or any 
regulatory authorities. The investigator agrees to promptly take any reasonable steps that are 
requested by the Sponsor or any regulatory authorities as a result of an audit or inspection to 
cure deficiencies in the study documentation and worksheets/CRFs.
The Sponsor or designee is responsible for the data management of this study including 
quality checking of the data. 
Study monitors will perform ongoing source data review and verification to confirm that data 
entered into the CRF by authorized site personnel are accurate, complete, and verifiable from 
source documents; that the safety and rights of participants are being protected; and that the 
study is being conducted in accordance with the currently approved protocol and any other 
study agreements, ICH-GCP, and all applicable regulatory requirements. 
Records and documents, including participants documented informed consent, pertaining to 
the conduct of this study must be retained by the investigator for 15 years after study 
completion unless local regulations or institutional policies require a longer retention period
(eg, EU CTR: 25 years after the end of the clinical study). No records may be destroyed 
during the retention period without the written approval of the Sponsor. No records may be 
transferred to another location or party without written notification to the Sponsor. 
Source Documents
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. Source documents are filed at the investigator’s site.
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Data reported on the CRF or entered in the eCRF that are transcribed from source documents 
must be consistent with the source documents or the discrepancies must be explained. The 
investigator may need to request previous medical records or transfer records, depending on 
the study. Also, current medical records must be available.
  Study and Site Closure
The Sponsor or its designee may stop the study or study site participation in the study for 
medical, safety, regulatory, administrative, or other reasons consistent with applicable laws, 
regulations, and GCP. 
In the event the Sponsor prematurely terminates a particular study site, the Sponsor will 
promptly notify that study site’s IRB/IEC.
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Appendix 2: Collection and Management of Specimens for Future Biomedical 
Research
1. Definitions
a.
Biomarker: A biological molecule found in blood, other body fluids, or tissues that is a 
sign of a normal or abnormal process or of a condition or disease. A biomarker may be 
used to see how well the body responds to a treatment for a disease or condition.1
b. Pharmacogenomics: The investigation of variations of DNA and RNA characteristics as 
related to drug/vaccine response.2
c.
Pharmacogenetics: A subset of pharmacogenomics, pharmacogenetics is the influence of 
variations in DNA sequence on drug/vaccine response.2
d. DNA: Deoxyribonucleic acid.
e.
RNA: Ribonucleic acid.
2.
3.
CCI
CCI
CCI
CCI
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4. Confidential Participant Information for Future Biomedical Research3,4
In order to optimize the research that can be conducted with future biomedical research
specimens, it is critical to link participant' clinical information with future test results. In fact 
little or no research can be conducted without connecting the clinical study data to the 
specimen. The clinical data allow specific analyses to be conducted. Knowing participant 
characteristics like gender, age, medical history and treatment outcomes are critical to 
understanding clinical context of analytical results.
To maintain privacy of information collected from specimens obtained for future biomedical 
research, the Sponsor has developed secure policies and procedures. All specimens will be 
single-coded per ICH E15 guidelines as described below. 
At the clinical study site, unique codes will be placed on the future biomedical research
specimens. This code is a random number which does not contain any personally identifying 
information embedded within it. The link (or key) between participant identifiers and this 
unique code will be held at the study site. No personal identifiers will appear on the specimen 
tube. 
5. Biorepository Specimen Usage3,4
Specimens obtained for the Sponsor will be used for analyses using good scientific practices. 
Analyses utilizing the future biomedical research specimens may be performed by the 
Sponsor, or an additional third party (eg, a university investigator) designated by the 
Sponsor. The investigator conducting the analysis will follow the Sponsor’s privacy and 
confidentiality requirements. Any contracted third party analyses will conform to the specific 
scope of analysis outlined in future biomedical research protocol and consent. Future 
CCI
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biomedical research specimens remaining with the third party after specific analysis is 
performed will be reported to the Sponsor.
6. Withdrawal From Future Biomedical Research3,4
Participants may withdraw their consent for future biomedical research and ask that their 
biospecimens not be used for future biomedical research. Participants may withdraw consent 
at any time by contacting the principal investigator for the main study. If medical records for 
the main study are still available, the investigator will contact the Sponsor using the 
designated mailbox (clinical.specimen.management@MSD.com). Subsequently, the 
participant's specimens will be flagged in the biorepository and restricted to main study use 
only. If specimens were collected from study participants specifically for future biomedical 
research, these specimens will be removed from the biorepository and destroyed. 
Documentation will be sent to the investigator confirming withdrawal and/or destruction, if 
applicable. It is the responsibility of the investigator to inform the participant of completion 
of the withdrawal and/or destruction, if applicable. Any analyses in progress at the time of 
request for withdrawal/destruction or already performed prior to the request being received 
by the Sponsor will continue to be used as part of the overall research study data and results. 
No new analyses would be generated after the request is received.
In the event that the medical records for the main study are no longer available (eg, if the 
investigator is no longer required by regulatory authorities to retain the main study records) 
or the specimens have been completely anonymized, there will no longer be a link between 
the participant’s personal information and their specimens. In this situation, the request for 
withdrawal of consent and/or destruction cannot be processed. 
7. Retention of Specimens3,4
Future biomedical research specimens will be stored in the biorepository for potential 
analysis for up to 20 years from the end of the main study. Specimens may be stored for 
longer if a regulatory or governmental authority has active questions that are being answered. 
In this special circumstance, specimens will be stored until these questions have been 
adequately addressed.
Specimens from the study site will be shipped to a central laboratory and then shipped to the 
Sponsor-designated biorepository. If a central laboratory is not utilized in a particular study, 
the study site will ship directly to the Sponsor-designated biorepository. The specimens will 
be stored under strict supervision in a limited access facility which operates to assure the 
integrity of the specimens. Specimens will be destroyed according to Sponsor policies and 
procedures and this destruction will be documented in the biorepository database.
8. Data Security3,4
Databases containing specimen information and test results are accessible only to the 
authorized Sponsor representatives and the designated study administrator research personnel 
and/or collaborators. Database user authentication is highly secure, and is accomplished 
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using network security policies and practices based on international standards to protect 
against unauthorized access.
9. Reporting of Future Biomedical Research Data to Participants3,4
No information obtained from exploratory laboratory studies will be reported to the 
participant, family, or physicians. Principle reasons not to inform or return results to the 
participant include: Lack of relevance to participant health, limitations of predictive 
capability, and concerns regarding misinterpretation.
If important research findings are discovered, the Sponsor may publish results, present results 
in national meetings, and make results accessible on a public website in order to rapidly 
report this information to doctors and participants. Participants will not be identified by name 
in any published reports about this study or in any other scientific publication or presentation.
10. Future Biomedical Research Study Population3,4
Every effort will be made to recruit all participants diagnosed and treated on Sponsor clinical 
studies for future biomedical research.
11. Risks Versus Benefits of Future Biomedical Research3,4
For future biomedical research, risks to the participant have been minimized and are 
described in the future biomedical research informed consent.
The Sponsor has developed strict security, policies and procedures to address participant data 
privacy concerns. Data privacy risks are largely limited to rare situations involving possible 
breach of confidentiality. In this highly unlikely situation there is risk that the information, 
like all medical information, may be misused.
12. Questions
Any questions related to the future biomedical research should be e-mailed directly to 
clinical.specimen.management@MSD.com.
13. References
1. National Cancer Institute [Internet]: Available from 
https://www.cancer.gov/publications/dictionaries/cancer-terms?cdrid=45618
2. International Conference on Harmonization [Internet]: E15: Definitions for Genomic 
Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding 
Categories. Available from http://www.ich.org/products/guidelines/efficacy/efficacy-
single/article/definitions-for-genomic-biomarkers-pharmacogenomics-pharmacogenetics-
genomic-data-and-sample-cod.html
3. Industry Pharmacogenomics Working Group [Internet]: Understanding the Intent, Scope 
and Public Health Benefits of Exploratory Biomarker Research: A Guide for IRBs/IECs 
and Investigational Site Staff. Available at http://i-pwg.org/
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4. Industry Pharmacogenomics Working Group [Internet]: Pharmacogenomics 
Informational Brochure for IRBs/IECs and Investigational Site Staff. Available at http://i-
pwg.org/
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Appendix 3:  Contraceptive Guidance and Pregnancy Testing
Definitions
Women of Childbearing Potential (WOCBP)
A woman is considered fertile following menarche and until becoming postmenopausal 
unless permanently sterile (see below) 
Women in the following categories are not considered WOCBP:
•
Premenarchal
•
Premenopausal female with 1 of the following:
-
Documented hysterectomy
-
Documented bilateral salpingectomy
-
Documented bilateral oophorectomy
Note:  Documentation can come from the site personnel’s review of the participant’s 
medical records, medical examination, or medical history interview.
•
Postmenopausal female
-
A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. 
◦
A high follicle-stimulating hormone (FSH) level in the postmenopausal range 
may be used to confirm a postmenopausal state in women not using hormonal 
contraception or hormone replacement therapy (HRT). However, in the absence 
of 12 months of amenorrhea, confirmation with 2 FSH measurements in the 
postmenopausal range is required. 
-
Females on HRT and whose menopausal status is in doubt will be required to use one
of the nonhormonal highly effective contraception methods if they wish to continue 
their HRT during the study. Otherwise, they must discontinue HRT to allow 
confirmation of postmenopausal status before study enrollment.
Contraception Requirements
Female Participants
Female participants of childbearing potential are eligible to participate if they agree to use a 
highly effective method of contraception consistently and correctly as described in Table 17
during the protocol-defined time frame in Section 5.1. 
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Table 17
Highly Effective Contraception Methods
Contraceptive allowed during the study includea:
Highly Effective Methods That Have Low User Dependency 
Failure rate of <1% per year when used consistently and correctly.
●
Progestogen-only subdermal contraceptive implantb, c 
●
Intrauterine hormone-releasing system (IUS)c, d
●
Nonhormonal intrauterine device (IUD)
●
Bilateral tubal occlusion
●
Azoospermic partner (vasectomized or secondary to medical cause)
This is a highly effective contraception method provided that the partner is the sole male 
sexual partner of the WOCBP and the absence of sperm has been confirmed. If not, an 
additional highly effective method of contraception should be used. A spermatogenesis cycle 
is approximately 90 days.
●
Sexual abstinence 
Sexual abstinence is considered a highly effective method only if defined as refraining from 
heterosexual intercourse during the entire period of risk associated with the study treatment. 
The reliability of sexual abstinence needs to be evaluated in relation to the duration of the 
study and the preferred and usual lifestyle of the participant.
LAM=lactational amenorrhea method; WOCBP=woman of childbearing potential.
Note: The following are not acceptable methods of contraception:
-
Periodic abstinence (calendar, symptothermal, postovulation methods), withdrawal (coitus interruptus), spermicides 
only, and LAM.
-
Male condom with cap, diaphragm, or sponge with spermicide.
-
Male and female condom should not be used together (due to risk of failure with friction).
a.
Contraceptive use should be consistent with local regulations regarding the use of contraceptive methods for 
participants of clinical studies. 
b.
If locally required, in accordance with Clinical Trial Facilitation Group (CTFG) guidelines, acceptable contraceptive
implants are limited to those which inhibit ovulation.
c.
For participants who receive olaparib (or olaparib placebo): male condoms must be used in addition to female hormonal 
contraception during the Treatment Period and for at least 180 days following the last dose of olaparib (or olaparib 
placebo).
d.
IUS is a progestin-releasing IUD.
Pregnancy Testing
Pregnancy testing:
•
Pregnancy testing requirements for study inclusion are described in Section 5.1.
•
Pregnancy testing (urine or serum [as required by local regulations]) should be conducted 
at cycle during study treatment.
•
Pregnancy testing (urine or serum [as required by local regulations]) should be conducted 
at the time of discontinuation and at 30 days after the last dose of study treatment.
•
Additional serum or urine pregnancy tests may be performed, as determined necessary by 
the investigator or required by local regulation, to establish the absence of pregnancy at 
any time during the individual’s participation in the study.
•
Refer to Appendix 7 for country-specific requirements.
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Appendix 4: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting
Definitions of Medication Error, Misuse, and Abuse
Medication Error
This is an unintended failure in the drug treatment process that leads to or has the potential to 
lead to harm to the patient.
Misuse
This refers to situations where the medicinal product is intentionally and inappropriately used 
not in accordance with the terms of the product information.
Abuse
This corresponds to the persistent or sporadic intentional, excessive use of a medicinal 
product for a perceived psychological or physiological reward or desired nontherapeutic 
effect.
Definition of AE
AE definition
●
An AE is any untoward medical occurrence in a patient or clinical study participant, 
temporally associated with the use of study treatment, whether or not considered 
related to the study treatment.
●
NOTE: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally 
associated with the use of a study treatment.
●
NOTE: for purposes of AE definition, study treatment includes any pharmaceutical 
product, biological product, vaccine, device, diagnostic agent or protocol-specified 
procedure whether investigational (including placebo or active comparator product) 
or marketed, manufactured by, licensed by, provided by or distributed by the Sponsor 
for human use in this study.
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Events meeting the AE definition
●
Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
other safety assessments (eg, ECG, radiological scans, vital signs measurements), 
including those that worsen from baseline, or are considered clinically significant in 
the medical and scientific judgement of the investigator.
●
Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition.
●
New conditions detected or diagnosed after study treatment administration even 
though it may have been present before the start of the study.
●
Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction.
●
Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
treatment or a concomitant medication. 
●
For all reports of overdose (whether accidental or intentional) with an associated AE, 
the AE term should reflect the clinical symptoms or abnormal test result. An overdose 
of study treatment without any associated clinical symptoms or abnormal laboratory 
results is reported using the terminology “accidental or intentional overdose without 
adverse effect.”
●
Any new cancer (that is not a condition of the study). 
Note: Progression of the cancer under study is not a reportable event. Refer to 
Section 8.4.5 for additional details.
Events NOT meeting the AE definition 
●
Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that 
leads to the procedure is the AE.
●
Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital).
●
Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present 
or detected at the start of the study that do not worsen.
●
Surgery planned prior to informed consent to treat a pre-existing condition that has 
not worsened.
●
Refer to Section 8.4.5 for protocol-specific exceptions
Definition of SAE
If an event is not an AE per definition above, then it cannot be an SAE even if serious 
conditions are met.
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An SAE is defined as any untoward medical occurrence that, at any dose:
a.
Results in death
b. Is life-threatening
●
The term 'life-threatening' in the definition of 'serious' refers to an event in which the 
participant was at risk of death at the time of the event. It does not refer to an event, 
which hypothetically might have caused death, if it were more severe.
c.
Requires inpatient hospitalization or prolongation of existing hospitalization
●
Hospitalization is defined as an inpatient admission, regardless of length of stay, even 
if the hospitalization is a precautionary measure for continued observation. Note: 
Hospitalization for an elective procedure to treat a pre-existing condition that has not 
worsened is not an SAE. A pre-existing condition is a clinical condition that is diagnosed 
prior to the use of an MSD product and is documented in the patient’s medical history.
d. Results in persistent or significant disability/incapacity
●
The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions.
●
This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and 
accidental trauma (eg, sprained ankle) which may interfere with or prevent everyday life 
functions but do not constitute a substantial disruption.
e.
Is a congenital anomaly/birth defect
●
In offspring of participant taking the product regardless of time to diagnosis.
f.
Other important medical events:
●
Medical or scientific judgement should be exercised in deciding whether SAE 
reporting is appropriate in other situations such as important medical events that may not 
be immediately life-threatening or result in death or hospitalization but may jeopardize 
the participant or may require medical or surgical intervention to prevent one of the other 
outcomes listed in the above definition. These events should usually be considered 
serious.
●
Examples of such events include invasive or malignant cancers, intensive treatment in 
an emergency room or at home for allergic bronchospasm, blood dyscrasias or 
convulsions that do not result in hospitalization, or development of drug dependency or 
drug abuse.
●
All potential DILI events meeting biochemical criteria of Hy’s Law will be reported 
to the Sponsor, regardless of suspected etiology, as an ECI and SAE with OME criteria in 
the absence of other SAE criteria within 24 hours of learning of the event.
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Definition of a Suspected Unexpected Serious Adverse Reaction (SUSAR)
A Suspected Unexpected Serious Adverse Reaction (SUSAR) is an adverse event 
that occurs during a clinical trial and meets the following criteria:
●
Unexpected, meaning the nature or severity of the event doesn’t match the reference 
safety information (RSI)
●
Serious adverse event as defined in Section 10.4.3
●
Reasonable possibility the event was caused by the study drug
Additional Events Reported in the Same Manner as SAE
Additional events which require reporting in the same manner as SAE
●
In addition to the above criteria, AEs meeting either of the below criteria, although 
not serious per ICH definition, are reportable to the Sponsor in the same time frame 
as SAEs to meet certain local requirements. Therefore, these events are considered 
serious by the Sponsor for collection purposes.
●
Is a new cancer (that is not a condition of the study);
●
Is associated with an overdose.
Recording AE and SAE
AE and SAE recording
●
When an AE/SAE occurs, it is the responsibility of the investigator to review all 
documentation (eg, hospital progress notes, laboratory, and diagnostics reports) 
related to the event.
●
The investigator will record all relevant AE/SAE information on the AE
CRFs/worksheets at each examination.
●
It is not acceptable for the investigator to send photocopies of the participant’s 
medical records to the Sponsor in lieu of completion of the AE CRF page.
●
There may be instances when copies of medical records for certain cases are 
requested by the Sponsor. In this case, all participant identifiers, with the exception of 
the participant number, will be blinded on the copies of the medical records before 
submission to the Sponsor.
●
The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. In such cases, the diagnosis (not the 
individual signs/symptoms) will be documented as the AE/SAE.
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Assessment of intensity
●
An event is defined as ‘serious’ when it meets at least 1 of the predefined outcomes as 
described in the definition of an SAE, NOT when it is rated as severe.
●
The investigator will make an assessment of intensity for each AE and SAE (and 
other reportable safety event) according to the NCI Common Terminology Criteria 
for Adverse Events (CTCAE), version 4.0. Any AE which changes CTCAE grade 
over the course of a given episode will have each change of grade recorded on the AE
CRFs/worksheets.
●
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic 
observations only; intervention not indicated.
●
Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting 
age-appropriate instrumental activities of daily living (ADL).
●
Grade 3: Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting 
self-care ADL.
●
Grade 4: Life-threatening consequences; urgent intervention indicated.
●
Grade 5: Death related to AE.
Assessment of causality
●
Did the study intervention cause the AE?
●
The determination of the likelihood that the study intervention caused the AE will 
be provided by an investigator who is a qualified physician. The investigator’s 
signed/dated initials on the source document or worksheet that supports the 
causality noted on the AE form, ensures that a medically qualified assessment of 
causality was done. This initialed document must be retained for the required 
regulatory time frame. The criteria below are intended as reference guidelines to 
assist the investigator in assessing the likelihood of a relationship between the test 
product and the AE based upon the available information
●
The following components are to be used to assess the relationship between 
the study intervention and the AE; the greater the correlation with the 
components and their respective elements (in number and/or intensity), the more 
likely the study intervention caused the AE:
●
Exposure:  Is there evidence that the participant was actually exposed to the 
study intervention such as:  reliable history, acceptable compliance assessment 
(pill count, diary, etc.), expected pharmacologic effect, or measurement of 
drug/metabolite in bodily specimen?
●
Time Course:  Did the AE follow in a reasonable temporal sequence from 
administration of the study intervention? Is the time of onset of the AE 
compatible with a drug-induced effect (applies to studies with investigational 
medicinal product)?
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●
Likely Cause:  Is the AE not reasonably explained by another etiology such 
as underlying disease, other drug(s)/vaccine(s), or other host or environmental 
factors
●
Dechallenge: Was the study intervention discontinued or 
dose/exposure/frequency reduced?
●
If yes, did the AE resolve or improve?
●
If yes, this is a positive dechallenge. 
●
If no, this is a negative dechallenge.
(Note:  This criterion is not applicable if:  (1) the AE resulted in death or 
permanent disability; (2) the AE resolved/improved despite continuation of 
the study intervention; (3) the study is a single-dose drug study); or (4) study 
intervention(s) is/are only used one time.)
●
Rechallenge:  Was the participant re-exposed to the study intervention in this 
study?
●
If yes, did the AE recur or worsen?
●
If yes, this is a positive rechallenge. 
●
If no, this is a negative rechallenge.
(Note:  This criterion is not applicable if:  (1) the initial AE resulted in death 
or permanent disability, or (2) the study is a single-dose drug study); or (3) 
study intervention(s) is/are used only one time.)
NOTE:  IF A RECHALLENGE IS PLANNED FOR AN AE WHICH WAS SERIOUS 
AND WHICH MAY HAVE BEEN CAUSED BY THE STUDY INTERVENTION, OR 
IF RE-EXPOSURE TO THE STUDY INTERVENTION POSES ADDITIONAL 
POTENTIAL SIGNIFICANT RISK TO THE PARTICIPANT THEN THE 
RECHALLENGE MUST BE APPROVED IN ADVANCE BY THE SPONSOR 
CLINICAL DIRECTOR AS PER DOSE MODIFICATION GUIDELINES IN THE 
PROTOCOL, AND IF REQUIRED, THE INIRB/IEC.
●
Consistency with Study treatment Profile:Is the clinical/pathological 
presentation of the AE consistent with previous knowledge regarding the 
study intervention or drug class pharmacology or toxicology?
●
The assessment of relationship will be reported on the CRFs/worksheets by an 
investigator who is a qualified physician according to his/her best clinical judgement, 
including consideration of the above elements.
●
Use the following scale of criteria as guidance (not all criteria must be present to be 
indicative of a study intervention relationship).
●
Yes, there is a reasonable possibility of study intervention relationship:
There is evidence of exposure to the study intervention. The temporal sequence of 
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the AE onset relative to the administration of the study intervention is reasonable. 
The AE is more likely explained by the study intervention than by another cause. 
●
No, there is not a reasonable possibility of study intervention relationship:
Participant did not receive the study intervention OR temporal sequence of the AE 
onset relative to administration of the study intervention is not reasonable OR the 
AE is more likely explained by another cause than the study intervention. (Also 
entered for a participant with overdose without an associated AE.)
●
For each AE/SAE, the investigator must document in the medical notes that he/she 
has reviewed the AE/SAE and has provided an assessment of causality.
●
There may be situations in which an SAE has occurred and the investigator has 
minimal information to include in the initial report to the Sponsor. However, it is very 
important that the investigator always make an assessment of causality for every 
event before the initial transmission of the SAE data to the Sponsor.
●
The investigator may change his/her opinion of causality in light of follow-up 
information and send an SAE follow-up report with the updated causality assessment.
●
The causality assessment is one of the criteria used when determining regulatory 
reporting requirements
●
For studies in which multiple agents are administered as part of a combination 
regimen, the investigator may attribute each AE causality to the combination regimen 
or to a single agent of the combination. In general, causality attribution should be 
assigned to the combination regimen (ie, to all agents in the regimen). However, 
causality attribution may be assigned to a single agent if in the investigator’s opinion, 
there is sufficient data to support full attribution of the AE to the single agent.
Follow-up of AE and SAE
●
The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by Sponsor 
to elucidate the nature and/or causality of the AE or SAE as fully as possible. This 
may include additional laboratory tests or investigations, histopathological 
examinations, or consultation with other health care professionals.
●
New or updated information will be recorded in the CRF.
●
The investigator will submit any updated SAE data to the Sponsor within 24 hours of 
receipt of the information.
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Reporting of AEs, SAEs, and Other Reportable Safety Events to the Sponsor
AE, SAE, and other reportable safety event reporting to Sponsor via electronic data 
collection tool
●
The primary mechanism for reporting to the Sponsor will be the electronic data 
collection (EDC) tool. 
●
Electronic reporting procedures can be found in the EDC data entry guidelines (or 
equivalent).
●
If the electronic system is unavailable for more than 24 hours, then the site will 
use the paper AE Reporting form. 
●
Reference Section 8.4.1 for reporting time requirements 
●
The site will enter the SAE data into the electronic system as soon as it becomes 
available.
●
After the study is completed at a given site, the EDC tool will be taken off-line to 
prevent the entry of new data or changes to existing data.
●
If a site receives a report of a new SAE from a study participant or receives updated 
data on a previously reported SAE after the EDC tool has been taken off-line, then the 
site can report this information on a paper SAE form or by telephone (see next 
section).
●
Contacts for SAE reporting can be found in the Investigator Trial File Binder (or 
equivalent).
SAE reporting to the Sponsor via paper CRF
●
If the EDC tool is not operational, facsimile transmission or secure e-mail of the SAE 
paper CRF is the preferred method to transmit this information to the Sponsor.
●
In rare circumstances and in the absence of facsimile equipment, notification by 
telephone is acceptable with a copy of the SAE data collection tool sent by overnight 
mail or courier service.
●
Initial notification via telephone does not replace the need for the investigator to 
complete and sign the SAE CRF pages within the designated reporting time frames.
●
Contacts and instructions for SAE reporting and paper reporting procedures can be 
found in the Investigator Trial File Binder (or equivalent).
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Appendix 5: Clinical Laboratory Tests
•
The tests detailed in Table 18 will be performed by the local laboratory. 
•
Following Cycle 1 Day 1, collection of samples for predose laboratory assessments may 
be performed up to 3 days (72 hours) prior to dosing in subsequent cycles.
•
Protocol-specific requirements for inclusion or exclusion of participants are detailed in 
Section 5.1 and Section 5.2 of the protocol.
•
Additional tests may be performed at any time during the study as determined necessary 
by the investigator or required by local regulations.
Table 18
Protocol-required Safety Laboratory Assessments
Laboratory 
Assessments
Parameters
Hematology
Platelet Count 
RBC Indices:
MCV
MCH
WBC count with 
Differential:
Neutrophils
Lymphocytes
Monocytes
Eosinophils
Basophils
RBC Count
Hemoglobin
Hematocrit
Chemistry
Blood Urea 
Nitrogen (BUN) or 
ureaa
Potassium
Aspartate 
Aminotransferase 
(AST)/ Serum 
Glutamic-
Oxaloacetic 
Transaminase 
(SGOT)
Total bilirubin (and 
direct bilirubin, if 
total bilirubin is 
elevated above the 
upper limit of normal)
Albumin
Carbon dioxide 
(CO2 or 
bicarbonate)b
Chloride
Phosphorous
Creatinine or 
creatinine 
clearancec
Sodium
Alanine 
Aminotransferase 
(ALT)/ Serum 
Glutamic-Pyruvic 
Transaminase 
(SGPT)
Total Protein
Glucose (fasting or 
nonfasting)
Calcium
Alkaline 
phosphatase
Magnesium
Thyroid-stimulating 
hormoned (TSH)
Triiodothyronine 
(T3) or free T3 
(where T3 cannot 
be determined)d
Free thyroxine 
(FT4)d
Lactate 
dehydrogenase
Routine 
Urinalysis

Specific gravity

pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase 
by dipstick or laboratory analysis

Microscopic examination (if blood or protein is abnormal)
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Laboratory 
Assessments
Parameters
Other Screening 
Tests

Serum or urine pregnancy test (as needed for WOCBP). Refer to Appendix 3 for 
additional testing requirements. 

Follicle-stimulating hormone (as needed in women of childbearing potential only).

Serology (HIV antibody, hepatitis B surface antigen [HBsAg], and hepatitis C virus 
antibody) if required by local health authority. Refer to Appendix 7 for country-
specific requirements.

PT or INR and aPTT/PTT is required during screening to establish eligibility; 
additional testing to be conducted as clinically indicated for participants taking 
anticoagulation therapy.

CEA (participants eligible for interval debulking surgery).

Cortisol (at screening for both primary and interval debulking participants).

CA-125 will be assessed at screening and then according to the same schedule as 
imaging (±14 days) by a local laboratory.
Other Tests

Bone marrow or blood cytogenetic analysis for prolonged hematological toxicities 
(Section 6.6.2.3). This should include an aspirate for cellular morphology, cytogenetic 
analysis and flow cytometry, and a core biopsy for bone marrow cellularity.

Cortisol – to be collected within 7 days prior to interval debulking surgery and prior to 
administration of study treatment in the next 2 treatment cycles following surgery for 
participants undergoing interval debulking only.
aPTT=activated partial thromboplastin time; CA-125=cancer antigen 125; CEA=cancer embryonic antigen; 
GFR=glomerular filtration rate; HIV=human immunodeficiency virus; INR=international normalized ratio; 
MCH=mean corpuscular hemoglobin; MCV=mean corpuscular volume; PT=prothrombin time; PTT=partial 
thromboplastin time; RBC=red blood cell; WBC=white blood cell; WOCBP=women of childbearing potential.
a.
BUN is preferred; if not available, urea may be tested.
b.
Performed only if considered local standard of care.
c.
GFR (measured or calculated) or creatinine clearance can be used in place of creatinine.
d.
There may be instances when sites are unable to obtain the thyroid function testing results prior to scheduled dosing. 
After Cycle 1 (randomization) review of thyroid function test results after dosing is acceptable.
The investigator (or medically qualified designee) must document their review of each 
laboratory safety report.
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Appendix 6:  Description of the iRECIST Process for Assessment of Disease 
Progression
Assessment at Screening and Prior to RECIST 1.1 Progression
Until radiographic disease progression based on RECIST 1.1, there is no distinct iRECIST 
assessment.
Assessment and Decision at RECIST 1.1 Progression
For participants who show evidence of radiological PD by RECIST 1.1, as determined by the 
investigator, the investigator will decide whether to continue a participant on study treatment 
until repeat imaging is obtained (using iRECIST for participant management) (see Table 9). 
This decision by the investigator should be based on the participant’s overall clinical 
stability. Clinical stability is defined as the following: 
•
Absence of symptoms and signs indicating clinically significant progression of disease
•
No decline in ECOG performance status 
•
No requirements for intensified management, including increased analgesia, radiation, or 
other palliative care
Any participant deemed clinically unstable should be discontinued from study treatment at 
site-assessed first radiologic evidence of PD, and is not required to have repeat tumor 
imaging for confirmation of PD by iRECIST.
If the investigator decides to continue treatment, the participant may continue to receive 
study treatment and the tumor assessment should be repeated 4 to 8 weeks later to confirm 
PD by iRECIST, per investigator assessment. For participants eligible for interval debulking 
surgery, the tumor assessment should be repeated 4 to 8 weeks later to confirm PD by 
iRECIST, but prior to debulking surgery. Images should continue to be sent in to the central 
imaging vendor for potential retrospective BICR.
Tumor flare may manifest as any factor causing radiographic progression per RECIST 1.1, 
including:
•
Increase in the sum of diameters of target lesion(s) identified at baseline to ≥20% and 
≥5 mm from nadir
-
Note: The iRECIST publication uses the terminology “sum of measurements,” but 
“sum of diameters” will be used in this protocol, consistent with the original RECIST 
1.1 terminology.
•
Unequivocal progression of non-target lesion(s) identified at baseline
•
Development of new lesion(s)
iRECIST defines new response categories, including iUPD (unconfirmed PD) and iCPD 
(confirmed PD). For purposes of iRECIST assessment, the first visit showing progression 
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according to RECIST 1.1 will be assigned a visit (overall) response of iUPD, regardless of 
which factors caused the progression.
At this visit, target and non-target lesions identified at baseline by RECIST 1.1 will be 
assessed as usual.
New lesions will be classified as measurable or non-measurable, using the same size 
thresholds and rules as for baseline lesion assessment in RECIST 1.1. From measurable new 
lesions, up to 5 lesions total (up to 2 per organ), may be selected as New Lesions – Target. 
The sum of diameters of these lesions will be calculated, and kept distinct from the sum of 
diameters for target lesions at baseline. All other new lesions will be followed qualitatively 
as New Lesions – Non-target.
Assessment at the Confirmatory Imaging
On the confirmatory imaging, the participant will be classified as disease progression 
confirmed (with an overall response of iCPD), or as showing persistent unconfirmed 
progression (with an overall response of iUPD), or as showing disease stability or response 
(iSD/iPR/iCR).
Confirmation of Disease Progression
Progression is considered confirmed, and the overall response will be iCPD, if ANY of the 
following occurs:
•
Any of the factors that were the basis for the initial iUPD show worsening
-
For target lesions, worsening is a further increase in the sum of diameters of ≥5 mm, 
compared with any prior iUPD time point
-
For non-target lesions, worsening is any significant growth in lesions overall, 
compared with a prior iUPD time point; this does not have to meet the “unequivocal” 
standard of RECIST 1.1
-
For new lesions, worsening is any of these:
◦
An increase in the new lesion sum of diameters by ≥5 mm from a prior iUPD time 
point 
◦
Visible growth of new non-target lesions 
◦
The appearance of additional new lesions
•
Any new factor appears that would have triggered PD by RECIST 1.1
Persistent iUPD
Progression is considered not confirmed, and the overall response remains iUPD, if:
•
None of the progression-confirming factors identified above occurs AND
•
The target lesion sum of diameters (initial target lesions) remains above the initial PD 
threshold (by RECIST 1.1)
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Additional imaging for confirmation should be scheduled 4 to 8 weeks from the imaging on 
which iUPD is seen. This may correspond to the next visit in the original visit schedule. The 
assessment of the subsequent confirmation imaging proceeds in an identical manner, with 
possible outcomes of iCPD, iUPD, and iSD/iPR/iCR.
Resolution of iUPD
Progression is considered not confirmed, and the overall response becomes iSD/iPR/iCR, if:
•
None of the progression-confirming factors identified above occurs, AND
•
The target lesion sum of diameters (initial target lesions) is not above the initial PD 
threshold. 
The response is classified as iSD or iPR (depending on the sum of diameters of the target 
lesions), or iCR if all lesions resolve.
In this case, the initial iUPD is considered to be pseudoprogression, and the level of 
suspicion for progression is “reset”. This means that the next visit that shows radiographic 
progression, whenever it occurs, is again classified as iUPD by iRECIST, and the 
confirmation process is repeated before a response of iCPD can be assigned.
Management Following the Confirmatory Imaging
If repeat imaging does not confirm PD per iRECIST, as assessed by the investigator, and the 
participant continues to be clinically stable, study treatment may continue and follow the 
regular imaging schedule. If PD is confirmed, participants will be discontinued from study 
treatment.
NOTE: If a participant has confirmed radiographic progression (iCPD) as defined above, but 
the participant is achieving a clinically meaningful benefit, an exception to continue study 
treatment may be considered following consultation with the Sponsor. In this case, if study 
treatment is continued, tumor imaging should continue to be performed following the 
intervals as outlined in Section 1.3 and submitted to the central imaging vendor.
Detection of Progression at Visits After Pseudoprogression Resolves
After resolution of pseudoprogression (ie, achievement of iSD/iPR/iCR), iUPD is indicated 
by any of the following events:
•
Target lesions
-
Sum of diameters reaches the PD threshold (≥20% and ≥5 mm increase from nadir) 
either for the first time, or after resolution of previous pseudoprogression. The nadir 
is always the smallest sum of diameters seen during the entire study, either before or
after an instance of pseudoprogression.
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•
Non-target lesions
-
If non-target lesions have never shown unequivocal progression, their doing so for the 
first time results in iUPD.
-
If non-target lesions have shown previous unequivocal progression, and this 
progression has not resolved, iUPD results from any significant further growth of 
non-target lesions, taken as a whole.
•
New lesions
-
New lesions appear for the first time
-
Additional new lesions appear
-
Previously identified new target lesions show an increase of ≥5 mm in the new lesion 
sum of diameters, from the nadir value of that sum
-
Previously identified non-target lesions show any significant growth
If any of the events above occur, the overall response for that visit is iUPD, and the iUPD 
evaluation process (see Assessment at the Confirmatory Imaging above) is repeated. 
Progression must be confirmed before iCPD can occur.
The decision process is identical to the iUPD confirmation process for the initial PD, with 
one exception: if new lesions occurred at a prior instance of iUPD, and at the confirmatory 
imaging the burden of new lesions has increased from its smallest value (for new target 
lesions, the sum of diameters is ≥5 mm increased from its nadir), then iUPD cannot resolve 
to iSD or iPR. It will remain iUPD until either a decrease in the new lesion burden allows 
resolution to iSD or iPR, or until a confirmatory factor causes iCPD.
Additional details about iRECIST are provided in the iRECIST publication [Seymour, L., et 
al 2017].
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Appendix 7:  Country-Specific Requirements
Germany
Section 1.3.1 SoA – Adjuvant Treatment Period With Primary Debulking Followed by Maintenance
Primary Debulking Followed by Adjuvant Treatment and Maintenance
Study Period
Screening
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screenb
Lead-
in
1
2
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Survival 
FU
The Screening Period is a total of 56 
days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or
following lead-in chemotherapy.
Maintenance is only for 
participants without radiographic 
evidence of disease progression. 
Participant must have SD, PR, CR, 
non-PD in order to enter 
maintenance.
Scheduling 
Window (Days):
–56 to 
start of 
lead-in
Start 
of lead-
in to –1
– 3
±
3
±
3
± 3
± 3
±
3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or 
Q24W
post DC 
(± 7)e
Q12W 
(± 7)
Safety Procedures
Pregnancy test -
WOCBP only
X
X
X
X
X
X
X
X
X
X
X
WOCBP require a negative pregnancy 
test within either 24 hours (urine) or
72 hours (serum) prior to starting 
lead-in chemotherapy and again 
within either 24 hours (urine) or 
72 hours (serum) prior to C1D1 as 
outlined in Appendix 3.
More frequent pregnancy testing may 
be performed if required by local 
regulations or clinically indicated.
HIV / HBV / HCV
X
Testing required
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Section 1.3.2 SoA – Neoadjuvant/Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Neoadjuvant / Adjuvant Treatment Period with Interval Debulking Followed by Maintenance
Study Period
Screening
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Survival 
FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period following 
lead-in chemotherapy.
Maintenance is only for 
participants without radiographic 
evidence of disease progression. 
Participant must have SD, PR, CR, 
or non-PD in order to enter 
maintenance.
Scheduling 
Window (Days):
-56 to
start of 
lead-in
Start 
of 
lead-
in
to -1
– 3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)e
Q12W 
(± 7)
Safety Procedures
Pregnancy test -
WOCBP only
X
X
X
X
X
X
X
X
X
X
X
WOCBP require a negative 
pregnancy test within either 24 hours 
(urine) or 72 hours (serum) prior to 
starting lead-in chemotherapy and 
again within either 24 hours (urine) 
or 72 hours (serum) prior to C1D1 as 
outlined in Appendix 3.
More frequent pregnancy testing 
may be performed if required by 
local regulations or clinically 
indicated.
HIV / HBV / HCV
X
Testing is required
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Section 5.2 Exclusion Criteria
17. Participant has a known history of human immunodeficiency virus (HIV) infection.
Testing for HIV is required at screening.
18. Participant has a known history of hepatitis B (defined as hepatitis B surface antigen 
[HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] 
is detected) infection. Testing for hepatitis B or hepatitis C is required at screening.
Note: Participants with a history of hepatitis B but who are HBsAg negative are eligible 
for the study.
Section 8.11.1 – Screening
•
Laboratory tests are to be performed within 7 days prior to the initiating chemotherapy in 
the Lead-in Period. An exception is HIV and hepatitis testing which may be done up to 
56-day Screening Period prior to randomization.
•
For women of reproductive potential, a pregnancy test (urine or serum) will be performed 
within either 24 hours (urine) or 72 hours (serum) prior to initiating chemotherapy during 
the Lead-in Period and within either 24 hours (urine) or 72 hours (serum) prior to Day 1 
of Cycle 1. If urine pregnancy results cannot be confirmed as negative, a serum 
pregnancy test will be required (performed by the local study site laboratory). Monthly 
pregnancy testing should be conducted per local regulation.
Appendix 3: Contraceptive Guidance and Pregnancy Testing
Pregnancy Testing
Monthly pregnancy testing should be performed as per local regulations.
Appendix 5: Clinical Laboratory Tests
Other Screening Tests: Serology (HIV RNA, hepatitis B surface antigen [HBsAg], and 
hepatitis C virus antibody).
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Section 1.3.1 SoA – Adjuvant Treatment Period With Primary Debulking Followed by Debulking
Primary Debulking Followed by Adjuvant Treatment and Maintenance
Study Period
Screening
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screenb
Lead-
in
1
2
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Survival 
FU
The Screening Period is a total of 56 
days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is only for 
participants without radiographic 
evidence of disease progression. 
Participant must have SD, PR, CR, 
or non-PD in order to enter 
maintenance.
Scheduling 
Window (Days):
–56 to 
start of 
lead-in
Start 
of lead-
in to –1
– 3
±
3
±
3
± 3
± 3
±
3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or 
Q24W
post DC 
(± 7)e
Q12W 
(± 7)
Safety Procedures
HIV / HBV / HCV
X
Testing required
Section 1.3.2 SoA – Neoadjuvant/Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
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Neoadjuvant / Adjuvant Treatment Period with Interval Debulking Followed by Maintenance
Study Period
Screening
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Survival 
FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is only for 
participants without radiographic 
evidence of disease progression. 
Participant must have SD, PR, CR, 
or non-PD in order to enter 
maintenance.
Scheduling 
Window (Days):
-56 to 
start of 
lead-in
Start 
of 
lead-
in
to -1
– 3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)e
Q12W 
(± 7)
Safety Procedures
HIV / HBV / HCV
X
Testing is required
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Section 5.2 Exclusion Criteria
17. Participant has a known history of human immunodeficiency virus (HIV) infection. 
Testing for HIV is required at screening.
18. Participant has a known history of hepatitis B (defined as hepatitis B surface antigen 
[HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] 
is detected) infection. Testing for hepatitis B or hepatitis C is required at screening.
Note: Participants with a history of hepatitis B but who are HBsAg negative are eligible 
for the study.
Section 6.5.1 Prohibited Concomitant Medications
6. Live vaccines within 30 days prior to the first dose of study treatment on Day 1 of 
Cycle 1, while participating in the study, and within 90 days of the last dose of study 
medication.
•
Examples of live vaccines include, but are not limited to, the following: measles, 
mumps, rubella, chickenpox, yellow fever, intranasal seasonal influenza, rabies, 
BCG, and typhoid (oral).
•
Note: Seasonal influenza vaccines for injection are generally killed virus vaccines and 
are allowed.
Section 8.11.1 – Screening
•
Laboratory tests are to be performed within 7 days prior to the initiating chemotherapy in 
the Lead-in Period. An exception is HIV and hepatitis testing which may be done up to
56-day Screening Period prior to randomization.
Appendix 5: Clinical Laboratory Tests
Other Screening Tests: Serology (HIV antibody, hepatitis B surface antigen [HBsAg], and 
hepatitis C virus antibody).
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Section 1.3.1 SoA – Adjuvant Treatment Period With Primary Debulking Followed by Maintenance
Primary Debulking Followed by Adjuvant Treatment and Maintenance
Study Period
Screening
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screenb
Lead-
in
1
2
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Survival 
FU
The Screening Period is a total of 56 
days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is only for 
participants without radiographic 
evidence of disease progression. 
Participant must have SD, PR, CR, 
non-PD in order to enter 
maintenance.
Scheduling 
Window (Days):
–56 to 
start of 
lead-in
Start 
of lead-
in to –1
– 3
±
3
±
3
± 3
± 3
±
3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or 
Q24W
post DC 
(± 7)
Q12W 
(± 7)
Safety Procedures
Pregnancy test -
WOCBP only
X
X
X
X
X
X
X
X
X
X
X
WOCBP require a negative pregnancy 
test within either 24 hours (urine) or
72 hours (serum) prior to starting 
lead-in chemotherapy and again 
within either 24 hours (urine) or 
72 hours (serum) prior to C1D1 as 
outline in Appendix 3.
Monthly pregnancy testing is 
required.
HIV
X
Testing is required at screening if 
mandated by local health authority
HBV/HCV
X
Testing is required 
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Section 1.3.2 SoA – Neoadjuvant/Adjuvant Treatment Period With Interval Debulking Followed by Maintenance
Neoadjuvant / Adjuvant Treatment Period with Interval Debulking Followed by Maintenance
Study Period
Screening
Treatment (C1 – C6) 
Maintenance (C7+)a
(3-Week Cycles)
EOT
Posttreatment Visits
Notes
Treatment Cycle
Screen
b
Lead-
in
1
2
SURGERY
3
4
5
6
7+
DC
Safety 
FUc
Efficacy 
FUd
Survival 
FU
The Screening Period is a total of 
56 days, which includes the 21-day 
Lead-in Period and an optional 
7-day recovery period during or 
following lead-in chemotherapy.
Maintenance is only for 
participants without radiographic 
evidence of disease progression. 
Participant must have SD, PR, CR, 
or non-PD in order to enter 
maintenance.
Scheduling 
Window (Days):
-56 to 
start of 
lead-in
Start 
of 
lead-
in
to -1
– 3
± 3
± 3
± 3
± 3
± 3
± 3
At 
DC
30 Days 
After 
Last 
Dose (+
7)
Q9W,
Q12W, 
or Q24W
post DC 
(± 7)e
Q12W 
(± 7)
Safety Procedures
Pregnancy test -
WOCBP only
X
X
X
X
X
X
X
X
X
X
X
WOCBP require a negative 
pregnancy test within either 24 hours 
(urine) or 72 hours (serum) prior to 
starting lead-in chemotherapy and 
again within either 24 hours (urine) 
or 72 hours (serum) prior to C1D1.
Monthly pregnancy testing is 
required.
HIV
X
Testing is required at screening if 
mandated by local health authority
HBV/HCV
X
Testing is required
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Section 5.1 Inclusion Criteria
Female participants:
8. A female participant is eligible to participate if she is not pregnant (see Appendix 3), not 
breastfeeding, and at least 1 of the following conditions applies:
a) Not a woman of childbearing potential (WOCBP) as defined in Appendix 3
OR
b) A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the 
Treatment Period and for at least 120 days following the last dose of pembrolizumab (or 
pembrolizumab placebo), at least 30 days following the last dose of olaparib (or olaparib 
placebo), and at least 210 days following the last dose of chemotherapy or bevacizumab 
(if administered).
Section 5.2 Exclusion Criteria
18. Participant has a known history of hepatitis B (defined as hepatitis B surface antigen 
[HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] 
is detected) infection. Testing for hepatitis B or hepatitis C is required at screening.
Note: Participants with a history of hepatitis B but who are HBsAg negative are eligible 
for the study.
37. Participant has a hypersensitivity to Chinese hamster ovary (CHO) cell products or other 
recombinant human or humanized antibodies.
Note: This only applies to participants who will receive bevacizumab.
Section 6.6.1.1 Dose Modification and Toxicity Management for Immune-Related AEs 
Associated With Pembrolizumab or Placebo
•
Permanent discontinuation of pembrolizumab/pembrolizumab placebo is required for 
Grade 4 or confirmed cases of Stevens-Johnson syndrome (SJS) and toxic epidermal 
necrolysis (TEN).
Section 8.11.1 – Screening
•
For women of reproductive potential, a pregnancy test (urine or serum) will be performed 
within either 24 hours (urine) or 72 hours (serum) prior to initiating chemotherapy during 
the Lead-in Period and within either 24 hours (urine) or 72 hours (serum) prior to Day 1 
of Cycle 1. If urine pregnancy results cannot be confirmed as negative, a serum 
pregnancy test will be required (performed by the local study site laboratory). Monthly 
pregnancy testing is required.
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Appendix 3: Contraceptive Guidance and Pregnancy Testing
Participants of childbearing potential must adhere to the contraception requirement 
(Appendix 3) from the day of study treatment initiation (or 14 days prior to the initiation of 
study treatment for oral contraception) throughout the study period up to 120 days following 
the last dose of pembrolizumab (or pembrolizumab placebo), up to 30 days following the last 
dose of olaparib (or olaparib placebo), and up to 210 days following the last dose of 
chemotherapy or bevacizumab (if administered).
Pregnancy Testing
Monthly pregnancy testing is required.
Appendix 5: Clinical Laboratory Tests
Screening Tests:  Serology (HIV RNA [if required], hepatitis B surface antigen [HBsAg], 
and hepatitis C virus antibody).
Japan
Section 6.1 Treatments Administered 
Table 2 Study Treatment(s)
Study 
Treatment 
Name
Dose 
Formula-
tion
Unit Dose 
Strength(s)
Dosage 
Level(s)
Route of 
Adminis-
tration
Regimen/
Treatment 
Period/
Vaccination 
Regimen
Use
IMP/
NIMPa
Sourcing
Placebo for 
pembrolizumab
Solution 
for infusion
N/A
N/A
IV
Q3W; Day 1 of 
each 3-week cycle
Placebo IMP
Local
Intravenous solution, not provided by the Sponsor, as placebo for pembrolizumab in this 
protocol is not categorized as “product(s) used in the clinical trial”.
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Appendix 8: Abbreviations
Abbreviation
Definition
ADL
activities of daily living
ADP
adenosine diphosphate
AE
adverse event
ALT
alanine aminotransferase
AML
acute myeloid leukemia
APaT
All Participants as Treated
AST
aspartate aminotransferase
AUC
area under the concentration-time curve
BCG
Bacillus Calmette–Guérin
BICR
blinded independent central review
BID
twice daily
BRCA
breast cancer
BRCA1/2
breast cancer susceptibility gene 1/2
BRCAmut
breast cancer susceptibility gene mutated
CA-125
cancer antigen-125
CD
cluster of differentiation
CEA
cancer embryonic antigen
CFR
Code of Federal Regulations
CI
confidence interval
CPS
combined positive score
CR
complete response
CRF
case report form
CrCl
creatinine clearance
CSR
clinical study report
CT
computed tomography
CTCAE
Common Terminology Criteria for Adverse Events
ctDNA
circulating tumor deoxyribonucleic acid
CTLA-4
cytotoxic T-lymphocyte-associated antigen-4
CTR
Clinical Trial Regulation
CYP
cytochrome P450
DILI
drug-induced liver injury
DNA
deoxyribonucleic acid
DSB
double-strand break
ECG
electrocardiogram
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Abbreviation
Definition
ECI
event of clinical interest
ECOG
Eastern Cooperative Oncology Group
eCRF
electronic case report form
eDMC
external data monitoring committee
EEA
European Economic Area
ELISA
enzyme-linked immunoassay
EMA
European Medicines Agency
EOC
epithelial ovarian cancer
ESMO
European Society for Medical Oncology
FDA
US Food and Drug Administration
FDAAA
Food and Drug Administration Amendments Act
FFPE
formalin-fixed paraffin-embedded
FIGO
International Federation of Gynecology and Obstetrics
FSH
follicle-stimulating hormone
FSR
First site ready
G-CSF
granulocyte colony-stimulating factor
gBRCAmut
germline breast cancer susceptibility gene 1/2 mutation
GCIG
Gynecologic Cancer Intergroup
GCP
Good Clinical Practice
GFR
glomerular filtration rate
GHS
global health status
GI
gastrointestinal
GM-CSF
granulocyte-monocyte colony-stimulating factor
HBsAg
hepatitis B surface antigen
HCV
hepatitis C virus
HGSC
high-grade serous carcinoma
HIV
human immunodeficiency virus
HR
hazard ratio
HRD
homologous recombination repair-deficient
HRQoL
health-related quality-of-life
HRR
homologous recombination repair
HRT
hormone replacement therapy
IB
investigator’s brochure
IC1%
1% of immune cells
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Abbreviation
Definition
ICF
informed consent form
ICH
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use
iCPD
Modified Response Evaluation Criteria 1.1 for immune-based 
therapeutics confirmed progressive disease
iCR
Modified Response Evaluation Criteria 1.1 for immune-based 
therapeutics confirmed complete response
ICSR
individual case safety report
IDS
interval debulking surgery
IEC
Independent Ethics Committee
Ig
immunoglobulin
IHC
immunohistochemistry
IMP
investigational medicinal product
IO
immune-oncology
iPR
Modified Response Evaluation Criteria 1.1 for immune-based 
therapeutics confirmed partial response
irAE
immune-related adverse event
IRB
Institutional Review Board
iRECIST
Modified Response Evaluation Criteria in Solid Tumors 1.1 for immune-
based therapeutics
IRT
Interactive response technology
iSD
Modified Response Evaluation Criteria 1.1 for immune-based 
therapeutics confirmed stable disease
ITT
intention-to-treat
iUPD
Modified Response Evaluation Criteria 1.1 for immune-based 
therapeutics unconfirmed progressive disease
IV
intravenous(ly)
IVD
in vitro diagnostic
lsmean
least square mean
MDS
myelodysplastic syndrome
MRI
magnetic resonance imaging
mRNA
messenger RNA
MSI
microsatellite instability
NCI
National Cancer Institute
NED
no evidence of disease
NHEJ
nonhomologous end-joining
NSCLC
non-small cell lung cancer
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Abbreviation
Definition
OC
ovarian cancer
OME
other important medical event
ORR
objective response rate
OS
overall survival
PARP
poly(adenosine-ribose) polymerase
pCR
pathological complete response
PD
progressive disease
PD-1
programmed cell death 1
PD-L1
programmed cell death 1 ligand 1
PD-L2
programmed cell death 1 ligand 2
PDLC
predefined limits of change
PDS
primary debulking surgery
PFS
progression-free survival
PFS2
progression-free survival after second-line treatment
PK
pharmacokinetics
PLD
pegylated liposomal doxorubicin
PR
partial response
Q3W
every 3 weeks
QLQ-C30
Quality-of-Life Questionnaire Core 30
QLQ-OV28
Ovarian Cancer-Specific Quality-of-Life Questionnaire
QoL
quality-of-life
QW
once weekly
R0
no residual tumor following primary debulking
R1
residual tumor following primary debulking
RECIST 1.1
Response Evaluation Criteria in Solid Tumors version 1.1
RNA
ribonucleic acid
SAE
serious adverse event
SD
stable disease
SGCTG
Scottish Gynaecological Cancer Trials Group
SHP
src homology region 2 domain-containing phosphatase
SLAB
supplemental laboratory test(s)
SNP
single nucleotide polymorphism
SoA
Schedule of Assessments
SOC
standard of care
sSAP
supplemental Statistical Analysis Plan
CCI
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Abbreviation
Definition
SSB
single-strand break
SUSAR
suspected unexpected serious adverse reaction
TDT
time to discontinuation of study treatment or death
TFST
time to first subsequent anticancer treatment
TIL
tumor-infiltrating lymphocytes
TSST
time to second subsequent anticancer treatment
TWiST
time without symptoms of disease progression or toxicity of treatment
ULN
upper limit of normal
US
United States
WOCBP
woman of childbearing potential
WPGSD
Weighted Parametric Group Sequential Design
wt
wild type
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Appendix 9:
Assessment of Response in Ovarian Cancer by Gynecologic 
Cancer Intergroup (CGIG) Criteria
Because of the pelvic location of the primary tumor in patients with OC and the frequent 
occurrence of peritoneal disease, imaging may not always be reliable for documentation of 
PD in patients with OC. Criteria other than RECIST may be applicable to define PD in these 
patients. For this protocol, the Gynecologic Cancer Intergroup (GCIG) criteria for disease 
progression will also be considered for patients with OC [Rustin, G. J., et al 2011]. Based on 
these criteria, PD may also be determined if at least 1 of the following criteria is met:
1. Additional diagnostic tests (eg, histology/cytology, ultrasound techniques, endoscopy, 
positron emission tomography) identify new lesions or determine existing lesions qualify 
for unequivocal PD AND CA-125 progression according to GCIG criteria:
An increase in CA-125 either ≥2 × the normal value or ≥2 × the lowest level it has been 
during the study
2. Definitive clinical signs and symptoms of PD unrelated to non-malignant or iatrogenic 
causes ([a] intractable cancer-related pain; [b] malignant bowel obstruction/worsening 
dysfunction; or [c] unequivocal symptomatic worsening of ascites or pleural effusion) 
AND CA-125 progression according to GCIG criteria:
An increase in CA-125 either ≥2 × the normal value or ≥2 × the lowest level it has been 
during the study
Abnormal CA-125 levels on study do not represent disease progression; however, they may 
prompt imaging if clinically indicated. Progressive disease will not be diagnosed in case of 
CA-125 progression in the absence of at least 1 of the criteria defined above. 
The investigator will describe how PD was diagnosed in the eCRF.
The date of PD is defined as the earliest time point when one of the PD criteria is met. If 
CT/MRI shows existing (baseline) lesions that only equivocally suggest PD and additional 
diagnostic tests are required to determine unequivocal PD, the official date of PD will be the 
date PD was unequivocally determined. Alternatively, with new lesions (except ascites and 
effusions) that are initially equivocal that are later unequivocally determined, the date of 
progression will be the date the lesion was initially identified.
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