A Phase 2 Open-label Randomized Study of Farletuzumab Ecteribulin (MORAb-202), a Folate Receptor Alpha-targeting Antibody-drug Conjugate, Versus Investigator's Choice Chemotherapy in Women With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Phase: PHASE2
Conditions: Neoplasms, Ovarian
Sponsor: Bristol-Myers Squibb

Official Title of Study: 
A Phase 2 Open-label Randomized Study of Farletuzumab Ecteribulin (MORAb-202), a Folate 
Receptor Alpha-targeting Antibody-drug Conjugate, versus Investigator’s Choice Chemotherapy 
in Women with Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or 
Fallopian Tube Cancer 
 
NCT Number: NCT05613088 
Document Date (Date in which document was last revised): 05 Aug 2024 
 
 
 

Page:
1
Protocol Number:
CA116001
Date:
24-Jun-2022
Revised Date:
05-Aug-2024
CLINICAL PROTOCOL CA116001/MORAB-202-G000-205
A Phase 2 Open-label Randomized Study of Farletuzumab Ecteribulin (MORAb-202), a Folate 
Receptor Alpha-targeting Antibody-drug Conjugate, versus Investigator’s Choice Chemotherapy
in Women with Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or 
Fallopian Tube Cancer
Compound: BMS-986445
Brief Title:
A Phase 2 Study of MORAb-202 in Platinum-resistant High-grade Serous Ovarian, Primary 
Peritoneal, or Fallopian Tube Cancer
Protocol Amendment 03
Medical Monitor Name and Contact Information:
Clinical Trial Physician – Medical Monitor
Bristol-Myers Squibb Company
3401 Princeton Pike
Lawrenceville, NJ 08648
Phone: 
email: 
24-hr Emergency Telephone Number
USA: 
International: 
Sponsor Name and Legal Registered Address:
Bristol-Myers Squibb Company
Route 206 & Province Line Road
Lawrenceville, NJ 08543
REGULATORY AGENCY IDENTIFIER NUMBER(S)
IND: 157,858
EudraCT/EU Trial Number: 2021-004807-42
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Protocol Amendment No.: 03
Date: 05-Aug-2024
2
This document is the confidential and proprietary information of Bristol-Myers Squibb 
Company and its global affiliates (BMS) and Eisai Co., Ltd. By reviewing this document, you 
agree to keep it confidential and to use and disclose it solely for the purpose of assessing 
whether your organization will participate in and/or the performance of the proposed 
BMS/Eisai co-sponsored study. Any permitted disclosures will be made only on a 
confidential “need to know” basis within your organization or to your Independent Ethics 
Committee(s). Any other use, copying, disclosure or dissemination of this information is 
strictly prohibited unless expressly authorized in writing by BMS. Any supplemental 
information (eg, amendments) that may be added to this document is also confidential and 
proprietary to BMS and must be kept in confidence in the same manner as the contents of 
this document. Any person who receives this document without due authorization from BMS 
is requested to return it to BMS or promptly destroy it. References to BMS in this protocol 
may apply to partners to which BMS has transferred obligations (eg, a Contract Research 
Organization [CRO]).
© 2024 Bristol-Myers Squibb Company
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MORAb-202
Protocol Amendment No.: 03
Date: 05-Aug-2024
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DOCUMENT HISTORY
Document
Date of Issue
Summary of Changes
Protocol 
Amendment 03
05-Aug-2024
 
 
 
 
 
Administrative 
Letter 01
25-Sep-2023
Change of medical monitor contact information and administrative 
changes in Table 2-1 and Table 9.4.4-1. 
Protocol 
Amendment 02
07-Apr-2023
 
 
 
Protocol 
Amendment 01
02-Aug-2022
The main purpose of this Protocol Amendment is to make updates 
. Additionally, further 
clarification was added to Table 2-4 and Table 7.4.1-2.
Original Protocol
24-Jun-2022
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OVERALL RATIONALE FOR PROTOCOL AMENDMENT 03:
 
 
 
 
The Protocol Summary has been updated to align with respective changes made in the protocol 
body and is not summarized in the table below. In addition, this amendment incorporates changes 
from an approved Administrative Letter 01, which are summarized in the table below. 
Minor editorial, formatting, and typographical corrections have been made and therefore have not
been summarized.
SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 03
Section Number & 
Title
Description of Change
Brief Rationale
Section 2: Schedule of 
Activities 
•
Table 2-1: Screening Procedural Outline 
(CA116001) updated the following:
Note section for Clinical Laboratory 
Assessments updated to include 12-or 24-
hour urine collections is required for CrCl 
measurements.
•
Table 2-2: On-treatment Procedural Outline 
for MoRab-202-
 
•
Table 2-3: On-treatment Procedural Outline 
for 21-Day Cycle 
Topotecan 
1.25mg/m2:
 
•
Table 2-4 On-treatment Procedural Outline 
for a 28-Day Cycle-
 (PLD, 
Paclitaxel, and Topotecan 4mg/m2):
 
•
Table 2-5 (Follow-up Procedural Outline 
(CA116001)) updated for following: 
o
Notes section for Survival Status was 
updated to include survival follow-up 
visits up to 1 year from the last 
participant randomized or LPLV (30 
 
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SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 03
Section Number & 
Title
Description of Change
Brief Rationale
days after the last patient's last 
treatment visit), whichever is later. 
Section 5.1: Overall Design
•
The section was updated to remove 
continuous long-term survival follow-up. 
•
The section has been updated to include 
survival follow-up every 3 months from the 
safety follow-up visit up to 1 year from the 
last participant randomized or LPLV (30 
days after the last patient's last treatment), 
whichever is later. 
•
The study design schema was updated to 
include a survival follow-up of 1 year. 
 
Section 8.1.1: Post-study 
Intervention Study Follow-
up
Section updated to include survival follow-up 
every three months from safety follow-up visit 
up to 1 year from the last participant randomized 
or LPLV (30 days after last patient last treatment 
visit); whichever is later.
 
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TABLE OF CONTENTS 
 
 
TITLE PAGE................................................................................................................
 
DOCUMENT HISTORY..............................................................................................
 
OVERALL RATIONALE FOR PROTOCOL AMENDMENT 03:............................
 
SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 03.........................
 
TABLE OF CONTENTS..............................................................................................
 
1 PROTOCOL SUMMARY.........................................................................................
 
2 SCHEDULE OF ACTIVITIES..................................................................................
 
3 INTRODUCTION .....................................................................................................
 
3.1 Study Rationale.................................................................................................
 
3.1.1 Research Hypothesis ................................................................................ 
 
3.2 Background.......................................................................................................
 
3.2.1 Ovarian Cancer Racial and Ethnic Diversity .......................................... 
 
3.2.2 Summary of Key Preclinical Data with MORAb-202 .............................. 
 
3.2.3 MORAb-202 Clinical Data ...................................................................... 
 
3.2.3.1 Clinical Efficacy.............................................................................. 
 
3.2.3.2 Clinical Safety ................................................................................. 
 
3.2.4 MORAb-202 Clinical Pharmacology ....................................................... 
 
3.2.4.1 MORAb-202 Clinical Pharmacokinetics ........................................ 
 
3.2.4.2 Exposure-response Efficacy and Safety .......................................... 
 
 
 
3.2.4.4 Corrected QTc Interval Assessment................................................ 
 
3.2.4.5 Drug-drug Interaction Potential ..................................................... 
 
3.3 Benefit/Risk Assessment ..................................................................................
 
3.3.1 Risk Assessment ....................................................................................... 
 
3.3.2 Benefit Assessment ................................................................................... 
 
3.3.3 Overall Benefit/Risk Conclusion .............................................................. 
 
4 OBJECTIVES AND ENDPOINTS ...........................................................................
 
5 STUDY DESIGN.......................................................................................................
 
5.1 Overall Design ..................................................................................................
 
5.1.1 Data Monitoring Committee and Other Committees ............................... 
 
5.1.1.1 Safety Committee (SC) .................................................................... 
 
5.1.1.2 ILD Expert Review Committee........................................................ 
 
5.2 Number of Participants .....................................................................................
 
5.3 End of Study Definition....................................................................................
 
5.4 Scientific Rationale for Study Design...............................................................
 
5.4.1 Participant Input Into Study Design ........................................................ 
 
5.4.2 Rationale for Open-label Design ............................................................. 
 
 
 
5.4.4 Rationale for Choice of Comparators and Dose Justification................. 
 
5.4.4.1 Paclitaxel ........................................................................................ 
 
5.4.4.2 Pegylated Liposomal Doxorubicin ................................................. 
 
5.4.4.3 Topotecan ........................................................................................ 
 
5.4.5 Rationale for Primary Endpoint .............................................................. 
 
5.5 Justification for Dose ........................................................................................
 
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CA116001
MORAb-202
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5.6
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5.6.2 Tumor Samples......................................................................................... 
 
5.6.2.1 Tumor Sample Collection ............................................................... 
 
5.6.2.2 Characterization of Tumor Microenvironment ............................... 
 
5.6.2.3 Tumor Genotyping, Mutational Analysis, and Gene Expression 
Profiling ................................................................................................ 
 
5.6.2.4 Tumor FRĮ Expression ................................................................... 
 
 
6 STUDY POPULATION............................................................................................
 
6.1 Inclusion Criteria ..............................................................................................
 
6.2 Exclusion Criteria .............................................................................................
 
6.3 Lifestyle Restrictions ........................................................................................
 
6.4 Screen Failures..................................................................................................
 
6.4.1 Re-testing During Screening .................................................................... 
 
7 STUDY INTERVENTION(S) AND CONCOMITANT THERAPY .......................
 
7.1 Study Interventions Administered ....................................................................
 
7.1.1 MORAb-202 Administration 
 ...................................................... 
 
7.1.2 Preparation and Administration of Paclitaxel ......................................... 
 
7.1.3 Preparation and Administration of Pegylated Liposomal Doxorubicin .. 
 
7.1.4 Preparation and Administration of Topotecan ........................................ 
 
7.1.5 Calculation of Dose Based on Body Surface Area .................................. 
 
7.2 Assignment to Study Intervention ....................................................................
 
7.3 Blinding.............................................................................................................
 
7.4 Dosage Modification.........................................................................................
 
7.4.1 Dose Modification for MORAb-202......................................................... 
 
7.4.1.1 Criteria to Resume MORAb-202 Treatment ................................... 
 
7.4.2 Dose Modification for Paclitaxel ............................................................. 
 
7.4.2.1 Dose Reduction for Paclitaxel ........................................................ 
 
7.4.3 Dose Modification for Pegylated Liposomal Doxorubicin (PLD) ........... 
 
7.4.3.1 Dose Reduction for Pegylated Liposomal Doxorubicin (PLD) ...... 
 
7.4.4 Dose Modification for Topotecan ............................................................ 
 
7.4.4.1 Dose Reduction for Topotecan........................................................ 
 
7.5 Preparation/Handling/Storage/Accountability..................................................
 
7.5.1 Retained Samples for Bioavailability/Bioequivalence/Biocomparability 
 
7.6 Study Intervention Compliance ........................................................................
 
7.7 Concomitant Therapy........................................................................................
 
7.7.1 Prohibited and/or Restricted Treatments................................................. 
 
7.7.2 Supportive Therapies ............................................................................... 
 
7.7.3 Other Restrictions and Precautions ......................................................... 
 
7.7.3.1 Imaging Restrictions and Precautions ............................................ 
 
7.8 Continued Access to Study Intervention After the End of the Study ...............
 
8 DISCONTINUATION CRITERIA ...........................................................................
 
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CA116001
MORAb-202
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8.1 Discontinuation of Study Intervention..............................................................
 
8.1.1 Post-study Intervention Study Follow-up ................................................. 
 
8.2 Discontinuation From the Study.......................................................................
 
8.2.1 Individual Discontinuation Criteria ........................................................ 
 
8.3 Lost to Follow-up..............................................................................................
 
9 STUDY ASSESSMENTS AND PROCEDURES.....................................................
 
9.1 Efficacy Assessments........................................................................................
 
9.1.1 Efficacy Assessment for the Study ............................................................ 
 
9.1.2 Imaging Assessment for the Study............................................................ 
 
 
 
 
 
 
 
 
 
 
 
9.2 Adverse Events .................................................................................................
 
9.2.1 Period and Frequency for Collecting AE and SAE Information ............. 
 
9.2.2 Method of Detecting AEs and SAEs ......................................................... 
 
9.2.3 Follow-up of AEs and SAEs ..................................................................... 
 
9.2.4 Regulatory Reporting Requirements for SAEs ......................................... 
 
9.2.5 Pregnancy ................................................................................................ 
 
9.2.6 Laboratory Test Result Abnormalities ..................................................... 
 
9.2.7 Potential Drug-induced Liver Injury ....................................................... 
 
9.2.8 Other Safety Considerations .................................................................... 
 
9.2.9 AEs of Special Interest ............................................................................. 
 
9.3 Overdose ...........................................................................................................
 
9.4 Safety ................................................................................................................
 
9.4.1 Physical Examinations ............................................................................. 
 
9.4.2 Vital Signs ................................................................................................ 
 
9.4.3 Electrocardiograms ................................................................................. 
 
9.4.4 Clinical Safety Laboratory Assessments .................................................. 
 
9.4.5 ILD/Pneumonitis Assessments ................................................................. 
 
9.4.6 Imaging Safety Assessment ...................................................................... 
 
9.4.7 Echocardiogram (ECHO)/Multigated Acquisition (MUGA) ................... 
 
 
 
 
 
 
 
 
 
9.9 Health Economics OR Medical Resource Utilization and Health Economics .
 
10 STATISTICAL CONSIDERATIONS ....................................................................
 
 
 
10.3 Analysis Sets...................................................................................................
 
10.4 Statistical Analyses.........................................................................................
 
10.4.1 General Considerations ......................................................................... 
 
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CA116001
MORAb-202
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10.4.2 Primary Endpoint(s) .............................................................................. 
 
10.4.3 Secondary Endpoints ............................................................................. 
 
 
 
10.4.5 Other Safety Analyses ............................................................................ 
 
 
 
 
 
 
 
 
 
 
11 REFERENCES ........................................................................................................
 
12 APPENDICES .........................................................................................................
 
APPENDIX 1 ABBREVIATIONS...............................................................................
 
APPENDIX 2 STUDY GOVERNANCE CONSIDERATIONS .................................
 
APPENDIX 3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, EVALUATING, 
FOLLOW-UP, AND REPORTING .......................................................................
 
APPENDIX 4 WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS AND 
METHODS OF CONTRACEPTION.....................................................................
 
APPENDIX 5 AMERICAN JOINT COMMITTEE ON CANCER (AJCC) STAGE 
AND TNM STAGE GROUPING FOR OVARIAN CANCER (8TH EDITION).
 
APPENDIX 6 ECOG PERFORMANCE STATUS .....................................................
 
APPENDIX 7 COUNTRY SPECIFIC APPENDIX.....................................................
 
APPENDIX 8 RESPONSE EVALUATION CRITERIA IN SOLID TUMORS 
GUIDELINES (VERSION 1.1) WITH BMS MODIFICATIONS ........................
 
APPENDIX 9 NEW YORK HEART ASSOCIATION FUNCTIONAL 
CLASSIFICATION ................................................................................................
 
APPENDIX 10 PROTOCOL AMENDMENT SUMMARY OF CHANGE HISTORY
.................................................................................................................................
 
 
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CA116001
MORAb-202
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BMS-986445
MORAb-202
1
PROTOCOL SUMMARY
Protocol Title:
A Phase 2 Open-label Randomized Study of Farletuzumab Ecteribulin (MORAb-202), a Folate 
Receptor Alpha-targeting Antibody-drug Conjugate, versus Investigator’s Choice Chemotherapy 
in Women with Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or 
Fallopian Tube Cancer
Brief Title: A Phase 2 Study of MORAb-202 in Platinum-resistant High-grade Serous Ovarian, 
Primary Peritoneal, or Fallopian Tube Cancer
Rationale:
There is an urgent clinical need for novel therapeutic approaches in platinum-resistant ovarian 
cancer (PROC). Despite progress in earlier lines of therapy, with the availability of new treatment 
modalities, patients with PROC still have a poor prognosis.
Debulking surgery and platinum-based chemotherapy form the foundation of care for the treatment 
of women with advanced ovarian cancer. Although many women with advanced disease may enter 
remission after surgery and chemotherapy, most patients will eventually relapse. Depending upon 
the response of the last platinum-based therapy and time for recurrence, most women will receive 
additional platinum-based regimens on subsequent lines of therapy. With every additional line of 
platinum-based regimens, the progression-free survival (PFS) decreases. A particular challenge 
arises when the disease returns less than 6 months after completing the last platinum-based 
chemotherapy, referred to as PROC. For these patients, additional lines of platinum-based 
chemotherapy usually provide a small clinical benefit; however, most patients will be only eligible 
to receive a single-agent non-platinum-based option (eg, pegylated liposomal doxorubicin [PLD], 
paclitaxel, or topotecan). Although these regimens can provide some clinical benefit, the observed 
objective response rate (ORR) is low (10% to 15%) with median PFS (mPFS) around 3.5 months. 
Patients with PROC have a median overall survival of less than 1 year, thus highlighting the unmet 
medical need.
Folate receptor alpha (FRĮ)-directed antibody-drug conjugate (ADC) therapy is a potential 
treatment option for advanced ovarian cancer and is currently under investigation. Various 
epithelial tumors (eg, ovarian, endometrial, lung, head and neck) have demonstrated abundant FRĮ 
messenger ribonucleic acid (mRNA) expression by quantitative polymerase chain reaction and 
membrane protein expression by immunohistochemistry (IHC). Although FRĮ expression is 
limited in normal ovary tissue, 80% to 90% of epithelial ovarian cancer (EOC) tumors express 
FRĮ. A recent meta analysis suggests that higher expression of FRĮ is associated with poor 
survival of patients with cancer and may serve as a prognostic indicator. Moreover, there is 
evidence that elevated FRĮ expression may be a negative prognostic marker for chemotherapeutic 
response in EOC. In addition to its cell surface localization, FRĮ can be shed into the bloodstream 
as a soluble form. Soluble FRĮ (sFRĮ) levels correlate with local tumor FRĮ expression. Higher 
serum concentrations of sFRĮ are indicative of the FRĮ expression status of the tumor and are 
correlated with clinical stage and poor prognosis. FRĮ is an attractive target for ADC-based 
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MORAb-202
therapies due to its ability to internalize large molecules, its limited expression in normal tissues, 
and its overexpression in malignant cells, allowing for effective, targeted drug delivery.
Preliminary efficacy and a manageable safety profile were observed in participants with PROC 
treated with MORAb-202 in a Phase 1 study, MORAb-202-J081-101 (hereafter referred to as 
Study 101), and a Phase 1/2 study, MORAb-202-G000-201 (hereafter referred to as Study 201), 
supporting further clinical development of MORAb-202 in this population. Responses were 
observed in participants with solid tumors across a range of FRĮ expression levels, supporting the 
evaluation in all randomized participants irrespective of their expression levels.
Objectives, Endpoints, and Estimands:
Objectives
Endpoints
Primary
•
To compare objective response rate (ORR) of 
MORAb-202 vs IC chemotherapy (in all 
randomized participants)
•
ORR by Response Evaluation Criteria in Solid 
Tumors (RECIST) v1.1 per investigator 
assessment
Main Estimand for the Primary Objective
Treatment: MORAb-202, 25 mg/m2
, IC 
chemotherapy 
Population: Platinum-resistant ovarian cancer
Variable: Best overall response (BOR), defined as the best response, as determined by the investigator, 
recorded between the date of randomization and the date of first objectively-documented progression per 
RECIST v1.1 or the date of subsequent therapy, whichever is earlier.
Intercurrent events (strategy): Early discontinuation of study treatment (treatment policy); initiation of 
subsequent anti-cancer therapy (while on treatment)
Population-level summary: Difference in ORR, defined as the number of randomized participants who 
achieve a BOR of confirmed complete response (CR) or confirmed partial response (PR) based on the 
investigator assessments (using RECIST v1.1) divided by the number of all randomized participants in each 
treatment group, with two-sided 95% exact confidence interval (CI) in each treatment group
•
To evaluate the proportion of participants with 
treatment-related adverse event (TRAEs) leading 
to discontinuation in each arm within 6 months
from first dose of study drug administration in all 
treated participants
•
TRAEs leading to discontinuation
Main Estimand for the Primary Objective
Treatment: MORAb-202, 25 mg/m2
 IC 
chemotherapy 
Population: Platinum-resistant ovarian cancer
Variable: Occurrence of TRAEs leading to discontinuation observed within 6 months from first dose of study 
drug administration
Intercurrent events (strategy): Early discontinuation of study treatment (while on treatment)
Population-level summary: TRAE discontinuation incidence rate
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Objectives
Endpoints
Secondary
•
To assess the safety and tolerability of MORAb-
202 and IC chemotherapy in all treated participants
•
Incidence and severity of adverse events 
(AEs)/serious adverse events (SAEs), AEs leading 
to discontinuation, treatment-related AEs/SAEs 
leading to discontinuation, AEs of special interest 
(AESIs), deaths, and laboratory abnormalities
Main Estimand for the Secondary Objective
Treatment: MORAb-202, 25 mg/m2
, IC 
chemotherapy 
Population: Platinum-resistant ovarian cancer
Variable: Occurrence of the AEs/SAEs, treatment-related AEs/SAEs, AEs leading to discontinuation, AESIs,
deaths, and laboratory abnormalities. There are multiple estimands corresponding to each specified safety 
endpoint.
Intercurrent events (strategy): Early discontinuation of study treatment (while on treatment)
Population-level summary: AE incidence rate/proportion
•
To evaluate disease control rate (DCR) of
MORAb-202 and IC chemotherapy in all 
randomized participants
•
DCR by RECIST v1.1 per investigator assessment
Main Estimand for the Secondary Objective
Treatment: MORAb-202, 25 mg/m2
 IC 
chemotherapy 
Population: Platinum-resistant ovarian cancer
Variable: Best overall response (BOR), defined as the best response, as determined by the investigator, 
recorded between the date of randomization and the date of first objectively-documented progression per 
RECIST v1.1 or the date of subsequent therapy
Intercurrent events (strategy): Early discontinuation of study treatment (treatment policy); initiation of 
subsequent anti-cancer therapy (while on treatment)
Population-level summary: Difference in DCR, defined as the number of randomized participants who 
achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on the investigator 
assessments (using RECIST v1.1) divided by the number of all randomized participants, with 95% exact CI 
in each treatment group
•
To evaluate duration of response (DoR) of 
MORAb-202 and IC chemotherapy in all 
randomized participants
•
DoR by RECIST v1.1 per investigator assessment
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Objectives
Endpoints
Main Estimand for the Secondary Objective
Treatment: MORAb-202, 25 mg/m2
, IC 
chemotherapy 
Population: Platinum-resistant ovarian cancer participants that achieved a CR or PR as BOR
Variable: DoR, defined as the time between the date of first documented response (CR or PR) that is 
subsequently confirmed, to the date of the first objectively-documented tumor progression as determined by 
investigator (per RECIST v1.1), or death due to any cause, whichever occurs first
Intercurrent events (strategy): Early discontinuation of study treatment (treatment policy); initiation of 
subsequent anti-cancer therapy (while on treatment)
Population-level summary: Kaplan Meier (KM) estimated median response time and landmark response rate 
of DoR in each treatment group
•
To evaluate progression-free survival (PFS) of 
MORAb-202 and IC chemotherapy in all 
randomized participants
•
PFS by RECIST v1.1 per investigator assessment
Main Estimand for the Secondary Objective
Treatment: MORAb-202, 25 mg/m2
, IC 
chemotherapy 
Population: Platinum-resistant ovarian cancer
Variable: PFS, defined as the time between the date of randomization and the first date of documented 
progression, determined by the investigator assessments (using RECIST v1.1), or death due to any cause, 
whichever occurs first.
Intercurrent events (strategy): Early discontinuation of study treatment (treatment policy); initiation of 
subsequent anti-cancer therapy prior to PD or death (treatment policy)
Population-level summary: KM estimated median survival time and landmark survival rate of PFS in each 
treatment group
Abbreviations: AE, adverse event; AESI, adverse event of special interest; BOR, best overall response; CI, confidence 
interval; CR, complete response; DCR, disease control rate; DoR, duration of response; IC, Investigator’s choice; KM, 
Kaplan Meier; ORR, objective response rate; PD, progressive disease; PFS, progression-free survival; PR, partial 
response; RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1; SAE, serious adverse event; SD, 
stable disease; TRAE, treatment-related adverse event.
Overall Design:
Study CA116001 is a Phase 2, open-label, randomized, multicenter study that will evaluate the 
safety, efficacy, and tolerability of MORAb-202 in female participants with platinum-resistant 
high-grade serous (HGS) ovarian, primary peritoneal, or fallopian tube cancer.
All screening assessments to determine participant eligibility must be performed within 28 days 
prior to randomization. 
 
 
All participants will be treated until disease progression by Response Evaluation Criteria in Solid 
Tumors version 1.1 ([RECIST v1.1 criteria]; as assessed by the investigator), unacceptable 
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MORAb-202
toxicity, participant withdrawal of consent for receiving study treatment, death, or the end of study, 
whichever occurs first. Maximum treatment duration will be up to 2 years.
A Safety Follow-up Visit will be conducted 30 days after the last study drug administration. All 
ongoing treatment-related serious adverse events and interstitial lung disease (ILD)/pneumonitis 
events will be followed until resolution or stabilization. All participants discontinuing treatment 
will be followed for tumor assessment until investigator-assessed disease progression by 
RECIST v1.1, death, or withdrawal of consent for tumor assessment, whichever occurs first. 
Subsequently, all participants will be followed for information on progression on next line of 
therapy and survival every 3 months for up to 1 year from last participant randomized or LPLV 
(30 days after last patient last treatment visit); whichever is later.
Number of Participants:
About 90 participants will be randomized in a 
 ratio to 1 of the 2 treatment groups, about 
 
participants in the MORAb-202 arm 
 and 
 in the IC chemotherapy arm 
It is 
estimated that approximately 
participants will be enrolled to achieve approximately 90
randomized participants, assuming a screen failure rate of approximately 
 
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MORAb-202
Study Population:
Main Inclusion Criteria:
•
Female participants with histologically-confirmed diagnosis of HGS ovarian, primary 
peritoneal, or fallopian tube cancer.
•
Platinum-resistant disease, defined as:

For participants who had only 1 line of platinum-based therapy: progression between 
> 1 month and  6 months after the last dose of platinum-based therapy of at least 4 cycles.

For participants who had 2 or 3 lines of platinum-based therapy: progression  6 months 
after the last dose of platinum-based therapy.
•
Participants have received at least 1 but no more than 3 prior lines of systemic therapy and for 
whom single-agent therapy is appropriate as the next line of therapy. Participants may have 
been treated with up to 1 line of therapy subsequent to determination of platinumresistance.
•
Participants must have received prior treatment with bevacizumab or must be deemed 
medically inappropriate or ineligible/intolerant to receive bevacizumab, refused to receive 
bevacizumab, or been unable to receive bevacizumab due to lack of access.
NOTES:
Neoadjuvant ± adjuvant chemotherapy will be considered 1 line of therapy.
Maintenance therapy (eg, bevacizumab, poly [adenosine disphosphate-ribose] polymerase 
[PARP] inhibitors) will be considered part of the preceding line of therapy.
Therapy changed in the absence of progression will be considered part of the same line.
•
Disease progression per RECIST v1.1 (by investigator assessment) of at least 1 measurable 
lesion on or after the most recent therapy.
•
Either formalin-fixed, paraffin-embedded tissue (up to
 old) or newly-obtained biopsies 
must be available for FRĮ assessment prior to randomization. The tumor sample (tissue block 
[preferred] or a minimum of 
unstained slides) must be evaluable for FRĮ IHC analysis to 
meet eligibility criteria. Sample resubmission will be permitted for participants with non-
evaluable FRĮ IHC who are otherwise eligible.
•
Eastern Cooperative Oncology Group Performance Status of 0 or 1.
•
Participant must be  18 years of age (or the legal age of consent in the jurisdiction in which 
the study is taking place) at the time of signing the informed consent form.
Main Exclusion Criteria:
•
Clear cell, mucinous, endometrioid or sarcomatous histology, or mixed tumors containing 
components of any of these histologies, or low grade or borderline ovarian cancer.
•
Primary platinum-refractory ovarian cancer is defined as disease progression within 1 month 
of the last dose of the first line platinum-containing regimen.
•
Pulmonary function test abnormalities: FEV1 < 70% or FVC < 60%, and DLCO < 80%.
•
Investigator-assessed current ILD/pneumonitis, or ILD/pneumonitis suspected at screening or 
history of ILD/pneumonitis of any severity including ILD/pneumonitis from prior anti-cancer 
therapy.
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•
Current infectious pneumonia, history of viral pneumonia (including coronavirus disease 2019 
[COVID-19]-related infection) with evidence of persistent radiologic abnormalities.
•
Significant third-space fluid retention (e.g., ascites or pleural effusion) that requires repeated 
drainage.
•
Clinically significant pericardial effusion requiring drainage.
•
Prior pneumonectomy. Prior lobectomy and segmentectomy are allowed >12 months before 
treatment.
•
Recent chest radiotherapy. Participants with chest or chest wall radiation (eg, history of breast 
cancer) may be permitted if the radiation is documented > 6 months before starting study 
treatment.
•
Any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, 
Sjögren’s syndrome, sarcoidosis, etc) where there is documented (or suspicion of) pulmonary 
involvement.
•
Spinal cord compression or untreated, symptomatic central nervous system (CNS) metastases. 
Participants are eligible if CNS metastases are asymptomatic and do not require immediate 
treatment, or have been treated and participants have neurologically returned to baseline 
(except for residual signs or symptoms related to the CNS treatment). In addition, participants 
have discontinued anticonvulsant therapy and must have been either off corticosteroids, or on 
a stable or decreasing dose of  10 mg daily prednisone (or equivalent) for at least 2 weeks 
prior to treatment. Imaging performed within 28 days prior to treatment must document 
radiographic stability of CNS lesions and be performed after completion of any CNS-directed 
therapy.
•
Concurrent malignancy (present during screening) requiring treatment, or history of prior 
malignancy active within 2 years prior to randomization (ie, participants with a history of prior 
malignancy are eligible if treatment was completed at least 2 years before randomization and 
the participant has no evidence of disease). Participants with history of prior early stage 
basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone 
definitive treatment at any time are also eligible.
•
Participants with a condition requiring systemic treatment with either corticosteroids > 10 mg 
daily prednisone equivalents or other immunosuppressive medications within 14 days of study 
treatment administration, except for steroid adrenal replacement where doses of > 10 mg daily 
prednisone equivalent, are allowed in the absence of active autoimmune disease.

Treatment with a short course (< 5 days) of steroids up to 7 days prior to initiating study 
treatment is permitted.
Intervention Groups and Duration:
At least 90 evaluable participants will be randomized in a 
 ratio to:
•
(N = 
): MORAb-202 25 mg/m2
•
 (N = 
): Investigator’s choice (IC) single-agent chemotherapy:

Paclitaxel 80 mg/m2 intravenous (IV) on Days 1, 8, 15, and 22 of a 28-day cycle; or

Pegylated liposomal doxorubicin (PLD) 40 mg/m2 IV on Day 1 of a 28-day cycle; or
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
Topotecan 4 mg/m2 IV on Days 1, 8, and 15 of a 28-day cycle or 1.25 mg/m2 on 
5 consecutive days on Days 1 to 5 of a 21-day cycle
Study Intervention:
Study Interventions for CA116001
Intervention Name
Unit Dose Strength(s)
IMP/Non-IMP/AxMP
MORAb-202 Lyophilized Powder in 
a Single Use Vial
 mg/mL
IMP
Paclitaxel
6 mg/mL
IMP
Pegylated Liposomal Doxorubicin 
(PLD)
2 mg/mL
IMP
Topotecan
1 mg/mL
IMP
Abbreviations: AxMP, auxiliary medicinal product; IMP, investigational medicinal product; PLD, pegylated 
liposomal doxorubicin.
Statistical Methods:
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MORAb-202
Data Monitoring Committee: No
A Data Monitoring Committee (DMC) will not be used in the study.
Given this is an early phase, open-label study, an independent DMC is not commissioned. 
Nonetheless, the safety of the participants will be closely monitored through a Safety Committee 
including external members to the Sponsor. 
Other Committee: Yes 
A Safety Committee will be established to provide oversight of the benefit/risk for the participants 
enrolled in the CA116001 study and give advice to the Sponsor regarding actions that the 
committee deems necessary for the continued protection of the participants enrolled. Additionally, 
an external ILD Expert Review Committee will provide further ILD oversight on the study.
Brief Summary:
CA116001 is a Phase 2 open-label, randomized study assessing the efficacy, safety, and 
tolerability of MORAb-202. The study research hypothesis is that MORAb-202 will have a 
favorable benefit risk profile at 25 mg/m2, compared to IC chemotherapy, as measured by ORR 
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and safety profile in participants with platinum-resistant HGS ovarian, primary peritoneal, or 
fallopian tube cancer.
Study Duration: Approximately 4 years
Study Intervention Duration: Until progression, unacceptable toxicity, withdrawal of consent, 
death, or end of study (whichever occurs first)
Study Visit Frequency: 
•
 (MORAb-202 at 25 mg/m2): 
•
 (IC Chemotherapy):

Paclitaxel: Every 4 weeks. However, paclitaxel will be administered in the clinic on 
Days 1, 8, 15, and 22 of a 28-day cycle

Topotecan 21-day cycle: Every 3 weeks. However, topotecan will be administered in the 
clinic on Days 1 to 5 of a 21-day cycle

Topotecan 28-day cycle: Every 4 weeks. However, topotecan will be administered in the 
clinic on Days 1, 8, and 15 of a 28-day cycle

PLD: Every 4 weeks
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2
SCHEDULE OF ACTIVITIES
Table 2-1:
Screening Procedural Outline (CA116001)
Procedurea
Screening Visit
(Day -28 to Day 1)
Notesb
All windows are based on calendar days
Eligibility Assessments
Informed Consent
X
A participant is considered enrolled only when a protocol-specific informed 
consent is signed; informed consent must be obtained prior to performing any 
screening procedures that are not conducted as part of the participant’s routine 
clinical management.
Study allows for re-enrollment of a participant who has discontinued the study as 
a screen failure. If re-enrolled, the participant must be re-consented and assigned 
a new participant number from Interactive Response Technology (IRT).
For participants who may take part remotely, prescreening will be done via a 
telephone call, and the informed consent will be obtained remotely using a 
telemedicine module (decentralized clinical trial [DCT] platform) and an 
electronic consent form, where allowed by applicable local laws and regulations. 
More details of the consenting process are provided in Appendix 2.
IRT Registration
X
Register in IRT system to obtain participant number at the time informed consent 
is obtained.
Informed Consent for Optional Sample Collection 
X
Consent for optional sample collection can be collected at a later visit if needed.
Inclusion/Exclusion Criteria
X
Must be confirmed prior to randomization. See Section 6.1 and Section 6.2.
Demography
X
Medical History
X
All general medical history, as well as any relevant history to the disease under 
study, including American Joint Committee on Cancer (AJCC) 8th edition
classifications (refer to Appendix 5), histology, breast cancer gene (BRCA)
mutation status, smoking history, alcohol use, history of pulmonary-related 
conditions, and other relevant history.
Include any toxicities or allergies to previous treatments.
Include findings from physical examination.
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Table 2-1:
Screening Procedural Outline (CA116001)
Procedurea
Screening Visit
(Day -28 to Day 1)
Notesb
All windows are based on calendar days
Prior Cancer Therapies
X
Include details and dates of prior anti-cancer systemic therapy, radiation therapy, 
and surgery.
Investigator’s Choice (IC) of Chemotherapy 
before Randomization
X
The investigator will select a single-agent chemotherapy regimen to be 
administered if randomized to 
 paclitaxel, PLD, or topotecan (see 
Section 7.1, Section 7.1.2, Section 7.1.3, and Section 7.1.4). The selection must 
be determined during screening, prior to randomization, and must be documented 
and captured in the eCRF. The selection of agent and regimen may not be 
changed after the participant has been randomized unless discussed with and 
approved by the Medical Monitor (or designee). 
Safety Assessments
Physical Examination (PE), Vital Signs, and 
Measurements
X
Includes BP, HR, temperature, height, weight, BMI, respiratory rate, and BSA 
(see Section 7.1.5 for details on BSA calculations). BP and HR should be 
measured after the participant has been resting quietly for at least 5 minutes.
Must be collected within 14 days prior to randomization.
Any findings during the PE will be recorded as medical history in the 
participant’s medical records and on the appropriate CRF.
Pulmonary Function Tests (PFTs)
X
Forced vital capacity (FVC), total lung capacity (TLC), forced expiratory volume 
during first second of expiration (FEV1), and diffusing capacity of the lungs for 
carbon monoxide (DLCO; %) must be collected within 14 days prior to 
randomization.
Pulse Oximetry
X
Oxygen saturation (SpO2) by pulse oximetry collected at rest and immediately 
after exercise (eg, walking for at least 6 minutes or equivalent effort) within 
14 days prior to randomization.
ECOG Performance Status (PS)
X
Eastern Cooperative Oncology Group (ECOG) PS must be collected within 
14 days prior to randomization. Refer to Appendix 6.
Prior/Concomitant Medication Use
X
Within 14 days prior to randomization.
Vaccine use within 30 days prior to first study treatment.
See Section 7.7.
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Table 2-1:
Screening Procedural Outline (CA116001)
Procedurea
Screening Visit
(Day -28 to Day 1)
Notesb
All windows are based on calendar days
12-lead Electrocardiogram (ECG)
X
ECGs should be recorded after the participant has been supine for at least 
5 minutes. Within 28 days prior to randomization.
ECHO/MUGA (PLD only)
X
Only for participants intended to receive PLD as the IC chemotherapy agent. 
LVEF assessment with documented LVEF by either transthoracic 
echocardiogram (TTE, preferred test) or MUGA.
Laboratory Tests
See Section 9.4.4.
Clinical Laboratory Assessments
X
Includes blood and urine samples. Note: 12- or 24-hour urine collections is 
required for CrCl measurments.
On-site/local laboratory tests must be performed within 14 days prior to 
randomization.
See Section 9.4.4 for list of laboratory tests to conduct.
Pregnancy Test (WOCBP Only)
X
Serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units 
of HCG) to be performed at screening visit and repeated within 24 hours prior to 
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 if the 
serum pregnancy result is positive.
Refer to Appendix 4.
Follicle-stimulating Hormone (FSH)
X
Required to confirm menopause in women < 55 years of age. Refer to
Appendix 4.
Serology
X
Includes hepatitis C virus (HCV) indicating presence of active viral replication 
(detectable HCV ribonucleic acid [RNA]), hepatitis B surface antigen, and human 
immunodeficiency virus [HIV]-1 and HIV-2 antibody. HIV testing to be 
performed based on local requirements. Refer to Appendix 7.
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Table 2-1:
Screening Procedural Outline (CA116001)
Procedurea
Screening Visit
(Day -28 to Day 1)
Notesb
All windows are based on calendar days
Tumor Sample
X
 
 Sample resubmission will be required for a result of “not 
evaluable.” If an archival tumor sample is not available or does not meet 
requirements, a fresh biopsy may be required during the 28-day screening period 
but prior to randomization. See Section 5.6.2.1 for further guidance on fresh 
tumor sample collection.
A FFPE tumor tissue block (preferred) or 
unstained slides (minimum of 
) of 
tumor tissue from core biopsy, punch biopsy, excisional biopsy, or surgical 
specimen obtained during screening or prior to enrollment must be sent to the 
vendor. If slides are submitted, the unstained slides should be sectioned within 
 from the latest FFPE block, which should not be more than 
. 
Fine needle aspirates, other cytology samples, and bone biopsy samples are not 
acceptable.
The Sponsor’s identified vendor must provide IRT with confirmation of receipt of 
evaluable tumor tissue 
 prior to 
participant randomization. Every effort should be made to obtain tumor tissue at 
the start of the screening period to account for shipping time and IHC analysis.
Please refer to the laboratory manual, Section 5.6.2, 
for additional 
information.
Baseline Tumor Assessments
Body Imagingc
X
Contrast-enhanced computed tomography (CT) of the chest abdomen, pelvis, and 
all other known and/or suspected sites of disease within 28 days prior to 
randomization. See Section 9.1.1 for further details. 
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Table 2-1:
Screening Procedural Outline (CA116001)
Procedurea
Screening Visit
(Day -28 to Day 1)
Notesb
All windows are based on calendar days
Brain Imagingc
X
Magnetic resonance imaging (MRI) of the brain (without and with contrast) is 
required for participants with known or suspected brain metastases, unless 
participant has completed an imaging study of the brain within 28 days of 
randomization.
CT of the brain (without and with contrast) can be performed if MRI is 
contraindicated. See Section 9.1.1 for further details.
Adverse Event (AE) Reporting
Assessment of Signs/Symptoms/Clinical 
Complaints
X
Within 14 days prior to randomization.
Monitor for Serious and Non-serious AEs
X
All AEs and SAEs must be collected from the date of participant’s written 
consent until 30 days post discontinuation of dosing or participant’s participation 
in the study if the last scheduled visit occurs at a later time.
All AEs (SAEs or non-serious AEs) associated with SARS-CoV-2 infection must 
be collected from the start of the participant’s written consent.
AEs/SAEs must be graded using the National Cancer Institute (NCI) Common 
Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Abbreviations: AE, adverse event; AJCC, American Joint Committee on Cancer; BICR, blinded independent central review; BMI, body mass index; BP, blood 
pressure; BRCA, breast cancer gene; BSA, body surface area; CRF, case report form; CT, computed tomography; CTCAE v5.0, Common Terminology Criteria 
for Adverse Events version 5.0; DCT, decentralized clinical trial; DLCO, carbon monoxide diffusing capacity; ECG, electrocardiogram; ECHO, echocardiogram; 
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ECOG, Eastern Cooperative Oncology Group; eCRF, electronic case report form;
 
 
 FEV1, 
forced expiratory volume in the first second of expiration; FFPE, formalin-fixed paraffin-embedded; 
; FSH, follicle-stimulating hormone; 
FVC, forced vital capacity; HCG, human chorionic gonadotropin; HCV, hepatitis C virus; HIV, human immunodeficiency virus; HR, heart rate; IC, Investigator’s 
choice; IHC, immunohistochemistry; IRT, Interactive Response Technology; LVEF, left ventricular ejection fraction; MRI, magnetic resonance imaging; MUGA, 
multigated acquisition; NCI, National Cancer Institute; PE, physical examination; PFT, pulmonary function test; PLD, pegylated liposomal doxorubicin; PS, 
performance status; RNA, ribonucleic acid; SAE, serious adverse event; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; SpO2, oxygen saturation; 
TLC, total lung capacity; TTE, transthoracic echocardiogram; WOCBP, women of child-bearing potential.
a Screening safety, laboratory, 
 that are performed within 3 days prior to dosing on Cycle 1 Day 1 and prior to randomization 
do not need to be repeated at the Cycle 1 Day 1 visit.
b Some of the assessments referred to in this section may not be captured as data in the CRF. They are intended to be used as safety monitoring by the treating 
physician. Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations.
c Images will be submitted to a central imaging vendor for blinded independent central review (BICR).
 
See Section 9.1.2.
 
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Table 2-2:
On-treatment Procedural Outline for MORAb-202 
Procedure
Cycle 1a
Cycle 2
onwardsa
EOTb
Notes
D1 ± 3
daysc,d
D8 ± 3
days
D15 ± 3
days
D1 ± 3
daysc
Safety Assessmentsd
Targeted PE/Vital Signs
X
X
X
X
X
If the screening full PE is performed within 24 hours prior to 
dosing on Day 1, then a single examination may count as both 
the screening and predose evaluation.
Vital signs include BP, HR, respiratory rate, and temperature. 
BP and HR should be measured after the participant has been 
resting quietly for at least 5 minutes.
Any findings from the PE will be reported on the AE CRF as 
appropriate.
Weight/
X
X
 
 
 
.
Pulse Oximetry
X
X
X
X
X
Oxygen saturation (SpO2) by pulse oximetry collected at rest
and immediately after exercise (eg, walking for at least 
6 minutes or equivalent effort).
PFTs
As Clinically Indicated
PFTs include FVC, TLC, FEV1, DLCO (%).
Perform as clinically indicated for assessment of pulmonary 
abnormalities.
ILD/Pneumonitis Signs/
Symptoms Assessment
Continuously
To be performed on the day of each scheduled MORAb-202 
dose, prior to MORAb-202 administration. See Section 9.4.5 for 
further information regarding detection & monitoring of
ILD/pneumonitis. 
 
For reporting information see Section 9.2.9.
 
 
 
 
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Table 2-2:
On-treatment Procedural Outline for MORAb-202 
Procedure
Cycle 1a
Cycle 2
onwardsa
EOTb
Notes
D1 ± 3
daysc,d
D8 ± 3
days
D15 ± 3
days
D1 ± 3
daysc
 
 
 
 
 
ECOG PS
X
X
X
X
X
Prior to treatment on Day 1 of each cycle. Refer to Appendix 6.
12-lead ECG
As Clinically Indicated
X
To be performed at screening, EOT, and as clinically indicated 
during treatment. ECGs should be recorded after the participant 
has been supine for at least 5 minutes. 
Laboratory Tests
Clinical Laboratory 
Assessments
Xd
X
X
Includes blood and urine samples.
Perform on site/local laboratory testing within 3 days prior to 
Day 1 dosing of each cycle. 
For the first treatment visit, labs need not be repeated if they 
were performed within 3 days and the results are available and 
have been reviewed for eligibility.
See Section 9.4.4 for the list of laboratory tests to be conducted.
Pregnancy Test 
(WOCBP only)
X
See Notes
For WOCBP only. Serum or urine pregnancy test (minimum 
sensitivity equivalent units 25 IU/L or equivalent units of HCG) 
to be performed within 24 hours prior to first dose of study 
treatment and then every 4 weeks (± 1 week) regardless of 
dosing schedule.
If a urine test cannot be confirmed as negative (eg, an 
ambiguous result), a serum pregnancy test is required. In such 
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Table 2-2:
On-treatment Procedural Outline for MORAb-202 
Procedure
Cycle 1a
Cycle 2
onwardsa
EOTb
Notes
D1 ± 3
daysc,d
D8 ± 3
days
D15 ± 3
days
D1 ± 3
daysc
cases, the participant must be discontinued from study treatment
if the serum pregnancy result is positive.
Refer to Appendix 4 for further information.
Adverse Event Reporting
Monitor for Non-serious 
and Serious AEs
Continuously
Record at each visit. All AEs and SAEs, including those 
associated with SARS-CoV-2 infection, must be collected 
continuously during the treatment period. All AEs/SAEs must 
be graded using CTCAE v5.0.
All AEs and SAEs must be collected from the date of 
participant’s written consent until 30 days post discontinuation 
of dosing or participant’s participation in the study if the last 
scheduled visit occurs at a later time.
Concomitant Medication 
Use
Continuously
Record at each visit.
Efficacy Assessments
Body Imaginge
See Notes
Contrast-enhanced CT of the chest, CT/MRI of the abdomen, 
pelvis, and all other known and/or suspected sites of disease 
should occur every 6 weeks (± 1week) starting from 
randomization for the first 36 weeks, then every 12 weeks 
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Table 2-2:
On-treatment Procedural Outline for MORAb-202
Procedure
Cycle 1a
Cycle 2
onwardsa
EOTb
Notes
D1 ± 3
daysc,d
D8 ± 3
days
D15 ± 3
days
D1 ± 3
daysc
(± 1 week) until investigator-assessed disease progression per 
RECIST v1.1 or treatment discontinuation, whichever occurs 
later. 
 
This schedule should be followed even if treatment delay 
occurs. In the event of unscheduled imaging, efforts should be 
made to return to the planned schedule for subsequent visits.
See Section 9.1.1 for further details.
 
 
Brain Imaginge
See Notes
Participants with a history of brain metastasis or symptoms 
should have a surveillance MRI (without and with contrast) per 
standard of care (approximately every 12 weeks), or sooner if 
clinically indicated until investigator-assessed disease 
progression per RECIST v1.1 or treatment discontinuation, 
whichever occurs later. 
CT of the brain without and with contrast can be performed if 
MRI is contraindicated. See Section 9.1.1 for further details. 
Protocol Amendment No.: 03
Date: 05-Aug-2024
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Clinical Protocol
CA116001
BMS-986445
MORAb-202
Table 2-2:
On-treatment Procedural Outline for MORAb-202 
Procedure
Cycle 1a
Cycle 2
onwardsa
EOTb
Notes
D1 ± 3
daysc,d
D8 ± 3
days
D15 ± 3
days
D1 ± 3
daysc
Study Treatment
Randomization
X
Participants must receive the first dose of study treatment within 
3 calendar days from treatment allocation, unless previously 
discussed with Medical Monitor (or designee).
MORAb-202 Premedication
X
See Notes
Premedication will be administered with the first MORAb-202 
infusion (30 to 60 minutes prior to infusion). If no infusion 
reactions are observed, premedications will not be administered 
with subsequent MORAb-202 infusions (see Section 7.1.1).
MORAb-202
Administrationg
X
X
MORAb-202 will be administered at a dose of 25 mg/m2 once 
 as an IV infusion 
 
 
 
 
The first infusion of MORAb-202 will be given over no less 
than 60 minutes. If no infusion reactions are observed, 
subsequent infusions can be infused as tolerated, but given over 
no less than 30 minutes. See Section 7.1.1 for further details on 
administration.
Dose will be recalculated every cycle based on the weight on 
the day of the dosing. All doses should be rounded to the nearest 
Protocol Amendment No.: 03
Date: 05-Aug-2024
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4.0
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Approved
1.0
v

Clinical Protocol
CA116001
BMS-986445
MORAb-202
Table 2-2:
On-treatment Procedural Outline for MORAb-202 
Procedure
Cycle 1a
Cycle 2
onwardsa
EOTb
Notes
D1 ± 3
daysc,d
D8 ± 3
days
D15 ± 3
days
D1 ± 3
daysc
milligram. See Section 7.1.5 for details on dose calculations. 
See Section 7.4.1 for dose modifications for management of 
AEs.
Abbreviations: AE, adverse event; BICR, blinded independent central review; BP, blood pressure; 
 CRF, case report form; CT, computed 
tomography; CTCAE v5.0, Common Terminology Criteria for Adverse Events version 5.0; D, day; DLCO, carbon monoxide diffusing capacity; ECG, 
electrocardiogram; ECOG, Eastern Cooperative Oncology Group; 
 
 
 FEV1, forced 
expiratory volume in the first second of expiration; FVC, forced vital capacity; HCG, human chorionic gonadotropin; HR, heart rate; ILD, interstitial lung disease; 
IV, intravenous; MRI, magnetic resonance imaging; PE, physical examination; PFT, pulmonary function test; 
PS, performance status; 
RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1; SAE, serious adverse event; SARS-CoV-2, severe acute respiratory syndrome coronavirus 
2; SpO2, oxygen saturation; TLC, total lung capacity; WOCBP, women of child-bearing potential.
a If study treatment dosing is delayed, the procedures scheduled for that same time point should also be delayed to coincide with when the time point’s dosing 
actually occurs, with the exception of tumor assessments and AE-related safety procedures/assessments.
b EOT is defined as the date at which the decision is made to discontinue the participant from study treatment. Participants must be followed for at least 30 days 
after the last dose of study treatment or the date of discontinuation, whichever occurs later. The safety follow-up visit should occur 30 days (+ 7 days) from EOT 
visit; if EOT occurs  30 days from last dose administration, then a single visit for EOT and safety follow-up is allowed. 
c Some of the assessments referred to in this section may not be captured as data in the CRF. They are intended to be used as safety monitoring by the treating
physician. Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations.
d Screening safety, laboratory, 
 that are performed within 3 days prior to dosing on Cycle 1 Day 1 and prior to randomization 
do not need to be repeated at the Cycle 1 Day 1 visit.
e Images will be submitted to a central imaging vendor for blinded independent central review (BICR).
 
See Section 9.1.2.
g The minimum time interval between 2 consecutive MORAb-202 doses cannot be < 18 days.
Protocol Amendment No.: 03
Date: 05-Aug-2024
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v

Clinical Protocol
CA116001
BMS-986445
MORAb-202
Table 2-3:
On-treatment Procedural Outline for a 21-Day Cycle 
Topotecan 1.25 mg/m2
Procedure
(1 Cycle = 21 Days)
Cycle 1a
Cycle 2
onwardsa
EOTb
Notes
D1 ± 3
daysc,d
D8 ± 3
days
D15 ± 3
days
D1 ± 3
daysc
Safety Assessmentsd
Targeted PE/Vital Signs
X
X
X
If the screening full PE is performed within 24 hours prior to 
dosing on Day 1, then a single examination may count as both 
the screening and predose evaluation.
Vital signs include BP, HR, respiratory rate, and temperature. 
BP and HR should be measured after the participant has been 
resting quietly for at least 5 minutes.
Any findings from the PE will be reported on the AE CRF as 
appropriate.
Weight/
X
X
ECOG PS
X
X
X
Prior to treatment on Day 1 of each cycle. Refer to Appendix 6.
12-lead ECG
As Clinically Indicated
X
To be performed at screening, EOT, and as clinically indicated 
during treatment. ECGs should be recorded after the participant 
has been supine for at least 5 minutes. 
Laboratory Tests
Clinical Laboratory 
Assessments
Xd
X
X
Includes blood and urine samples. 
Perform on site/local laboratory testing within 3 days prior to 
Day 1 dosing of each cycle. 
For the first treatment visit, labs need not be repeated if they 
were performed within 3 days and the results are available and 
have been reviewed for eligibility.
See Section 9.4.4 for the list of laboratory tests to be conducted.
Protocol Amendment No.: 03
Date: 05-Aug-2024
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1.0
v

Clinical Protocol
CA116001
BMS-986445
MORAb-202
Table 2-3:
On-treatment Procedural Outline for a 21-Day Cycle
Topotecan 1.25 mg/m2
Procedure
(1 Cycle = 21 Days)
Cycle 1a
Cycle 2
onwardsa
EOTb
Notes
D1 ± 3
daysc,d
D8 ± 3
days
D15 ± 3
days
D1 ± 3
daysc
Pregnancy Test 
(WOCBP only)
X
See Notes
For WOCBP only. Serum or urine pregnancy test (minimum 
sensitivity equivalent units 25 IU/L or equivalent units of HCG) 
to be performed within 24 hours prior to first dose of study 
treatment and then every 4 weeks (± 1 week) regardless of 
dosing schedule.
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 discontinued from study treatment
if the serum pregnancy result is positive.
Refer to Appendix 4 for further information.
Adverse Event Reporting
Monitor for Non-serious 
and Serious AEs
Continuously
Record at each visit. All AEs and SAEs, including those 
associated with SARS-CoV-2 infection, must be collected 
continuously during the treatment period. All AEs/SAEs must 
be graded using CTCAE v5.0.
All AEs and SAEs must be collected from the date of 
participant’s written consent until 30 days post discontinuation 
of dosing or participant’s participation in the study if the last 
scheduled visit occurs at a later time.
Concomitant Medication 
Use
Continuously
Record at each visit.
Protocol Amendment No.: 03
Date: 05-Aug-2024
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4.0
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1.0
v

Clinical Protocol
CA116001
BMS-986445
MORAb-202
Table 2-3:
On-treatment Procedural Outline for a 21-Day Cycle 
Topotecan 1.25 mg/m2
Procedure
(1 Cycle = 21 Days)
Cycle 1a
Cycle 2
onwardsa
EOTb
Notes
D1 ± 3
daysc,d
D8 ± 3
days
D15 ± 3
days
D1 ± 3
daysc
Efficacy Assessments
Body Imaginge
See Notes
Contrast-enhanced CT of the chest, CT/MRI of the abdomen, 
pelvis, and all other known and/or suspected sites of disease 
should occur every 6 weeks (± 1 week) starting from 
randomization for the first 36 weeks, then every 12 weeks 
(± 1 week) until investigator-assessed disease progression per 
RECIST v1.1 or treatment discontinuation, whichever occurs 
later. This schedule should be followed even if treatment delay 
occurs. In the event of unscheduled imaging, efforts should be 
made to return to the planned schedule for subsequent visits.
See Section 9.1.1 for further details.
Brain Imaginge
See Notes
Participants with a history of brain metastasis or symptoms 
should have a surveillance MRI (without and with contrast) per 
standard of care (approximately every 12 weeks), or sooner if 
clinically indicated until investigator-assessed disease 
progression per RECIST v1.1or treatment discontinuation, 
whichever occurs later.
CT of the brain without and with contrast can be performed if 
MRI is contraindicated. See Section 9.1.1 for further details. 
Protocol Amendment No.: 03
Date: 05-Aug-2024
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930188312
4.0
v
Approved
1.0
v

Clinical Protocol
CA116001
BMS-986445
MORAb-202
Table 2-3:
On-treatment Procedural Outline for a 21-Day Cycle 
Topotecan 1.25 mg/m2
Procedure
(1 Cycle = 21 Days)
Cycle 1a
Cycle 2
onwardsa
EOTb
Notes
D1 ± 3
daysc,d
D8 ± 3
days
D15 ± 3
days
D1 ± 3
daysc
Study Treatment
Randomization
X
Participants must receive the first dose of study treatment within 
3 calendar days from treatment allocation, unless previously 
discussed with Medical Monitor (or designee).
Topotecan Administration
See Notes
For a 21-day cycle, topotecan will be administered at a dose of 
1.25 mg/m2 by IV infusion over 30 minutes on Days 1 to 5 of a 
21-day cycle. Other study-related assessments and procedures
are not required for Days 2 to 5. See Section 7.1.4 for further 
details on administration.
Refer to the approved local Product Label for complete 
information.
Dose calculations will be performed using BSA and body 
weight assessed within 3 days prior to start of study dose 
administration on Cycle 1 Day 1. Dose will be recalculated 
every cycle based on the weight on the day of the dosing. All 
doses should be rounded to the nearest milligram. See Section 
7.1.5 for details on dose calculations. See Section 7.4.4 for dose 
modifications for management of AEs.
Abbreviations: AE, adverse event; BICR, blinded independent central review; BP, blood pressure; BSA, body surface area; CRF, case report form; CT, computed 
tomography; CTCAE v5.0, Common Terminology Criteria for Adverse Events version 5.0; D, day; ECG, electrocardiogram; ECOG, Eastern Cooperative Oncology 
Group; 
 
 
Protocol Amendment No.: 03
Date: 05-Aug-2024
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v

Clinical Protocol
CA116001
BMS-986445
MORAb-202
HCG, human chorionic gonadotropin; HR, heart rate; IU, international 
unit; IV, intravenous; MRI, magnetic resonance imaging; PE, physical examination; PS, performance status; RECIST v1.1, Response Evaluation Criteria in Solid 
Tumors version 1.1; SAE, serious adverse event; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; WOCBP, women of child-bearing potential.
a If study treatment dosing is delayed, the procedures scheduled for that same time point should also be delayed to coincide with when the time point’s dosing 
actually occurs, with the exception of tumor assessments and AE-related safety procedures/assessments.
b EOT is defined as the date at which the decision is made to discontinue the participant from study treatment. Participants must be followed for at least 30 days 
after the last dose of study treatment or the date of discontinuation, whichever occurs later. The safety follow-up visit should occur 30 days (+ 7 days) from EOT 
visit; if EOT occurs  30 days from last dose administration, then a single visit for EOT and safety follow-up is allowed. 
c Some of the assessments referred to in this section may not be captured as data in the CRF. They are intended to be used as safety monitoring by the treating
physician. Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations.
 
e Images will be submitted to a central imaging vendor for blinded independent central review (BICR).
 
See Section 9.1.2.
 
Protocol Amendment No.: 03
Date: 05-Aug-2024
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930188312
4.0
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Approved
1.0
v

Clinical Protocol
CA116001
BMS-986445
MORAb-202
Table 2-4:
On-treatment Procedural Outline for a 28-Day Cycle -
 (PLD, Paclitaxel, and Topotecan 
4 mg/m2)
Procedure
(1 Cycle = 28 Days)
Cycle 1a
Cycle 2, 
onwardsa
EOTb
Notes
D1 ± 3 
daysc,d
D8
D15
D22
D1 ± 3 daysc
Safety Assessmentsd
Targeted PE/Vital 
Signs
X
X
X
If the screening full PE is performed within 24 hours prior to dosing 
on Day 1, then a single examination may count as both the screening 
and predose evaluation.
Vital signs include BP, HR, respiratory rate, and temperature. BP and 
HR should be measured after the participant has been resting quietly 
for at least 5 minutes.
Weight/
X
X
ECOG PS
X
X
X
Prior to treatment on Day 1 of each cycle. Refer to Appendix 6.
12 Lead ECG
As Clinically Indicated
X
To be performed at screening, EOT, and as clinically indicated during 
treatment. ECGs should be recorded after the participant has been 
supine for at least 5 minutes. ECGs will be performed locally.
ECHO/MUGA 
(PLD only)
See Notes
X
To be performed at screening and every 4 cycles from screening 
assessment or as medically indicated.
Performed locally with the same assessment of LVEF used at 
screening. 
Protocol Amendment No.: 03
Date: 05-Aug-2024
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1.0
v

Clinical Protocol
CA116001
BMS-986445
MORAb-202
Table 2-4:
On-treatment Procedural Outline for a 28-Day Cycle -
 (PLD, Paclitaxel, and Topotecan 
4 mg/m2)
Procedure
(1 Cycle = 28 Days)
Cycle 1a
Cycle 2, 
onwardsa
EOTb
Notes
D1 ± 3 
daysc,d
D8
D15
D22
D1 ± 3 daysc
Laboratory Tests
Clinical Laboratory
Assessments
Xd
Xe
Xe
Xe
X
X
Includes blood and urine samples.
Perform on site/local laboratory testing within 3 days prior to Day 1 
dosing of each cycle. 
Hematologic and chemistry laboratory assessments to be performed at 
every treatment visit for paclitaxel or topotecan 4mg/m2. All other 
clinical laboratory assessments (see Table 9.4.4-1) will be performed 
at the start of each cycle.
For participants receiving PLD, all clinical laboratory assessments to 
be performed at every cycle.  
For the first treatment visit, labs need not be repeated if they were 
performed within 3 days and the results are available and have been 
reviewed for eligibility.
See Section 9.4.4 for the list of laboratory tests to be conducted.
Pregnancy Test 
(WOCBP)
X
See Notes
X
For WOCBP only. Serum or urine pregnancy test (minimum 
sensitivity equivalent units 25 IU/L or equivalent units of HCG) to be 
performed within 24 hours prior to first dose of study treatment and 
then every 4 weeks (± 1 week) regardless of dosing schedule.
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 discontinued from study treatment if the serum 
pregnancy result is positive.
Refer to Appendix 4.
Protocol Amendment No.: 03
Date: 05-Aug-2024
38
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930188312
4.0
v
Approved
1.0
v

Clinical Protocol
CA116001
BMS-986445
MORAb-202
Table 2-4:
On-treatment Procedural Outline for a 28-Day Cycle -
 (PLD, Paclitaxel, and Topotecan 
4 mg/m2)
Procedure
(1 Cycle = 28 Days)
Cycle 1a
Cycle 2, 
onwardsa
EOTb
Notes
D1 ± 3 
daysc,d
D8
D15
D22
D1 ± 3 daysc
Adverse Event Reporting
Monitor for 
Non-serious and 
Serious AEs
Continuously
Record at each visit. All AEs and SAEs, including those associated 
with SARS-CoV-2 infection, must be collected continuously during 
the treatment period. All AEs/SAEs must be graded using 
CTCAE v5.0.
All AEs and SAEs must be collected from the date of participant’s 
written consent until 30 days post discontinuation of dosing or 
participant’s participation in the study if the last scheduled visit 
occurs at a later time.
Concomitant 
Medication Use
Continuously
Record at each visit.
Protocol Amendment No.: 03
Date: 05-Aug-2024
39
4.0
Approved
930188312
4.0
v
Approved
1.0
v

Clinical Protocol
CA116001
BMS-986445
MORAb-202
Table 2-4:
On-treatment Procedural Outline for a 28-Day Cycle -
 (PLD, Paclitaxel, and Topotecan 
4 mg/m2)
Procedure
(1 Cycle = 28 Days)
Cycle 1a
Cycle 2, 
onwardsa
EOTb
Notes
D1 ± 3 
daysc,d
D8
D15
D22
D1 ± 3 daysc
Efficacy Assessment
Body Imagingf
See Notes
Contrast-enhanced CT of the chest, CT/MRI of the abdomen, pelvis, 
and all other known and/or suspected sites of disease should occur 
every 6 weeks (± 1 week) starting from randomization for the first 
36 weeks, then every 12 weeks (± 1 week) until investigator-assessed 
disease progression per RECIST v1.1 or treatment discontinuation, 
whichever occurs later. 
This schedule should be followed even if treatment delay occurs. In 
the event of unscheduled imaging, efforts should be made to return to 
the planned schedule for subsequent visits.
See Section 9.1.1 for further details.
Brain Imagingf
See Notes
Participants with a history of brain metastasis or symptoms should 
have a surveillance MRI (without and with contrast) per standard of 
care (approximately every 12 weeks), or sooner if clinically indicated 
until investigator-assessed disease progression per RECIST v1.1 or 
treatment discontinuation, whichever occurs later.
CT of the brain without and with contrast can be performed if MRI is 
contraindicated. See Section 9.1.1 for further details.
Protocol Amendment No.: 03
Date: 05-Aug-2024
40
4.0
Approved
930188312
4.0
v
Approved
1.0
v

Clinical Protocol
CA116001
BMS-986445
MORAb-202
Table 2-4:
On-treatment Procedural Outline for a 28-Day Cycle -
 (PLD, Paclitaxel, and Topotecan 
4 mg/m2)
Procedure
(1 Cycle = 28 Days)
Cycle 1a
Cycle 2, 
onwardsa
EOTb
Notes
D1 ± 3 
daysc,d
D8
D15
D22
D1 ± 3 daysc
Study Treatment
Randomization
X
Participants must receive the first dose of study treatment within 
3 calendar days from treatment allocation, unless previously discussed 
with Medical Monitor (or designee).
Paclitaxel 
Premedication
See Notes
participants receiving paclitaxel should be premedicated prior 
to paclitaxel administration in order to prevent severe hypersensitivity 
reactions, per the approved local Product Label. Such premedication 
may consist of dexamethasone 20 mg PO administered approximately 
12 and 6 hours before paclitaxel, diphenhydramine (or its equivalent) 
50 mg IV 30 to 60 minutes prior to paclitaxel, and cimetidine 
(300 mg) or ranitidine (50 mg) IV 30 to 60 minutes before paclitaxel.
Paclitaxel 
Administration
See Notes
Paclitaxel will be administered at a dose of 80 mg/m2 by IV infusion 
over 60 minutes on Days 1, 8, 15, and 22 of a 28-day cycle. Use BSA 
for dosing calculations using height measured at screening, and 
weight measured on Day 1 of each cycle (or up to 3 days prior to 
Day 1). See Section 7.4.2 for dose modifications for management of 
AEs. See Section 7.1.2 for further details on administration. Refer to 
the approved local Product Label for complete information.
Dose calculations will be performed using BSA and body weight 
assessed within 3 days prior to start of study dose administration on 
Cycle 1 Day 1. Dose will be recalculated every cycle based on the 
weight on the day of the dosing. All doses should be rounded to the 
nearest milligram. See Section 7.1.5 for details on dose calculations.
Protocol Amendment No.: 03
Date: 05-Aug-2024
41
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930188312
4.0
v
Approved
1.0
v

Clinical Protocol
CA116001
BMS-986445
MORAb-202
Table 2-4:
On-treatment Procedural Outline for a 28-Day Cycle -
 (PLD, Paclitaxel, and Topotecan 
4 mg/m2)
Procedure
(1 Cycle = 28 Days)
Cycle 1a
Cycle 2, 
onwardsa
EOTb
Notes
D1 ± 3 
daysc,d
D8
D15
D22
D1 ± 3 daysc
Topotecan 
Administration
See Notes
For a 28-day cycle, topotecan will be administered at dose of 4 mg/m2
by IV infusion over 30 minutes on Days 1, 8, and 15 of a 28-day 
cycle. Use BSA for dosing calculations using height measured at 
screening, and weight measured on Day 1 of each cycle (or up to 
3 days prior to Day 1). See Section 7.4.4 for dose modifications for 
management of AEs. See Section 7.1.4 for further details on 
administration. Refer to the approved local Product Label for 
complete information.
Dose calculations will be performed using BSA and body weight 
assessed within 3 days prior to start of study dose administration on 
Cycle 1 Day 1. Dose will be recalculated every cycle based on the 
weight on the day of the dosing. All doses should be rounded to the 
nearest milligram. See Section 7.1.5 for details on dose calculations. 
PLD 
Administrationh
X
X
PLD will be administered at a dose of 40 mg/m2 by a 1 mg/min IV 
infusion on Day 1 (± 3 days) of a 28-day cycle. After Cycle 1, if 
tolerated, PLD can be administered as a 60-minute infusion. Use BSA 
for dosing calculations using height measured at screening, and 
weight measured on Day 1 of each cycle (or up to 3 days prior to 
Day 1). See Section 7.4.3 for dose modifications for management of 
AEs. See Section 7.1.3 for further details on administration. Refer to 
the approved local Product Label for complete information.
Dose calculations will be performed using BSA and body weight 
assessed within 3 days prior to start of study dose administration on 
Cycle 1 Day 1. Dose will be recalculated every cycle based on the 
weight on the day of the dosing. All doses should be rounded to the 
nearest milligram. See Section 7.1.5 for details on dose calculations.
Abbreviations: AE, adverse event; BICR, blinded independent central review; BP, blood pressure; BSA, body surface area; CRF, case report form; CT, computed 
tomography; CTCAE v5.0, Common Terminology Criteria for Adverse Events version 5.0; D, day; ECG, electrocardiogram; ECHO, echocardiogram; ECOG, 
Protocol Amendment No.: 03
Date: 05-Aug-2024
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930188312
4.0
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1.0
v

Clinical Protocol
CA116001
BMS-986445
MORAb-202
Eastern Cooperative Oncology Group; 
 
 
 HCG, human chorionic gonadotropin; HR, 
heart rate; IU, international unit; IV, intravenous; LVEF, left ventricular ejection fraction; MRI, magnetic resonance imaging; MUGA, multigated acquisition; PE,
physical examination; PLD, pegylated liposomal doxorubicin; PO, per os (oral route of administration); PS, performance status; RECIST v1.1, Response Evaluation 
Criteria in Solid Tumors version 1.1; SAE, serious adverse event; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; WOCBP, women of 
child-bearing potential.
a If study treatment dosing is delayed, the procedures scheduled for that same time point should also be delayed to coincide with when the time point’s dosing 
actually occurs, with the exception of tumor assessments and AE-related safety procedures/assessments.
b EOT is defined as the date at which the decision is made to discontinue the participant from study treatment. Participants must be followed for at least 30 days 
after the last dose of study treatment or the date of discontinuation, whichever occurs later. The safety follow-up visit should occur 30 days (+ 7 days) from EOT 
visit; if EOT occurs  30 days from last dose administration, then a single visit for EOT and safety follow-up is allowed. 
c Some of the assessments referred to in this section may not be captured as data in the CRF. They are intended to be used as safety monitoring by the treating
physician. Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations.
 
e Hematologic and chemistry laboratory assessments only for participants receiving paclitaxel or topotecan.
f Images will be submitted to a central imaging vendor for blinded independent central review (BICR). 
 
 See Section 9.1.2.
.
h The minimum time interval between 2 consecutive PLD doses cannot be < 24 days.
Protocol Amendment No.: 03
Date: 05-Aug-2024
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v

Clinical Protocol
CA116001
BMS-986445
MORAb-202
Table 2-5:
Follow-up Procedural Outline (CA116001)
Procedure
Safety Follow-up Visita,
Survival Follow-upb,c
Notes
Safety Assessments
Targeted PE/Vital Signs
X
Includes BP, HR, respiratory rate, and temperature. BP 
and HR should be measured after the participant has 
been resting quietly for at least 5 minutes.
Any findings from the PE will be reported on the AE 
CRF as appropriate.
ECOG PS
X
Refer to Appendix 6.
Pulse Oximetry (MORAb-202 only)
X
Oxygen saturation (SpO2) by pulse oximetry collected 
at rest and immediately after exercise (eg, walking for at 
least 6 minutes or equivalent effort). 
ILD/Pneumonitis Signs/Symptoms 
Assessment (MORAb-202 only)
X
See Table 7.4.1-2, Section 9.2.9, and Section 9.4.5 for 
further information.
AE and SAE Assessment
X
Collect continuously throughout the treatment period 
and for a minimum of 30 days following treatment 
discontinuation.
Participants will be followed for all SAEs, non-serious 
AEs of special interest, and all AEs (SAEs and 
non-serious AEs) associated with confirmed or 
suspected SARS-CoV-2 infection until resolution; the 
condition stabilizes; the event is otherwise explained; 
the event is deemed irreversible; the participant is lost to 
follow-up; or, for suspected cases, until SARS-CoV-2 
infection is ruled-out.
 
 
 
Concomitant Medication Use
X
Review/document all concomitant medications.
Laboratory Tests
Pregnancy Test (WOCBP only)
X
Serum or urine pregnancy test. See Section 9.4.4.
Protocol Amendment No.: 03
Date: 05-Aug-2024
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930188312
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1.0
v

Clinical Protocol
CA116001
BMS-986445
MORAb-202
Table 2-5:
Follow-up Procedural Outline (CA116001)
Procedure
Safety Follow-up Visita,
Survival Follow-upb,c
Notes
Clinical Laboratory Assessments
X
Includes blood and urine samples. 
On site/local laboratory testing. See Section 9.4.5 for the 
list of laboratory tests.
Efficacy Assessments
Body Imagingd
See Notes
Only for participants who discontinue study treatment 
prior to documented radiographic progression per 
RECIST v1.1 (refer to Appendix 8).
Contrast-enhanced CT of the chest, CT/MRI of the 
abdomen, pelvis, and all other known and/or suspected 
sites of disease should occur every 6 weeks (± 7 days) 
starting from randomization for the first 36 weeks, then 
every 12 weeks (± 7 days) until investigator-assessed 
disease progression per RECIST v1.1. 
See Section 9.1.1 for further details.
 
 
 
Brain Imagingd
See Notes
Only for participants who discontinue study treatment 
prior to documented radiographic progression per 
RECIST v1.1 (refer to Appendix 8).
Participants with a history of brain metastasis or 
symptoms should have a surveillance MRI (without and 
with contrast) per standard of care (approximately every 
12 weeks), or sooner if clinically indicated, until 
investigator-assessed disease progression per 
RECIST v1.1.
CT of the brain with and without contrast can be 
performed if MRI is contraindicated. See Section 9.1.1
for further details. 
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Table 2-5:
Follow-up Procedural Outline (CA116001)
Procedure
Safety Follow-up Visita,
Survival Follow-upb,c
Notes
Participant Status
Subsequent Anti-cancer Therapy
X
X
Include documentation of subsequent cancer therapy (ie,
systemic therapy, tumor-directed surgery, or radiation 
therapy) and response to the regimen and date of 
progression.
Survival Status
X
X
Participant survival status will be assessed by a 
documented clinic visit, email, or telephone contact 
every 3 months (+/- 14 days) from safety follow-up visit 
up to 1 year from the last participant randomized or 
LPLV (30 days after last patient last treatment visit); 
whichever is later. 
Abbreviations: AE, adverse event; BICR, blinded independent central review; BP, blood pressure; CRF, case report form; CT, computed tomography; ECOG, 
Eastern Cooperative Oncology Group; 
 
 
HR, heart rate; ILD, interstitial lung disease; MRI, magnetic resonance imaging; PE, physical examination; SpO2, oxygen saturation; 
PS, performance status; RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1; SAE, serious adverse event; SARS-CoV-2, 
severe acute respiratory syndrome coronavirus 2; WOCBP, women of child-bearing potential.
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a Participants must be followed for at least 30 days after the last dose of study treatment or the date of discontinuation, whichever occurs later. The safety follow-up 
visit should occur 30 days (+ 7 days) from EOT visit; if EOT occurs  30 days from last dose administration, then a single visit for EOT and safety follow-up is 
allowed.
b Survival follow-up visits may be conducted in clinic or by telephone or via digital technology (including email and participant portal). The Sponsor may request 
that survival data be collected on all treated participants outside of the 3-month specified window. At the time of this request, each participant will be contacted 
to determine their survival status unless the participant has withdrawn consent for all contact.
c Some of the assessments referred to in this section may not be captured as data in the CRF. They are intended to be used as safety monitoring by the treating 
physician. Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulation.
d Images will be submitted to a central imaging vendor blinded independent central review (BICR).
 
See Section 9.1.2.
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3
INTRODUCTION
Study CA116001 is a Phase 2, open-label, randomized, multicenter, study assessing the safety, 
tolerability, and efficacy of farletuzumab ecteribulin MORAb-202 (BMS-986445), a folate 
receptor alpha (FRĮ)-targeting antibody-drug conjugate (ADC) in female participants with 
platinum-resistant high-grade serous (HGS) ovarian, primary peritoneal, or fallopian tube cancer.
Folate functions as a coenzyme to transfer one-carbon units that are necessary for 
deoxythymidylate synthesis, purine synthesis, and various methylation reactions, thus contributing
to growth and development.1 FRĮ, also known as FOLR1 or folate-binding protein, is a 
glycosylphosphatidylinositol-anchored membrane protein and is one of the cell surface receptors 
that internalizes folate. Interestingly, normal adult tissues mainly employ folate receptor ȕ, 
reduced folate carrier and proton-coupled folate transporter for folate uptake, and FRĮ distribution
is restricted to low level expression in the apical surfaces of some organs such as the kidney, lung,
and choroid plexus. Importantly, in all normal tissues except the kidneys, the receptor is out of 
direct contact with folate and any folate receptor-targeting agents in the circulation. Up regulation 
of FRĮ occurs in epithelial cancer, and it has been demonstrated that in this setting FRĮ may 
function not only as a folate transporter but may also confer signaling and growth advantages on 
malignant cells.2,3,4,5,6
MORAb-202 is a novel ADC consisting of farletuzumab, a humanized monoclonal antibody that 
binds to FRĮ paired with eribulin (E7389) mesylate, a microtubule dynamics inhibitor, via a 
cathepsin B-cleavage linker (1:4 antibody-payload ratio).7 Upon binding to FRĮ-expressing cancer 
cells, MORAb-202 is internalized into the lysosomal compartment where the novel serum-stable 
cathepsin B linker is enzymatically cleaved and releases the active payload, free eribulin, within 
the lysosomal compartment of target cells.
Once internalized, MORAb-202 elicits its anti-tumor activity through apoptosis mediated by free 
eribulin-inhibition of microtubule elongation and mitotic spindle formation. Moreover, 
MORAb-202 exhibits bystander antiproliferative activity against surrounding tumor cells in the 
tumor microenvironment (TME) by the release of free eribulin from apoptotic cancer cells. The 
payload, eribulin, also exerts anti-tumor activity within the TME and tumor phenotype by 
mechanisms independent of its antimitotic effects, such as i) tumor vasculature remodeling 
whereby inner tumor cores become better perfused and less hypoxic; and ii) promotion of cellular 
differentiation processes resulting in shifts to less aggressive phenotypes, either via reversal of the 
epithelial-mesenchymal transition (EMT) in carcinomas or tissue-specific differentiation of 
sarcomas.8,9,10 Thus, MORAb-202 is expected to exhibit a bystander effect on the surrounding 
tumor microenvironment by eribulin leaching from apoptotic tumors, in addition to showing direct 
cytotoxicity against the targeted tumor.11
MORAb-202 has shown encouraging clinical activity in various solid tumor types that express 
FRĮ 
 
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3.1
Study Rationale
There is an urgent clinical need for novel therapeutic approaches in platinum-resistant ovarian 
cancer (PROC). Despite progress in earlier lines of therapy, with the availability of new treatment 
modalities, patients with PROC still have a poor prognosis.
Debulking surgery and platinum-based chemotherapy form the foundation of care for the treatment 
of women with advanced ovarian cancer. Although many women with advanced disease may enter 
remission after surgery and chemotherapy, most patients will eventually relapse.12,13 Depending 
upon the response of the last platinum-based therapy and time for recurrence, most women will 
receive additional platinum-based regimens on subsequent lines of therapy. With every additional 
line of platinum-based regimens, the progression-free survival (PFS) decreases.14 A particular 
challenge arises when the disease returns less than 6 months after completing the last 
platinum-based chemotherapy, referred to as PROC. For these patients, additional lines of 
platinum-based chemotherapy usually provide a small clinical benefit; however, most patients will 
be only eligible to receive a single-agent non-platinum-based option (eg, pegylated liposomal 
doxorubicin [PLD], paclitaxel, or topotecan). Although these regimens can provide some clinical 
benefit, the observed objective response rate (ORR) is low (10% to 15%) with median PFS (mPFS) 
around 3.5 months. Patients with PROC have a median overall survival (mOS) of less than 1 year, 
thus highlighting the unmet medical need.15,16,17,18
FRĮ-directed ADC therapy is a potential treatment option for advanced ovarian cancer and is 
currently under investigation. Various epithelial tumors (eg, ovarian, endometrial, lung, head and 
neck) have demonstrated abundant FRĮ messenger ribonucleic acid (mRNA) expression by 
quantitative 
polymerase 
chain 
reaction 
and 
membrane 
protein 
expression 
by 
immunohistochemistry (IHC).19 Although FRĮ expression is limited in normal ovary tissue, 80% 
to 90% of EOC tumors express FRĮ.20,21 A recent meta-analysis suggests that higher expression 
of FRĮ is associated with poor survival of patients with cancer and may serve as a prognostic 
indicator.22 Moreover, there is evidence that elevated FRĮ expression may be a negative prognostic 
marker for chemotherapeutic response in EOC.23 In addition to its cell surface localization, FRĮ 
can be shed into the bloodstream as a soluble form. Soluble FRĮ (sFRĮ) levels correlate with local 
tumor FRĮ expression.24 Higher serum concentrations of sFRĮ are indicative of the FRĮ 
expression status of the tumor and are correlated with clinical stage and poor prognosis.25 FRĮ is 
an attractive target for ADC-based therapies due to its ability to internalize large molecules, its 
limited expression in normal tissues, and its overexpression in malignant cells, allowing for 
effective, targeted drug delivery.20
Preliminary efficacy and a manageable safety profile were observed in participants with PROC 
treated with MORAb-202 in a Phase 1 study, MORAb-202-J081-101 (hereafter referred to as 
Study 101), and a Phase 1/2 study, MORAb-202-G000-201 (hereafter referred to as Study 201),
supporting further clinical development of MORAb-202 in this population.11 Responses were 
observed in participants with solid tumors across a range of FRĮ expression levels, supporting the 
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evaluation in all randomized participants irrespective of their expression levels. See Section 3.2.3
for additional details on clinical efficacy and safety.
3.1.1
Research Hypothesis
MORAb-202 monotherapy will demonstrate a favorable overall benefit/risk profile compared to 
Investigator’s choice (IC) chemotherapy in participants with HGS platinum-resistant epithelial 
ovarian, primary peritoneal, or fallopian tube cancer.
3.2
Background
Ovarian cancer is the second most common cause of gynecologic cancer death in women 
worldwide.26 In the United States (US), ovarian cancer is the leading cause of death from 
gynecological cancer and the country’s fifth most common cause of cancer mortality in women.
Ovarian cancer remains a major cause of death, with an estimated 313,959 new cases in 2020
worldwide and a 5-year survival of 30.3% for patients with advanced stage disease. For 2022, the 
American Cancer Society estimates 19,880 new cases and 12,810 deaths from ovarian cancer in 
the US, while 26,500 deaths are predicted by the World Health Organization and Eurostats in the
European Union (EU) countries.27,28
Several types of malignancies arise from the ovary; however, EOCs comprise 90% of ovarian 
cancers. Epithelial cancers of ovarian, fallopian tube, and peritoneal origin exhibit similar clinical 
characteristics and, as such, are grouped together. Subtypes of EOC include high-grade serous, 
low-grade serous, endometrioid, clear cell, mucinous, and mixed subtypes. HGS ovarian 
carcinoma is the most common type of ovarian cancer and accounts for approximately 70% to 
80% of all malignant ovarian neoplasms.29 Most HGS ovarian carcinomas are diagnosed at an 
advanced stage (Stage III or IV) and have a poor overall prognosis. HGS carcinomas that are 
confined to the ovary at diagnosis are rare (< 10%).30
The initial treatment of advanced ovarian cancer involves a combination of cytoreductive surgery 
(either at the time of diagnosis or interval debulking) and chemotherapeutic agents. Platinum- and 
taxane-based chemotherapy is the global standard of care. However, despite cytoreductive 
(debulking) surgery and platinum-based chemotherapy, most patients will experience disease 
recurrence, requiring further treatment.12
The addition of bevacizumab as maintenance therapy after first line chemotherapy demonstrated 
an increase in PFS of up to 4 months. With the approval of bevacizumab-based chemotherapy in 
the front line and maintenance setting, outcomes have improved in ovarian cancer, and a large 
proportion of patients are expected to receive bevacizumab in the earlier lines of therapy and will 
no longer be eligible to receive bevacizumab in the PROC setting. Nevertheless, if not used in 
earlier lines, its use can be considered for patients with PROC in addition to single-agent 
chemotherapy, where it showed benefit in ORR (27.3%) and PFS (6.7 months) when compared to 
single-agent chemotherapy, but without survival benefit.31
Molecular analysis of HGS ovarian carcinomas by The Cancer Genome Atlas has shown that 
around half have aberrations in homologous recombination repair, a critical deoxyribonucleic 
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acid (DNA) damage response pathway.32 Repair of DNA damage following platinum-based 
therapy has long been considered an important determinant of tumor chemosensitivity. Several 
genetic lesions causing homologous recombination deficiency (HRD) include germline and 
somatic breast cancer gene 1 (BRCA1) and BRCA2 mutations as well as mutations of genes such 
as ATM, CHEK2, RAD51, and MRE11A, and epigenetic silencing of homologous recombination 
repair genes has also been described in HGS ovarian carcinomas.13
Furthermore, exploitation of HRD by inhibiting poly (adenosine diphosphate-ribose) polymerase
(PARP), a DNA repair enzyme involved in base-excision repair, produces further disruption of 
DNA damage repair and has formed the basis of a new molecularly-targeted therapeutic strategy 
to treat ovarian cancer.33 Recently, PARP inhibitor (PARPi) maintenance therapy has emerged as 
a strategy to prolong the period between platinum responses and disease relapse in the first-line 
and relapsed settings in both HRD and non-HRD tumors. However, as with platinum 
chemotherapy, many patients will eventually acquire resistance to PARPi treatment.
Antibody–drug conjugates (ADCs) are a novel approach that show promise as emerging therapy 
in ovarian cancer. ADC are composed of a monoclonal antibody (mAb) conjugated to a cytotoxic 
payload via a chemical linker and are tailored to highly specific target antigens expressed on cancer 
cell surfaces. ADCs are capable of delivering highly potent drugs to tumor cells while sparing 
normal cells, thus attenuating the clinical obstacles of traditional chemotherapy. Ovarian tumors 
differentially express a large number of tumor antigens such as FRĮ that are ideal candidates for 
this novel approach. Presently, there are several ADC undergoing clinical evaluation in ovarian 
cancer.34
Due to the overall high disease burden and likelihood of recurrence despite standard-of-care 
treatments, there remains an urgent unmet need for novel treatment approaches in advanced 
ovarian cancer. This study will investigate MORAb-202, a novel FRĮ-directed ADC, as a potential 
treatment option in this population.
3.2.1
Ovarian Cancer Racial and Ethnic Diversity
Data from the Surveillance, Epidemiology, and End Results (SEER) database project that in the 
US, ovarian cancer incidence rates are highest in Non-hispanic White (NHW) women, followed 
by Hispanic, Asian/Pacific Islander, and African American (AA) women (12.2, 10.6, 9.5, and 
9.4 cases per 100,000 women, respectively).35Among NHW and AA women, the distribution of 
ovarian cancer is similar across the age groups, while Hispanic and Asian women are 
comparatively younger at the time of diagnosis than NHW or AA women.36
Although the incidence of epithelial ovarian cancer (EOC) is approximately 30% higher among 
NHW women than AA women,37 AA women have a 5-year lower survival than NHW women 
(39% vs 48%, respectively).38,39 The difference in relative survival between AA and NHW women 
is greatest for distant disease (18% vs 27%) respectively. This lower survival among AA women 
persists across both serous and non-serous (clear cell, endometrioid, mucinous) carcinoma. 
Hispanic and Asian women demonstrate similar or improved survival compared with NHW 
women.36 A study evaluating the differences in survival between NHW and Asian women in 
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SEER from 1988 to 2009 reported that the 5-year disease-specific survival for Asian women was 
considerably higher than NHW women, 59.1% and 47.3%, respectively. This improved outcome 
persisted after adjustment for age, year of diagnosis, surgery, stage, and grade.40
This study plans to enroll and evaluate MORAb-202 in a diverse and representative patient 
population with PROC to explore any clinically meaningful differences 
 
 to inform safe and 
effective dosing regimens across the intended patient population.
3.2.2
Summary of Key Preclinical Data with MORAb-202
Preclinical data support clinical exploration of MORAb-202 in HGS platinum-resistant ovarian, 
primary peritoneal, and fallopian tube cancer, as proposed in this study. MORAb-202 is selectively 
cytotoxic to FRĮ-positive cells, with low levels of off-target killing. It demonstrates a clear in vitro 
bystander effect in mixed tumor cell populations of FRĮ-positive and FRĮ-negative cells. The total 
balance of the physicochemical properties of MORAb-202 could account for this clear in vitro 
bystander effect. Consistent with these in vitro profiles, MORAb-202 was highly efficacious 
against FRĮ-expression positive ovarian cancer (OC) tumor cell line-derived and patient-derived 
xenograft (PDX) models of human cancer with a single administration at 5 and 12.5 mg/kg.41,7
MORAb-202 resulted in tumor regression against FRĮ-positive tumors. 
 
 
 
 
 
 
 
 
 
 
 
 
Please refer to the current MORAb-202 Global Investigator’s Brochure (IB) for additional 
details.11
These results suggest that MORAb-202 may have antitumor 
 
 and warrants clinical investigation.
3.2.3
MORAb-202 Clinical Data
MORAb-202 clinical trial data are presented as of the cut-off date of 31-Aug-2021, unless 
otherwise specified. Please refer to the MORAb-202 IB for complete information on MORAb-202 
clinical trials. See Section 3.3 for further information on overall benefit/risk.
MORAb-202 has been clinically evaluated in 2 clinical trials: Study 101 and Study 201. Across 
both trials, a total of 107 participants have been treated with MORAb-202. Study 101 is a 
first-in-human, open-label, dose-escalation and expansion study with a primary objective to 
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evaluate the safety, tolerability, and PK of MORAb-202 as a single agent administered by 
intravenous (IV) injection every 3 weeks (Q3W) in participants with solid tumors (Part 1: Dose 
Escalation part) or PROC 
 (Part 2: Dose Expansion part) in the Japan population. 
Preliminary efficacy of MORAb-202 was also evaluated in Study 101. Study 201 is an open-label 
study with a two-dose level escalation part, evaluating the safety, tolerability, and efficacy of 
MORAb-202 in participants with select tumor types 
 in the US 
population.
In Study 101, 82 participants have been exposed to MORAb-202 across 5 dose levels during the 
dose escalation and dose expansion parts. In the dose escalation part of Study 101, a total of 
22 participants with solid tumors were enrolled across the following 5 MORAb-202 dose cohorts: 
0.3 mg/kg Q3W; 0.45 mg/kg Q3W; 0.68 mg/kg Q3W; 0.9 mg/kg Q3W; and 1.2 mg/kg Q3W. 
Based on the observed safety and preliminary efficacy profile of MORAb-202 in the dose 
escalation part of Study 101, the dose expansion part of Study 101 (N = 60) evaluated 
45 participants with PROC in 2 expansion cohorts at 0.9 mg/kg (n = 24) and 1.2 mg/kg (n = 21) 
and 15 participants 
 in one expansion cohort at 1.2 mg/kg. Across both parts of 
Study 101, 2 participants with ovarian cancer were treated with MORAb-202 at the 0.68 mg/kg 
Q3W dose, 28 participants with MORAb-202 at the 0.9 mg/kg Q3W dose, and 24 participants at 
the 1.2 mg/kg Q3W dose.42
In the dose escalation part of Study 201, 25 participants have been exposed to MORAb-202 at 
dose levels of 0.9 mg/kg Q3W and 1.2 mg/kg Q3W. Of the 25 participants exposed to MORAb-202
in Study 201, 10 OC and 3 non-OC participants were enrolled in the 0.9 mg/kg dose cohort, and 
10 OC and 2 non-OC participants were enrolled in the 1.2 mg/kg dose cohort.43
 
3.2.3.1
Clinical Efficacy
In both Study 101 and Study 201, durable responses were observed in participants 
 
 across a range of tumor FRĮ expression levels.20 Anti-tumor activity was 
evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for all participants in 
Studies 101 and 201.
Study 101:
In the dose escalation part of Study 101, the investigator-assessed objective response rate (ORR) 
was 45% (10/22 participants) across cohorts. Responses included 1 CR (OC at 0.9 mg/kg) and 
9 PRs in 1 participant 
 at 0.3 mg/kg, 4 participants 
 1 OC, and 
 at 
0.68 mg/kg, 2 participants (OC) at 0.9 mg/kg, and 2 participants (OC) at 1.2 mg/kg. 
Across both OC expansion cohorts, 39/45 participants had HGS OC: 19 HGS OC participants were 
enrolled in the 0.9 mg/kg MORAb-202 dose cohort, and 20 HGS OC participants were enrolled in 
the 1.2 mg/kg MORAb-202 dose cohort. In ovarian cohorts, 50% and 66.7% of the participants 
had 3 or more previous lines of therapy at the 0.9 and 1.2 mg/kg dose levels, respectively. Clinical 
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efficacy data for participants with HGS and overall PROC in Study 101 are presented in Table 
3.2.3.1-1. 
Table 3.2.3.1-1:
Study 101 Dose Expansion Clinical Efficacy in HGS/Overall PROC 
Participants
HGS
Total PROC
MORAb-202 Treatment
0.9 mg/kg
Q3W
(n=19)
1.2 mg/kg
Q3W
(n=20)
0.9 mg/kg
Q3W
(n=24)
1.2 mg/kg
Q3W
(n=21)
Best Overall Response (BOR)a
Complete Response (CR), n (%)
1 (5.3)
0
1 (4.2)
0
Partial Response (PR), n (%)
5 (26.3)
10 (50.0)
5 (20.8)
11 (52.4)
Stable Disease (SD), n (%)
6 (31.6)
9 (45.0)
10 (41.7)
9 (42.9)
Progressive Disease (PD), n (%)
7 (36.8)
1 (5.0)
8 (33.3)
1 (4.8)
Objective Response Rate (CR + PR), n (%)
6 (31.6)
10 (50.0)
6 (25.0)
11 (52.4)
Duration of Response (months)
Median 
10.6 
8.0 
10.6 
7.6 
Progression-free Survival (months)
Median 
6.7 
7.2 
6.7 
8.2 
Abbreviations: BOR, best overall response; CR, complete response; HGS, high-grade serous; n, number of 
participants; PD, progressive disease; PR, partial response; PROC, platinum-resistant ovarian cancer; Q3W, every 
3 weeks; SD, stable disease.
a Confirmed responses are used in this analysis. Data cut-off: 31-Aug-2021.
Study 201:
A total of 20 PROC participants were treated with MORAb-202 in the dose escalation part of 
Study 201, 10 each at 0.9 and 1.2 mg/kg. Clinical efficacy data for PROC participants at each 
MORAb-202 dose cohort in Study 201 are presented in Table 3.2.3.1-2.
Table 3.2.3.1-2:
Study 201 Dose Escalation Clinical Efficacy in PROC Participants 
MORAb-202 Dose Cohort 
MORAb-202
0.9 mg/kg
PROC
(n=10) 
n (%)
MORAb-202
1.2 mg/kg
PROC
(n=10) 
n (%)
Best Overall Response, n (%)a
Complete Response (CR)
0 (0.0)
0 (0.0)
Partial Response (PR)
1 (10.0)
1 (10.0)
Stable Disease (SD)
6 (60.0)
5 (50.0)
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Table 3.2.3.1-2:
Study 201 Dose Escalation Clinical Efficacy in PROC Participants 
MORAb-202 Dose Cohort 
MORAb-202
0.9 mg/kg
PROC
(n=10) 
n (%)
MORAb-202
1.2 mg/kg
PROC
(n=10) 
n (%)
Progressive Disease (PD)
2 (20.0)
4 (40.0)
Objective Response Rate (CR + PR), n (%)
1 (10.0)
1 (10.0)
Duration of Objective Response (months)
Median 
4.7 
NE 
Progression-free Survival (months)
Median 
3.4 
2.5 
Abbreviations: BOR, best overall response; CR, complete response; n, number of participants; NE, not estimable; PD, 
progressive disease; PR, partial response; PROC, platinum-resistant ovarian cancer; SD, stable disease.
a Data cut-off: 31-Aug-2021. Confirmed responses are used in this analysis.
Participants in the Study 201 were more heavily pretreated, had more extensive disease burden 
upon study entry, and had disease characteristics related to a poorer prognosis, as compared with 
Study 101 participants. However, despite an overall compromised baseline disease status in 
Study 201 PROC participants, stable disease was observed, justifying further exploration with 
MORAb-202 treatment in this population.
In summary, encouraging efficacy with MORAb-202 was observed in both studies across tumor 
types, including in participants with HGS PROC.
3.2.3.2
Clinical Safety
Study 101:
Across both parts of Study 101, 79/82 (96.3%) of participants treated with single-agent 
MORAb-202 experienced at least 1 treatment-emergent adverse event (TEAE), and the most 
frequently (> 20%) reported TEAEs were interstitial lung disease (ILD)/pneumonitis (26.8%), 
alanine aminotransferase (ALT) increased (26.8%), aspartate aminotransferase (AST) increased 
(23.2%), nausea (23.2%), and pyrexia (23.2%). The maximum tolerated dose (MTD) was not 
reached in Study 101.
In the dose escalation part of Study 101, Grade  3 TEAEs were reported in 2/22 (9.1%) of 
participants. Serious TEAEs were reported in 2/22 (9.1%) of participants, of which 1/22 (4.5%) 
were related. There were no reported treatment-related deaths.
In the dose expansion part of Study 101, Grade  3 TEAEs were reported in 
15/60 (25.0%) participants. Serious TEAEs were reported in 12/60 (20.0%) participants, of which 
7/60 (11.7%) participants had treatment-related events. In the dose expansion ovarian cancer 
cohorts (0.9 mg/kg, n = 24; 1.2 mg/kg, n = 21) of Study 101, Grade > 3 TEAEs were reported in 
8/24 (33.3%) and 5/21 (23.8%) of participants, respectively. Serious TEAEs were reported in 
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5/24 (20.8%) and 5/21 (23.8%) of participants, of which 2/24 (8.3%) and 3/21 (14.3%) were 
related, respectively. There were no reported treatment-related deaths at the time of data cut-off.
ILD/pneumonitis events were reported in 9/24 (37.5%) and 14/21 (66.7%) of participants, 
respectively. As of the cut-off date, all events of ILD/pneumonitis were reported as Grade 1 or 
Grade 2. However, after the data cut-off date, one Grade 1 event in the 1.2 mg/kg ovarian cancer 
expansion cohort was retrospectively reclassified as Grade 3 by the investigator, and a Grade 5 
respiratory-related event was reported in a 0.9 mg/kg ovarian cancer expansion cohort.42
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3.2.4
MORAb-202 Clinical Pharmacology 
MORAb-202 is an immunoglobulin G1 (IgG1) antibody (farletuzumab) conjugated to the 
microtubule inhibitor eribulin via a cathepsin cleavable linker
 
 Eribulin mesylate, marketed as Halaven®, is approved in the US and European Union 
(EU) for the treatment of metastatic breast cancer and for unresectable or metastatic liposarcoma.44
3.2.4.1
MORAb-202 Clinical Pharmacokinetics 
MORAb-202 PK was evaluated after IV administration at doses of 0.3 mg/kg (n = 3), 0.45 mg/kg
(n = 3), 0.68 mg/kg(n = 6), 0.9 mg/kg (n = 7), and 1.2 mg/kg Q3W (n = 3) in Part 1 (dose escalation) 
and at doses of 0.9 mg/kg (n = 39) and 1.2 mg/kg Q3W (n = 21) in Part 2 (dose expansion) in 
Study 101 (Japanese population). PK was also evaluated at doses of 0.9 mg/kg (n = 9) and 
1.2 mg/kg (n = 6) Q3W in Study 201 (global, non-Japanese population). MORAb-202, total 
antibody (antibodies that are both unconjugated and conjugated to at least 1 payload molecule) 
and released eribulin PK have been previously described over the escalation dose range 0.3 to 
1.2 mg/kg Q3W in Study 101.44 From noncompartmental analysis (NCA), MORAb-202 PK was 
near dose-proportional from 0.3 to 1.2 mg/kg Q3W with a half-life of 4 to 6 days and no
accumulation using Q3W dosing with steady state concentrations achieved after Cycle 1. 
Concentration vs time profiles were similar for MORAb-202 and total antibody levels with low 
levels of released eribulin near the assay limit of quantitation, indicating MORAb-202 is stable in 
the systemic circulation. Released eribulin levels detected in plasma from MORAb-202 ranged 
from 0.5 to 2 ng/mL and were significantly lower than the maximum concentration of eribulin in 
plasma (approximately 300 ng/mL) when dosed at the United States Prescribing Information 
(USPI) approved dose of 1.4 mg/m2 IV on Days 1 and 8 of a 21-day cycle.44,45,46
 
 
 
 
 Based on human metabolism studies conducted with 14C-eribulin as 
described in the Halaven® USPI, released eribulin is expected to be eliminated primarily in the 
feces (82% of dose) with no major circulating metabolites in plasma (< 0.6% of parent compound). 
Furthermore, released eribulin is expected to have a mean half-life of approximately 40 hours, the 
same as single-agent eribulin mesylate dosed at the USPI-recommended dose.
PK was also characterized using a population PK approach to include those participants with both 
intense and sparse PK sampling. The analysis included 1299 MORAb-202 PK observations across 
97 participants (Study 101 N=82; 
). PK was linear and described by a 
two-compartment model with significant effects of baseline body weight (BW) on clearance (CL) 
and volume distribution of the central compartment (V) and baseline albumin levels on CL. This 
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results in participants with higher baseline BW having higher CL and V and participants with low 
albumin having higher CL and is consistent with that observed for other monoclonal antibodies.47
3.2.4.2
Exposure-response Efficacy and Safety
There was an apparent dose and exposure-response (E-R) relationship observed for ORR in 
Study 101 over the dose range 0.68 to 1.2 mg/kg Q3W in PROC, which was the tumor type with 
the largest number of patients enrolled (N=58). There was also a dose and E-R relationship 
observed for ILD combining data across tumor types from Studies 101 and 201 (N = 96 total; 
n = 81 [Study 101]
). The highest tested dose at 1.2 mg/kg Q3W in Study 
101 (including both escalation and expansion) had the highest ORR 54.2% (13/24) in PROC and
highest ILD rate 58.3% (14/24) across tumor types. The next lower dose level, 0.9 mg/kg Q3W, 
led to a lower ORR 32.1% (9/28) and ILD rate 37.0 % (17/46) in Study 101. At the next lower 
dose 0.68 mg/kg Q3W, a 50% ORR (1/2) in PROC and ILD rate 16.7% (1/6) in Study 101 were 
observed. 
E-R Efficacy (ORR) Analysis
An E-R efficacy (ORR) analysis was conducted with PROC participants from Study 101 (N = 58) 
across the dose range 0.3 to 1.2 mg/kg Q3W. Twenty-one participants had a partial response (PR),
and 2 participants had a CR in PROC with an ORR of 39.7 % (23/58) across the dose range. 
Exposure (area under the concentration-time curve [AUC]) was the only significant predictor of 
the probability of an objective response (OR) in a multivariate logistic regression analysis
 
Age, weight, non-HGS (versus HGS OC), and Eastern 
Cooperative Oncology Group (ECOG) performance status (PS) (1 vs 0) were not significant 
predictors of an OR. Based on the results of the E-R analysis, clinically meaningful efficacy is 
expected across the dose range of 0.68 to 1.2 mg/kg. However, as described below, an overlapping 
AUC dependent ILD is observed, indicating doses < 1.2 mg/kg may provide the optimal balance 
of benefit/risk and requires further dose optimization.
 
 
 
 
 
E-R Safety (ILD) Analysis
An E-R analysis of ILD by expert review was conducted including participants from Study 101 
across the dose range of 0.3 to 1.2 mg/kg Q3W and from Study 201 across the dose range of 0.9 
to 1.2 mg/kg Q3W (N = 96 participants in total). Forty-eight participants had ILD identified by 
expert review for an ILD rate of 50% (48/96) across the studies and dose range. AUC and age were 
significant predictors in multivariate analysis with both higher AUC and higher age predicting a 
higher probability of ILD.47
 
 
 
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3.2.4.4
Corrected QTc Interval Assessment
 
 
 
 While single-agent eribulin mesylate at the 
prescribed dose of 1.4 mg/m2 prolonged QTc with a maximum mean QTcF change from baseline 
(95% upper confidence interval [CI]) of 11.4 ms (19.5) in 26 patients with solid tumors, there was 
no concentration effect identified.48 The total dose of eribulin (free form) at the highest 
MORAb-202 dose evaluated (1.2 mg/kg Q3W) is 0.85 mg/m2, which is 1.6-fold lower than the 
approved eribulin single-agent dose of 1.4 mg/m2. This combined with plasma levels of released 
eribulin from MORAb-202 that are approximately 300-fold lower than with single-agent eribulin 
indicates a low risk of MORAb-202 QTc prolongation. Therefore, for 
 participants, 
electrocardiograms (ECGs) will only be required at screening and end of treatment (EOT). During 
study treatment and safety follow-up, ECGs should be performed as clinically indicated. 
3.2.4.5
Drug-drug Interaction Potential 
There are no drug-drug interactions expected for MORAb-202 and released eribulin.
There have been no in vitro or in vivo drug-drug interactions studies conducted for MORAb-202. 
The antibody portion of MORAb-202 (farletuzumab) is not expected to impact cytochrome P450 
(CYP)-mediated metabolism since its mechanism of action does not involve increases in 
proinflammatory cytokines that have historically been linked to antibody-based modulation of 
P450s. As described in the Halaven® (eribulin mesylate) USPI, drug-drug interaction studies have 
been conducted for eribulin and there were no clinically meaningful differences in exposure (AUC) 
observed in patients with advanced solid tumors when eribulin was administered with or without 
ketoconazole (a strong inhibitor of CYP3A and a P-gp inhibitor) and when eribulin was 
administered with or without rifampin (a CYP3A inducer). In vitro, eribulin did not inhibit 
CY1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A enzymes or induce CYP1A2, 
CYP2C9, CYP2C19 or CYP3A4 enzymes at relevant clinical concentrations. Since eribulin did 
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not induce or inhibit the CYP3A enzyme, pharmacokinetic interactions with corticosteroids, 
including dexamethasone, which is metabolized by CYP3A, are not expected. Investigators should 
refer to the prescribing information for the selected corticosteroids.
3.3
Benefit/Risk Assessment
Overall, the observed safety profile of MORAb-202 has been manageable and generally consistent 
across clinical trials with no MTD reached at dose levels up to 1.2 mg/kg. 
 
 
As described in Section 3.2.3.1, clinical activity with MORAb-202 was observed 
across multiple FRD-expressing tumor types. Clinical responses were observed in participants 
 
 across a 
range of MORAb-202 dose levels; however, lower rates of all-grade ILD were observed with lower 
doses, while a trend for higher grade ILD was observed in participants with higher body weights. 
Furthermore, based on clinical trial experience to date, ILD/pneumonitis associated with 
MORAb-202 appears to be responsive to systemic corticosteroids. For several participants who 
experienced ILD/pneumonitis, corticosteroid treatment along with dose delays and reductions 
allowed for MORAb-202 treatment and maintenance of disease control. AEs due to corticosteroid 
use in Study 101 were generally not reported, which aligns with current clinical experience with 
corticosteroid use as a treatment for AEs in cancer patients.49,50
 
 
 
Lastly, the recommendations for monitoring and management of ILD/pneumonitis included in this 
protocol have been revised from the initial recommendations implemented in Studies 101 and 201, 
based upon thorough analyses of clinical data from participants who experienced events of 
MORAb-202-related ILD/pneumonitis (see Section 7.4.1 for ILD management guidelines) and 
advisement from expert medical oncologists, pulmonologists, and radiologists experienced with 
management of drug-induced ILD/pneumonitis. 
 
 
 
 
 
 
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 See Section 3.2.3.2 for further 
details on overall safety profile observed in MORAb-202 clinical trials.
More detailed information about the known and expected benefits and risks and reasonably 
anticipated AEs of MORAb-202 may be found in the IB. Please refer to the approved local Product 
Label for the IC chemotherapy agents for a summary of the known benefits and risks of treatment 
in approved indications.
With respect to the benefit/risk of receiving coronavirus disease 2019 (COVID-19) vaccinations 
during treatment with MORAb-202, non-live COVID-19 vaccination is considered a concomitant 
medication within the study. The efficacy and safety of non-live vaccines (including non-live 
COVID-19 vaccines) in participants receiving MORAb-202 is unknown.
The assessed benefit/risk profile of MORAb-202 in participants with PROC is described further 
in the following sections.
3.3.1
Risk Assessment
Table 3.3.1-1:
Risk Assessment
Potential Risk of Clinical 
Significance
Summary of Data/Rationale for 
Risk
Mitigation Strategy
Study Intervention: MORAb-202 (
ILD/pneumonitis
MORAb-202 IB 
I/E criteria, consistent safety 
monitoring (eg, 
 
, 
pulse oximetry, signs/symptoms, 
6-minute walk test), close weekly 
monitoring visits 
 and via 
phone calls during 
 
 
 
 
 
 
 
investigator/site training on ILD 
detection and management, 
participant alert card, SC, and ILD 
Expert Review Committee.
 
 
 
 
 
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Table 3.3.1-1:
Risk Assessment
Potential Risk of Clinical 
Significance
Summary of Data/Rationale for 
Risk
Mitigation Strategy
Infusion-related reactions
MORAb-202 IB 
Premedications for first 
MORAb-202 infusion, I/E criteria,
close monitoring for 
hypersensitivity/allergic reactions 
during MORAb-202 infusions, and 
secondary prophylaxis.
Guidelines for management and 
dose modification are included in 
protocol Section 7.4.1.
AST/ALT elevations
MORAb-202 IB 
I/E criteria and safety monitoring 
with predose liver enzymes at each 
cycle.
Guidelines for management and 
dose modification are included in 
protocol Section 7.4.1.
Nausea
MORAb-202 IB
Monitoring at each cycle.
Guidelines for dose modification 
are included in protocol 
Section 7.4.1. Management per 
institutional protocol/investigator 
discretion.
Pyrexia
MORAb-202 IB
Monitoring at each cycle.
Guidelines for dose modification
and recommended management 
algorithm is included in protocol 
Section 7.4.1. Management or as 
per institutional 
protocol/investigator discretion.
Potential reproductive toxicity
MORAb-202 IB 
I/E criteria, pregnancy testing, and 
contraception requirements per 
protocol Section 6.1, Section 6.2, 
Section 9.2.5, and Appendix 4.
Study Intervention: Paclitaxel
Bone marrow suppression (eg, 
neutropenia, thrombocytopenia, 
anemia, infections)
USPI and SmPC for paclitaxel
I/E criteria and safety monitoring 
with predose CBCs at every 
treatment visit.
Recommended dose reductions and 
discontinuations included in 
protocol Section 7.4.2 or per 
approved Product Label or as per 
institutional protocol/investigator 
discretion.
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Table 3.3.1-1:
Risk Assessment
Potential Risk of Clinical 
Significance
Summary of Data/Rationale for 
Risk
Mitigation Strategy
Hypersensitivity reactions
USPI and SmPC for paclitaxel
I/E criteria, premedication, and 
close monitoring for 
hypersensitivity/allergic reactions 
during paclitaxel infusions.
Recommended dose reductions and 
discontinuations included in 
protocol Section 7.4.2 or per 
approved Product Label or as per 
institutional protocol/investigator 
discretion.
Peripheral neuropathy
USPI and SmPC for paclitaxel
I/E criteria and monitoring at every 
cycle.
Recommended dose reductions and 
discontinuations included in 
protocol Section 7.4.2 or per 
approved Product Label or 
institutional protocol/investigator 
discretion.
Mucositis
USPI and SmPC for paclitaxel
I/E criteria and monitoring at every 
cycle.
Recommended dose reductions and 
discontinuations included in 
protocol Section 7.4.2 or per 
approved Product Label or 
institutional protocol/investigator 
discretion.
Potential reproductive toxicity
USPI and SmPC for paclitaxel
I/E criteria, pregnancy testing, and 
contraception requirements per 
protocol Section 6.1,Section 6.2, 
Section 9.2.5 and Appendix 4.
Study Intervention: PLD
Palmar-Plantar 
erythrodyesthesia/hand-foot 
syndrome (HFS)
USPI and SmPC for PLD
Monitoring at every cycle.
Recommended dose reductions and 
discontinuations included in 
protocol Section 7.4.3 or per 
approved Product Label or 
institutional protocol/investigator 
discretion.
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Table 3.3.1-1:
Risk Assessment
Potential Risk of Clinical 
Significance
Summary of Data/Rationale for 
Risk
Mitigation Strategy
Infusion-related reactions
USPI and SmPC for PLD
I/E criteria and close monitoring for 
hypersensitivity/allergic reactions 
during PLD infusions.
Recommended dose reductions and 
discontinuations included in 
protocol Section 7.4.3 or per 
approved Product Label or 
institutional protocol/investigator 
discretion.
Bone marrow suppression (eg, 
anemia, leukopenia, 
thrombocytopenia, neutropenia), 
febrile neutropenia, superinfection, 
and hemorrhage
USPI and SmPC for PLD
I/E criteria and safety monitoring 
with predose CBCs at every cycle.
Recommended dose reductions and 
discontinuations included in 
protocol Section 7.4.3 or per 
approved Product Label or 
institutional protocol/investigator 
discretion.
Secondary hematological 
malignancies
USPI and SmPC for PLD
I/E criteria and safety monitoring 
with hematology clinical laboratory 
assessments at every cycle.
Recommended dose reductions and 
discontinuations included in 
protocol Section 7.4.3 or per 
approved Product Label or 
institutional protocol/investigator 
discretion.
Secondary oral neoplasms
USPI and SmPC for PLD
Monitoring at every cycle.
Recommended dose reductions and 
discontinuations included in 
protocol Section 7.4.3 or per 
approved Product Label or 
institutional protocol/investigator 
discretion.
Extravasation
USPI and SmPC for PLD
Close monitoring for symptoms of 
extravasation (eg, stinging, 
erythema) during PLD infusion. 
Recommended dose reductions and 
discontinuations included in 
protocol Section 7.4.3 or per 
approved Product Label or 
institutional protocol/investigator 
discretion.
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Table 3.3.1-1:
Risk Assessment
Potential Risk of Clinical 
Significance
Summary of Data/Rationale for 
Risk
Mitigation Strategy
Cardiac toxicity (eg, reduced 
LVEF)
USPI and SmPC for PLD
I/E criteria and safety monitoring of 
LVEF with ECHO/MUGA every
4 cycles.
Recommended dose reductions and 
discontinuations included in 
protocol Section 7.4.3 or per 
approved Product Label or 
institutional protocol/investigator 
discretion.
Mucositis
USPI and SmPC for PLD
Monitoring at every cycle.
Recommended dose reductions and 
discontinuations included in 
protocol Section 7.4.3 or per 
approved Product Label or 
institutional protocol/investigator 
discretion.
Gastrointestinal toxicity (eg, 
nausea, vomiting)
USPI and SmPC for PLD
Monitoring at every cycle.
Recommended dose reductions and 
discontinuations included in 
protocol Section 7.4.3 or per 
approved Product Label or 
institutional protocol/investigator 
discretion.
Potential reproductive toxicity
USPI and SmPC for PLD
I/E criteria, pregnancy testing, and 
contraception requirements per 
protocol Section 6.1, Section 6.2, 
Section 9.2.5, and Appendix 4.
Study Intervention: Topotecan
Bone marrow suppression (eg, 
neutropenia, thrombocytopenia, 
anemia), febrile neutropenia, and 
neutropenic enterocolitis; infection
USPI and SmPC for topotecan
I/E criteria and safety monitoring 
with predose CBCs at every 
treatment visit.
Recommended dose reductions and 
discontinuations included in 
protocol Section 7.4.4 or per 
approved Product Label or 
institutional protocol/investigator 
discretion.
Gastrointestinal toxicity (eg, severe 
nausea, vomiting, and/or diarrhea, 
constipation, abdominal pain, 
mucositis)
USPI and SmPC for topotecan
Monitoring at every cycle.
Recommended dose reductions and 
discontinuations included in 
protocol Section 7.4.4 or per 
approved Product Label or 
institutional protocol/investigator 
discretion.
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Table 3.3.1-1:
Risk Assessment
Potential Risk of Clinical 
Significance
Summary of Data/Rationale for 
Risk
Mitigation Strategy
Interstitial lung disease (ILD)
USPI and SmPC for topotecan
I/E criteria and consistent safety 
monitoring (eg, 
, 
pulse oximetry, signs/symptoms).
Recommended dose reductions and 
discontinuations included in 
protocol Section 7.4.4 or per 
approved Product Label or 
institutional protocol/investigator 
discretion.
Pyrexia, asthenia, and fatigue
USPI and SmPC for topotecan
Monitoring at every cycle.
Recommended dose reductions and 
discontinuations included in 
protocol Section 7.4.4 or per 
approved Product Label or 
institutional protocol/investigator 
discretion.
Potential reproductive toxicity
USPI and SmPC for topotecan
I/E criteria, pregnancy testing, and 
contraception requirements per 
protocol Section 6.1, Section 6.2, 
Section 9.2.5, and Appendix 4.
Infertility
USPI and SmPC for topotecan
Informed consent.
Study Procedures
Tumor biopsy (eg, pain, infection)
for participants without archival 
tissue
--
Allow submission of archival tumor 
sample of sufficient quality and 
quantity. If tumor biopsy 
performed, management will be per 
institutional protocol/investigator 
discretion.
Blood draws/use of IV catheter for 
laboratory assessments (eg, pain, 
bruising, bleeding, infection, 
fainting)
--
Per institutional 
protocol/investigator discretion.
CT scan/MRI radiation exposure
--
Per institutional 
protocol/investigator discretion.
Allergy to contrast agent for CT 
scan/MRI (eg, allergic reaction, 
anaphylaxis)
Contrast USPI and SmPC
Prophylaxis and/or treatment per 
institutional protocol/investigator 
discretion.
Other (if applicable)
SARS-CoV-2 infection
Policy and Guidance for the 
conduct of BMS-sponsored clinical 
research in light of SARS-CoV-2
See exclusion criteria (Section 6.2), 
re-screening criteria (Section 6.4.1),
and dose modifications 
(Section 7.4) sections for 
SARS-CoV-2 Safety Surveillance 
Plan.
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Table 3.3.1-1:
Risk Assessment
Potential Risk of Clinical 
Significance
Summary of Data/Rationale for 
Risk
Mitigation Strategy
Dosing delay due to SARS-CoV-2 
lockdowns
BMS SARS-CoV-2 Clinical 
Research Project Management 
Office
Specific measures have been 
considered to ensure the trial can 
continue should the hospital be 
subject to increased 
demands/restrictions due to the 
pandemic (travel restrictions, 
remote access / monitoring, 
preventative measures, etc).
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; BMS, Bristol-Myers Squibb; 
 
 CBC, complete blood count; CT, computed tomography; ECHO, 
echocardiogram; HFS, hand-foot syndrome; IB, Investigator’s Brochure; I/E, inclusion/exclusion criteria; ILD, 
interstitial lung disease; IV, intravenous; LVEF, left ventricular ejection fraction; MRI, magnetic resonance imaging;
MUGA, multigated acquisition; PLD, pegylated liposomal doxorubicin; SARS-CoV-2, severe acute respiratory 
syndrome coronavirus 2; SC, Safety Committee; SmPC, Summary of Product Characteristics; USPI, United States 
Prescribing Information.
3.3.2
Benefit Assessment
Effective treatment of patients with PROC remains a substantial unmet need (see Section 3.1 and 
Section 3.2). Patients with platinum-resistant disease who relapse typically receive single-agent 
chemotherapy alone (eg, liposomal doxorubicin, topotecan, or paclitaxel) or in combination with 
bevacizumab.17 Randomized Phase 3 studies for these agents in this patient population 
demonstrated response rates of 10% to 15%, mPFS of 3 to 4 months, and poor median overall 
survival (OS) of approximately 12 months.31 Furthermore, these treatments are associated with 
significant toxicities such as myelosuppression, hypersensitivity reactions, palmar plantar 
erythrodysesthesia, mucositis, and neuropathy.46 Because PROC remains a significant unmet 
medical need, the National Comprehensive Cancer Network (NCCN) guidelines and the European 
Society for Medical Oncology (ESMO) guidelines recommend that patients with PROC consider 
participation in clinical trials.8,51
MORAb-202 may address the high unmet need in a large subset of PROC patients, given its 
unique, tumor-specific mechanism (ie, FRĮ-directed ADC), the high
prevalence of 
FRĮ-expression in ovarian cancer, and the clinical activity seen to date in this population (see 
Section 3.2.3). HGS carcinoma is the most common histologic subtype of OC, accounting for 
approximately 70% of epithelial cell OC and is responsible for the majority of deaths in OC.52
The additional medical surveillance provided by a clinical trial translates into close monitoring of 
the participants for toxicities and promotes prompt identification and adequate treatment of 
adverse events.
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3.3.3
Overall Benefit/Risk Conclusion
MORAb-202 has the potential to provide an overall favorable benefit/risk balance based on clinical 
responses observed at various doses, in combination with measures to minimize overexposure to 
participants.
In addition to the eligibility criteria, safety assessments, AE management/dose modification 
guidelines, 
 incorporated in the study protocol, to ensure safety of 
participants, the Sponsor and SC will continuously assess safety throughout the course of the study 
(see Section 5.1.1 and Section 5.1.1.1). 
 
 
 Additionally, the Sponsor will evaluate the benefit/risk profile 
of the study intervention on an ongoing basis. This evaluation will be based on all available data, 
with particular attention to: i) AEs, including ILD/pneumonitis, or other safety trends in this or 
any other clinical study of MORAb-202 whose character, severity, and/or frequency suggest that 
participants would be exposed to an unreasonable and significant risk of illness or injury, and ii) 
new nonclinical data suggesting unreasonable and significant risk of illness or injury.
If such evaluation suggests that the benefit/risk profile of the study intervention has become
unfavorable to participants, the Sponsor will pause enrollment and/or treatment until further 
evaluation of data and communication with the appropriate Health Authority(ies) on potential 
actions. Such actions may include, but are not limited to, study continuation, substantial 
amendment, or termination of the study.
•
Enrollment will continue in 
 (MORAb-202 25 mg/m2) and 
 (IC Chemotherapy)
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4
OBJECTIVES AND ENDPOINTS
Table 4-1:
Objectives, Endpoints, and Estimands
Objectives
Endpoints
Primary
•
To compare objective response rate (ORR) of 
MORAb-202 
vs 
IC 
chemotherapy 
(in
all 
randomized participants)
•
ORR by Response Evaluation Criteria in Solid 
Tumors (RECIST) v1.1 per investigator assessment
Main Estimand for the Primary Objective
Treatment: MORAb-202, 25 mg/m2
, IC 
chemotherapy 
Population: Platinum-resistant ovarian cancer
Variable: Best overall response (BOR), defined as the best response, as determined by the investigator, 
recorded between the date of randomization and the date of first objectively-documented progression per 
RECIST v1.1 or the date of subsequent therapy, whichever is earlier.
Intercurrent events (strategy): Early discontinuation of study treatment (treatment policy); initiation of 
subsequent anti-cancer therapy (while on treatment)
Population-level summary: Difference in ORR, defined as the number of randomized participants who achieve 
a BOR of confirmed complete response (CR) or confirmed partial response (PR) based on the investigator 
assessments (using RECIST v1.1) divided by the number of all randomized participants in each treatment 
group, with two-sided 95% exact confidence interval (CI) in each treatment group
•
To evaluate the proportion of participants with 
treatment-related adverse event (TRAEs) leading to 
discontinuation in each arm within 6 months from 
first dose of study drug administration in all treated 
participants
•
TRAEs leading to discontinuation
Main Estimand for the Primary Objective
Treatment: MORAb-202, 25 mg/m2
 IC 
chemotherapy 
Population: Platinum-resistant ovarian cancer
Variable: Occurrence of TRAEs leading to discontinuation observed within 6 months from first dose of study 
drug administration
Intercurrent events (strategy): Early discontinuation of study treatment (while on treatment)
Population-level summary: TRAE discontinuation incidence rate
Secondary
•
To assess the safety and tolerability of MORAb-202 
and IC chemotherapy in all treated participants
•
Incidence 
and 
severity 
of 
adverse 
events 
(AEs)/serious adverse events (SAEs), AEs leading 
to discontinuation, treatment-related AEs/SAEs
leading to discontinuation, AEs of special interest 
(AESIs), deaths, and laboratory abnormalities
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Table 4-1:
Objectives, Endpoints, and Estimands
Objectives
Endpoints
Main Estimand for the Secondary Objective
Treatment: MORAb-202, 25 mg/m2
, IC 
chemotherapy 
Population: Platinum-resistant ovarian cancer
Variable: Occurrence of the AEs/SAEs, treatment-related AEs/SAEs, AEs leading to discontinuation, AESIs,
deaths, and laboratory abnormalities. There are multiple estimands corresponding to each specified safety 
endpoint.
Intercurrent events (strategy): Early discontinuation of study treatment (while on treatment)
Population-level summary: AE incidence rate/proportion
•
To evaluate disease control rate (DCR)
of
MORAb-202
and 
IC
chemotherapy
in 
all 
randomized participants
•
DCR by RECIST v1.1 per investigator assessment
Main Estimand for the Secondary Objective
Treatment: MORAb-202, 25 mg/m2
, IC 
chemotherapy 
Population: Platinum-resistant ovarian cancer
Variable: Best overall response (BOR), defined as the best response, as determined by the investigator, 
recorded between the date of randomization and the date of first objectively-documented progression per 
RECIST v1.1 or the date of subsequent therapy
Intercurrent events (strategy): Early discontinuation of study treatment (treatment policy); initiation of 
subsequent anti-cancer therapy (while on treatment)
Population-level summary: Difference in DCR, defined as the number of randomized participants who achieve 
a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on the investigator assessments (using 
RECIST v1.1) divided by the number of all randomized participants, with 95% exact CI in each treatment 
group
•
To evaluate duration of response (DoR) of 
MORAb-202 
and 
IC 
chemotherapy 
in 
all 
randomized participants
•
DoR by RECIST v1.1 per investigator assessment
Main Estimand for the Secondary Objective
Treatment: MORAb-202, 25 mg/m2
, IC 
chemotherapy
Population: Platinum-resistant ovarian cancer participants that achieved a CR or PR as BOR
Variable: DoR, defined as the time between the date of first documented response (CR or PR) that is 
subsequently confirmed, to the date of the first objectively-documented tumor progression as determined by 
investigator (per RECIST v1.1), or death due to any cause, whichever occurs first
Intercurrent events (strategy): Early discontinuation of study treatment (treatment policy); initiation of 
subsequent anti-cancer therapy (while on treatment)
Population-level summary: Kaplan Meier (KM) estimated median response time and landmark response rate 
of DoR in each treatment group
•
To evaluate progression-free survival (PFS) of 
MORAb-202 
and 
IC 
chemotherapy 
in 
all 
randomized participants
•
PFS by RECIST v1.1 per investigator assessment
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Table 4-1:
Objectives, Endpoints, and Estimands
Objectives
Endpoints
Main Estimand for the Secondary Objective
Treatment: MORAb-202, 25 mg/m2
 IC 
chemotherapy 
Population: Platinum-resistant ovarian cancer
Variable: PFS, defined as the time between the date of randomization and the first date of documented 
progression, determined by the investigator assessments (using RECIST v1.1), or death due to any cause, 
whichever occurs first.
Intercurrent events (strategy): Early discontinuation of study treatment (treatment policy); initiation of 
subsequent anti-cancer therapy prior to PD or death (treatment policy)
Population-level summary: KM estimated median survival time and landmark survival rate of PFS in each 
treatment group
Abbreviations: 
; AE, adverse event; AESI, adverse event of special interest; BOR, best 
overall response; CI, confidence interval; CR, complete response; 
; DCR, disease control 
rate; DoR, duration of response;
 
 
 
 IC, Investigator’s choice; 
; KM, Kaplan Meier; ORR, objective response rate; 
; PD, progressive 
disease; PFS, progression-free survival; 
 PR, partial response; RECIST v1.1, Response 
Evaluation Criteria in Solid Tumors version 1.1; SAE, serious adverse event; SD, stable disease; TRAE, 
treatment-related adverse event;
.
5
STUDY DESIGN
5.1
Overall Design
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Study CA116001 is a Phase 2, open-label, randomized, multicenter study that will evaluate the 
safety, efficacy, and tolerability of MORAb-202 in female participants with platinum-resistant 
HGS ovarian, primary peritoneal, or fallopian tube cancer.
At least 90 evaluable participants will be randomized in a 
 ratio to:
•
(N = 
): MORAb-202 25 mg/m2
•
 (N = 
): IC single-agent chemotherapy: 

Paclitaxel 80 mg/m2 IV on Days 1, 8, 15, and 22 of a 28-day cycle; or

Pegylated liposomal doxorubicin (PLD) 40 mg/m2 IV on Day 1 of a 28-day cycle; or

Topotecan 4 mg/m2 IV on Days 1, 8, and 15 of a 28-day cycle or 1.25 mg/m2 on 
5 consecutive days on Days 1 to 5 of a 21-day cycle
All screening assessments to determine participant eligibility must be performed within 28 days 
prior to randomization (see Table 2-1). 
 
All participants will be treated until disease progression by RECIST v1.1 criteria (as assessed by
the investigator), unacceptable toxicity, participant withdrawal of consent for receiving study 
treatment, death, or the end of study, whichever occurs first. Maximum treatment duration will be 
up to 2 years. .
A Safety Follow-up Visit will be conducted 30 days after the last study drug administration (see
Table 2-5). All ongoing treatment-related SAEs and ILD/pneumonitis events will be followed until 
resolution or stabilization. All participants discontinuing treatment will be followed for tumor 
assessment until investigator-assessed disease progression by RECIST v1.1, death, or withdrawal 
of consent for tumor assessment, whichever occurs first. Subsequently, all participants will be 
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followed for information on progression on next line of therapy and survival every 3 months from 
safety follow-up visit up to 1 year from the last participant randomized or LPLV (30 days after 
last patient last treatment); whichever is later.
5.1.1
Data Monitoring Committee and Other Committees
Given this is an early phase, open-label study, an independent Data Monitoring Committee (DMC) 
is not commissioned. Nonetheless, the safety of the participants will be closely monitored through 
a Safety Committee (SC) including external members to the Sponsor. Additionally, an external 
ILD Expert Review Committee will provide further ILD oversight on the study (see 
Section 5.1.1.1 and Section 5.1.1.2). 
5.1.1.1
Safety Committee (SC)
An SC will be established to provide oversight of the benefit/risk for the participants enrolled in 
the CA116001 study and give advice to the Sponsor regarding actions that the committee deems 
necessary for the continued protection of the participants enrolled. 
 
 
 
The SC will hold regularly-scheduled and ad-hoc meetings to evaluate the ongoing 
benefit/risk for the participants included in the study in the context of internal and external data. 
The SC will perform its first safety review after approximately
 
 
 or earlier if otherwise warranted. 
 
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Following each meeting, the SC will recommend continuation, 
modification, or discontinuation of the dose based on observed benefit/risk profile of each arm. 
Information reviewed at each time point may include disposition, demographics, AEs, SAEs, 
treatment-related AEs (TRAEs), TRAEs leading to discontinuation, exposure, death data, and any 
other data deemed relevant (laboratory, pathology, autopsy reports, physical descriptions, and 
investigator-assessed clinical response). The minutes of these meetings will be documented and 
stored in the Trial Master File. Decisions on safety, toxicity, and benefit/risk regarding the dose 
level will be solely the responsibility of BMS and will take account of the totality of the data 
available. The Oncology Research and Development unit of BMS (or BMS study team) has 
primary responsibility for the design and conduct of the study, including managing the 
communication of study data. The Sponsor will be responsible for promptly reviewing the SC 
recommendations, for providing guidance regarding the continuation or termination of the study, 
and for determining whether amendments to the protocol or changes to the study conduct are 
required. Periodic safety reviews for all arms will continue at a frequency determined and specified 
in the charter.
Procedures related to the committee membership, responsibilities, and procedures will be 
described in the SC Charter.
5.1.1.2
ILD Expert Review Committee
An external independent ILD Expert Review Committee will be established for this study. This 
committee is comprised of independent central ILD expert reviewers who will assess 
 
 for potential ILD/pneumonitis diagnosis from all participants receiving 
MORAb-202 following submission 
 and will 
communicate findings to the site and the Sponsor. Adjudicated ILD/pneumonitis events will be 
submitted to the SC routinely, and when required, sent to Health Authorities for review. Details of 
the ILD Committee membership, responsibilities, and procedures will be described in the 
Committee Charter.
5.2
Number of Participants
Approximately 90 participants will be randomized in a 
 ratio to 1 of 2 treatment groups, about 
 participants in the MORAb-202 arm (
 and 
participants in the IC chemotherapy arm 
(
 It is estimated that approximately 
participants will be enrolled to achieve 
approximately 90 randomized participants, assuming a screen failure rate of approximately 
 
 
5.3
End of Study Definition
The start of the study is defined as the first participant’s first visit.
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The primary completion date is defined as the date on which the last data point is collected for the 
study’s primary endpoint. If the study has multiple primary endpoints, the primary completion date 
is the date on which the last data point is collected for the last primary endpoint.
End of study is defined as the last participant’s last visit.
A participant is considered to have completed the study if he/she has completed all periods of the 
study including the safety and all survival follow-up visits or the last procedure shown in the 
Schedule of Activities.
5.4
Scientific Rationale for Study Design
Study CA116001 is a Phase 2, open-label, randomized, multicenter study to evaluate the safety, 
tolerability, and efficacy of MORAb-202, a FRĮ-targeting ADC in female participants with 
platinum-resistant HGS ovarian, primary peritoneal, or fallopian tube cancer.
Previous studies have demonstrated that 81.7% of recurrent serous ovarian tumors have detectable 
expression of FRĮ by IHC, which can be targeted by MORAb-202.53 Upon binding to FRĮ, 
MORAb-202 is internalized into the tumor cell by endocytosis and is transported into the 
lysosome, where the cathepsin ȕ-cleavable linker is enzymatically cleaved to release the payload, 
eribulin. Unconjugated eribulin has demonstrated significant cytotoxic effects on tumor cells as 
well as to the surrounding TME in cell culture and in tumor xenograft models. These preclinical 
data and the clinical activity of MORAb-202 from early dose exploration and expansion Phase 1/2 
Study 101 and Study 201, support the current study design and further dose exploration. The study 
will evaluate the clinically-active 
 MORAb-202; 25 mg/m2
 
 
The study randomly assigns participants to 1 of 2 cohorts (MORAb-202 25 mg/m2 or Investigator’s 
choice chemotherapy) in a
 ratio, in an effort to balance any variables that may impact study 
outcomes and mitigate potential selection bias. 
 
 
 
The safety profile of the agents in 
the control arm is well defined. Furthermore, this design allows for adequate characterization of 
the benefit/risk profile of each dose cohort and selection of a dose that maximizes tolerability, 
safety, and efficacy in patients with platinum-resistant HGS ovarian, primary peritoneal, or 
fallopian tube cancer, in line with the Food and Drug Administration’s (FDA’s) current initiative 
of oncology drug dose optimization.54,55 To ensure the safety of all participants, the study will be 
closely monitored by an SC and includes prospectively established stopping rules to mitigate 
higher incidence of severe ILD events. Additionally, an external ILD Expert Review Committee 
will provide further ILD oversight on the study (see Section 5.1.1.1 and Section 5.1.1.2).
Emerging data from the dose-confirmation part of Study 201 prompted an ad-hoc SC meeting. The 
Sponsor proposed 
 and this was supported by the SC members. The 
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safety and preliminary efficacy in the 25 mg/m2 cohort support continued investigation of this dose 
level.
5.4.1
Participant Input Into Study Design
BMS approached advocacy groups to discuss key details of the study. Feedback was positive as 
the trial serves a population with a high unmet medical need. This population has a high level of 
burden given the advanced stage of their disease, but may be more familiar with managing 
treatment side effects. Efforts for reducing patient burden have been implemented into the study 
design and will continue to be assessed via Patient Voice interactions. Specific suggestions from 
patient advocates are aligned with the study design as follows:
•
Patient advocates further noted that the inclusion of patients with brain metastasis is a positive 
feature of the study. To address their concern to limit the number of scans as possible, the study 
will only require baseline brain magnetic resonance imaging (MRI) imaging for participants
with a history or symptoms of brain metastasis, and not for all participants. An additional 
request was to provide clarity in the eligibility criteria on prior lines of treatment; detailed 
guidance is now provided in the inclusion criteria on this topic.
•
There was also a recommendation to reduce waiting times in the study design, as longer 
timelines may cause more anxiety, and it is less likely that participants will stay in the study. 
Operational logistics have been streamlined and will require short turnaround times for 
 
 
 
•
Another suggestion was to administer questionnaires separate from the study visit. Taking this 
into consideration and to help minimize the potential burden of participation, this study 
implements decentralized aspects (refer to Appendix 2), such as telemedicine visits when 
appropriate,
In addition, telehealth visits may be implemented 
on this study. 
 eConsent will 
be an option. The eConsent platform will minimize in-person clinic visits and allow for less 
burdensome participation.
5.4.2
Rationale for Open-label Design
This trial will follow an open-label design. Key differences in adverse event profiles, 
administration schedules, dose modifications, and safety management of MORAb-202 and the IC
chemotherapy agents make blinding impractical. The complexity of including multiple visits for 
placebo infusions are burdensome for this participant population. An open-label design will help 
to ensure that the adverse events typically seen with MORAb-202 or IC chemotherapy are 
promptly identified and managed appropriately. 
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5.4.4
Rationale for Choice of Comparators and Dose Justification
In the platinum-resistant setting, OC patients are typically treated with a non-platinum agent used 
as monotherapy, such as paclitaxel, pegylated liposomal doxorubicin, or topotecan. None of these 
agents stand out as superior to others, with similar efficacy but different patterns of side effects. 
The choice among these agents is primarily based on prior therapies, the side effect profile, and 
the clinician’s experience. 
For participants who are randomized 
, the investigator will select a single-agent 
chemotherapy regimen based on individual eligibility criteria to be administered: paclitaxel, PLD, 
or topotecan (see Table 2-1).
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5.4.4.1
Paclitaxel
Paclitaxel is a taxoid antineoplastic agent that interferes with the normal function of microtubule
growth. Paclitaxel promotes the assembly of microtubules from tubulin dimers and stabilizes
microtubules by preventing depolymerization. This stability results in the inhibition of the normal
dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic
cellular functions.67
Paclitaxel is a highly active agent used in front-line treatment of ovarian cancer in combination
with a platinum-based drug. Paclitaxel has been used at several doses and schedules; however, the 
optimal dose for PROC has not been defined. A doseဩdense approach of weekly paclitaxel may be 
associated with greater antitumor potency than Q3W dosing through increased exposure of 
proliferating tumor cells to the drug. The lower doses used with weekly dosing should also 
minimize bone marrow suppression and other toxicities associated with standard paclitaxel 
3-weekly administration.68 In PROC, weekly administration of paclitaxel has shown better 
tolerance compared to the approved 3-weekly schedule and is recommended by the NCCN and 
ESMO guidelines.8,69 A Phase 2 trial reported response rates of 21% in 48 women with both 
platinum- and paclitaxel-resistant ovarian cancer receiving weekly paclitaxel (80 mg/m2/week).
SAEs were relatively uncommon, with 21% and 4% of patients experiencing Grade 2 and Grade 3 
neuropathy, respectively.70 The weekly versus every-3-weeks paclitaxel schedule for treatment of 
advanced ovarian cancer was furthered studied in a randomized Phase 3 trial in women with 
recurrent EOC. Results showed comparable efficacy in platinum resistant patients with ORRs of 
19% in the weekly group and 26% in the every 3 weeks group. However, the toxicity profile 
favored a weekly administration with less neuropathy, arthralgia/myalgia, alopecia, and 
neutropenia observed compared to the 3ဩweekly group.71
These considerations support the dose selection of paclitaxel at 80 mg/m2 weekly as an option for 
participants who are randomized to the IC chemotherapy arm.
5.4.4.2
Pegylated Liposomal Doxorubicin
Pegylated liposomal doxorubicin is a nucleic acid synthesis inhibitor (intercalating agent) 
packaged in a liposome (phospholipid bilayer) surrounded by a polyethylene glycol layer. The 
active ingredient of PLD is doxorubicin hydrochloride. The mechanism of action of doxorubicin 
hydrochloride is thought to be related to its ability to bind DNA and inhibit nucleic acid synthesis. 
The polyethylene glycol hydrophilic polymer protects the doxorubicin liposome from being 
degraded by the reticuloendothelial system in a process called pegylation. This allows for a longer 
circulation time by decreasing uptake in the liver, lowering peak plasma levels of free drug, and 
allowing greater tumor concentration of PLD. PLD represents a novel chemotherapy delivery 
system that improves the therapeutic index of doxorubicin for patients with ovarian cancer.
PLD 40 mg/m2 IV every 4 weeks (Q4W) has been selected as an option for participants who are 
randomized to the IC chemotherapy arm. PLD is an active agent indicated for the treatment of 
patients with ovarian cancer that has progressed or recurred after platinum-based chemotherapy, 
approved at a dose of 50 mg/m2 every 28 days. Clinical studies in this setting have shown that,
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compared with other standard chemotherapy regimens, PLD possesses a non-inferior survival rate 
and is well tolerated, exhibiting reduced alopecia and neurotoxicity.72 The distinguishing toxicity 
of PLD is palmar-plantar erythrodysesthesia (PPE) or hand–foot syndrome (HFS). A Phase 3 trial 
of PLD at a 50 mg/m2 dose in PROC showed an ORR of 12.3%, with 23% of participants 
developing Grade 3 to 4 PPE. Reducing the PLD dose from 50 to 40 mg/m2 every 28 days 
decreases the incidence of PPE from 23% to 8% without affecting therapeutic efficacy.73 A 
recently updated meta-analysis showed that PLD was well-tolerated at the 40 mg/m2 regimen, 
which did not adversely affect survival compared with other single regimens, and confirmed PLD 
40 mg/m2 as a good choice for women in whom monotherapy was a treatment. PLD is widely 
recognized to be administered in clinical practice at an initial dose of 40 mg/m2 rather than at the 
higher approved dose. To emphasize this point, a recent retrospective review at a tertiary cancer 
center revealed that 96% of 321 patients with gynecologic cancer treated with single-agent PLD 
received their initial dose at 40 mg/m2, compared to only 4% of patients treated at 50 mg/m2. These 
considerations support the use of PLD at a dose of 40 mg/m2 in this trial.74
5.4.4.3
Topotecan
Topotecan, a topoisomerase I inhibitor, is a commonly used agent in recurrent ovarian cancer.
Topoisomerase I relieves torsional strain in DNA by inducing reversible single-strand breaks.
Topotecan binds to the topoisomerase I-DNA complex and prevents religation of these single
strand breaks. The cytotoxicity of topotecan is thought to be due to double-strand DNA damage
produced during DNA synthesis, when replication enzymes interact with the ternary complex
formed by topotecan, topoisomerase I, and DNA.75
Topotecan either at a dose of 1.25 mg/m2 IV on consecutive Days 1 to 5 of a 21-day cycle, or at a 
dose of 4.0 mg/m2 IV on Days 1, 8, and 15 of a 28-day cycle has been selected as an option for 
participants who are randomized to the IC chemotherapy arm. The approved topotecan dosing for 
relapsed ovarian cancer is 1.5 mg/m2 as a once-daily infusion for 5 days of a 28-day cycle.
However, a reduced dose of 1.25 mg/m2/day is associated with decreased toxicity and similar
outcomes and is now widely used in routine clinical practice.76
Topotecan is commonly used on a weekly schedule. A randomized trial in 194 women with
platinum-resistant disease from the North Eastern German Society of Gynecologic Oncology
showed there was no difference in survival outcomes between topotecan 5-day treatment
(1.25 mg/m2/day on 5 consecutive days on Days 1 through 5 of a 21-day cycle) or weekly
topotecan (4 mg/m2 on Days 1, 8, and 15 of a 28-day cycle). Compared to the conventional 5-day 
therapy, the weekly dosing significantly reduced the incidence of Grade 3 and 4 hematotoxicity
with relative risk reduction for major adverse events ranging from 62% (neutropenia) to 77%
(thrombocytopenia). The results from this study showed that use of topotecan 4.0 mg/m2 on a 
weekly schedule is associated with a better toxicity profile and tolerability compared with the 
conventional 5-day regimen.77
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These considerations support the use of topotecan either at a dose of 1.25 mg/m2 IV on consecutive
Days 1 to 5 of a 21-day cycle, or at a weekly dose of 4.0 mg/m2 on Days 1, 8, and 15 of a 28-day 
cycle in this trial.
5.4.5
Rationale for Primary Endpoint
ORR is an accepted Phase 2 efficacy endpoint in PROC studies that allows data to be assessed 
earlier and in a smaller study population compared with survival-based endpoints. ORR allows the 
effect to be attributed to a single regimen, removed from subsequent therapies.78 Furthermore, 
clinical data for MORAb-202 has shown significant cytotoxicity and tumor reduction. The 
mechanism of action of the drug indicates direct activity on the tumor; hence, ORR is an 
appropriate measure of activity in this dose-finding study. In this study, ORR will be assessed by 
the investigator using RECIST v1.1 to avoid delays in implementation of subsequent intervention 
in this advanced cancer setting. The tumor response will be further described by the durability of 
responses.
Preliminary data has shown a dose-response relationship in PROC, with a higher ORR, but also 
elevated rates of ILD at higher doses of MORAb-202.11 ORR as a primary endpoint, with safety 
and tolerability as co-primary endpoints, will allow the selection of the dose with the optimal 
benefit/risk profile.
5.5
Justification for Dose
A MORAb-202 dose of 25 mg/m2
 was selected for evaluation in 
CA116001. The dose selection was based on a detailed assessment of PK, exposure-response (E-R) 
efficacy (ORR), and E-R safety (ILD) (see Section 3.2.4.2).
In Study 101 dose escalation phase, multiple doses of MORAb-202 (0.3, 0.45, 0.68, 0.9, and 
1.2 mg/kg Q3W) were assessed and MTD was not reached. In Study 101 dose expansion phase 
 doses were further explored. 
 
 
 The 
next lower dose,0.45 mg/kg evaluated in Study 101 dose escalation, has potential to be efficacious 
and safe based on E-R efficacy and safety analyses. Since the prediction of efficacy for the 0.45 
mg/kg dose is based on a model prediction of efficacy (albeit lower than 0.68 mg/kg) and none of 
the N = 3 PROC participants dosed at 0.45 mg/kg in Study 101 escalation had a tumor response, 
the 0.45 mg/kg dose will be reserved for dose reduction to manage ILD. 
 
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Several different doses and dosing scenarios were simulated using height, weight, and serum 
albumin levels obtained from a previous farletuzumab Phase 3 study in OC.79 Stochastic 
simulations (N=1000) were conducted using the MORAb-202 population PK model to predict 
exposures (AUC) for different dosing scenarios and then AUCs were used to predict ORR and 
ILD rate
44
 
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5.6.2
Tumor Samples
Tumor biopsy specimens (archival and/or fresh samples) will be obtained from consenting 
participants prior to treatment to characterize the tumor microenvironment and assess gene 
expression and tumor genomics. 
 
 
A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (preferred) or 
 unstained slides 
(minimum of 
) of tumor tissue from core biopsy, punch biopsy, excisional biopsy, or surgical 
specimen obtained during screening or prior to enrollment must be sent to the vendor. If slides are 
submitted, the unstained slides should be sectioned within
 from latest FFPE block, which 
should not be more than 
 old.
Fine needle aspirates, other cytology samples, and bone biopsy samples are not acceptable.
An optional biopsy while on treatment may be scheduled within 7 days prior to Cycle 2 Day 1. 
Submission of on-treatment biopsy samples is strongly encouraged unless a biopsy is not clinically 
feasible and provided that the participant’s disease is easily accessible and the tumor biopsies can 
be performed with minimal risk and discomfort. An additional optional biopsy will be performed 
to obtain a tumor sample at time of progression or recurrence (+ 21 days) unless not clinically 
feasible and provided the participant’s disease is easily accessible and the tumor biopsies can be 
performed with minimal risk and discomfort.
5.6.2.1
Tumor Sample Collection
The investigator, in consultation with the radiology staff, must determine the degree of risk 
associated with the procedure and find it acceptable. Biopsies may be done with local anesthesia 
or conscious sedation. Institutional guidelines for the safe performance of biopsies should be 
followed. Excisional biopsies may be performed to obtain tumor biopsy samples. Invasive 
procedures that require general anesthesia should not be performed to obtain a biopsy specimen; 
however, if a surgical procedure is performed for a clinical indication, excess tumor tissue should 
be submitted with the consent of the participant. Detailed instructions of the obtaining, processing, 
labeling, handling, storing, and shipping of specimens will be provided in a separate laboratory 
manual.
5.6.2.2
Characterization of Tumor Microenvironment
IHC or other technologies may be used to assess tumor markers and the tumor microenvironment 
within FFPE tumor tissue before, during, and/or after exposure to therapy. These IHC analyses 
may include, but are not limited to, natural killer cell markers, macrophage markers, and EMT 
markers.
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5.6.2.3
Tumor Genotyping, Mutational Analysis, and Gene Expression Profiling
DNA and/or RNA isolated from the tumor tissue collected at baseline and on treatment may be 
analyzed using next generation sequencing or other appropriate techniques to interrogate 
association of various genomic correlates 
 
 with treatment efficacy or safety. Tumor 
mutational burden may be examined in this study.
 
 
 
 
5.6.2.4
Tumor FRĮ Expression
 
 
 The estimated prevalence of EOC with FRĮ 
expression  75% is approximately 35%.80
 
6
STUDY POPULATION
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted.
6.1
Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
1) Signed Written Informed Consent
a) Participants or their legally acceptable representative (LAR; refer to Appendix 2) must 
have signed and dated an Institutional Review Board (IRB)-/Independent Ethics 
Committee (IEC)-approved written informed consent form (ICF) in accordance with 
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regulatory, local, and institutional guidelines. This must be obtained before the 
performance of any protocol-related procedures that are not part of normal patient care.
b) Participants must be willing and able to comply with scheduled visits, treatment schedule, 
laboratory testing, and other requirements of the study.
2) Type of Participant and Target Disease Characteristics
a) Female participants with histologically-confirmed diagnosis of HGS ovarian, primary 
peritoneal, or fallopian tube cancer.
b) Platinum-resistant disease, defined as:
i)
For participants who had only 1 line of platinum-based therapy: progression between 
> 1 month and  6 months after the last dose of platinum-based therapy of at least 
4 cycles.
ii) For participants who had 2 or 3 lines of platinum-based therapy: progression
 6 months after the last dose of platinum-based therapy.
c) Participants have received at least 1 but no more than 3 prior lines of systemic therapy and 
for whom single-agent therapy is appropriate as the next line of therapy. Participants may 
have been treated with up to 1 line of therapy subsequent to determination of 
platinum-resistance.
i)
Participants must have received prior treatment with bevacizumab or must be deemed 
medically inappropriate or ineligible/intolerant to receive bevacizumab, refused to 
receive bevacizumab, or been unable to receive bevacizumab due to lack of access.
NOTES:
Neoadjuvant ± adjuvant chemotherapy will be considered 1 line of therapy.
Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered part of the 
preceding line of therapy.
Therapy changed in the absence of progression will be considered part of the same line.
d) Disease progression per RECIST v1.1 (by investigator assessment) of at least 1 measurable 
lesion on or after the most recent therapy.
e) Either FFPE tissue (up to 
 old) or newly-obtained biopsies must be available for 
FRĮ assessment prior to randomization. The tumor sample (tissue block [preferred] or a 
minimum of 
 unstained slides) must be evaluable for FRĮ IHC analysis to meet eligibility 
criteria. Sample resubmission will be permitted for participants with non-evaluable FRĮ 
IHC who are otherwise eligible. See Section 5.6.2 for tumor tissue requirements.
f)
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
3) Age of Participant
a) Participant must be  18 years of age (or the legal age of consent in the jurisdiction in 
which the study is taking place) at the time of signing the ICF.
4) Reproductive Status
•
Investigators shall counsel women of childbearing potential (WOCBP, as defined in 
Appendix 4) participants on the importance of pregnancy prevention and the implications of 
an unexpected pregnancy.
•
The investigator shall evaluate the effectiveness of the contraceptive method in relationship to 
the first dose of study intervention.
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•
Local laws and regulations may require the use of alternative and/or additional contraception 
methods.
a) Female Participants:
i)
Female participants must have documented proof that they are not of childbearing 
potential.
(1) Women who are not of childbearing potential (as defined in Appendix 4) are 
exempt from contraceptive requirements.
ii) WOCBP must have a negative highly sensitive serum or urine pregnancy test 
(minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) 
within 24 hours prior to the start of study intervention.
•
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 intervention are in 
Section 2: Schedule of Activities.
•
The investigator is responsible for review of medical history, menstrual history, and recent 
sexual activity to potentially decrease the risk for inclusion of a woman with an undetected 
pregnancy.
iii) WOCBP must agree to follow instructions for method(s) of contraception as described 
below and included in the ICF.
•
WOCBP are permitted to use hormonal contraception methods (as described in Appendix 4).
iv) A female participant is eligible to participate if she is not pregnant or breastfeeding, 
and at least 1 of the following conditions applies:
(1) Is not a WOCBP
OR
(2) Is a WOCBP and using a contraceptive method that is highly effective (with a 
failure rate of < 1% per year), with user independent methods, as described in 
Appendix 4, during the intervention period and for at least 28 days before dosing 
and throughout the study and for 90 days after MORAb-202 discontinuation and 
agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the 
same period. For 
 participants, WOCBP are required to use a highly effective 
contraceptive method during the intervention period and for at least 28 days before 
dosing and throughout the study and for 6 months after IC chemotherapy 
discontinuation and agrees not to donate eggs (ova, oocytes) for the purpose of 
reproduction for the same period.
6.2
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
1) Medical Conditions
a) Clear cell, mucinous, endometrioid or sarcomatous histology, or mixed tumors containing 
components of any of these histologies, or low grade or borderline ovarian cancer.
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b) Primary platinum-refractory ovarian cancer defined as disease progression within 1 month 
of the last dose of the first line platinum-containing regimen.
c) Pulmonary function test (PFT) abnormalities: FEV1 < 70% or FVC < 60%, and
DLCO < 80%.
d) Investigator-assessed current ILD/pneumonitis, or ILD/pneumonitis suspected at screening 
or history of ILD/pneumonitis of any severity including ILD/pneumonitis from prior 
anti-cancer therapy.
e) Current infectious pneumonia, history of viral pneumonia (including COVID-19-related 
infection) with evidence of persistent radiologic abnormalities.
f)
Significant third-space fluid retention (eg, ascites or pleural effusion) that requires repeated 
drainage.
g) Clinically significant pericardial effusion requiring drainage.
h) Prior pneumonectomy. Prior lobectomy and segmentectomy are allowed >12 months 
before treatment.
i)
Recent chest radiotherapy. Participants with chest or chest wall radiation (eg, history of 
breast cancer) may be permitted if the radiation is documented > 6 months before starting 
study treatment.
j)
Any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, 
Sjögren’s syndrome, sarcoidosis, etc) where there is documented (or suspicion of) 
pulmonary involvement.
k) Spinal cord compression or untreated, symptomatic central nervous system (CNS) 
metastases. Participants are eligible if CNS metastases are asymptomatic and do not require 
immediate treatment, or have been treated and participants have neurologically returned to 
baseline (except for residual signs or symptoms related to the CNS treatment). In addition, 
participants have discontinued anticonvulsant therapy and must have been either off 
corticosteroids, or on a stable or decreasing dose of  10 mg daily prednisone (or 
equivalent) for at least 2 weeks prior to treatment. Imaging performed within 28 days prior 
to treatment must document radiographic stability of CNS lesions and be performed after 
completion of any CNS-directed therapy.
l)
Concurrent malignancy (present during screening) requiring treatment, or history of prior 
malignancy active within 2 years prior to randomization (ie, participants with a history of 
prior malignancy are eligible if treatment was completed at least 2 years before 
randomization and the participant has no evidence of disease). Participants with history of 
prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that 
have undergone definitive treatment at any time are also eligible.
m) Participants with a condition requiring systemic treatment with either corticosteroids 
> 10 mg daily prednisone equivalents or other immunosuppressive medications within 
14 days of study treatment administration, except for steroid adrenal replacement where 
doses of > 10 mg daily prednisone equivalent, are allowed in the absence of active 
autoimmune disease.
i)
Treatment with a short course (< 5 days) of steroids up to 7 days prior to initiating study 
treatment is permitted.
n) Evidence of active infection including tuberculosis and uncontrolled infection requiring 
systemic antibacterial, antiviral, or antifungal therapy  14 days prior to treatment.
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o) Previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, either 
suspected or confirmed within 4 weeks prior to screening. Additionally, acute symptoms 
must have completely resolved and based on the investigator assessment in consultation 
with the BMS Medical Monitor (or designee), there are no sequelae that would place the 
participant at a higher risk of receiving investigational treatment.
i)
Note: COVID-19 polymerase chain reaction (PCR) viral testing may be required prior 
to randomization based on specific country/regional guidelines, and the result of this 
testing may impact study participation. Testing results should be discussed with the 
BMS Medical Monitor (or designee) to confirm eligibility.
p) Evidence of active bleeding or bleeding susceptibility; or medically significant hemorrhage 
within 3 months prior to enrollment.
q) Known 
human 
immunodeficiency 
virus 
(HIV) 
positive 
with 
an 
acquired 
immunodeficiency syndrome (AIDS) defining opportunistic infection within the last year, 
or a current CD4 count < 350 cells/ȝL. Participants with HIV are eligible if:
i)
They have received antiretroviral therapy (ART) for at least 4 weeks prior to 
randomization as clinically indicated while enrolled on study.
ii) They continue on ART as clinically indicated while enrolled on study.
iii) CD4 counts and viral load are monitored per standard of care by a local health care 
provider.
NOTE: Testing for HIV must be performed at sites where mandated locally. HIV positive 
participants must be excluded where mandated locally.
r)
Has a known history of active TB (bacillus tuberculosis).
s) History of active chronic hepatitis as evidenced by the following:
i)
Any positive test result for hepatitis B virus (HBV) indicating presence of virus, eg, 
hepatitis B surface antigen (HBsAg, Australia antigen) positive.
ii) Any positive test result for hepatitis C virus (HCV) indicating presence of active viral 
replication (detectable HCV-ribonucleic acid [RNA]). Note: Participants with positive 
HCV antibody and an undetectable HCV RNA are eligible to enroll.
iii) Additional testing or substitute testing per institutional guidelines to rule out infection 
is permitted.
t)
Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment, 
including, but not limited, to any of the following: 
i)
Cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery 
bypass graft surgery, symptomatic peripheral vascular disease, class III or IV 
congestive heart failure (as defined by the New York Heart Association; refer to
Appendix 9), pericarditis, or myocarditis.
ii) Ongoing symptomatic cardiac dysrhythmias, history of clinically significant 
arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de 
pointes).
u) History of deep vein thrombosis (DVT) within 6 weeks prior to enrollment. Participants 
who completed at least 1 month of anticoagulation prior to starting study treatment and 
continue while on study are eligible.
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i)
Participants at risk for DVT secondary to central venous catheters or with past medical 
history of DVT or clinical symptoms suggestive of DVT must have venous Doppler 
ultrasonography to rule out DVT during the screening period and prior to initiation of 
study treatment.
v) Any condition requiring folate supplementation (eg, folate deficiency).
w) Uncontrolled medical disorders that, in the opinion of the investigator or Sponsor, may 
increase the risk associated with study participation or study drug administration, impair 
the ability of the participant to receive protocol therapy, or interfere with the interpretation 
of study results.
x) For 
 participants intended to receive Investigator’s choice of PLD: Left ventricular 
ejection fraction (LVEF) below institutional lower limit of normal or below 50%,
whichever is lower.
2) Prior/Concomitant Therapy
a) Time from the end of prior anticancer therapy to the first administration of the study drug:
i)
Radiation therapy (other than bone or chest):  4 weeks.
ii) Bone radiation therapy:  2 weeks.
iii) Chemotherapy, endocrine therapy, or small-molecule targeted therapy: < 2 weeks or 
5 half-lives, whichever is shorter.
iv) Immunotherapy, antibody, and other biologic therapeutic agents: < 4 weeks or 
5 half-lives, whichever is shorter.
v) Investigational product(s) (IPs) < 4 weeks or 5 half-lives, whichever is shorter.
b) Any major surgery within 4 weeks of the first dose of study treatment. Participants must 
have recovered from the effects of major surgery or significant traumatic injury at least 
14 days before the first dose of study treatment.
c) Resolution of anticancer therapy-related or radiation-related toxicities to Grade 1 (National 
Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 [NCI 
CTCAE v5.0) severity or lower prior to start of study treatment, except for stable sensory 
neuropathy (Grade  2), anemia (hemoglobin  9.0 g/dL), and alopecia (any grade). 
d) Treatment with any live/attenuated vaccine within 30 days of first study treatment.
e) Treatment with complementary medications (eg, herbal supplements or traditional Chinese 
medicines) to treat the disease under study within 2 weeks prior to first study treatment. 
Such medications are permitted if they are used as supportive care. See Section 7.7.1 for 
prohibited therapies.
f)
Prior treatment with an investigational FRĮ-targeting agent and FRĮ-targeting ADC.
3) Physical and Laboratory Test Findings
a) Evidence of organ dysfunction or any clinically-significant deviation from normal in 
physical examination, vital signs, ECG, or clinical laboratory determinations beyond 
what is consistent with the target population.
i)
Inadequate renal function as evidenced by calculated creatinine clearance 
(CrCl) < 50 mL/minute according to a 12- or 24-hour urine collection.
ii) Inadequate bone marrow function, as evidenced by:
(1) Absolute neutrophil count (ANC) < 1.0 × 109/L
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(2) Hemoglobin < 9.0 g/dL
(3) Platelet count < 100 × 109/L
NOTE: Supportive therapies such as blood/platelet transfusion, hematopoietic stimulating 
agent including granulocyte colony-stimulating factor (G-CSF) formulation needed to achieve 
the above values are allowed, as per institutional practice, if given  1 week before study 
treatment.
iii) Inadequate liver function, as evidenced by:
(1) Total bilirubin > 1.5× upper limit of normal (ULN) except for unconjugated 
hyperbilirubinemia (eg, Gilbert’s syndrome, who must have a total bilirubin 
< 3× ULN).
(2) Alkaline phosphatase (ALP), alanine aminotransferase (ALT) and aspartate 
aminotransferase (AST) > 3× ULN (in the case of liver metastases > 5× ULN) 
unless there are bone metastases. Participants with alkaline phosphatase (ALP) 
> 3× ULN, unless they and are known to have bone metastases in which case higher 
ALP values will also be allowed. In case ALP is > 3× ULN (in absence of liver 
metastases) or > 5× ULN (in presence of liver metastases) and participant is also 
known to have bone metastases, the liver-specific ALP must be separated from the 
total and used to assess the liver function instead of the total ALP.
iv) Serum albumin < 3.0 g/dL.
b) Clinically significant ECG abnormality, including marked prolonged baseline QTcF 
(repeated demonstration of a QTcF interval > 480 msec). A history of risk factors for 
torsade de pointes (eg, heart failure, hypokalemia, family history of long QT Syndrome) or 
the use of concomitant medications that prolong the QTcF.
4) Allergies and Adverse Drug Reactions
a) Has any prior severe hypersensitivity ( Grade 3) to monoclonal antibodies or eribulin or 
contraindication to the receipt of corticosteroids or any of the excipients (investigators 
should refer to the prescribing information for the selected corticosteroid).
b) History of allergy or contraindication to IC chemotherapy agent selected if randomized  
.
5) Other Exclusion Criteria
a) Male participants.
b) Participants are unable to follow contraception guidelines as specified in the protocol.
c) Prisoners or participants who are involuntarily incarcerated. (Note: Under certain specific 
circumstances and only in countries where local regulations permit, a person who has been 
imprisoned may be included or permitted to continue as a participant. Strict conditions 
apply, and Sponsor approval is required.)
d) Participants who are compulsorily detained for treatment of either a psychiatric or physical 
illness (eg, infectious disease).
e) Participants currently in other interventional trials, including those for COVID-19, may not 
participate in BMS clinical trials until the protocol specific washout period is achieved. If 
a study participant has received an investigational COVID-19 vaccine or other 
investigational product (IP) designed to treat or prevent COVID-19 prior to screening, 
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enrollment must be delayed until the biologic impact of the vaccine or IP is stabilized, as 
determined by documented discussion between the investigator and the Medical Monitor 
(or designee).
6.3
Lifestyle Restrictions
Not applicable. No restrictions are required.
6.4
Screen Failures
Screen failures are defined as participants who consent to participate in the clinical study but who 
are not subsequently randomized in the study/included in the analysis population. 
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, as applicable, and to respond to queries from regulatory authorities. 
Minimal information includes date of consent, demography, screen failure details, eligibility 
criteria, and any serious adverse events (SAEs) that occurred following consent.
6.4.1
Re-testing During Screening 
This study permits the re-enrollment of a participant who has discontinued the study as a screen
failure (ie, participant has not been randomized/has not been treated). If re-enrolled, the participant 
must be re-consented and all other screening activities must be met within the designated screening 
window.
Re-testing of laboratory parameters and/or other assessments within any single screening or lead-in 
period will be permitted (in addition to any parameters that require a confirmatory value).
The most current result prior to randomization is the value by which study inclusion will be 
assessed because it represents the participant’s most current clinical state.
Laboratory parameters and/or assessments that are included in Table 2-1, Screening Procedural 
Outline, may be repeated in an effort to find all possible well-qualified participants. Consultation 
with the Medical Monitor may be needed to identify whether repeat testing of any particular 
parameter is clinically relevant.
7
STUDY INTERVENTION(S) AND CONCOMITANT THERAPY
Study intervention is defined as any investigational intervention(s), marketed product(s), placebo, 
procedure(s), or medical device intended to be administered to a study participant according to the 
study protocol.
Study intervention includes both Investigational [Medicinal] Product (IP/IMP) and 
Non-investigational/Auxiliary [Medicinal] Product (Non-IP/Non-IMP/AxMP) as indicated in
Table 7.1-1.
An IP, also known as an IMP in some regions, is defined as a pharmaceutical form of an active 
substance or placebo being tested or used as a reference in a clinical study, including products 
already with a marketing authorization but used or assembled (formulated or packaged) differently 
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from the authorized form, used for an unauthorized indication, or when used to gain further 
information about the authorized form.
Other medications used as support or escape medication for preventative, diagnostic, or therapeutic 
reasons, as components of the standard of care for a given diagnosis may be considered 
Non-IMPs/AxMPs.
7.1
Study Interventions Administered
Table 7.1-1:
Study Intervention(s) Administered
Type/
Intervention 
Name/
Dose 
Formulation
Unit Dose 
Strength(s)
IMP/Non-
IMP/AxMP
Blinded or 
Open-label 
Use
Sourcing
Packaging 
and Labeling
Current/
Former 
Name(s) or 
Alias(es)
MORAb-202 
Lyophilized 
Powder in a Single 
Use Vial
 mg/mL
IMP
Provided 
centrally by the 
Sponsor
Study 
intervention 
will be 
provided in 
vials. Each 
vial will be 
labeled as 
required per 
country 
requirement.
--
Paclitaxel
6 mg/mL
IMP
Provided 
centrally by the 
Sponsor or 
locally by the 
trial site, 
subsidiary, or 
designee
Study 
intervention 
will be 
provided in 
vials. Each 
vial will be 
labeled as 
required per 
country 
requirement
Paclitaxel 
Bendalis
Pegylated 
Liposomal 
Doxorubicin 
(PLD)
2 mg/mL
IMP
Provided 
centrally by the 
Sponsor or 
locally by the 
trial site, 
subsidiary, or 
designee
Study 
intervention 
will be 
provided in 
vials. Each 
vial will be 
labeled as 
required per 
country 
requirement
Caelyx 
Pegylated 
Liposomal
Doxorubicin
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Table 7.1-1:
Study Intervention(s) Administered
Type/
Intervention 
Name/
Dose 
Formulation
Unit Dose 
Strength(s)
IMP/Non-
IMP/AxMP
Blinded or 
Open-label 
Use
Sourcing
Packaging 
and Labeling
Current/
Former 
Name(s) or 
Alias(es)
Topotecan
1 mg/mL
IMP
Provided 
centrally by the 
Sponsor or 
locally by the 
trial site, 
subsidiary, or 
designee
Study 
intervention 
will be 
provided in 
vials. Each 
vial will be 
labeled as 
required per 
country 
requirement
Hycamtin
Abbreviations: AxMP, auxiliary medicinal product; IMP, investigational medicinal product; PLD, pegylated 
liposomal doxorubicin.
Table 7.1-2:
Study Arm(s)
Arm Title/
Arm Type
Intervention Description/
Dosage Levels
Route of Administration
MORAb-202 25 mg/m2
 
IV infusion
 a
Paclitaxel 80 mg/m2 on Days 1, 8, 15, 
and 22 of a 28-day cycle
IV infusion 
PLD 40 mg/m2 on Day 1 (±3 days) of 
a 28-day cycle
IV infusion
Topotecan 1.25 mg/m2 on 
5 consecutive days on Days 1 to 5 of a 
21-day cycle
IV infusion
Topotecan 4.0 mg/m2 on Days 1, 8, 
and 15 of a 28-day cycle
IV infusion 
Abbreviation: IV, intravenous, PLD, pegylated liposomal doxorubicin.
a The investigator will select paclitaxel, topotecan, or PLD as the single-agent chemotherapy prior to participant 
randomization.
7.1.1
MORAb-202 Administration
Participants will receive MORAb-202 at a dose 25 mg/m2
, for a 
maximum treatment duration of 2 years, or until disease progression, unacceptable toxicity, death, 
withdrawal of consent, or the study ends, whichever occurs first.
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Table 7.1.1-1:
Administration of MORAb-202
Study Intervention
Cycle 1 Day 1,
onwards
Notes
Premedication
Acetaminophen/paracetamol 400 to 600 mg 
orally or clinical equivalent per clinic routine
X
Premedication will be administered 30 to 60 minutes prior to the first infusion of 
MORAb-202.
If no infusion reactions are observed, premedications will not be administered with 
subsequent MORAb-202 infusions.
Monitor participants carefully for infusion reactions during each MORAb-202 
administration. If an acute infusion reaction is noted, manage participants according to Table 
7.4.1-2.
 
MORAb-202 25 mg/m2 
 
X
Participants must receive the first dose of study treatment within 3 calendar days from 
randomization, unless previously discussed with Medical Monitor (or designee).
MORAb-202 will be administered as an intravenous (IV) infusion 
 
for a maximum treatment duration of 2 years, until disease progression, 
unacceptable toxicity, withdrawal of consent, death, or the study ends, whichever occurs 
first.
Participants may be dosed no less than 18 days from the previous dose.
 
 
Doses of MORAb-202 may be reduced, interrupted, delayed, or discontinued depending on 
how well the participant tolerates the treatment (see Section 7.4.1 for dose modifications for 
management of TRAEs). Dosing visits are not skipped, only delayed.
The first infusion of MORAb-202 will be given over no less than 60 minutes. If no infusion 
reactions are observed, subsequent infusions can be infused as tolerated, but given over no 
less than 30 minutes.
Flush the intravenous line with an appropriate amount of diluent (eg, 0.9% sodium chloride) 
to ensure that the complete dose is administered.
Abbreviations: 
IV, intravenous; TRAE, treatment-related adverse event.
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Please refer to the current Investigator’s Brochure and/or Pharmacy Manual for further details 
regarding storage, preparation, and handling of MORAb-202.
Care must be taken to assure sterility of the prepared solution as the product does not contain any 
antimicrobial preservative or bacteriostatic agent. 
7.1.2
Preparation and Administration of Paclitaxel
Paclitaxel will be prepared according to institutional standards or the approved local Product 
Label. Paclitaxel will be administered at a dose of 80 mg/m2 by IV infusion over 60 minutes on 
Days 1, 8, 15, and 22 of a 28-day cycle.
Participants should be premedicated prior to paclitaxel administration to prevent severe 
hypersensitivity reactions, per the approved local Product Label. Such premedication may consist 
of dexamethasone 20 mg by mouth (per os [PO]) administered approximately 12 and 6 hours 
before paclitaxel, diphenhydramine (or its equivalent) 50 mg IV 30 to 60 minutes prior to 
paclitaxel, and cimetidine (300 mg) or ranitidine (50 mg) IV 30 to 60 minutes before paclitaxel.
Use BSA for dosing calculations using height measured at screening, and weight measured on 
Day 1 of each cycle (or up to 3 days prior to Day 1). Round all doses to the nearest milligram per 
institutional standard.
Doses of paclitaxel may be reduced, interrupted, delayed, or discontinued depending on how well 
the participant tolerates the treatment (see Section 7.4.2 for dose modifications for management of 
TRAEs). Dosing visits are not skipped, only delayed.
Please refer to the approved local Product Label for complete details regarding storage, 
preparation, and handling of paclitaxel.
7.1.3
Preparation and Administration of Pegylated Liposomal Doxorubicin
PLD will be prepared according to institutional standards or the approved local Product Label. 
PLD will be administered at dose of 40 mg/m2 by IV infusion at an initial rate of 1 mg/min on 
Day 1 (± 3 days) of a 28-day cycle. After Cycle 1, if tolerated, PLD can be administered as a 
60-minute infusion. Use BSA for dosing calculations using height measured at screening, and 
weight measured on Day 1 of each cycle (or up to 3 days prior to Day 1). Round all doses to the 
nearest milligram per institutional standard. 
Doses of PLD may be reduced, interrupted, delayed, or discontinued depending on how well the 
participant tolerates the treatment (see Section 7.4.3 for dose modifications for management of 
TRAEs). Dosing visits are not skipped, only delayed.
The minimum time interval between 2 consecutive PLD doses cannot be < 24 days.
Please refer to the approved local Product Label for complete details regarding storage, 
preparation, and handling of PLD.
7.1.4
Preparation and Administration of Topotecan
Topotecan will be prepared according to institutional standards or the approved local Product 
Label. Topotecan will be administered as a 21-day cycle regimen or a 28-day cycle regimen. For 
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a 21-day cycle, topotecan will be administered at a dose of 1.25 mg/m2 by IV infusion over 
30 minutes on Days 1 to 5 of a 21-day cycle. For a 28-day cycle, topotecan will be administered 
at dose of 4 mg/m2 by IV infusion over 30 minutes on Days 1, 8, and 15 of a 28-day cycle. Use 
BSA for dosing calculations using height measured at screening, and weight measured on Day 1 
of each cycle (or up to 3 days prior to Day 1). Round all doses to the nearest milligram per 
institutional standard.
Doses of topotecan may be reduced, interrupted, delayed, or discontinued depending on how well 
the participant tolerates the treatment (see Section 7.4.4 for dose modifications for management of 
TRAEs). Dosing visits are not skipped, only delayed.
Please refer to the approved local Product Label for complete details regarding storage, 
preparation, and handling of topotecan.
7.1.5
Calculation of Dose Based on Body Surface Area
Before dose administration, the amount of study treatment needed for each participant will be 
calculated in the following manner:
Dose (mg) = scheduled dose (mg/m2) × body surface area (BSA) (m2)
BSA will be calculated using any accepted method customarily used by the clinical site, such as 
the Haycock, Du Bois and Du Bois or the Mosteller formula:
•
BSA (m2) = 0.024265 × Height (cm)^0.3964 × Weight (kg)^0.5378 (Haycock)81
•
BSA (m2) = 0.007184 × Height (cm)^0.725 × Weight (kg)^0.425 (Du Bois and Du Bois)82
•
BSA (m2) = ([Height (cm) × Weight (kg)]/3600)½ (Mosteller)83
7.2
Assignment to Study Intervention
All participants will be centrally randomized 
 using Interactive 
Response Technology (IRT). Before the study is initiated, each user will receive log-in information 
and directions on how to access the IRT.
Study intervention will be dispensed at the study visits as listed in Schedule of Activities 
(Section 2). 
After the participant’s informed consent has been obtained and initial eligibility is established, the 
participant must be enrolled into the study by using IRT to obtain the participant number. Every 
participant who signs the ICF must be assigned a participant number in IRT. Specific instructions 
for using IRT will be provided to the investigational site in a separate document. The investigator
or designee will register the participant for enrollment by following the enrollment procedures 
established by the Sponsor.
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After enrollment in the IRT, participants who have met all eligibility criteria will be randomized 
through the IRT.
The IC chemotherapy must be identified prior to randomization and captured in both IRT and 
eCRFs. The selection of agent and regimen may not be changed after the participant has been 
randomized and prior to the first dose unless discussed with and approved by the Medical Monitor 
(or designee).
7.3
Blinding
Not applicable as this is a randomized open-label study; it has been determined that blinding is not 
required to meet study objectives and access to treatment assignment information is unrestricted. 
Aggregate data by arm will be provided only for Safety Committee review. The specific treatment 
to be taken by a participant will be assigned using IRT. The site will contact the Interactive 
Response System prior to the start of study intervention administration for each participant. The 
site will record the treatment assignment on the case report form (CRF).
The bioanalytical laboratory will receive treatment assignments in order to minimize unnecessary 
analysis of samples.
7.4
Dosage Modification
Recommendations for dose reduction, delay, interruption, or discontinuation of individual study 
drugs in the management of study drug-related adverse reactions are summarized below. For 
additional information, please refer to individual drug labels. Clinical judgment of the treating 
physician should guide the management plan of each participant based on individual benefit/risk 
assessment. However, for events requiring a discontinuation, treatment must be discontinued. Any 
changes to the dose must be recorded on the appropriate electronic case report form (eCRF).
7.4.1
Dose Modification for MORAb-202
For participants who experience toxicity but meet criteria for dose modification, the next 
administration of MORAb-202 should be reduced 1 dose level lower (see Table 7.4.1-1). Once a 
dose is decreased, it cannot be increased again.
Table 7.4.1-1:
MORAb-202 Dose Levels
Dose level
MORAb-202
Starting dose
25 mg/m2
First dose reduction (Dose level -1)
Only 1 dose level reduction is allowed. If more than 1 dose level reduction is required, study 
treatment must be discontinued.
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Table 7.4.1-2:
Recommended Dose Modifications and Management for MORAb-202 Treatment-related Adverse 
Events
Drug-related 
Adverse Event
per CTCAE v5.0
Severity
Action Taken
Infusion-related reaction
Infusion-related 
reaction
Grade 1
•
Supervise at bedside and continue the infusion of MORAb-202, or manage the infusion per institutional 
standard (eg, suspending infusion).
•
If necessary, give 400 to 600 mg orally (PO) acetaminophen/paracetamol, either alone or in combination 
with diphenhydramine 30 to 50 mg PO or intravenous (IV). Equivalent premedications may be used, as 
per local standard of care.
•
If the infusion is interrupted, then restart the infusion at 50% of the original infusion rate when symptoms 
resolve. If no further complications ensue after 30 minutes, the rate may be increased to 100% of the 
original infusion rate. Monitor participant closely. If symptoms recur, then no further study medication 
will be administered at that visit.
•
Subsequent prophylaxis: 

Administer acetaminophen 1000 mg PO + diphenhydramine 30 to 50 mg PO ± ranitidine 50 mg IV 
or famotidine 20 mg IV; equivalent medications may be used, as per local standard of care.

Administer 30 to 60 minutes prior to MORAb-202 infusion.
Grade 2
•
Suspend the infusion of MORAb-202.
•
Give 400 to 600 mg acetaminophen/paracetamol PO, either alone or in combination with diphenhydramine 
30 to 50 mg PO or IV.
•
Restart the infusion at 50% of the original infusion rate when symptoms resolve. If no further complications 
ensue after 30 minutes, the rate may be increased to 100% of the original infusion rate. Monitor participant 
closely. If symptoms recur, then no further study medication will be administered at that visit.
•
Subsequent prophylaxis:

Administer acetaminophen 1000 mg PO + diphenhydramine 30 to 50 mg PO ± ranitidine 50 mg IV or 
famotidine 20 mg IV ± dexamethasone 20 mg IV; equivalent medications may be used, as per local 
standard of care.

Administer 30 to 60 minutes prior to MORAb-202 infusion.
•
Note: No MORAb-202 dose reduction by 1 dose level is needed if symptoms are resolved at next cycle.
See Table 7.4.1-1.
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Table 7.4.1-2:
Recommended Dose Modifications and Management for MORAb-202 Treatment-related Adverse 
Events
Drug-related 
Adverse Event
per CTCAE v5.0
Severity
Action Taken
•
If Grade 2 infusion reactions occur despite subsequent prophylaxis, MORAb-202 must be permanently 
discontinued.
Grade 3 or 4
•
Permanently discontinue.
Pulmonary
Interstitial Lung 
Disease 
(ILD)/Pneumonitis
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Table 7.4.1-2:
Recommended Dose Modifications and Management for MORAb-202 Treatment-related Adverse 
Events
Drug-related 
Adverse Event
per CTCAE v5.0
Severity
Action Taken
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Table 7.4.1-2:
Recommended Dose Modifications and Management for MORAb-202 Treatment-related Adverse 
Events
Drug-related 
Adverse Event
per CTCAE v5.0
Severity
Action Taken
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Table 7.4.1-2:
Recommended Dose Modifications and Management for MORAb-202 Treatment-related Adverse 
Events
Drug-related 
Adverse Event
per CTCAE v5.0
Severity
Action Taken
Hematological
Neutrophil count 
decreased
Grade  3
Hold MORAb until absolute neutrophil count (ANC) is  1000/ȝL
Grade 4
Dose reduce 1 level (Table 7.4.1-1) if lasting > 7 days
Febrile neutropenia
Grade  3
Hold MORAb-202 until < 38°C (100.4°F) + ANC  1000/ȝL
Dose reduce 1 level (Table 7.4.1-1) if Grade  3 febrile neutropenia (fever > 38°C [100.4°F] + ANC < 1000/ȝL)
Platelet count 
decreased
Grade  2
Hold MORAb-202 until platelet count is  75,000/ȝL
Dose reduce 1 level (Table 7.4.1-1) if:
•
Thrombocytopenia Grade 4 on 2 separate days, or requiring a platelet transfusion on 2 separate days, within 
a 7-day period.
•
Thrombocytopenia Grade  3 complicated by bleeding and/or requiring platelet or blood transfusion.
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Table 7.4.1-2:
Recommended Dose Modifications and Management for MORAb-202 Treatment-related Adverse 
Events
Drug-related 
Adverse Event
per CTCAE v5.0
Severity
Action Taken
Other
All other 
laboratory
abnormalities
(both symptomatic 
and asymptomatic)
Grade  3
•
Hold MORAb-202 until resolution to Grade  1 or baseline.
•
Dose reduce 1 level (Table 7.4.1-1).
•
Do not dose reduce for Grade 3 labs without clinical significance, such as hypophosphatemia, 
hypocalcemia, or hypomagnesemia responsive to oral supplementation, which resolve to baseline or
Grade 1 within 48 hours.
All other non-
hematologic 
toxicities:
Grade  3
Hold MORAb-202 until resolution to Grade  1 or baseline.
Dose reduce 1 level after AE resolves, except:
•
Grade 3 fatigue for < 5 days.
•
Diarrhea, nausea, and vomiting, unless lasting > 3 days despite optimal supportive care
Abbreviations: AE, adverse event;
 ; ANC, absolute neutrophil count;
; CTCAE v5.0, Common 
Terminology Criteria for Adverse Events version 5.0; ILD, interstitial lung disease; IV, intravenous; PO, per os (oral route of administration); 
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7.4.1.1
Criteria to Resume MORAb-202 Treatment
Starting Next Cycle:
To start the next cycle of MORAb-202 administration, participants must meet the following 
minimum requirements plus be appropriate for additional cycles per investigator judgment:
•
ANC  1000/ȝL
•
Platelet count  75,000/ȝL
•
All non-hematologic toxicity has resolved to Grade  1 or baseline.
•
Participants with Grade  2 peripheral neuropathy should not be retreated until neuropathy is 
Grade < 2, except for stable sensory neuropathy that was present at baseline, which can be 
Grade  2, as per exclusion criterion 2) c).
•
All Grade  3 laboratory abnormalities even if asymptomatic must be corrected to Grade  1 
or baseline.
•
Meet the requirements for dosing (see Table 7.4.1-2).
Dose Reduction for the Next Cycle:
For participants who experience toxicity and meet criteria for dose modification, the next 
administration of MORAb-202 should be reduced 1 dose level lower (see Table 7.4.1-1 for dose 
levels). Once a dose is decreased, it cannot be increased again. Only one dose level reduction is 
allowed.
Postponement of Next Cycle:
MORAb-202 administration in subsequent cycles may be postponed 
 to recover 
from any toxicities. Treatment delay 
 may be allowed in participants with 
ILD/pneumonitis to allow for recovery, which requires consultation with and approval from the 
Sponsor’s Medical Monitor.
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7.4.2
Dose Modification for Paclitaxel
Table 7.4.2-1:
Dose Modification for Paclitaxel
Drug-related AE per 
CTCAE v5.0
Severity
Action Taken
Hematologic Toxicities
Grade 1
Investigator judgement to continue or interrupt paclitaxel 
treatment. 
Grade 2 or 3
Hold paclitaxel until ANC and platelet levels meet the 
following criteria:
•
Day 1: 

ANC  1.5 × 109/L (1,500/ȝL), and

Platelets  100 × 109/L (100,000/ȝL)
•
Day 8, 15, and 22: 

ANC  1.0 × 109/L (1,000/ȝL), and

Platelets  100 × 109/L (100,000/ȝL)
Retreat at same dose level.
Grade 4
Hold paclitaxel until ANC and platelet levels meet the 
following criteria:
•
Day 1: 

ANC  1.5 × 109/L (1,500/ȝL), and

Platelets  100 × 109/L (100,000/ȝL)
•
Day 8, 15, and 22: 

ANC  1.0 × 109/L (1,000/ȝL), and

Platelets  100 × 109/L (100,000/ȝL)
Dose reduce by 1 level.
For febrile neutropenia and/or severe bleeding, permanently discontinue paclitaxel.
Non-hematologic 
Toxicities
Grade 1
Investigator judgement to continue or interrupt paclitaxel 
treatment. 
Grade 2
•
Investigator judgement to continue or interrupt paclitaxel 
treatment. 
•
For participants experiencing neuropathy, dose reduce by 
1 level.
•
Dose delay if:

Total bilirubin > 1× ULN or if AST and/or ALT > 1.5×
ULN occurs concomitant with ALP > 2.5× ULN.
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Table 7.4.2-1:
Dose Modification for Paclitaxel
Drug-related AE per 
CTCAE v5.0
Severity
Action Taken
Grade 3 or 4
•
Hold paclitaxel until the event resolves or improves to Grade 
1. Dose reduce by 1 level.
•
Grade 3 lymphopenia does not require a dose delay.
•
Grade 
3 neuropathy lasting > 7 days permanently 
discontinue paclitaxel
Abbreviations: AE, adverse events; ALP, alkaline phosphatase; ALT, alanine aminotransferase; ANC, absolute 
neutrophil count; AST, aspartate aminotransferase; CTCAE v5.0, Common Terminology Criteria for Adverse Events 
version 5.0; ULN, upper limit of normal.
Subsequent dose reductions may be required, per Section 7.4.2.1. 
A dose given more than 3 days after the intended dose date will be considered a dose delay. Longer 
delays may be allowed following discussion with the Medical Monitor (or designee).
7.4.2.1
Dose Reduction for Paclitaxel
The full dose of paclitaxel is 80 mg/m2. This dose may be reduced by 1 dose level to 70 mg/m2
and subsequently by 1 more dose level to 60 mg/m2. In the case of any toxicity requiring more 
than 2 dose reductions, paclitaxel must be discontinued, unless the participant is benefitting from 
therapy.
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7.4.3
Dose Modification for Pegylated Liposomal Doxorubicin (PLD)
Table 7.4.3-1:
Dose Modification for Pegylated Liposomal Doxorubicin (PLD)
Drug-related AE 
per CTCAE v5.0
Severity
Action Taken 
Hematologic 
Toxicities
Grade 1
ANC: LLN-1.5 × 109/L (< LLN-1,500/ȝL)
Platelets: < LLN-75.0 × 109/L 
(< LLN-75,000/uL)
Resume treatment; no dose reduction.
Grade 2 
ANC: < 1.5-1.0 × 109/L (< 1,500-1000/ȝL)
Platelets: < 75.0-50.0 × 109/L 
(< 75,000-50,000/uL)
Hold PLD until ANC and platelet levels 
meet the following criteria:
•
ANC  1.5 × 109/L (1,500/ȝL), and
•
Platelets  75.0 × 109/L (75,000/ȝL)
Retreat at same dose level.
Grade 3
ANC: < 1.0-0.5 ×109/L (< 1,000-500/ȝL)
Platelets: < 50.0-25.0 × 109/L 
(< 50,000-25,000/ȝL)
Hold PLD until ANC and platelet levels 
meet the following criteria:
•
ANC  1.5 × 109/L (1,500/ȝL), and
•
Platelets  75.0 × 109/L (75,000/ȝL)
Retreat at same dose level.
Grade 4
ANC: < 0.5 × 109/L (< 500/ȝL)
Platelets: < 25.0 × 109/L (< 25,000/ȝL)
Hold PLD until ANC and platelet levels 
meet the following criteria: 
•
ANC  1.5 × 109/L (1,500/ȝL), and
•
Platelets  75.0 × 109/L (75,000/ȝL)
Dose reduce by 25% dose level or continue 
previous dose with cytokine support.
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Table 7.4.3-1:
Dose Modification for Pegylated Liposomal Doxorubicin (PLD)
Drug-related AE 
per CTCAE v5.0
Severity
Action Taken 
Non-hematologic 
Toxicities (HFS and
Mucositis)
Grade 1
HFS: mild erythema, swelling or 
desquamation not interfering with daily 
activities
Mucositis: painful ulcers, erythema, or mild 
soreness
Continue PLD unless previous Grade 3 
or 4 HFS. In case of previous Grade 3 or 4 
HFS delay up to 2 weeks and decrease 
dose by 25%.
Grade 2
HFS: Erythema, desquamation, or swelling 
interfering with but not precluding normal 
physical activities; small blisters or 
ulcerations less than 2 cm in diameter 
Mucositis: painful erythema, edema, ulcers, 
but can eat
Hold PLD until resolved to Grade 1 or 
baseline. If after 2 weeks there is no 
resolution, PLD should be discontinued. If 
no prior Grade 3 or 4 HFS resume at the 
dose prior to the event. If previous Grade 3 
or 4 toxicity, decrease dose by 25%.
Grade 3
HFS: Blistering, ulceration, or swelling 
interfering with walking or normal daily 
activities; cannot wear regular clothing
Mucositis: painful erythema, edema, or 
ulcers; cannot eat
•
Hold PLD until the event resolves or 
improves to Grade 1 or baseline.
•
Dose reduce by 25% dose level. If after 
2 weeks there is no resolution, PLD 
should be discontinued.
Grade 4
HFS: diffuse or local process causing 
infectious complications, a bed ridden state 
or hospitalization
Mucositis: requires parenteral or enteral 
support
•
Hold PLD until the event resolves or 
improves to Grade 1 or baseline.
•
Dose reduce by 25% dose level. If after 
2 weeks there is no resolution, PLD 
should be discontinued.
Abbreviations: AE, adverse event; ANC, absolute neutrophil count; CTCAE v5.0, Common Terminology Criteria for 
Adverse Events version 5.0; HFS, hand-foot syndrome; LLN, lower limit of normal; PLD, pegylated liposomal 
doxorubicin. 
7.4.3.1
Dose Reduction for Pegylated Liposomal Doxorubicin (PLD)
The full dose of PLD is 40 mg/m2. This dose may be reduced by 1 dose level to 30 mg/m2 and 
subsequently by 1 more dose level to 20 mg/m2. In the case of any toxicity requiring more than 
2 dose reductions, PLD must be discontinued, unless the participant is benefitting from therapy.
If a participant’s LVEF drops below normal or by at least 15% from baseline value, treatment with 
PLD should be interrupted and event should be discussed with the Medical Monitor before 
restarting treatment.
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7.4.4
Dose Modification for Topotecan
Table 7.4.4-1:
Dose Modification for Topotecan
Drug-related AE per CTCAE v5.0
Severity
Action Taken 
Hematologic Toxicities
Grade 1
Investigator judgement to continue or 
interrupt topotecan treatment. 
Grade 2 or 3
Hold topotecan until ANC and platelet levels 
meet the following criteria:
Day 1:
•
ANC  1.5 × 109/L (1,500/ȝL), and
•
Platelets  100 × 109/L (100,000/ȝL) 
Days 8 and 15:
•
ANC  1.0 × 109/L (1,000/ȝL), and
•
Platelets  100 × 109/L (100,000/ȝL)
Re-treat at same dose level. 
Grade 4 or any grade 
neutropenia 
complications (fever, 
infection)
Hold topotecan until ANC and platelet levels 
meet the following criteria:
Day 1:
•
ANC  1.5 × 109/L (1,500/ȝL) and
•
Platelets  100 × 109/L (100,000/ȝL)
Days 8 and 15:
•
ANC  1.0 × 109/L (1,000/ȝL) and
•
Platelets  100 × 109/L (100,000/ȝL)
Dose reduce by 1 level.
Non-hematologic Toxicities
Grade 1
Investigator judgement to continue or 
interrupt topotecan treatment.
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Table 7.4.4-1:
Dose Modification for Topotecan
Drug-related AE per CTCAE v5.0
Severity
Action Taken 
Grade 2
Investigator judgement to continue or 
interrupt topotecan treatment.
Grade 3 or 4
Hold topotecan until the event resolves or 
improves to Grade 1.
Dose reduce by 1 level.
Abbreviations: AE, adverse event; ANC, absolute neutrophil count; CTCAE v5.0, Common Terminology Criteria for 
Adverse Events version 5.0.
7.4.4.1
Dose Reduction for Topotecan 
The full dose of topotecan is 4 mg/m2 on Days 1, 8, and 15 of a 28-day cycle or 1.25 mg/m2 on 
5 consecutive days of a 21-day cycle. These doses may be reduced by 1 dose level to 3.5 mg/m2
and to 1 mg/m2, respectively, and subsequently by 1 more dose level to 3 mg/m2 and 0.75 mg/m2. 
In the case of any toxicity requiring more than 2 dose reductions, topotecan must be discontinued, 
unless the participant is benefitting from therapy.
7.5
Preparation/Handling/Storage/Accountability
The IP/IMP/Non-IMP/AxMP must be stored in a secure area according to local regulations. It is 
the responsibility of the investigator, or designee where permitted, to ensure that 
IP/IMP/Non-IMP/AxMP is only dispensed to study participants. The IP/IMP/Non-IMP/AxMP 
must be dispensed only from official study sites by authorized personnel according to local 
regulations.
The product storage manager should ensure that the study intervention is stored in accordance with 
the environmental conditions (temperature, light, and humidity) as determined by the Sponsor. If 
concerns regarding the quality or appearance of the study intervention arise, the study intervention 
should not be dispensed, and the Sponsor should be contacted immediately.
Study intervention not supplied by the Sponsor will be stored in accordance with the package 
insert.
IP/IMP/Non-IMP/AxMP documentation (whether supplied by the Sponsor or not) must be 
maintained and must include all processes required to ensure the drug is accurately administered. 
This includes documentation of drug storage, administration and, as applicable, storage 
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temperatures, reconstitution, and use of required processes (eg, required diluents, administration 
sets).
•
The investigator or designee must confirm that appropriate temperature conditions have been 
maintained during transit for all study intervention received and any discrepancies are reported 
and resolved before use of the study intervention.
•
Only participants enrolled in the study may receive study intervention, and only authorized site 
staff may supply, prepare, or administer study intervention.
•
All study intervention 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, head of the medical institution (where applicable), or authorized 
site staff is responsible for study intervention accountability, reconciliation, and record 
maintenance (ie, receipt, reconciliation, and final disposition of records).
•
Further guidance and information for the final disposition of unused study interventions are 
provided in the Pharmacy Manual and Appendix 2.
Please refer to the current IB and/or Pharmacy Manual for further details regarding storage, 
preparation, and handling.
7.5.1
Retained Samples for Bioavailability/Bioequivalence/Biocomparability
At the time of receipt of the IP by the investigator or designee, the Sponsor will specify the 
appropriate number of containers or units to select for retention, the conditions of sample storage, 
required duration of sample retention, and provisions for returning or disposing of the IP. When 
samples are selected, containers or units should be placed in packaging with a tamper-evident seal 
provided by the Sponsor or sourced by the site. Package labeling should clearly identify the 
contents as retention samples and state that the IP should be stored in the restricted area with 
limited access.
Additional details regarding the retention process will be provided in a Pharmacy Manual or other 
written documentation.
7.6
Study Intervention Compliance
Study intervention compliance will be periodically monitored by drug accountability. Drug 
accountability should be reviewed by the site study staff at each visit to confirm treatment 
compliance. Sites should discuss discrepancies with the participant at each on-treatment study 
visit. 
Treatment compliance will be monitored by drug accountability as well as the participant’s 
medical record and electronic case report form (eCRF). This will be source data verified by the 
BMS Unblinded Site Monitor through regularly scheduled monitoring visits.
When participants are dosed at the site, they will receive study intervention directly from the 
investigator or designee, under medical supervision. The date and time of each dose administered 
in the clinic will be recorded in the source documents and recorded in the CRF. The dose of study 
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intervention and study participant identification will be confirmed at the time of dosing by a 
member of the study site staff other than the person administering the study intervention.
7.7
Concomitant Therapy
7.7.1
Prohibited and/or Restricted Treatments
The following medications and treatments are prohibited during the study (unless utilized to treat 
a drug-related AE):
•
Any folate supplementation prescribed for folate deficiency.
•
Any complementary medications (eg, herbal supplements or traditional Chinese medicines) 
intended to treat the disease under study. Such medications are permitted if they are used as 
supportive care.
•
Any concurrent anti-neoplastic therapy (eg, chemotherapy, hormonal therapy, immunotherapy, 
radiotherapy, investigational agents for treatment of malignancy). However, the continued use 
of drugs for bone diseases (such as bisphosphonates and anti-receptor activator of nuclear 
factor kappa-B ligand monoclonal antibody) that were already being used by the participant 
prior to the initial study treatment is permitted. These uses of such agents can be discussed 
with the Sponsor Medical Monitor as needed.
•
Any live, attenuated vaccine within 30 days prior to the first dose of study drug, during study 
treatment, and 30 days post last dose. Inactivated vaccines (such as hepatitis A or polio 
vaccines) are permitted during the study. Seasonal influenza and COVID-19 vaccines that do 
not contain live virus are permitted.
7.7.2
Supportive Therapies
Supportive therapies as blood/platelet transfusion, hematopoietic stimulating agent, including
granulocyte colony stimulating factor (G-CSF) formulation, are allowed at the discretion of the 
investigators, in accordance with institutional and/or current American Society of Clinical 
Oncology guidelines within 1 week prior to initiating/resuming study treatment.
7.7.3
Other Restrictions and Precautions
Participants are prohibited from enrolling in another clinical trial while participating in this study.
7.7.3.1
Imaging Restrictions and Precautions
It is the local imaging facility’s responsibility to determine, based on participant attributes 
(eg, allergy history, diabetic history, and renal status), the appropriate imaging modality and 
contrast regimen per imaging study. Imaging contraindications and contrast risks are to be 
considered in this assessment. Participants with renal insufficiency are to be assessed as to whether 
they should receive contrast and if so, which contrast agent and dose are appropriate. Specific to 
magnetic resonance imaging (MRI), participants with severe renal insufficiency (ie, estimated 
glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) are at increased risk of nephrogenic 
systemic fibrosis; therefore, MRI contrast is contraindicated. In addition, participants may be 
excluded from MRI if they have tattoos, metallic implants, pacemakers, etc. These restrictions will 
be outlined in the Imaging Manual.
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Gentle hydration before and after IV contrast should follow local standard of care. The ultimate 
decision to perform MRI in an individual participant enrolled in this study rests with the site 
radiologist, the investigator, and standards set by the local Ethics Committee.
7.8
Continued Access to Study Intervention After the End of the Study
At the end of the study, the Sponsor will not continue to provide Sponsor-supplied study 
intervention to participants or investigators unless the Sponsor chooses to extend the study. The 
investigator should ensure that the participant receives appropriate standard of care to treat the 
condition under study. The Sponsor reserves the right to terminate access to Sponsor-supplied 
study intervention if any of the following occur: a) the study is terminated due to safety concerns; 
b) the development of MORAb-202 is terminated for other reasons, including, but not limited to, 
lack of efficacy and/or not meeting the study objectives; or c) the participant can obtain medication 
from a government-sponsored or other health program. In all cases, the Sponsor will follow local 
regulations.
8
DISCONTINUATION CRITERIA
Discontinuation of specific sites or of the study as a whole is detailed in Appendix 2.
8.1
Discontinuation of Study Intervention
Participants MUST discontinue IP/IMP (and Non-IMP/AxMP at the discretion of the investigator) 
for any of the following reasons:
•
Participant’s request to stop study intervention. Participants who request to discontinue study 
intervention will remain in the study and must continue to be followed for protocol-specified 
follow-up procedures. The only exception to this is when a participant specifically withdraws 
consent for any further contact with him/her or persons previously authorized by the participant 
to provide this information.
•
Any clinical AE, laboratory test result abnormality, or intercurrent illness which, in the opinion 
of the investigator, indicates that continued participation in the study is not in the best interest 
of the participant.
•
Termination of the study by the Sponsor.
•
Loss of ability to freely provide consent through imprisonment or involuntary incarceration for 
treatment of either a psychiatric or physical illness (eg, infectious disease). (Note: Under 
specific circumstances and only in countries where local regulations permit, a participant who 
has been imprisoned may be permitted to continue as a participant. Strict conditions apply, and 
Sponsor approval is required).
•
Pregnancy (see Section 9.2.5).
•
Documented disease progression per RECIST v1.1, as assessed by the investigator.
•
Clinical deterioration while receiving active study therapy, that, in the opinion of the 
investigator, indicates that continued participation in the study is not in the best interest of the 
participant. Significant noncompliance with protocol (eg, procedures, assessments, 
medications, etc). The investigator should discuss such issues with the Medical Monitor.
•
Per criteria for permanent discontinuation in Section 7.4 and in accordance with the local 
Product Label for IC chemotherapy agents.
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•
Any dosing delay lasting >
 with the following exception:

Treatment delay 
may be allowed in participants with ILD/pneumonitis 
to allow for recovery, which requires consultation with and approval from the Sponsor’s 
Medical Monitor.
Prior to re-initiating treatment in a participant with a dosing delay lasting > 12 weeks, the Medical 
Monitor (or designee) must be consulted. Tumor assessments should continue as per protocol even 
if dosing is delayed. Periodic study visits to assess safety and laboratory studies should also 
continue every 6 weeks or more frequently if clinically indicated during such dosing delays.
Refer to the Section 2: Schedule of Activities for data to be collected at the time of treatment 
discontinuation and follow-up and for any further evaluations that can be completed.
All participants who discontinue study intervention should comply with protocol-specified 
follow-up procedures as outlined in Section 2: Schedule of Activities. The only exception to this 
requirement is when a participant withdraws consent for all study procedures, including 
post-treatment study follow-up, or loses the ability to consent freely (eg, is imprisoned or 
involuntarily incarcerated for the treatment of either a psychiatric or physical illness).
If study intervention is discontinued prior to the participant’s completion of the study, the reason 
for the discontinuation must be documented in the participant’s medical records per local 
regulatory requirements in each region/country and entered on the appropriate CRF page.
8.1.1
Post-study Intervention Study Follow-up
In this study, PFS is a key secondary endpoint 
 of the study. 
Post-study follow-up is of critical importance and is essential to preserving participant safety and 
the integrity of the study. Participants who discontinue study intervention must continue to be 
followed for data collection of outcome, disease response (until investigator-assessed disease 
progression by RECIST 1.1), and/or survival follow-up every 3 months from safety follow-up visit 
up to 1 year from the last participant randomized or  LPLV (30 days after last patient last treatment 
visit); whichever is later as required and in line with Section 5 until death or the conclusion of the 
study. 
8.2
Discontinuation From the Study
Participants who request to discontinue study intervention will remain in the study and must 
continue to be followed for protocol-specified safety follow-up procedures. The only exception to 
this is when a participant specifically withdraws consent for any further contact with him/her or 
persons previously authorized by the participant to provide this information.
•
Participants should notify the investigator of the decision to withdraw consent from future 
follow-up.
•
The withdrawal of consent should be explained in detail in the medical records by the 
investigator as to whether the withdrawal is from further treatment with study intervention only 
or also from study procedures and/or post-treatment study follow-up, and entered on the 
appropriate CRF page.
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•
In the event that vital status (whether the participant is alive or dead) is being measured, 
publicly available information should be used to determine vital status only as appropriately 
directed in accordance with local law.
•
If the participant withdraws consent for disclosure of future information, the Sponsor may 
retain and continue to use any data collected before such a withdrawal of consent.
8.2.1
Individual Discontinuation Criteria
•
A participant may withdraw completely from the study at any time at his/her own request, or 
may be withdrawn at any time at the discretion of the investigator for safety, behavioral, 
compliance, or administrative reasons. This is expected to be uncommon. Stopping study 
intervention is not considered withdrawal from the study.
•
At the time of discontinuing from the study, if possible, an early termination visit should be 
conducted, as shown in the Schedule of Activities. See the Schedule of Activities for data to 
be collected at the time of study discontinuation and follow-up and for any further evaluations 
that need to be completed.
•
The participant will be permanently discontinued from both the study intervention and the 
study at that time.
•
If the participant withdraws consent for disclosure of future information, the Sponsor may 
retain and continue to use any data collected before such a withdrawal of consent.
8.3
Lost to Follow-up
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit:
•
All reasonable efforts must be made to locate participants to determine and report their ongoing 
status. This includes follow-up with persons authorized by the participant.
•
Lost to follow-up is defined by the inability to reach the participant after a minimum 
of 3 documented phone calls, faxes, or emails, as well as lack of response by participant 
to 1 registered mail letter. All attempts should be documented in the participant’s 
medical records.
•
If the investigator’s use of a third-party representative to assist in the follow-up portion of the 
study has been included in the participant’s informed consent, then the investigator may use a 
Sponsor-retained third-party representative to assist site staff with obtaining the participant’s 
contact information or other public vital status data, such as public health registries and 
databases, necessary to complete the follow-up portion of the study.
•
The site staff and representative will consult publicly available sources, such as public health 
registries and databases, to obtain updated contact information.
•
If, after all attempts, the participant remains lost to follow-up, then the last known alive date 
as determined by the investigator should be reported and documented in the participant’s 
medical records.
•
If it is determined that the participant has died, the site will use permissible local methods to 
obtain date and cause of death.
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9
STUDY ASSESSMENTS AND PROCEDURES
•
Study procedures and timing are summarized in the Schedule of Activities.
•
Protocol waivers or exemptions are not allowed.
•
All immediate safety concerns must be discussed with the Sponsor immediately upon 
occurrence or awareness to determine if the participant should continue or discontinue 
treatment.
•
Adherence to the study design requirements, including those specified in the Schedule of
Activities, is essential and required for study conduct.
•
All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria before randomization. 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 informed consent may be utilized for screening or baseline 
purposes provided the procedure meets the protocol-defined criteria and has been performed 
within the timeframe defined in the Schedule of Activities (see Section 2).
•
Repeat or unscheduled samples may be taken for safety reasons or for technical issues with the 
samples.
•
Perform additional measures, including non-study required laboratory tests, as clinically 
indicated or to comply with local regulations. Laboratory toxicities (eg, suspected 
drug-induced liver enzyme evaluations) will be monitored during the follow-up phase via 
on-site/local labs until all study drug-related toxicities resolve, return to baseline, or are 
deemed irreversible.
•
Evaluate the participant immediately to rule out pulmonary toxicity if the participant shows 
pulmonary-related signs (eg, 
 hypoxemia) or symptoms (eg,
shortness of breath, dyspnea, non-productive cough, fever). See Section 9.4.5 for further details 
and Section 7.4.1 for ILD/pneumonitis management guidelines.
•
Some of the assessments referred to in this section may not be captured as data in the CRF. 
They are intended to be used as safety monitoring by the treating physician. Additional testing 
or assessments may be performed as clinically necessary or where required by institutional or 
local regulations.
9.1
Efficacy Assessments
9.1.1
Efficacy Assessment for the Study
Contrast-enhanced CT of the chest, abdomen, pelvis, and all other known and/or suspected sites 
of disease should be performed for tumor assessments. Images should be acquired with slice 
thickness of 5 mm or less with no intervening gap (contiguous). 
 
 
 
Every attempt should be made to image each participant using an identical acquisition protocol on 
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the same scanner for all imaging timepoints. Tumor measurements should be made by the same 
investigator or radiologist for each assessment, whenever possible.
If a participant has a contraindication for CT intravenous contrast, then a non-contrast CT of the 
chest and a contrast-enhanced MRI of the abdomen, pelvis, and other known/suspected sites of 
disease should be obtained.
If a participant has a contraindication for both MRI and CT intravenous contrasts, then a 
non-contrast CT of the chest and a non-contrast MRI of the abdomen, pelvis, and other 
known/suspected sites of disease should be obtained.
If a participant has a contraindication for MRI (eg, incompatible pacemaker) in addition to 
contraindication to CT intravenous contrast, then a non-contrast CT of the chest, abdomen, pelvis, 
and other known/suspected sites of disease is acceptable.
Use of CT component of a positron emission tomography-computed tomography (PET-CT)
scanner: Combined modality scanning such as with PET-CT is increasingly used in clinical care, 
and is a modality/technology that is in rapid evolution; therefore, the recommendations outlined 
here may change rather quickly with time. At present, low dose or attenuation correction CT 
portions of a combined PET-CT are of limited use in anatomically-based efficacy assessments and 
it is therefore suggested that they should not be substituted for dedicated diagnostic contrast-
enhanced CT scans for anatomically-based RECIST v1.1 measurements. However, if a site can 
document that the CT performed as part of a PET-CT is of identical diagnostic quality to a 
diagnostic CT (with IV and oral contrast), then the CT portion of the PET-CT can be used for 
RECIST v1.1 measurements. Note, however, that the PET portion of the CT introduces additional 
data which may bias an investigator if it is not routinely or serially performed.
For this study, a rise in CA-125 alone is not sufficient to declare progression, and progression 
events should be determined by radiographic evidence of progression per RECIST v1.1 criteria.
9.1.2
Imaging Assessment for the Study
Images will be submitted to a central imaging vendor for blinded independent central 
review (BICR). Prior to scanning the first participant, sites should be qualified and understand the 
image acquisition guidelines and submission process as outlined in the Imaging Manual provided 
by the central imaging vendor.
Tumor assessments 
 should continue on the protocol-defined imaging schedule 
regardless of dosing delays or discontinuation. Collect any additional imaging that may 
demonstrate tumor response or progression (including scans performed at unscheduled timepoints 
and/or at an outside institution) for RECIST v1.1 tumor assessment and submit to the central 
imaging vendor as soon as possible. X-rays and/or bone scans that clearly demonstrate interval 
progression of disease, for example most commonly as unequivocal lesions that are unmistakably 
new since the prior CT/MRI, should be submitted to central imaging vendor. Otherwise, they do 
not need to be submitted centrally.
Changes in tumor measurements and tumor responses will be assessed by the same investigator or 
designee using RECIST v1.1 criteria. Investigators will report the number and size of new lesions 
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that appear while on study. The timepoint of tumor assessments will be reported on the eCRF 
based on the investigator’s assessment using RECIST v1.1 criteria (refer to Appendix 8 for 
specifics of RECIST v1.1 criteria to be used in this study). Assessments of PR and CR must be 
confirmed at least 4 weeks (28 days) after initial response. A best overall response (BOR) of stable 
disease (SD) requires a minimum of 35 days on study from randomization to the date of the first 
imaging assessment.
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9.2
Adverse Events
The definitions of an AE or SAE can be found in Appendix 3.
AEs will be reported by the participant (or, when appropriate, by a caregiver, a surrogate, or the 
participant’s legally acceptable representative).
The investigator and any qualified designees are responsible for detecting, documenting, and 
reporting events that meet the definition of an AE or SAE and remain responsible for following up 
on AEs that are serious, considered related to the study intervention or the study, or that caused 
the participant to discontinue before completing the study.
Refer to Appendix 3 for SAE reporting.
Use CTCAE v5.0 definitions and grading for safety reporting of all AE and SAEs on the CRF.
9.2.1
Period and Frequency for Collecting AE and SAE Information
All AEs and SAEs must be collected from the time of signing the consent, including those thought 
to be associated with protocol-specified procedures and until 30 days following discontinuation of 
dosing.
The investigator must report any SAE that occurs after these periods and that is believed to be 
related to a study intervention or protocol-specified procedure (eg, a follow-up biopsy).
•
All SAEs will be recorded and reported to the Sponsor or designee, promptly and not to exceed 
24 hours of awareness of the event, as indicated in Appendix 3.
•
The investigator will submit any updated SAE data to the Sponsor or designee within 24 hours
of updated information being available.
Investigators are not obligated to actively seek AEs or SAEs in former study participants. 
However, if the investigator learns of any SAE, including a death, at any time after a participant 
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has been discharged from the study, and he/she considers the event reasonably related to the study 
intervention or study participation, the investigator must promptly notify the Sponsor.
The method of evaluating and assessing causality of AEs and SAEs and the procedures for 
completing and reporting/transmitting SAE reports are provided in Appendix 3.
All SAEs, and all AEs (SAEs and non-serious AEs) associated with confirmed or suspected 
SARS-CoV-2 infection, must be collected from the date of the participant’s written consent until 
30 days following discontinuation of dosing.
For participants assigned to treatment and never treated with study drug, collect SAEs for 30 days 
from the date of treatment assignment.
9.2.2
Method of Detecting AEs and SAEs
AEs can be spontaneously reported or elicited during open-ended questioning, examination, or 
evaluation of a participant. Care should be taken not to introduce bias when collecting AEs and/or 
SAEs. Inquiry about specific AEs should be guided by clinical judgment in the context of known 
AEs, when appropriate for the program or protocol.
9.2.3
Follow-up of AEs and SAEs
•
Non-serious AEs should be followed to resolution or stabilization, or reported as SAEs if they 
become serious (see Appendix 3).
•
Follow-up is also required for non-serious AEs that cause interruption or discontinuation of 
study intervention and for those present at the end of study intervention as appropriate.
•
All identified non-serious AEs must be recorded and described on the non-serious AE page of 
the CRF (paper or electronic). Completion of supplemental CRFs may be requested for AEs 
and/or laboratory test result abnormalities that are reported/identified during the study.
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts. All SAEs, and non-serious AEs of special interest (as defined in 
Section 9.2.9), and all AEs (SAEs and non-serious AEs ) associated with confirmed or suspected 
SARS-CoV-2 infection will be followed until resolution, until the condition stabilizes, until the 
event is otherwise explained, or until the participant is lost to follow-up (as defined in Section 8.3), 
or, for suspected cases, until SARS-CoV-2 infection is ruled out.
In addition, any serious/nonserious ILD/pneumonitis event (AEs of special interest, as defined in 
Section 9.2) must be followed 
 approximately every 3 weeks until resolution 
or stabilization 
 , until the event is otherwise 
explained, or until the participant is lost to follow-up (as defined in Section 8.3).
 
 
 
Further information on follow-up procedures is given in Appendix 3.
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9.2.4
Regulatory Reporting Requirements for SAEs
•
Prompt notification by the investigator to the Sponsor of SAEs is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of a 
product under clinical investigation are met.
•
An investigator who receives an investigator safety report describing SAEs or other specific 
safety information (eg, summary or listing of SAEs) from the Sponsor will file it along with 
the Investigator’s Brochure and will notify the IRB/IEC, if appropriate, according to local 
requirements.
The Sponsor or designee must report AEs to regulatory authorities and ethics committees 
according to local applicable laws and regulations. A suspected, unexpected serious adverse 
reaction (SUSAR) is a subset of SAEs and must be reported to the appropriate regulatory 
authorities and investigators following local and global guidelines and requirements.
9.2.5
Pregnancy
This section is not applicable for women not of childbearing potential (WNOCBP).
If, following initiation of the study intervention, it is discovered that a participant is pregnant or 
may have been pregnant at the time of study intervention exposure, including at least 90 days after 
MORAb-202 administration or 6 months after IC chemotherapy administration, the investigator 
must immediately notify the Sponsor Medical Monitor/designee of this event and complete and 
forward a Pregnancy Surveillance Form to the Sponsor designee within 24 hours of awareness of 
the event and in accordance with SAE reporting procedures described in Appendix 3.
In all cases, the study intervention will be discontinued in an appropriate manner (eg, dose tapering 
if necessary for participant safety).
Follow-up information regarding the course of the pregnancy, including perinatal and neonatal 
outcome and, where applicable, offspring information, must be reported on the Pregnancy 
Surveillance Form. Protocol-required procedures for study discontinuation and follow-up must 
be performed.
9.2.6
Laboratory Test Result Abnormalities
The following laboratory test result abnormalities should be captured on the Adverse Events –
Non-serious and Serious Events CRF page. Paper forms are only intended as a back-up option 
when the electronic system is not functioning.
•
Any laboratory test result that is clinically significant or meets the definition of an SAE 
•
Any laboratory test result abnormality that requires the participant to have study intervention
discontinued or interrupted
•
Any laboratory test result abnormality that requires the participant to receive specific 
corrective therapy
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It is expected that, wherever possible, the clinical rather than the laboratory term will be used by 
the reporting investigator (eg, anemia vs low hemoglobin value).
9.2.7
Potential Drug-induced Liver Injury
Wherever possible, timely confirmation of initial liver-related laboratory test result abnormalities 
should occur prior to the reporting of a potential drug-induced liver injury (DILI) event. All 
occurrences of potential DILIs meeting the defined criteria must be reported as SAEs (see 
Section 9.2 and Appendix 3 for reporting details).
A potential DILI is defined as follows: 
•
Aminotransferase (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) 
elevation > 3× upper limit of normal (ULN)
AND
•
Total bilirubin > 2× ULN, without initial findings of cholestasis (elevated serum alkaline 
phosphatase)
AND
•
No other immediately apparent possible causes of aminotransferase elevation and 
hyperbilirubinemia, including, but not limited to, viral hepatitis, pre-existing chronic or acute 
liver disease, or the administration of other drug(s) known to be hepatotoxic
9.2.8
Other Safety Considerations
Any significant worsening of conditions noted during interim or final physical examinations, ECG, 
radiographic imaging, or any other potential safety assessment required or not required by the 
protocol should also be recorded as a non-serious AE or SAE, as appropriate, and reported 
accordingly.
9.2.9
AEs of Special Interest
An adverse event of special interest (AESI) is an AE (serious or nonserious) of scientific and 
medical concern specific to the Sponsor’s product or program. Such events may require further 
investigation in order to characterize and understand them. Adverse events of special interest may 
be added, modified or removed during a study by protocol amendment. 
Below events are considered as AESIs for MORAb-202:
Any ILD/pneumonitis events, and for Grade  3 infusion-related reactions, sites must report the 
event in the database immediately (ie, within 24 hours of diagnosis by the investigator).
AESIs that are Grade  3 in severity are considered important medical events and will be 
immediately reported by a completed SAE form using the procedures detailed in Appendix 3. 
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9.3
Overdose
An overdose is defined as the accidental or intentional administration of any dose of a product that 
is considered both excessive and medically important. Overdoses that meet the regulatory 
definition of an SAE will be reported as SAEs (see Appendix 3).
In the event of an overdose with MORAb-202, the investigator should:
•
Contact the Medical Monitor immediately.
•
Closely monitor the participant for AEs/SAEs and laboratory test result abnormalities until 
MORAb-202 can no longer be detected systemically (at least 30 days).
•
Document the quantity of the excess dose as well as the duration of the overdosing in the CRF.
In the event of an overdose for IC chemotherapy agents, refer to USPI/SmPC.67,75,89
9.4
Safety
Planned time points for all safety assessments are listed in Section 2: Schedule of Activities.
9.4.1
Physical Examinations
See Section 2: Schedule of Activities.
9.4.2
Vital Signs
See Section 2: Schedule of Activities.
9.4.3
Electrocardiograms
See Section 2: Schedule of Activities.
9.4.4
Clinical Safety Laboratory Assessments
•
Investigators must document their review of each laboratory safety report.
•
Laboratory assessments are listed in Table 9.4.4-1.
•
All clinical safety laboratory assessments will be performed locally per the Schedule of 
Activities (Section 2).
Table 9.4.4-1:
Clinical Laboratory Assessments
Hematology
Hemoglobin
Hematocrit
Total leukocyte count, including differential
RBC Count
Platelet count
PT/INR, aPTT
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Table 9.4.4-1:
Clinical Laboratory Assessments
Chemistry
AST
ALT
T. bili
Direct bilirubin (reflex)a
GGT (reflex)b
ALP
LDH
Creatinine
BUN or serum urea
Uric acid
Glucose
Total protein
C-reactive protein
Albumin
Sodium
Potassium
Chloride
Calcium
CO2
Phosphorus
Magnesium
Folate
Creatinine clearance (CrCl) by 12- or 24-hour urine
collection - screening only
Urinalysis
Protein
Glucose
Blood
Leukocyte esterase
Specific gravity
pH
Microscopic examination of the sediment if blood, protein or leukocytes esterase are positive on the dipstick
Serology
Hepatitis B/C (HBsAg, HCV Ab or HCV RNA) - screening only. HIV-1 and -2 Ab - screening only (as mandated 
by local requirement [refer to Appendix 7])
Other Analyses
Pregnancy test (WOCBP only: minimum sensitivity 25 IU/L or equivalent units of HCG).
FSH (screening only for confirmation of menopause in women age < 55 years; refer to Appendix 4).
Abbreviations: Ab, antibody; ALP, alkaline phosphatase; ALT, alanine aminotransferase; aPTT, activated partial 
thromboplastin time; AST, aspartate aminotransferase; BUN, blood urea nitrogen; CO2, carbon dioxide; CrCl,
creatinine clearence; FSH, follicle-stimulating hormone; GGT, gamma-glutamyl transferase; HBsAg, hepatitis B 
surface antigen; HCG, human chorionic gonadotropin; HCV, hepatitis C virus; HIV, human immunodeficiency virus; 
INR, international normalized ratio; LDH, lactate dehydrogenase; PT, prothrombin time; RBC, red blood cell; RNA, 
ribonucleic acid; T. bili, total bilirubin; WOCBP, women of childbearing potential.
a Reflex testing to be performed only if T.bili test is abnormal.
b Reflex testing to be performed only if liver function test is abnormal.
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9.4.5
ILD/Pneumonitis Assessments
ILD/pneumonitis is a known TRAE associated with MORAb-202 (see Section 3.2.3.2). All 
 
participants must be assessed and monitored regularly for any new onset of signs and symptoms 
potentially consistent with ILD/pneumonitis. To monitor for onset of ILD/pneumonitis, 
investigators should routinely ask participants about any new onset of pulmonary symptoms, and 
 and pulse oximetry results should be reviewed for potential abnormal findings.  
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The clinical symptoms of ILD/pneumonitis are generally nonspecific, and patients may be 
asymptomatic 
Signs/symptoms potentially 
consistent with ILD/pneumonitis may include but are not limited to the following:
•
Shortness of breath (at rest and/or with ordinary physical activity) 
•
Dyspnea
•
Non-productive cough
•
Malaise
•
Fever (low-grade)
•
Oxygen saturation (SpO2) of < 92% at rest or immediately after exercise (eg, walking for at 
least 6 minutes or equivalent effort)
9.4.6
Imaging Safety Assessment
Any incidental findings of potential clinical relevance that are not directly associated with the 
objectives of the protocol should be evaluated and handled by the study investigator per standard 
medical/clinical judgment.
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9.4.7
Echocardiogram (ECHO)/Multigated Acquisition (MUGA) 
Electrocardiogram (ECHO)/multigated acquisition (MUGA) assessments are only required for 
participants receiving treatment with PLD. See the Schedule of Activities (Section 2).
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9.9
Health Economics OR Medical Resource Utilization and Health 
Economics
Health economics/medical resource utilization and health economics parameters will not be 
evaluated in this study.
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10
STATISTICAL CONSIDERATIONS
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10.3
Analysis Sets
For the purposes of analysis, the following populations are defined:
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Analysis Sets
Description
Enrolled 
All participants have agreed to participate in the clinical study following 
completion of the informed consent process, unless otherwise specified by the 
protocol.
All Randomized
All participants who were randomized using IRT.
All Treated
All randomized participants who received at least 1 dose of study intervention.
All Response Evaluable
All randomized participants with baseline tumor assessment. 
Abbreviations: 
 IRT, interactive response technology; 
10.4
Statistical Analyses
10.4.1
General Considerations
In general, continuous data will be summarized by descriptive statistics, including number of 
participants, mean, standard deviation, median, minimum, and maximum. Categorical data will be 
summarized by the number and percentage of participants. Unless otherwise specified, data will 
be summarized by treatment arm. 
The posterior probabilities corresponding to the decision guidelines at the interim and final 
analysis are reported as follows:
•
Successful efficacy benefit assessment criteria
•
Explore alternative strategies
The posterior probability will be compared to a pre-defined threshold.
The statistical analysis plan (SAP) will be developed and finalized before database lock and will 
describe the selection of participants to be included in the analyses and procedures for accounting 
for missing, unused, and spurious data.
Participant characteristics and/or demographic data may be pooled across studies for future 
analysis.
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10.4.2
Primary Endpoint(s)
Table 10.4.2-1:
Primary Endpoints
Endpoint
Statistical Analysis Methods
Primary Analyses
ORR by 
Response 
Evaluation 
Criteria in Solid 
Tumors 
(RECIST) v1.1 
per Investigator 
Assessment
Objective Response Rate (ORR) is defined as the number of randomized participants who 
achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed 
partial response (PR), based on investigator assessments (using RECIST v1.1), divided by the 
number of all randomized participants. BOR is defined as the best response, as determined by 
the investigator, recorded between the date of randomization and the date of first 
objectively-documented progression per RECIST v1.1 or the date of subsequent therapy, 
whichever occurs first. For participants without documented progression or subsequent therapy, 
all available response designations will contribute to the BOR determination. 
The number and percentage of participants in each category of BOR per investigator (CR, PR, 
stable disease [SD], progressive disease [PD], or unable to determine [UTD]) will be presented, 
by treatment group. Estimates of difference in response rates, along with its exact two-sided 
95% CI by Clopper and Pearson93 will be presented, by treatment group. The treatment effect 
is summarized using the estimated difference in ORR. A similar supportive/sensitivity analysis 
would be conducted based on BICR assessment.
TRAEs Leading 
to 
Discontinuation
TRAE discontinuation incidence rate is computed using the proportion of participants with 
TRAEs leading to discontinuation in each arm within 6 months from first dose of study drug 
administration in all treated participants. 
The number and percentage of participants per arm will be described in a frequency table.
 
 
Abbreviations: BICR, blinded independent central review; BOR, best overall response; CI, confidence interval; CR, 
complete response; ORR, objective response rate; PD, progressive disease; 
; PR, partial response; 
RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1; SD, stable disease; TRAE, treatment-related 
adverse event; UTD, unable to determine.
10.4.3
Secondary Endpoints
Table 10.4.3-1:
Summary of Secondary Endpoint Analysis
Endpoint
Statistical Analysis Methods
Secondary Analyses
AEs, SAEs, 
Treatment-
related 
AEs/SAEs, AEs
Leading to 
Discontinuation,
AESIs, Deaths, 
Laboratory 
Abnormalities
To assess the safety and tolerability of the investigational product in the target population, 
incidence and severity of the following safety events will be evaluated: adverse events 
(AEs)/serious adverse events (SAEs), AEs leading to discontinuation, TRAEs leading to 
discontinuation, AEs of special interest (AESIs), deaths, and laboratory abnormalities.
AE, SAE, and TRAE discontinuation incidence rate is computed using the proportion of 
participants with AEs, SAEs, and TRAEs leading to discontinuation in each arm within 
6 months from first dose of study drug administration in all treated participants. 
AE, SAE, and TRAE incidence rate is computed using the proportion of participants with AEs, 
SAEs, and TRAEs occurring at least once in each arm within 6 months from first dose of study 
drug administration in all treated participants.
The number and percentage of participants per arm will be described in a frequency table. 
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Table 10.4.3-1:
Summary of Secondary Endpoint Analysis
Endpoint
Statistical Analysis Methods
PFS by RECIST 
v1.1 per 
Investigator 
Assessment
PFS is defined as the time between the date of randomization and the first date of documented 
progression, per investigator assessments (using RECIST v1.1), or death due to any cause, 
whichever occurs first. Participants who did not progress or die will be censored on the date of 
their last evaluable tumor assessment. Participants who did not have any on study tumor 
assessments and did not die will be censored on their date of randomization. 
The PFS function for each treatment group will be estimated using the Kaplan Meier (KM) 
product limit method and will be displayed graphically. The hazard ratio is the measure of the 
difference in PFS. A two-sided 95% CI for median PFS in each treatment group will be 
computed via the log-log transformation method. PFS rates at fixed time points (eg, 3, 
6 months, depending on the minimum follow-up) will be presented along with their associated 
95% CIs. These estimates will be derived from the KM estimate and corresponding CIs will be 
derived based on Greenwood’s formula94 for variance derivation and the log-log 
transformation applied on the survivor function.95 A similar supportive/sensitivity analysis 
would be conducted based on BICR assessment.
DCR by RECIST 
v1.1 per 
Investigator 
Assessment
Disease control rate (DCR) is defined as the number of randomized participants who achieve 
a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on investigator
assessments (using RECIST v1.1) divided by the number of all randomized participants.
Estimates of DCR, along with its exact two-sided 95% CI by Clopper and Pearson, will be 
presented by treatment group. The treatment effect is summarized using the estimated 
difference in DCR. A similar supportive/sensitivity analysis would be conducted based on 
BICR assessment.
DoR by RECIST 
v1.1 per 
Investigator 
Assessment 
among 
Responders
Duration of Response (DoR) is defined as the time between the date of first documented 
response (CR or PR) that is subsequently confirmed, to the date of the first 
objectively-documented tumor progression as determined by investigator (per RECIST v1.1), 
or death due to any cause, whichever occurs first. Participants who die without a reported prior 
progression will be considered to have an event on the date of their death. Participants who 
neither progress nor die will be censored on the date of their last evaluable tumor assessment. 
DoR will be evaluated for responders (confirmed CR or PR) only.
DoR will be analyzed using similar method as PFS. A similar supportive/sensitivity analysis 
would be conducted based on BICR assessment.
Abbreviations: AE, adverse event; AESI, adverse event of special interest; BICR, blinded independent central review; 
BOR, best overall response; CI, confidence interval; CR, complete response; DCR, disease control rate; DoR, duration 
of response; KM, Kaplan Meier; PFS, progression-free survival; PR, partial response; RECIST v1.1, Response 
Evaluation Criteria in Solid Tumors version 1.1; SAE, serious adverse events; SD, stable disease; TRAE, treatment-
related adverse event.
10.4.5
Other Safety Analyses
All safety analyses will be performed on the All Treated set.
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Table 10.4.5-1:
Summary of Safety Analysis
Summary of 
Safety Analysis
Statistical Analysis Methods
Primary Analyses
Safety
Incidence and severity of AEs/SAEs, treatment-related AEs/SAEs, AEs leading to 
discontinuation, adverse events of special interest (AESI), deaths, and laboratory abnormalities.
Safety analysis will be performed in all treated participants. Descriptive statistics of safety will 
be presented using NCI CTCAE v5.0 by treatment group. All on-study AEs, drug-related AEs, 
SAEs, and drug-related SAEs will be tabulated using worst grade per NCI CTCAE v5.0 by 
system organ class and preferred term. On-study laboratory parameters including hematology, 
chemistry, liver function, and renal function will be summarized using worst grade per NCI 
CTCAE v5.0.
Abbreviations: AE, adverse event; AESI, adverse event of special interest; CTCAE v5.0, Common Terminology 
Criteria for Adverse Events version 5.0; NCI, National Cancer Institute; SAE, serious adverse event.
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11
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75 Hycamtin. Highlights of US Prescribing Information. Novartis Pharmaceuticals Corporation; 
2018.
76 Sehouli J, Oskay-Ozcelik G. Current role and future aspects of topotecan in relapsed ovarian 
cancer. Curr Med Res Opin 2009;25:639-51.
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77 Sehouli J, Stengel D, Harter P, et al. Topotecan weekly versus conventional 5-day schedule in 
patients with platinum-resistant ovarian cancer: a randomized multicenter phase II trial of the 
North-Eastern German Society of Gynecological Oncology Ovarian Cancer Study Group. J 
Clin Oncol 2011;29:242-8.
78 Guidance for Industry, Clinical Trial Endpoints for the Approval of Cancer Drugs and
Biologics. US Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and 
Research (CBER). 2007.
79 Vergote I, Armstrong D, Scambia G, et al. A randomized, double-blind, placebo-controlled, 
phase III study to assess efficacy and safety of weekly farletuzumab in combination with 
carboplatin and taxane in patients with ovarian cancer in first platinum-sensitive relapse. J Clin 
Oncol 2016;34:2271-8.
80 Moore K, Oza A, Oaknin A, et al. FORWARD I (GOG 3011): A Phase III study of 
mirvetuximab soravtansine, a folate receptor alpha (FRa)-targeting antibody-drug conjugate 
(ADC), versus chemotherapy in patients (pts) with platinum-resistant ovarian cancer (PROC). 
Ann Oncol 2019;30:v403-34
81 Haycock GB, Schwartz GJ, Wisolsky D. Geometric method for measuring body surface area: 
A height-weight formula validated in infants, children, and adults. J Pediatr 1978;93:62-6.
82 Du Bois D, Du Bois EF. A formula to estimate the approximate surface area if height and 
weight be known. Arch Intern Med 1916;17:863-71.
83 Mosteller RD. Simplified calculation of body surface area. N Engl J Med 1987;317:1098.
89 Doxil. Highlights of Prescribing Information. Baxter Healthcare Corporation; 2019.
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93 Clopper C, Pearson ES. The use of confidence or fiducial limits illustrated in the case of the 
binomial. Biometrika 1934;26:404-13.
94 Greenwood M. The errors of sampling of the survivorship tables. Reports on Public Health 
and Statistical Subjects. Vol 33. London: HMSO; 1926. Appendix 1.
95 Kalbfleisch JD, Prentice RL. The Statistical Analysis of Failure Time Data. 2nd ed. New York: 
John Wiley & Sons; 2002. (Available upon request).
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APPENDICES
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APPENDIX 1
ABBREVIATIONS
Term
Definition
AA
African American
ADC
antibody-drug conjugate
AE
adverse event
AESI
adverse event of special interest
AIDS
acquired immunodeficiency syndrome
AJCC
American Joint Committee on Cancer
ALP
alkaline phosphatase
ALT
alanine aminotransferase
ANC
absolute neutrophil count
aPTT
activated partial thromboplastin time
ART
antiretroviral therapy
AST
aspartate aminotransferase
AUC
area under the concentration-time curve
AxMP
Auxiliary Medicinal Product
BICR
blinded independent central review
BMI
body mass index
BMS
Bristol-Myers Squibb
BOR
best overall response
BP
blood pressure
BRCA1/BRCA2
breast cancer gene 1/2
BSA
body surface area
BUN
blood urea nitrogen
BW
body weight
C
cycle
CBC
complete blood count
CI
confidence interval
CL
clearance
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Term
Definition
CNS
central nervous system
CO2
carbon dioxide
CONSORT
Consolidated Standards of Reporting Trials
COVID-19
coronavirus disease 2019
CR
complete response
CrCl
creatinine clearance
CRF
case report form, paper or electronic
CT
computed tomography
CTCAE v5.0
Common Terminology Criteria for Adverse Events version 5.0
CYP
cytochrome P450
D
day
DCR
disease control rate
DCT
decentralized clinical trial
DILI
drug-induced liver injury
DLCO
carbon monoxide diffusing capacity
DMC
Data Monitoring Committee
DNA
deoxyribonucleic acid
DoR
duration of response
DVT
deep vein thrombosis
ECG
electrocardiogram
ECHO
echocardiogram
ECOG
Eastern Cooperative Oncology Group
eCRF
electronic Case Report Form
EMT
epithelial-mesenchymal transition
EOC
epithelial ovarian cancer
EOS
end of study
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Term
Definition
EOT
end of treatment
ESMO
European Society for Medical Oncology
EU
European Union
E-R
exposure-response
FEV1
forced expiratory volume in the first second of expiration
FFPE
formalin-fixed, paraffin-embedded
FRĮ
folate receptor alpha
FSH
follicle-stimulating hormone
FVC
forced vital capacity
G-CSF
granulocyte colony-stimulating factor
GGT
gamma-glutamyl transferase
HBsAg
hepatitis B surface antigen
HBV
hepatitis B virus
HCG
human chorionic gonadotropin
HCV
hepatitis C virus
HFS
hand-foot syndrome
HGS
high-grade serous
HIV
human immunodeficiency virus
HR
heart rate
HRD
homologous recombination deficiency
IB
Investigator’s Brochure
IC
Investigator’s choice
ICF
informed consent form
I/E
inclusion/exclusion
IEC
Independent Ethics Committee
IHC
immunohistochemistry
ILD
interstitial lung disease
IMP
investigational medicinal product
INR
international normalized ratio
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Term
Definition
IP
investigational product
IRB
Institutional Review Board
IRT
Interactive Response Technology
IU
international unit
IV
intravenous
KD
dissociation constant
KM
Kaplan Meier
LAR
legally acceptable representative
LDH
lactate dehydrogenase
LLN
lower limit of normal
LVEF
left ventricular ejection fraction
mAb
monoclonal antibody
min
minute
mOS
median overall survival
mPFS
median progression-free survival
MRI
magnetic resonance imaging
mRNA
messenger ribonucleic acid
MTD
maximum tolerated dose
MUGA
multigated acquisition
N/n
number of participants
NCA
noncompartmental analysis
NCCN
National Comprehensive Cancer Network
NCI
National Cancer Institute
NHW
Non-hispanic White
OC
ovarian cancer
OS
overall survival
OR
objective response
ORR
objective response rate
PARP
poly (adenosine disphosphate-ribose) polymerase
PARPi
poly (adenosine disphosphate-ribose) polymerase inhibitor
PCR
polymerase chain reaction
PD
progressive disease
PDX
patient-derived xenograft
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Term
Definition
PE
physical examination
PET-CT
positron emission tomography-computed tomography
PFS
progression-free survival
PFT
pulmonary function test
PK
pharmacokinetic
PLD
pegylated liposomal doxorubicin
PO
per os (oral route of administration)
PPE
palmar-plantar erythrodysesthesia
PPK
population pharmacokinetics
PR
partial response
PROC
platinum-resistant ovarian cancer
PS
performance status
PT
prothrombin time
PTT
partial thromboplastin time
Q3W
every 3 weeks
Q4W
every 4 weeks
QTc
corrected QT interval
QTcF
Fridericia corrected QTc
RBC
red blood cell
RBC
red blood cell
RECIST v.1.1
Response Evaluation Criteria in Solid Tumors version 1.1
RNA
ribonucleic acid
SAE
serious adverse event
SAP
statistical analysis plan
SARS-CoV-2
severe acute respiratory syndrome coronavirus 2
SC
safety committee
SD
stable disease
SEER
Surveillance, Epidemiology, and End Results
sFRĮ
soluble folate receptor alpha
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Term
Definition
SmPC
Summary of Product Characteristics
SpO2
oxygen saturation
SUSAR
suspected, unexpected serious adverse reaction
TB
bacillus tuberculosis
T. bili
total bilirubin
TEAE
treatment-emergent adverse event
TLC
total lung capacity
TME
tumor microenvironment
TRAE
treatment-related adverse event
TTE
transthoracic echocardiogram
ULN
upper limit of normal
US
United States
USPI
United States Prescribing Information
V
volume distribution of the central compartment
WNOCBP
women not of childbearing potential
WOCBP
women of childbearing potential
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APPENDIX 2
STUDY GOVERNANCE CONSIDERATIONS
The terms “participant” and “subject” refer to a person who has consented to participate in the 
clinical research study. Typically, the term “participant” is used in the protocol and the term
“subject” is used in the Case Report Form (CRF).
REGULATORY AND ETHICAL CONSIDERATIONS
This study will be conducted in accordance with:
•
Consensus ethical principles derived from international guidelines, including the Declaration 
of Helsinki and Council for International Organizations of Medical Sciences (CIOMS)
international ethical guidelines
•
Applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP)
guidelines
•
Applicable laws, regulations, and requirements
The study will be conducted in compliance with the protocol. The protocol,
any 
revisions/amendments,
and the participant
informed consent form (ICF) will receive 
approval/favorable 
opinion 
by 
the 
Institutional 
Review 
Board/Independent 
Ethics 
Committee (IRB/IEC), and regulatory authorities according to applicable regulations prior to 
initiation of the study.
All potential serious breaches must be reported to the Sponsor or designee immediately. A 
potential serious breach is defined as a quality issue (eg, protocol deviation) that is likely to affect, 
to a significant degree, 1 or more of the following: (1) the rights, physical safety, or mental integrity 
of 1 or more participants; (2) the scientific value of the clinical trial (eg, reliability and robustness 
of generated data). Items (1) or (2) can be associated with either GCP regulation(s) or trial 
protocol(s).
Personnel involved in conducting this study will be qualified by education, training, and 
experience to perform their respective tasks.
This study will not use the services of study personnel where sanctions have been invoked or where 
there has been scientific misconduct or fraud (eg, loss of medical licensure, debarment). 
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE
Before study initiation, the investigator must have written and dated approval/favorable opinion 
from the IRB/IEC for the protocol, Investigator’s Brochure, product labeling information, ICF, 
participant recruitment materials (eg, advertisements), and any other written information to be 
provided to participants.
The investigator, Sponsor, or designee should provide the IRB/IEC with reports, updates, and other 
information (eg, expedited safety reports, amendments, administrative letters) annually, or more 
frequently, in accordance with regulatory requirements or institution procedures.
The investigator is responsible for providing oversight of the conduct of the study at the site and 
adherence to requirements of the following where applicable:
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•
ICH guidelines
•
United States (US) Code of Federal Regulations, Title 21, Part 50 (21CFR50)
•
European Union (EU) Directive 2001/20/EC
•
European Regulation 536/2014 for clinical studies (if applicable)
•
European Medical Device Regulation 2017/745 for clinical device research (if applicable)
•
the IRB/IEC
•
all other applicable local regulations
COMPLIANCE WITH THE PROTOCOL AND PROTOCOL REVISIONS
The investigator should not implement any deviation or change to the protocol without prior 
review and documented approval/favorable opinion of an amendment from the IRB/IEC (and, if 
applicable, by the local Health Authority), except where necessary to eliminate an immediate 
hazard(s) to study participants. 
If a deviation or change to a protocol is implemented to eliminate an immediate hazard(s) prior to 
obtaining relevant approval/favorable opinion(s), the deviation or change will be submitted as soon 
as possible to the following:
•
IRB/IEC
•
Regulatory authority(ies), if applicable according to local regulations (per national 
requirements)
Documentation of approval/favorable opinion signed by the chairperson or designee of the 
IRB(s)/IEC(s) and, if applicable, by the local Health Authority must be sent to Bristol-Myers 
Squibb Company (BMS).
If an amendment substantially alters the study design or increases the potential risk to the 
participant: (1) the ICF must be revised and submitted to the IRB(s)/IEC(s) for review and 
approval/favorable opinion; (2) the revised form must be used to obtain consent from participants 
currently enrolled in the study if they are affected by the amendment; and (3) the new form must 
be used to obtain consent from new participants prior to enrollment.
FINANCIAL DISCLOSURE
Investigators and sub-investigators will provide the Sponsor with sufficient, accurate financial 
information, in accordance with regulations, to allow the Sponsor to submit complete and accurate 
financial certification or disclosure statements to the appropriate Health Authorities. Investigators 
are responsible for providing information on financial interests during the study and for 1 year
after completion of the study.
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INFORMED CONSENT PROCESS
Investigators must ensure that participants are clearly and fully informed about the purpose, 
potential risks, and other critical issues regarding clinical studies in which they volunteer to 
participate.
The Sponsor or designee will provide the investigator with an appropriate sample ICF, which will 
include all elements required by the ICH GCP, and applicable regulatory requirements. The sample 
ICF will adhere to the ethical principles that have their origin in the Declaration of Helsinki.
The investigator or his/her representative must:
•
Obtain IRB/IEC written approval/favorable opinion of the written ICF and any other 
information to be provided to the participant prior to the beginning of the study and after any 
revisions are completed for new information.
•
Provide a copy of the ICF and written information about the study in the language in which 
the participant is proficient prior to clinical study participation. The language must be 
nontechnical and easily understood. 
•
Explain the nature of the study to the participant or his/her legally acceptable representative
and answer all questions regarding the study.
•
Inform the participant that his/her participation is voluntary. The participant or his/her legally
acceptable representative will be required to sign a statement of informed consent that meets 
the requirements of 21 CFR Part 50, local regulations, ICH guidelines, Health Insurance 
Portability and Accountability Act (HIPAA) requirements, where applicable, and the IRB/IEC 
or study center.
•
Allow time necessary for the participant or his/her legally acceptable representative to inquire 
about the details of the study.
•
Obtain an ICF signed and personally dated by the participant or his/her legally acceptable 
representative and by the person who conducted the informed consent discussion. 
•
Include a statement in the participant’s medical record that written informed consent was 
obtained before the participant was enrolled in the study and the date the written consent was 
obtained. The authorized person obtaining the informed consent must also sign the ICF.
•
Re-consent the participant to the most current version of the ICF(s) during his/her participation.
•
Revise the ICF whenever important new information becomes available that is relevant to the 
participant’s consent. The investigator, or a person designated by the investigator, should fully 
inform the participant or his/her legally acceptable representative of all pertinent aspects of the 
study and of any new information relevant to the participant’s willingness to continue 
participation in the study. This communication should be documented.
The confidentiality of records that could identify participants must be protected, respecting the 
privacy and confidentiality rules applicable to regulatory requirements, the participant’s signed 
ICF, and, in the US, the participant’s signed HIPAA authorization.
The ICF must also include a statement that BMS and local and foreign regulatory authorities have 
direct access to participant records.
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In situations where consent cannot be given by participants, their legally acceptable representatives 
(per country regulation) are clearly and fully informed about the purpose, potential risks, and other 
critical issues regarding clinical studies in which the participant volunteers to participate. 
If informed consent is initially given by a participant’s legally acceptable representative or legal 
guardian and the participant subsequently becomes capable of making and communicating his or 
her informed consent during the study, consent must additionally be obtained from the participant.
The rights, safety, and well-being of the study participants are the most important considerations 
and should prevail over interests of science and society.
BMS COMMITMENT TO DIVERSITY IN CLINICAL TRIALS
The mission of BMS is to transform patients’ lives through science by discovering, developing, 
and delivering innovative medicines that help them prevail over serious diseases. 
BMS is committed to doing its part to ensure that patients have a fair and just opportunity to 
achieve optimal health outcomes.
BMS is working to improve the recruitment of a diverse participant population with the goal that 
the clinical trial becomes more reflective of the real-world population and the people impacted by 
the diseases studied.
DATA PROTECTION, DATA PRIVACY, AND DATA SECURITY
BMS collects and processes personal data of study participants, patients, health care providers,
and researchers for biopharmaceutical research and development to advance innovative, high-
quality medicines that address the medical needs of patients. BMS ensures the privacy, protection,
and confidentiality of such personal data to comply with applicable laws. To achieve these goals, 
BMS has internal policies that indicate measures and controls for processing personal data. BMS 
adheres to these standards to ensure that collection and processing of personal data are limited and 
proportionate to the purpose for which BMS collects such personal data. This purpose is clearly 
and unambiguously notified to the individual at the time of collection of personal data. In the true 
spirit of science, BMS is dedicated to sharing clinical trial information and data with participants, 
medical/research communities, the media, policy makers, and the general public. This is done in a 
manner that safeguards participant privacy and informed consent while respecting the integrity of 
national regulatory systems. Clinical trial data, health-related research, and pharmacovigilance 
activities on key-coded health data transferred by BMS across national borders is done in 
compliance with the relevant data protection laws in the country and GCP requirements.
BMS protects Personal Information with adequate and appropriate security controls as indicated 
under the data protection laws. To align with the recommended security standards, BMS has 
adopted internal security standards and policies to protect personal data at every stage of 
its processing.
To supplement these standards, BMS enters into Clinical Trial Agreements (CTAgs) with 
confidentiality obligations to ensure proper handling and protection of personal data by third 
parties accessing and handling personal data.
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BMS takes unauthorized access and disclosure of Personal Information very seriously. BMS has 
adopted the security standards that include National Institute of Standards and Technology 
Cybersecurity Framework for studies in the US. BMS aligns with these standards to continuously 
assess and improve its ability to protect, detect, and respond to cyber attacks and other 
unauthorized attempts to access personal data. These standards also aid in mitigating possible 
adverse effects. Furthermore, BMS Information Technology has defined 6 principles to protect our 
digital resources and information:
1)
Responsibilities of IT Personnel
2) Securing the BMS Digital Infrastructure
3) Identity and Access Management
4) External Partner Connections
5) Cyber Threat Detection and Response
6) Internal Cyber Incident Investigation
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.
Data reported on the CRF or entered in the electronic Case Report Form (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.
•
Definition of what constitutes source data and its origin can be found in the source data location 
list/map or equivalent document.
The investigator is responsible for ensuring that the source data are accurate, legible, 
contemporaneous, original, and attributable, whether the data are handwritten on paper or entered 
electronically. If source data are created (first entered), modified, maintained, archived, retrieved, 
or transmitted electronically via computerized systems (and/or any other kind of electronic 
devices) as part of regulated clinical trial activities, such systems must be compliant with all 
applicable laws and regulations governing use of electronic records and/or electronic signatures. 
Such systems may include, but are not limited to, electronic medical records/electronic health 
records, adverse event (AE) tracking/reporting, protocol-required assessments, and/or drug 
accountability records.
When paper records from such systems are used in place of an electronic format to perform 
regulated activities, such paper records should be certified copies. A certified copy consists of a 
copy of original information that has been verified, as indicated by a dated signature, as an exact 
copy having all of the same attributes and information as the original.
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STUDY INTERVENTION RECORDS
Records for study intervention (whether supplied by BMS, its vendors, or the site) must 
substantiate study intervention integrity and traceability from receipt, preparation, administration, 
and through destruction or return. Records must be made available for review at the request of 
BMS/designee or a Health Authority.
If
Then
Supplied by BMS (or its vendors)
Records or logs must comply with applicable 
regulations and guidelines and should include the 
following:
•
amount received and placed in storage area
•
amount currently in storage area
•
label identification number or batch number
•
amount dispensed to and returned by each 
participant, including unique participant identifiers
•
amount transferred to another area/site for 
dispensing or storage
•
non-study disposition (eg, lost, wasted) 
•
amount destroyed at study site, if applicable
•
amount returned to BMS
•
retain samples for 
bioavailability/bioequivalence/biocomparability, if 
applicable 
•
dates and initials of person 
responsible for Investigational Product 
dispensing/accountability per the Delegation of 
Authority Form
Sourced by site and not supplied by 
BMS or its vendors (examples include 
Investigational Product sourced from 
the site’s stock or commercial supply 
or a specialty pharmacy)
The investigator or designee accepts responsibility for 
documenting traceability and study intervention
integrity in accordance with requirements applicable 
under 
law 
and 
the 
standard 
operating 
procedures/standards of the sourcing pharmacy
BMS or its designee will provide forms to facilitate inventory control if the investigational site 
does not have an established system that meets these requirements.
CASE REPORT FORMS
An investigator is required to prepare and maintain adequate and accurate case histories designed 
to record all observations and other data pertinent to the investigation on each individual treated 
or entered as a control in the investigation. Data that are derived from source documents and 
reported on the CRF must be consistent with the source documents, or the discrepancies must be 
explained. Additional clinical information may be collected and analyzed in an effort to enhance 
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understanding of product safety. CRFs may be requested for AEs and/or laboratory test result 
abnormalities that are reported or identified during the study.
For sites using the Sponsor or designee electronic data capture (EDC) tool, eCRFs will be prepared 
for all data collection fields except for fields specific to serious adverse events (SAEs) and 
pregnancy, which will be reported on the electronic SAE form and Pregnancy Surveillance Form, 
respectively. If the electronic SAE form is not available, a paper SAE form can be used.
The confidentiality of records that could identify participants must be protected, respecting the 
privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
The investigator will maintain a signature sheet to document signatures and initials of all persons 
authorized to make entries and/or corrections on CRFs. 
The completed CRF and SAE/pregnancy CRFs must be promptly reviewed, signed, and dated by 
the investigator or qualified physician who is a sub-investigator and who is delegated this task on 
the Delegation of Authority Form. Sub-investigators in Japan may not be delegated the CRF 
approval task. The investigator must retain a copy of the CRFs, including records of the changes 
and corrections.
Each individual electronically signing eCRFs must meet Sponsor or designee training 
requirements and must only access the BMS EDC tool using the unique user account provided by 
the Sponsor or designee. User accounts are not to be shared or reassigned to other individuals.
MONITORING
Monitoring details describing strategy, including definition of study critical data items and 
processes (eg, risk-based initiatives in operations and quality such as risk management and 
mitigation strategies and analytical risk-based monitoring), methods, responsibilities, and 
requirements, including handling of non-compliance issues and monitoring techniques (central, 
remote, or on-site monitoring) are provided in the monitoring plan.
Representatives of BMS must be allowed to visit all study site locations periodically to assess the 
data quality and study integrity. On site, they will review study records and directly compare them 
with source documents, discuss the conduct of the study with the investigator, and verify that the 
facilities remain acceptable.
In addition, the study may be evaluated by the Sponsor or designee internal auditors and 
government inspectors who must be allowed access to CRFs, source documents, other study files, 
and study facilities. BMS audit reports will be kept confidential.
The investigator must notify BMS promptly of any inspections scheduled by regulatory authorities 
and promptly forward copies of inspection reports to the Sponsor or designee.
RECORDS RETENTION
The investigator (or head of the study site in Japan) must retain all study records and source 
documents for the maximum period required by applicable regulations and guidelines, or 
institution procedures, or for the period specified by BMS or its designee, whichever is longer. 
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The investigator (or head of the study site in Japan) must contact BMS prior to destroying any 
records associated with the study.
BMS or its designee will notify the investigator (or head of the study site in Japan) when the study 
records are no longer needed.
If the investigator withdraws from the study (eg, relocation, retirement), the records shall be 
transferred to a mutually agreed-upon designee (eg, another investigator, study site, IRB). Notice 
of such transfer will be given in writing to BMS or its designee. 
RETURN OF STUDY INTERVENTION
For this study, study interventions (those supplied by BMS or a vendor or sourced by the 
investigator), such as partially used study intervention containers, vials, and syringes, may be 
destroyed on site. 
If
Then
Study interventions supplied by BMS 
(including its vendors)
Any unused study interventions supplied by BMS can 
only be destroyed after being inspected and reconciled 
by the responsible Study Monitor, unless study 
intervention containers must be immediately destroyed 
as required for safety or to meet local regulations (eg, 
cytotoxic or biologic agents).
Partially used study interventions and/or empty 
containers may be destroyed after proper reconciliation 
and documentation. However, unused Investigational 
Medicinal Product must be reconciled by the site 
monitor/clinical research associate prior to destruction.
If study interventions will be returned, the return will 
be arranged by the responsible study monitor.
Study interventions sourced by site, 
not supplied by BMS (or its vendors; 
eg, study interventions sourced from 
the site’s stock or commercial supply 
or a specialty pharmacy)
It is the investigator’s or designee’s responsibility to 
dispose of all containers according to the institutional 
guidelines and procedures.
It is the investigator’s or designee’s responsibility to arrange for disposal of study interventions, 
provided that procedures for proper disposal have been established according to applicable federal, 
state, local, and institutional guidelines and procedures, and provided that appropriate records of 
disposal are kept. The following minimal standards must be met:
•
On-site disposal practices must not expose humans to risks from the drug.
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•
On-site disposal practices and procedures are in agreement with applicable laws and
regulations, including any special requirements for controlled or hazardous substances.
•
Written procedures for on-site disposal are available and followed. The procedures must be 
filed with the site’s standard operating procedures and a copy provided to BMS upon request.
•
Records are maintained that allow for traceability of each container, including the date 
disposed of, quantity disposed, and identification of the person disposing the containers. The 
method of disposal (eg, incinerator, licensed sanitary landfill, or licensed waste-disposal 
vendor) must be documented.
•
Accountability and disposal records are complete, up-to-date, and available for the 
Study Monitor to review throughout the clinical trial period.
It is the investigator’s or designee’s responsibility to arrange for disposal of all empty containers.
If conditions for destruction cannot be met, the responsible Study Monitor will make arrangements 
for return of study interventions provided by BMS (or its vendors). Destruction of non-study 
interventions sourced by the site, not supplied by BMS, is solely the responsibility of the 
investigator or designee.
STUDY AND SITE CLOSURE
The Sponsor/designee reserves the right to close the study site or to terminate the study at any time 
for any reason at the sole discretion of the Sponsor. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study supplies have 
been collected and a study-site closure visit has been performed.
The investigator may initiate study-site closure at any time, provided there is reasonable cause and 
sufficient notice is given in advance of the intended termination.
Reasons for the early closure of a study site by the Sponsor or investigator may include, but are 
not limited to, the following:
For study termination:
•
Discontinuation of further study intervention development
For site termination:
•
Failure of the investigator to comply with the protocol, the requirements of the IRB/IEC or 
local Health Authorities, the Sponsor’s procedures, or GCP guidelines
•
Inadequate or no recruitment (evaluated after a reasonable amount of time) of participants by 
the investigator
If the study is prematurely terminated or suspended, the Sponsor shall promptly inform the 
investigators, the IECs/IRBs, the regulatory authorities, and any contract research organization(s) 
used in the study of the reason for termination or suspension, as specified by the applicable 
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regulatory requirements. The investigator shall promptly inform the participant and should ensure
appropriate participant therapy and/or follow-up.
DISSEMINATION OF CLINICAL STUDY DATA
To benefit potential study participants, patients, health care providers, and researchers and to help 
BMS honor its commitments to study participants, BMS will make information about clinical 
research studies and a summary of their results available to the public per regulatory and BMS 
requirements. BMS will post study information on local, national, or regional databases in 
compliance with national and international standards for disclosure. BMS may also voluntarily 
disclose information to applicable databases.
CLINICAL STUDY REPORT
A Signatory Investigator must be selected to sign the Clinical Study Report (CSR).
For each CSR related to this protocol, the following criteria will be used to select the Signatory 
Investigator:
•
External Principal Investigator designated at protocol development
•
National Coordinating Investigator 
•
Study Steering Committee chair or designee
•
Participant recruitment (eg, among the top quartile of enrollers)
•
Involvement in trial design
•
Regional representation (eg, among top quartile of enrollers from a specified region or country)
SCIENTIFIC PUBLICATIONS
The data collected during this study are confidential and proprietary to the Sponsor or designee. 
Any publications or abstracts arising from this study must adhere to the publication requirements 
set forth in the Clinical Trial Agreement (CTAg) governing [study site or investigator] 
participation in the study. These requirements include, but are not limited to, submitting proposed 
publications to the Sponsor or designee at the earliest practicable time prior to submission or 
presentation and otherwise within the period set forth in the CTAg.
Scientific publications (such as abstracts, congress podium presentations and posters, and 
manuscripts) of the study results will be a collaborative effort between the study Sponsor and the 
external authors. No public presentation or publication of any interim results may be made by any 
Principal Investigator, sub-investigator, or any other member of the study staff without the prior 
written consent of the Sponsor.
Authorship of publications at the Sponsor is aligned with the criteria of the International 
Committee of Medical Journal Editors (ICMJE; www.icmje.org). Authorship selection is based on 
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significant contributions to the study (ie, ICMJE criterion #1). Authors must meet all 4 ICMJE 
criteria for authorship:
1) Substantial intellectual contribution to the conception or design of the work; or the acquisition 
of data (ie, evaluable participants with quality data), analysis, or interpretation of data for the 
work (eg, problem solving, advice, evaluation, insights, and conclusion)
2) Drafting the work or revising it critically for important intellectual content
3) Final approval of the version to be published
4) Agreement to be accountable for all aspects of the work in ensuring that questions related to 
the accuracy or integrity of any part of the work are appropriately investigated and resolved
Those who make the most significant contributions, as defined above, will be considered by the 
Sponsor for authorship of the primary publication. Sub-investigators will generally not be 
considered for authorship in the primary publication. Geographic representation will also be 
considered.
Authors will be listed by order of significant contributions (highest to lowest), with the exception 
of the last author. Authors in first and last position have provided the most significant contributions 
to the work.
For secondary analyses and related publications, author list and author order may vary from 
primary to reflect additional contributions.
DECENTRALIZED CLINICAL TRIAL (DCT)
A Decentralized Clinical Trial (DCT) gives patients and site staff the flexibility to take trials home 
with them. The DCT platform used (Medable, Inc. platform) is a HIPAA, 21 CFR part 11 
compliant and easy to use. With TeleVisit, patients can bring the in-office experience home, 
maintaining the same level of rapport and face-to-face interactions. Additionally, TeleVisits may 
be paired with eConsent 
 to improve patient 
access, increase patient engagement and reduce both site and patient burden. For example, within 
the DCT platform TeleVisit, 
 eConsents may be viewed in real-time, enabling 
discussions between the patient and the healthcare provider. For compliance and regulatory 
reasons, the platform automatically creates a log of the time, date stamp and duration of activities 
completed in the DCT platform for the Tele Visit, in order to augment the visit recording. TeleVisit 
is a 21CFR Part 11, HIPAA compliant solution that is fully integrated with the clinical studies’ 
clinical workflows.
Elements of this study may be conducted remotely, ie, the participant will remain in their own
home and complete study assessments via technology. The design of the study requires each
participant to interact with study personnel. Where allowed by applicable laws and regulations,
remote assessments may be done in parallel to, but separate from, other sites in other countries that
will conduct study visits in the traditional manner, ie, with all assessments performed at the study
center (ie, with the original site personnel performing survival follow-up).
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Data collected from participants via remote assessments will be collected electronically within
purpose-built technology (Medable platform or EDC) and will be monitored remotely by the
Sponsor or designee representatives, where allowed by applicable country law and regulation.
Serious adverse events (reporting, assessing and follow-ups) will be handled similarly to a
traditional model, with the participant contacting study personnel or engaging local care for
emergencies.
Televisit
This study may deploy TeleVisits as part of the eConsent 
 described in the study
schedule of events. This means that some study visits (see Table 2-3 in the protocol Schedule of
Activities) may be conducted using a telehealth video remote visit platform. The TeleVisit module
will provide a remote environment for the clinical research team and clinical trial patient to remain
closely connected throughout the life of the study. The study has opted to convert some 
nontreatment study visits to a TeleVisit to help ease the study burden for participants and hence
minimize participant drop-out.
For participants who may take part in the study remotely, pre-screening will be done remotely via
a telephone call, and the informed consent will be obtained remotely. TeleVisit and an electronic
consent form will be used where allowed by applicable local laws and regulations.
In accordance with country and local regulations, participants who have completed study treatment
and safety follow-up visits, quarterly survival follow-up visits may be conducted at the
investigative site, through telephone contact or conducted remotely with TeleVisit. Data will be
collected digitally, if regulations permit (see Schedule of Activities).
The survival follow-up portion of the study that may be conducted remotely is not complex.
Allowing the participants to take part in the study remotely will not increase complexity or increase
difficulty in adhering to the protocol. As the aim of the long-term follow-up study does not include
participants currently under treatment, there is no increased risk to participants by conducting the
survival status assessments remotely. No impact on the data in support of endpoints is expected.
eConsent
eConsent is a platform designed to present IRB/EC-approved informed consent information to a
potential participant within a secure system. The platform is designed to enhance participant
comprehension and facilitate a better informed consent discussion that is the cornerstone to any
informed consent process. This consent discussion will either be conducted within an on-site visit
in a face-to-face (F2F) environment, or remotely via an on-TeleVisit platform that enables virtual
F2F communication between participant and site staff over a video connection. Consent to
participation within the clinical trial, if this is the participant̓s decision, is then captured within
the eConsent platform via a 21CFR part 11 compliant eSignatures (equivalent to an Advanced
eSignature under electronic IDentification, Authentication and trust Services [eIDAS] guidelines)
from both participant and site staff as well as any other witnesses, legally authorized
representatives, or caregivers necessary.
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For participants who may take part remotely, pre-screening will be done remotely via a telephone
call, and the informed consent will be obtained remotely using telemedicine and an electronic
consent form, where allowed by applicable local laws and regulations.
In order to facilitate the management of the study, and the remote monitoring of the consenting
process by Clinical Research Associates (CRAs), there are 2 standard reports held within the Study
Manager portal. The first of these, the Signed Document Report, contains no Personal Identifiable
Information (PII) and only reports the patient ID number, consent template signed, and the date
stamp of the eSignature. The second report, the CRA Signed Document Report, provides an
additional URL link to the PDF of the signed eConsent form. Access to this report is limited to the
‘Study Monitor’ role (see User Roles below) and so only CRAs, and those permitted to view PII
data, would be granted this role. The URL link provided to the signed consent form has a number
of additional security features, and will expire after a set period of time (15 min as standard) to
prevent inadvertent access.
User Roles
The platform utilizes a role-based access management system for the creation and managing of
specific roles and users. All access design and assignment is controlled by the client. Clients first
create or use pre-templated roles for the study, then assign access rights to each role group. Once
access by role is complete, users can be assigned to a specific role.
The role assigned to a user determines the level of permissions, options, and features available
within the web application.
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In order to facilitate the management of the study, and the remote monitoring of the data collection
process, CRAs are given the Site Monitor role and access to the Study Manager portal. The CRA
can review data, raise manual queries and view participant status, missed ePRO, and Query
Reports.
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APPENDIX 3
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW-UP, AND REPORTING
ADVERSE EVENTS
Adverse Event Definition:
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a 
pre-existing medical condition occurring in a clinical investigation participant after signing of 
informed consent, whether or not considered related to the study intervention.
An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory 
test result), symptom, or disease temporally associated with the study intervention.
Events Meeting the AE Definition
•
Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
results from other safety assessments (eg, electrocardiograms, radiological scans, vital sign 
measurements), including those that worsen from baseline, considered clinically significant 
in the medical and scientific judgment of the investigator. Note that abnormal laboratory test 
results or other safety assessment findings should only be reported as AEs if the final 
diagnosis is not available. Once the final diagnosis is known, the reported term should be 
updated to be the diagnosis.
•
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 intervention administration, even though 
the condition 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 intervention 
or a concomitant medication. Overdose, as a verbatim term (as reported by the investigator),
should not be reported as an AE/serious adverse event (SAE) unless it is an intentional 
overdose taken with possible suicidal/self-harming intent. Such overdoses should be 
reported regardless of sequelae and should specify “intentional overdose” as the 
verbatim term.
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).
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DEFINITION OF SAE
If an event is not an AE per the definition above, then it cannot be an SAE, even if serious 
conditions are met.
SERIOUS ADVERSE EVENTS
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at 
any dose:
Results in death.
Is life threatening (defined as an event in which the participant was at risk of death at the time 
of the event; it does not refer to an event that hypothetically might have caused death if it were 
more severe).
Requires inpatient hospitalization or causes prolongation of existing hospitalization 
(see NOTE below).
NOTE:
The following hospitalizations are not considered SAEs in BMS clinical studies:
•
A visit to the emergency department or other hospital department < 24 hours that does not 
result in admission (unless considered an important medical or life-threatening event).
•
Elective surgery that was planned prior to signing consent.
•
Admissions per protocol for a planned medical/surgical procedure.
•
Routine health assessment requiring admission for baseline/trending of health 
status (eg, routine colonoscopy).
•
Medical/surgical admission other than to remedy ill health and planned prior to enrollment
in the study. Appropriate documentation is required in these cases.
•
Admission encountered for another life circumstance that carries no bearing on health status 
and requires no medical/surgical intervention (eg, lack of housing, economic inadequacy, 
caregiver respite, family circumstances, administrative reason).
•
Admission for administration of anticancer therapy in the absence of any other 
SAEs (applies to oncology protocols).
Results in persistent or significant disability/incapacity.
Is a congenital anomaly/birth defect.
Is an important medical event (defined as a medical event[s] that may not be immediately life
threatening or results in death or hospitalization but, based upon appropriate medical and 
scientific judgment, may jeopardize the participant or may require intervention [eg, medical, 
surgical] to prevent one of the other serious outcomes listed in the definition above). Examples 
of such events include, but are not limited to, intensive treatment in an emergency department
or at home for allergic bronchospasm and blood dyscrasias or convulsions that do not result in 
hospitalization. Potential drug-induced liver injury (DILI) is also considered an important 
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medical event. (See Section 9.2.7: Potential Drug-induced Liver Injury of the protocol for the 
definition of a potential DILI.)
Pregnancy and DILI must follow the same transmission timing and processes to BMS as those 
used for SAEs. (See Section 9.2.5: Pregnancy of the protocol for reporting pregnancies.)
EVALUATING AES AND SAES
Assessment of Causality
•
The investigator is obligated to assess the relationship between study intervention and each 
occurrence of each AE/SAE.
•
A “reasonable possibility” of a relationship conveys that there are facts, evidence, and/or 
arguments to suggest a causal relationship, rather than a relationship that cannot be ruled 
out.
•
The investigator will use clinical judgment to determine the relationship.
•
Alternative causes, such as underlying disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study intervention administration,
will be considered and investigated.
•
The investigator will also consult the Investigator’s Brochure and/or product information for 
marketed products, in his/her assessment.
•
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 1 of the criteria used when determining regulatory reporting 
requirements.
Assessment of Intensity
For the reporting of all AEs, including intensity or severity, on case report forms, please follow 
the definitions in National Cancer Institute Common Terminology Criteria for Adverse Events 
version 5 (NCI CTCAE v5).
The investigator will make an assessment of intensity for each AE and SAE reported during the 
study and assign it to 1 of the following categories:
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•
Mild: An event that is easily tolerated by the participant, causing minimal discomfort, and 
not interfering with everyday activities.
•
Moderate: An event that causes sufficient discomfort and interferes with normal everyday 
activities.
•
Severe: An event that prevents normal everyday activities. An AE that is assessed as severe 
should not be confused with an SAE. Severe is a category utilized for rating the intensity of 
an event, and both AEs and SAEs can be assessed as severe.
An event is defined as “serious” when it meets at least 1 of the pre-defined outcomes as described 
in the definition of an SAE, NOT when it is rated as severe.
Follow-up of AEs and SAEs
If only limited information is initially available, follow-up reports are required. 
(Note: Follow-up SAE reports must include the same investigator term[s] initially reported.).
If an ongoing SAE changes in its intensity or relationship to study intervention or if new 
information becomes available, the SAE report must be updated and submitted within 24 hours 
to BMS (or the designee) using the same procedure used for transmitting the initial SAE report.
All AEs/SAEs must be followed to resolution or stabilization.
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REPORTING OF SAES TO SPONSOR OR DESIGNEE
•
SAEs, whether related or not related to study intervention, and pregnancies must be reported 
to BMS (or the designee) promptly and not to exceed 24 hours of awareness of the event.
•
SAEs must be recorded on the SAE Report Form.

The required method for SAE data reporting is through the electronic Case Report 
Form (eCRF).

The paper SAE Report Form is intended only as a back-up option when the electronic 
data capture system is unavailable/not functioning for transmission of the eCRF to BMS 
(or the designee).
i In this case, the paper form is transmitted via email or confirmed fax transmission.
i When paper forms are used, the original paper forms are to remain on site.
•
Pregnancies must be recorded on paper Pregnancy Surveillance Forms and transmitted via 
email or confirmed fax transmission.
SAE Email Address:
SAE Fax Number: Will be provided by local site monitor.
SAE Telephone Contact (required for SAE and pregnancy reporting): Will be provided by 
local site monitor.
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APPENDIX 4
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS AND 
METHODS OF CONTRACEPTION
Appendix 4 provides general information and definitions related to Women of Childbearing 
Potential (WOCBP) and methods of contraception that can be applied to most clinical trials. For 
information specific to this study regarding acceptable contraception requirements for female and 
male participants, refer to Section 6.1: Inclusion Criteria of the protocol. Only the contraception 
methods as described in Section 6.1: Inclusion Criteria of the protocol are acceptable for this study.
DEFINITIONS
Women of Childbearing Potential (WOCBP)
A woman is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile. Permanent sterilization methods include hysterectomy, bilateral 
salpingectomy, and bilateral oophorectomy.
Women in the following categories are not considered WOCBP:
•
Premenarchal
•
Pre-menopausal 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.
•
Post-menopausal female

A post-menopausal state is defined as 12 months of amenorrhea in a woman over the age 
of 45 years in the absence of other biological or physiological causes. In addition, females 
under the age of 55 years must have a serum follicle-stimulating hormone (FSH) level 
> 40 mIU/mL to confirm menopause.
Note: Females treated with hormone replacement therapy (HRT) are likely to have artificially 
suppressed FSH levels and may require a washout period to obtain a physiologic FSH level. The 
duration of the washout period is a function of the type of HRT used. Suggested guidelines for the 
duration of the washout periods for HRT types are presented below. Investigators should use their 
judgment in checking serum FSH levels. 
•
1-week minimum for vaginal hormonal products (rings, creams, gels)
•
4-week minimum for transdermal products
•
8-week minimum for oral products
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Other parenteral products may require washout periods as long as 6 months. If the serum FSH 
level is > 40 mIU/mL at any time during the washout period, the woman can be considered 
postmenopausal.
End of Relevant Systemic Exposure
End of relevant systemic exposure is the time point at which the study intervention (Investigational 
Medicinal Product [IP/IMP] and other study interventions ie, Non-IMP/AxMP required for study)
or any active major metabolites have decreased to a concentration that is no longer considered 
relevant for human teratogenicity or fetotoxicity. This should be evaluated in context of safety 
margins from the no-observed-adverse-effect level or the time required for 5 half-lives of the study 
intervention to pass.
METHODS OF CONTRACEPTION
Local laws and regulations may require use of alternative and/or additional contraception methods.
Highly Effective Contraceptive Methods That Are User Dependent
Failure rate of < 1% per year when used consistently and correctly.a
•
Combined (estrogen- and progestogen-containing) hormonal contraception associated with 
inhibition of ovulation and/or implantation. (This method of contraception can only be used 
by WOCBP participants in studies in which hormonal contraception is permitted by the 
study protocol.)b

Oral (birth control pills)

Intravaginal (rings)

Transdermal
•
Combined (estrogen- and progestogen-containing) hormonal contraception must begin at 
least 30 days prior to initiation of study therapy.
•
Progestogen-only hormonal contraception associated with inhibition of ovulation. (This
method of contraception can only be used by WOCBP participants in studies in which 
hormonal contraception is permitted by the study protocol.)b

Oral

Injectable
•
Progestogen-only hormonal contraception must begin at least 30 days prior to initiation of 
study therapy.
Highly Effective Methods That Are User Independent
•
Implantable progestogen-only hormonal contraception associated with inhibition of 
ovulation and/or implantation. (This method of contraception can only be used by WOCBP 
participants in studies in which hormonal contraception is permitted by the study protocol.)b
•
Intrauterine device.
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•
Intrauterine system (IUS). (This method of contraception can only be used by WOCBP 
participants in studies in which hormonal contraception is permitted by the study 
protocol.)b,c
•
Bilateral tubal occlusion.
•
Vasectomized partner.
Having a vasectomized partner 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.
•
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 intervention. 
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.
•
Continuous abstinence must begin at least 30 days prior to initiation of study therapy.
•
It is not necessary to use any other method of contraception when complete abstinence 
is elected.
•
WOCBP participants who choose complete abstinence must continue to have pregnancy 
tests, as specified in Section 2 of the protocol.
•
Acceptable alternate methods of highly effective contraception must be discussed in the 
event that the WOCBP participant chooses to forego complete abstinence.
•
Periodic abstinence (including, but not limited to, calendar, symptothermal, post-ovulation 
methods), withdrawal (coitus interruptus), spermicides only, and lactation amenorrhea 
method (LAM) are not acceptable methods of contraception for this study.
NOTES: 
a Typical use failure rates may differ from failure rates when contraceptive methods are used consistently and 
correctly. Use should be consistent with local regulations regarding the use of contraceptive methods for 
participants in clinical studies.
b Hormonal contraception may be susceptible to interaction with the study intervention, which may reduce the 
efficacy of the contraceptive method. Hormonal contraception is permissible only when there is sufficient 
evidence that the Investigational Medicinal Product and other study medications will not alter hormonal 
exposures such that contraception would be ineffective or result in increased exposures that could be potentially 
hazardous. In this case, alternative methods of contraception should be utilized. For information specific to 
this study regarding permissibility of hormonal contraception, refer to Section 6.1: Inclusion Criteria and 
Section 7.7.1: Prohibited and/or Restricted Treatments of the protocol.
c IUSs are acceptable methods of contraception in the absence of definitive drug interaction studies when hormone 
exposures from intrauterine devices do not alter contraception effectiveness. For information specific to this 
study regarding permissibility of hormonal contraception, refer to Section 6.1: Inclusion Criteria and 
Section 7.7.1: Prohibited and/or Restricted Treatments of the protocol.
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Less Than Highly Effective Contraceptive Methods That Are User Dependent 
Failure rate of > 1% per year when used consistently and correctly.
•
Male or female condom with or without spermicide. Male and female condoms cannot be 
used simultaneously.
•
Diaphragm with spermicide.
•
Cervical cap with spermicide.
•
Vaginal sponge with spermicide.
•
Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the 
primary mechanism of action. (This method of contraception cannot be used by WOCBP 
participants in studies in which hormonal contraception is prohibited.)
Unacceptable Methods of Contraception
•
Periodic abstinence (calendar, symptothermal, post-ovulation methods).
•
Withdrawal (coitus interruptus).
•
Spermicide only.
•
LAM.
COLLECTION OF PREGNANCY INFORMATION
Guidance for collection of pregnancy information and outcome of pregnancy on the Pregnancy 
Surveillance Form is provided in Section 9.2.5: Pregnancy of the protocol and Appendix 3.
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APPENDIX 5
AMERICAN JOINT COMMITTEE ON CANCER (AJCC) STAGE 
AND TNM STAGE GROUPING FOR OVARIAN CANCER (8TH 
EDITION)
1
DEFINITIONS OF AJCC TNM
1.1
Definition of Primary Tumor (T)
T Category
T criteria
TX
Primary tumor cannot be assessed
T0
No evidence of primary tumor
T1
Tumor limited to ovaries (one or both) or fallopian tube(s)
T1a
Tumor limited to one ovary (capsule intact) or fallopian tube; no 
tumor on ovarian or fallopian tube surface; no malignant cells in 
ascites or peritoneal washings
T1b
Tumor limited to both ovaries (capsule intact) or fallopian tubes; no 
tumor on ovarian or fallopian tube surface; no malignant cells in 
ascites or peritoneal washings
T1c
Tumor limited to one or both ovaries or fallopian tubes, with any of 
the following:
•
Surgical spill
•
Capsule ruptured before surgery or tumor on ovarian or 
fallopian tube surface
•
Malignant cells in ascites or peritoneal washings
T2
Tumor involves one or both ovaries or fallopian tubes with pelvic 
extension below pelvic brim or primary peritoneal cancer
T2a
Extension and/or implants on the uterus and/or fallopian tube(s) 
and/or ovaries
T2b
Extension to and/or implants on other pelvic tissues
T3
Tumor involves one or both ovaries or fallopian tubes, or primary 
peritoneal cancer, with microscopically confirmed peritoneal 
metastasis outside the pelvis and/or metastasis to the retroperitoneal 
(pelvic and/or para-aortic) lymph nodes
T3a
Microscopic extrapelvic (above the pelvic brim) peritoneal 
involvement with or without positive retroperitoneal lymph nodes
T3b
Macroscopic peritoneal metastasis beyond the pelvis 2 cm or less in 
greatest dimension with or without metastasis to the retroperitoneal 
lymph nodes
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T Category
T criteria
T3c
Macroscopic peritoneal metastasis beyond the pelvis more than 2 cm 
in greatest dimension with or without metastasis to the retroperitoneal 
lymph nodes (includes extension of tumor to capsule of liver and 
spleen without parenchymal involvement of either organ)
1.2
Definition of Regional Lymph Node (N)
N Category
N criteria
NX
Regional lymph nodes cannot be assessed
N0
No regional lymph node metastasis
N0(i+)
Isolated tumor cells in regional lymph node(s) no greater than 0.2 mm
N1
Positive retroperitoneal lymph nodes only (histologically confirmed)
N1a
Metastasis up to and including 10 mm in greatest dimension
N1b
Metastasis more than 10 mm in greatest dimension
1.3
Definition of Distant Metastases
M Category
M criteria
M0
No distant metastases
M1
Distant metastases, including pleural effusion with positive cytology; liver 
or splenic parenchymal metastasis; metastasis to extra-abdominal organs 
(including inguinal lymph nodes and lymph nodes outside the abdominal 
cavity); and transmural involvement of intestine
M1a
Pleural effusion with positive cytology
M1b
Liver or splenic parenchymal metastases; metastases to extra-abdominal 
organs (including inguinal lymph nodes and lymph nodes outside the 
abdominal 
cavity); 
and 
transmural 
involvement 
of 
intestine, 
microscopically confirmed
2
AJCC PROGNOSTIC STAGE GROUPS
When T is...
And N is...
And M is...
Then the stage group is...
T1
N0
M0
I
T1a
N0
M0
IA
T1b
N0
M0
IB
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When T is...
And N is...
And M is...
Then the stage group is...
T1c
N0
M0
IC
T2
N0
M0
II
T2a
N0
M0
IIA
T2b
N0
M0
IIB
T1/T2
N1
M0
IIIA1
T3a
NX, N0, N1
M0
IIIA2
T3b
NX, N0, N1
M0
IIIB
T3c
NX, N0, N1
M0
IIIC
Any T
Any N
M1
IV
Any T
Any N
M1a
IVA
Any T
Any N
M1b
IVB
3
HISTOLOGIC GRADE (G)
G
G Definition
GX
Grade cannot be defined
GB
Borderline tumor
G1
Well differentiated
G2
Moderately differentiated
G3
Poorly differentiated or undifferentiated
4
LYMPHOVASCULAR INVASION (LVI)
Component of LVI Coding
Description
0
LVI not present (absent)/not identified
1
LVI present/identified, NOS
2
Lymphatic and small vessel invasion only (L)
3
Venous (large vessel) invasion only (V)
4
BOTH lymphatic and small vessel AND venous (large vessel) 
invasion
9
Presence of LVI unknown/indeterminate
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APPENDIX 6
ECOG PERFORMANCE STATUS
ECOG PERFORMANCE STATUS 
0
Fully active, able to carry on all pre-disease performance without restriction
1
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or 
sedentary nature, eg, light housework, office work
2
Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about 
more than 50% of waking hours
3
Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours
4
Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair
5
Dead
Reference: Oken MM, Creech RH, et al. Toxicity and Response Criteria of the Eastern Cooperative Oncology Group. 
Am J Clin Oncol 1982; 5: 649-655.
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APPENDIX 7
COUNTRY SPECIFIC APPENDIX
Criteria for exclusion of HIV-positive subjects in Any Countries Where Exclusion of HIV Positive 
Participants Is Locally Mandated.
Section 6.2 Exclusion Criteria
Exclusion criterion 1) q)
“Known human immunodeficiency virus (HIV) 
positive with an acquired immunodeficiency syndrome 
(AIDS)-defining opportunistic infection within the last 
year, or a current CD4 count < 350 cells/ȝL. 
Participants with HIV are eligible if:
i)
They have received antiretroviral therapy (ART) 
for at least 4 weeks prior to randomization as clinically 
indicated while enrolled on study.
ii)
They continue on ART as clinically indicated 
while enrolled on study.
iii) CD4 counts and viral load are monitored per 
standard of care by a local health care provider.
NOTE: Testing for HIV must be performed at sites 
where mandated locally. HIV positive participants 
must be excluded where mandated locally.”
To be replaced with: 
“Positive test for HIV”.
Section 2 FlowChart/Time and Events Schedule,
Table 2- 1:Screening Assessments- LaboratoryTests
Add “HIV” to the list of laboratory tests
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APPENDIX 8
RESPONSE EVALUATION CRITERIA IN SOLID TUMORS 
GUIDELINES (VERSION 1.1) WITH BMS MODIFICATIONS
1
EVALUATION OF LESIONS
Solid tumors will be evaluated using Response Evaluation Criteria In Solid Tumors version 1.1 
(RECIST v1.1) guideline with BMS modifications.1
At baseline, tumor lesions/lymph nodes will be categorized as measurable or non-measurable as 
follows:
1.1
Measurable
Tumor lesions: Must be accurately measured in at least one dimension (longest diameter in the 
plane of measurement is to be recorded) with a minimum size of:
•
10 mm by CT/MRI scan (scan slice thickness no greater than 5 mm), or ൒2x slice thickness if
greater than 5 mm.
Malignant lymph nodes: To be considered pathologically enlarged and measurable, a lymph node 
must be t 15 mm in short axis when assessed by CT/MRI scan (scan slice thickness recommended 
to be no greater than 5 mm).
Lymph nodes merit special mention since they are normal anatomical structures that may be visible 
by imaging even if not involved by tumor. Pathological nodes which are defined as measurable 
and may be identified as target lesions must meet the criterion of a short axis of t 15 mm by 
CT/MRI scan. Only the short axis of these nodes will contribute to the baseline sum. The short 
axis of the node is the diameter normally used by radiologists to judge if a node is involved by 
solid tumor. Nodal size is normally reported as two dimensions in the plane in which the image is 
obtained (for CT scan this is almost always the axial plane; for MRI the plane of acquisition may 
be axial, sagittal or coronal). The smaller of these measures is the short axis. For example, an 
abdominal node which is reported as being 20 mm x 30 mm has a short axis of 20 mm and qualifies 
as a malignant, measurable node. In this example, 20 mm should be recorded as the node 
measurement. All other pathological nodes (those with short axis t 10 mm but < 15 mm) should 
be considered non-target lesions. Nodes that have a short axis < 10 mm are considered 
non-pathological and should not be recorded or followed.
Note: Lesions on X-Ray are not to be selected as Target or Non-Target Lesions.
1.2
Non-Measurable
All other lesions are considered non-measurable, including small lesions (longest diameter 
< 10 mm or pathological lymph nodes with t 10 to < 15 mm short axis) as well as truly 
non-measurable lesions. Lesions considered truly non-measurable include: leptomeningeal 
disease, inflammatory breast disease, lymphangitic involvement of skin or lung, abdominal 
masses/abdominal organomegaly identified by physical exam that is not measurable by 
reproducible imaging techniques.
Note: Lesions on X-Ray are not to be selected as Target or Non-Target Lesions.
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1.3
Special Considerations Regarding Lesion Measurability
1.3.1
Bone lesions
•
Bone scan, PET scan and plain films are not considered adequate imaging techniques to 
measure bone lesions. However, these techniques can be used to confirm the presence or 
disappearance of bone lesions. 
•
Lytic bone lesions or mixed lytic-blastic lesions, with identifiable soft tissue components, that 
can be evaluated by cross sectional imaging techniques such as CT or MRI can be considered 
as measurable lesions if the soft tissue component meets the definition of measurability 
described above.
•
Blastic bone lesions are non-measurable.
1.4
Baseline Documentation Of ‘Target’ And ‘Non-Target’ Lesions
When more than one measurable lesion is present at baseline all lesions up to a maximum of five 
lesions total (and a maximum of two lesions per organ) representative of all involved organs should 
be identified as target lesions and will be recorded and measured at baseline (this means in 
instances where patients have only one or two organ sites involved a maximum of two and four 
lesions respectively will be recorded).
Note: A maximum of two lesions can be selected per organ system. For example, a maximum of 
two lung lesions can be selected (selected from one lung or one lesion from each). A maximum of 
two lymph nodes can be selected at baseline, as the lymphatic system is considered one organ.
Target lesions should be selected on the basis of their size (lesions with the longest diameter), be 
representative of all involved organs, but in addition should be those that lend themselves to 
reproducible repeated measurements. It may be the case that, on occasion, the largest lesion does 
not lend itself to reproducible measurement in which circumstance the next largest lesion which 
can be measured reproducibly should be selected.
A sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) for all target 
lesions will be calculated and reported as the baseline sum diameters. If lymph nodes are to be 
included in the sum, then as noted above, only the short axis is added into the sum. The baseline 
sum diameters will be used as reference to further characterize any objective tumor regression in 
the measurable dimension of the disease.
All other lesions (or sites of disease) including pathological lymph nodes should be identified as 
non-target lesions and should also be recorded at baseline. Measurements are not required, and 
these lesions should be followed as ‘present’, ‘absent’, or in rare cases ‘unequivocal progression’ 
(more details to follow). In addition, it is possible to record multiple non-target lesions involving 
the same organ as a single item on the case record form (eg, ‘multiple enlarged pelvic lymph nodes’ 
or ‘multiple liver metastases’).
2
RESPONSE CRITERIA
2.1
Evaluation of Target Lesions
•
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes 
(whether target or non-target) must have reduction in short axis to < 10 mm.
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•
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, 
taking as reference the baseline sum diameters.
•
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, 
taking as reference the smallest sum on study (this includes the baseline sum if that is the 
smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate 
an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also 
considered progression).
•
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to 
qualify for PD, taking as reference the smallest sum diameters while on study.
•
Not Evaluable (NE): If one or more target lesions cannot be measured or adequately assessed 
as either fully resolved or too small to measure (due to missing or poor quality images), and 
the sum of diameters of the remaining measured target lesions (if any) has not increased 
sufficiently to meet Progressive Disease as defined above.
2.1.1
Special Notes on the Assessment of Target Lesions
2.1.1.1
Lymph nodes
Lymph nodes identified as target lesions should always have the actual short axis measurement 
recorded (measured in the same anatomical plane as the baseline examination), even if the nodes 
regress to below 10 mm on study. This means that when lymph nodes are included as target lesions, 
the ‘sum’ of lesions may not be zero even if complete response criteria are met, since a normal 
lymph node is defined as having a short axis of < 10 mm. Case report forms or other data collection 
methods may therefore be designed to have target nodal lesions recorded in a separate section 
where, in order to qualify for CR, each node must achieve a short axis < 10 mm. For PR, SD and 
PD, the actual short axis measurement of the nodes is to be included in the sum of target lesions.
2.1.1.2
Target lesions that become ‘too small to measure’
While on study, all lesions (nodal and non-nodal) recorded at baseline should have their actual 
measurements recorded at each subsequent evaluation, even when very small (eg, 2 mm). 
However, sometimes lesions or lymph nodes that are recorded as target lesions at baseline become 
so faint on CT scan that the radiologist may not feel comfortable assigning an exact measure and 
may report them as being ‘too small to measure’. When this occurs, it is important that a value be 
recorded on the case report form. If it is the opinion of the radiologist that the lesion has likely 
disappeared, the measurement should be recorded as 0 mm. If the lesion is believed to be present 
and is faintly seen but too small to measure, a default value of 5 mm should be assigned as the 
reference diameter. (Note: It is less likely that this rule will be used for lymph nodes since they 
usually have a definable size when normal and are frequently surrounded by fat such as in the 
retroperitoneum; however, if a lymph node is believed to be present and is faintly seen but too 
small to measure, a default value of 5 mm should be assigned in this circumstance as well). This 
default value is derived from the 5 mm CT slice thickness (but should not be changed with varying 
CT slice thickness). The measurement of these lesions is potentially non-reproducible, therefore 
providing this default value will prevent false responses or progressions based upon measurement 
error. To reiterate, however, if the radiologist is able to provide an actual measure, that should be 
recorded, even if it is below 5 mm.
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2.1.1.3
Lesions that split or coalesce on treatment
When non-nodal lesions ‘fragment’, the longest diameters of the fragmented portions should be 
added together to calculate the target lesion sum. Similarly, as lesions coalesce, a plane between 
them may be maintained that would aid in obtaining maximal diameter measurements of each 
individual lesion. If the lesions have truly coalesced such that they are no longer separable, the 
vector of the longest diameter in this instance should be the maximal longest diameter for the 
‘coalesced lesion’.
2.2
Evaluation of Non-Target Lesions
This section provides the definitions of the criteria used to determine the tumor response for the 
group of non-target lesions. While some non-target lesions may actually be measurable, they need 
not be measured and instead should be assessed only qualitatively at the time points specified in 
the protocol.
•
Complete Response (CR): Disappearance of all non-target lesions. All lymph nodes must be 
non-pathological in size (< 10 mm short axis). 
•
Non-CR/Non-PD: Persistence of one or more non-target lesion(s)
•
Progressive Disease (PD): Unequivocal progression of existing non-target lesions.
2.2.1
Special Notes on Assessment of Progression of Non-Target Disease
The concept of progression of non-target disease requires additional explanation as follows:
2.2.1.1
When the Patient Also Has Measurable Disease
In this setting, to achieve ‘unequivocal progression’ on the basis of the non-target disease, there 
must be an overall level of substantial worsening in non-target disease such that, even in presence 
of SD or PR in target disease, the overall tumor burden has increased sufficiently to merit 
discontinuation of therapy. A modest ‘increase’ in the size of one or more non-target lesions is 
usually not sufficient to qualify for unequivocal progression status. Pleural effusions, pericardial 
effusions, and ascites will not be followed as a target or non-target lesions and will not contribute 
to response or progression. The designation of overall progression solely on the basis of change in 
non-target disease in the face of SD or PR of target disease will therefore be extremely rare.
2.2.1.2
When the Patient Has Only Non-measurable Disease
This circumstance arises in some trials when it is not a criterion of study entry to have measurable 
disease. The same general concepts apply here as noted above, however, in this instance there is 
no measurable disease assessment to factor into the interpretation of an increase in non-measurable 
disease burden. Because worsening in non-target disease cannot be easily quantified (by definition: 
if all lesions are truly non-measurable) a useful test that can be applied when assessing patients for 
unequivocal progression is to consider if the increase in overall disease burden based on the change 
in non-measurable disease is comparable in magnitude to the increase that would be required to 
declare PD for measurable disease: ie, an increase in tumor burden representing an additional 73% 
increase in ‘volume’ (which is equivalent to a 20% increase diameter in a measurable lesion). 
Examples include, an increase in lymphangitic disease from localized to widespread, or may be 
described as ‘sufficient to require a change in therapy’. If ‘unequivocal progression’ is seen, the 
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patient should be considered to have had overall PD at that point. While it would be ideal to have 
objective criteria to apply to non-measurable disease, the very nature of that disease makes it 
impossible to do so; therefore, the increase must be substantial.
2.2.2
New Lesions
The appearance of new malignant lesions denotes disease progression; therefore, some comments 
on detection of new lesions are important. There are no specific criteria for the identification of 
new radiographic lesions; however, the finding of a new lesion should be unequivocal: ie, not 
attributable to differences in scanning technique, change in imaging modality or findings thought 
to represent something other than tumor (for example, some ‘new’ bone lesions may be simply 
healing or flare of pre-existing lesions). This is particularly important when the patient’s baseline 
lesions show partial or complete response. For example, necrosis of a liver lesion may be reported 
on a CT scan report as a ‘new’ cystic lesion, which it is not.
NOTE: Fluid collections (pleural effusions, pericardial effusions, and ascites) will not be 
considered new lesions and will not contribute to response or progression. In the event a new fluid 
collection is seen on a post-baseline imaging exam, a comment may be made, but the appearance 
of a new fluid collection alone should not result in an assessment of Progressive Disease (PD). A 
lesion identified on a follow-up study in an anatomical location that was not scanned at baseline 
is considered a new lesion and will indicate disease progression. An example of this is the patient 
who has visceral disease at baseline and while on study has a CT or MRI brain ordered which 
reveals metastases. The patient’s brain metastases are considered to be evidence of PD even if 
he/she did not have brain imaging at baseline. A lesion identified on Chest X-Ray that was not 
present in prior CT can be considered a new lesion and will result in Progressive Disease (PD).
If a new lesion is equivocal, for example because of its small size, continued follow-up evaluation 
will clarify if it represents truly new disease. If repeat scans confirm there is definitely a new 
lesion, then progression should be declared using the date of the initial scan. While FDG-PET 
response assessments need additional study, it is sometimes reasonable to incorporate the use of 
FDG-PET scanning to complement CT scanning in assessment of progression (particularly 
possible ‘new’ disease). New lesions on the basis of FDG-PET imaging can be identified according 
to the following algorithm:
1) Negative FDG-PET at baseline, with a positive FDG-PET at follow-up is a sign of PD based 
on a new lesion.
2) No FDG-PET at baseline and a positive FDG-PET at follow-up: If the positive FDG-PET at 
follow-up corresponds to a new site of disease confirmed by CT, this is PD. If the positive 
FDG-PET at follow-up is not confirmed as a new site of disease on CT, additional follow-up 
CT scans are needed to determine if there is truly progression occurring at that site (if so, the 
date of PD will be the date of the initial abnormal FDG-PET scan). If the positive FDG-PET 
at follow-up corresponds to a pre-existing site of disease on CT that is not progressing on the 
basis of the anatomic images, this is not PD.
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2.3
Response Assessment
2.3.1
Evaluation of Best Overall Response
The best overall response is the best response recorded from the start of the study treatment until 
disease progression or the last response recorded, taking into account any requirement for 
confirmation and censoring rules regarding subsequent therapy. The patient’s best overall response 
assignment will depend on the findings of both target and non-target disease and will also take into 
consideration the appearance of new lesions. Furthermore, depending on the nature of the study 
and the protocol requirements, it may also require confirmatory measurement.
2.3.2
Time Point Response
At each protocol specified time point, a response assessment occurs. Table 2.3.2-1 provides a 
summary of the overall response status calculation at each time point for patients who have 
measurable disease at baseline. When patients have non-measurable (therefore non-target) disease 
only, Table 2.3.2-2 is to be used. 
Table 2.3.2-1:
Time Point Response
Target Lesions
Non-Target Lesions
New Lesions
Overall Response
CR
CR
No
CR
CR
Non-CR/non-PD
No
PR
CR
Not evaluated
No
PR
PR
Non-PD or not all 
evaluated
No
PR
SD
Non-PD or not all 
evaluated
No
SD
Not all evaluated
Non-PD
No
NE
PD
Any
Yes or No
PD
Any
PD
Yes or No
PD
Any
Any
Yes
PD
Abbreviations: CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; NE,
inevaluable.
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Table 2.3.2-2:
Time Point Response: Patients with Non-target Disease Only
Non-Target Lesions
New Lesions
Overall Response
CR
No
CR
Non-CR/non-PD
No
Non-CR/non-PDa
Not all evaluated
No
NE
Unequivocal PD
Yes or No
PD
Any
Yes
PD
Abbreviations: CR, complete response; PD, progressive disease; NE, unevaluable.
a Non-CR/non-PD is preferred over SD for non-target disease since SD is increasingly used as endpoint for 
assessment of efficacy in some trials so to assign this category when no lesions can be measured is not advised.
2.3.3
Best Overall Response 
Best response determination of complete or partial response requires confirmation: Complete or 
partial responses may be claimed only if the criteria for each are met at a subsequent time point of 
t 4 weeks (28 days) later. In this circumstance, the best overall response can be interpreted as in 
Table 2.3.3-1. When SD is believed to be best response, it must meet the protocol specified 
minimum time from the date of first treatment or randomization date.
For example, if the first scheduled follow-up imaging visit is Week 6 (± 7 days) for a particular 
protocol, a Best Response of SD can only be made after the subject is on-study for a minimum of 
6 weeks (42 days) minus 7 days, for an absolute minimum time on-study of 35 days from the 
reference start date (reference date is considered Day 1 on study).  If the subject is not on-study 
for at least this amount of time, any tumor assessment indicating stable disease before this time 
period will have a Best Response of NE unless PD is identified.
Special note on response assessment: When nodal disease is included in the sum of target lesions 
and the nodes decrease to ‘normal’ size (< 10 mm), they may still have a measurement reported 
on scans. This measurement should be recorded even though the nodes are normal in order not to 
overstate progression should it be based on the increase in the size of the nodes. As noted earlier, 
this means that patients with CR may not have a total sum of ‘zero’ on the case report form (CRF).
Table 2.3.3-1:
Best Overall Response (Confirmation of CR and PR Required)
Overall Response 
First Time Point
Overall Response 
Subsequent Time Point
Best Overall Response
CR
CR
CR
CR
PR
SD, PD OR PRa
CR
SD
SD provided minimum criteria for SD duration met, otherwise, 
PD
CR
PD
SD provided minimum criteria for SD duration met, otherwise, 
PD
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Table 2.3.3-1:
Best Overall Response (Confirmation of CR and PR Required)
Overall Response 
First Time Point
Overall Response 
Subsequent Time Point
Best Overall Response
CR
NE
SD provided minimum criteria for SD duration met, otherwise, 
NE
PR
CR
PR
PR
PR
PR
PR
SD
SD
PR
PD
SD provided minimum criteria for SD duration met, otherwise, 
PD
PR
NE
SD provided minimum criteria for SD duration met, otherwise, 
NE
NE
NE
NE
Abbreviations: CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; NE, 
inevaluable.
a If a CR is truly met at first time point, then any disease seen at a subsequent time point, even disease meeting PR 
criteria relative to baseline, makes the disease PD at that point (since disease must have reappeared after CR). Best 
response would depend on whether minimum duration for SD was met. However, sometimes ‘CR’ may be claimed 
when subsequent scans suggest small lesions were likely still present and in fact the patient had PR, not CR at the 
first time point. Under these circumstances, the original CR should be changed to PR and the best response is PR.
2.3.4
Confirmation Scans
Verification of Response: To be assigned a status of CR or PR, changes in tumor measurements 
must be confirmed by consecutive or subsequent repeat assessments that should be performed no 
less than 28 days after the criteria for response are first met. Subsequent documentation of a CR 
may provide confirmation of a previously identified CR even with an intervening NE or PR (eg, 
CR NE CR or CR PR CR). Subsequent documentation of a PR may provide confirmation of a 
previously identified PR even with an intervening NE or SD (eg, PR NE PR or PR SD PR). 
However, only one (1) intervening time point will be allowed between PR/CRs for confirmation.
Verification of Progression: Progression of disease should be verified in cases where progression 
is equivocal. If repeat scans confirm PD, then progression should be declared using the date of the 
initial scan. If repeat scans do not confirm PD, then the subject is considered to not have 
progressive disease.
REFERENCES
1
Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumors: 
revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45: 228-47.
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APPENDIX 9
NEW YORK HEART ASSOCIATION FUNCTIONAL 
CLASSIFICATION
Heart failure is usually classified according to the severity of the patient’s symptoms. The table 
below describes the most commonly used classification system, the New York Heart Association 
(NYHA) functional classification. It places patients in 1 of 4 categories based on how much they 
are limited during physical activity.
Class
Patient Symptoms
I
No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, 
palpitation, or dyspnea (shortness of breath).
II
Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in 
fatigue, palpitation, or dyspnea (shortness of breath).
III
Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes 
fatigue, palpitation, or dyspnea.
IV
Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If 
any physical activity is undertaken, discomfort increases.
Class
Objective Assessment
A
No objective evidence of cardiovascular disease. No symptoms and no limitation in ordinary 
physical activity.
B
Objective evidence of minimal cardiovascular disease. Mild symptoms and slight limitation 
during ordinary activity. Comfortable at rest.
C
Objective evidence of moderately severe cardiovascular disease. Marked limitation in activity due 
to symptoms, even during less-than-ordinary activity. Comfortable only at rest.
D
Objective evidence of severe cardiovascular disease. Severe limitations. Experiences symptoms 
even while at rest.
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APPENDIX 10
PROTOCOL AMENDMENT SUMMARY OF CHANGE HISTORY
Overall Rationale for Protocol Amendment 02: 07-Apr-2023
The main purpose of Protocol Amendment 02 is 
 
 
 in the ongoing Phase 1/2 Study, MORAb-202-G000-201, 
 
 As of 
March 31 2023,
 
MORAb-202, 25 mg/m2 . 
Enrollment of eligible participants will continue in 
 (MORAb-202, 25 mg/m2) and 
 
(Investigator’s Choice Chemotherapy).
Additional revisions, including to sections of the Protocol Summary, have been made to align the 
protocol with respect to these changes.
Minor editorial, formatting, and typographical corrections have been made and therefore have not 
been summarized.
This protocol amendment applies to all participants.
SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 02
Section Number & Title
Description of Change
Brief Rationale
Table 2-2, On-treatment 
Procedural Outline for 
MORAb-202 
 
 
 
Table headers and footnotes updated to 
remove reference
 
 
 
 
 
 
Table 2-2, On-treatment 
Procedural Outline for 
MORAb-202
Section 3.2.4.4, Corrected QTc 
Interval Assessment
Section 3.3, Benefit/Risk 
Assessment
Section 3.3.1, Risk Assessment
Section 4, Objectives and 
Endpoints
Section 5, Study Design
Section 5.1.1.1, Safety 
Committee (SC)
Section 5.2, Number of 
Participants
All references 
 have been removed 
throughout the study.
 
 
 
 
 
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SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 02
Section Number & Title
Description of Change
Brief Rationale
Section 5.4, Scientific 
Rationale for Study Design
Section 5.5, Justification for 
Dose
Section 7.1.1, MORAb-202 
Administration 
Table 7.1.1-1, Administration 
of MORAb-202
Table 7.4.1-1, MORAb-202 
Dose Levels
Section 9.4.5, ILD/Pneumonitis 
Assessments
 
Table 10.4.2-1, Primary 
Endpoints
Section 3.2.3, MORAb-202 
Clinical Data
Added updated data from Study 201.
Section 3.2.3.2, Clinical Safety
Added updated data from Study 201.
Section 3.2.4.2, Exposure-
response Efficacy and Safety
Modified wording from exposure-response 
paragraph based on updated data.
Wording modified due to 
emerging safety data from 
Study 201.
Section 3.3.3, Overall 
Benefit/Risk Conclusion
Update to the benefit risk conclusion based 
on data from Study 201.
 
 
 
 
 
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SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 02
Section Number & Title
Description of Change
Brief Rationale
Section 5.1, Overall Design
The study design schema has been updated. 
Section 5.5, Justification for 
Dose
Revisions to the justification for dose 
section have been made based on the 
changes in Protocol Amendment 02.
Section 5.6.2.4, Tumor FRĮ 
Expression
Moved from 5.6.2.2 to 5.6.2.4, but content 
is the same
Administrative move.
Table 7.1-2, Study Arm
study intervention information was 
removed.
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SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 02
Section Number & Title
Description of Change
Brief Rationale
Overall Rationale for Protocol Amendment 01:02-Aug-2022
The main purpose of this Protocol Amendment is to make updates 
 
. Additionally, further clarification was added to Table 2-4 and Table 7.4.1-2.
Summary of Changes for Protocol Amendment 01
Section Number & Title
Description of Change
Brief Rationale
Title Page
Removed local addresses for Belgium and 
Japan.
Addresses removed as any 
differences in the local sponsor 
information will be submitted 
in local applications.
Table 2-4: On-treatment 
Procedural Outline for a 
28-Day Cycle -
 (PLD, 
Paclitaxel, and Topotecan 
4 mg/m2)
Table 3.3.1-1: Risk Assessment
Added Clinical Laboratory Assessments to 
be conducted before each treatment visit. 
Updated the notes and added a footnote for 
these additional assessments to clarify that 
only hematologic and chemistry 
assessments were to be conducted for 
participants receiving paclitaxel or 
topotecan. Also updated the notes to clarify 
that participants receiving pegylated 
liposomal doxorubicin will have all clinical 
laboratory assessments performed at every 
cycle. 
Updated predose complete blood cell count 
assessments to be conducted at every 
treatment visit, instead of every cycle, for 
both paclitaxel and topotecan treatments 
 
To ensure appropriate safety 
monitoring in accordance with 
standard of care in participants 
Section 6.1: Inclusion Criteria
Under inclusion criterion 4) a):
•
Updated numbering for “WOCBP must 
agree to follow instructions for 
Corrected errors in the 
numbering of the inclusion 
criteria.
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Summary of Changes for Protocol Amendment 01
Section Number & Title
Description of Change
Brief Rationale
method(s) of contraception as described 
below and included in the ICF.” from 
i) to iii).
•
Updated numbering for “A female 
participant is eligible to participate if 
she is not pregnant or breastfeeding, 
and at least 1 of the following 
conditions applies:” from i) to iv).
Section 6.2 Exclusion Criteria
Updated exclusion criterion 3) a) iii) (2) to 
clarify the eligibility requirements for the 
assessment of alkaline phosphatase (ALP). 
To further clarify a population 
with elevated ALP values and 
known bone and liver 
metastases.
Updated the repeated demonstration of a 
QTcF interval from > 500 msec to 
> 480 msec in exclusion criterion 3) b).
Updated the QTcF cutoff to a 
more stringent value of 
> 480 msec.
Section 7.4.1.1: Criteria to 
Resume MORAb-202 
Treatment
Clarified that the next cycle of MORAb-202 
could be resumed when participants return 
to their baseline stable sensory neuropathy 
Grade  2, as per exclusion criterion 2) c).
Clarified MORAb-202 dose 
resumption to align with 
exclusion criterion 2) c).
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