A Phase 2, Open-label, Randomized Study of MORAb-202 (Farletuzumab Ecteribulin), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) After Progression on Prior Therapies
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Bristol-Myers Squibb

Official Title of Study: 
A Phase 2, Open-label, Randomized Study of MORAb-202 (Farletuzumab Ecteribulin), a Folate 
Receptor Alpha-targeting Antibody-Drug Conjugate, in Participants with Metastatic Non-Small 
Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) After Progression on Prior Therapies 
 
NCT Number: NCT05577715 
Document Date (Date in which document was last revised): 07 Apr 2023 
 
 
 

Clinical Protocol
CA116003
BMS-986445
MORAb-202
Protocol Amendment No.: 03
Date: 07-Apr-2023
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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 
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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]).
© 2023 Bristol-Myers Squibb Company
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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 Metastatic Non-Small Cell Lung Cancer ................................................. 
 
 
 
3.2.3 MORAb-202 Mechanism of Action .......................................................... 
 
3.2.4 Summary of Key Preclinical Data with MORAb-202 .............................. 
 
3.2.5 MORAb-202 Clinical Data ...................................................................... 
 
3.2.6 Summary of Clinical Efficacy .................................................................. 
 
3.2.6.1 Study 101 ......................................................................................... 
 
3.2.6.2 Study 201 ......................................................................................... 
 
3.2.6.3 Key Differences Between Study 101 and Study 201 ........................ 
 
3.2.7 Summary of Clinical Safety ...................................................................... 
 
3.2.7.1 Study 101 ......................................................................................... 
 
. 
 
3.2.8 Summary of Clinical Safety in 
.................................................... 
 
3.2.9 Summary of Data from Subjects who Resumed Treatment After 
 
 .......................................................................................................... 
 
3.2.10 Clinical Pharmacology .......................................................................... 
 
3.2.10.1 Pharmacokinetics .......................................................................... 
 
3.2.10.2 Exposure-response Analysis of Efficacy (ORR) and Safety (ILD) 
 
 
 
3.2.10.4 Corrected QT Interval Assessment ............................................... 
 
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 ............................................................................ 
 
5.1.1.2 ILD Expert Review Committee ........................................................ 
 
5.1.1.3 Study Steering Committee ............................................................... 
 
5.2 Number of Participants ..................................................................................... 
 
5.3 End of Study Definition .................................................................................... 
 
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9.2 Adverse Events ................................................................................................. 
 
9.2.1 Time 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 Adverse Events of Special Interest - Infusion-related Reactions and 
ILD/Pneumonitis ......................................................................................... 
 
9.2.7 Laboratory Test Result Abnormalities ..................................................... 
 
9.2.8 Potential Drug-induced Liver Injury ....................................................... 
 
9.2.9 Other Safety Considerations .................................................................... 
 
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 ...................................................................... 
 
 
 
 
 
 
 
 
 
 
 
9.9 Additional Research .......................................................................................... 
 
9.10 Other Assessments .......................................................................................... 
 
9.11 Health Economics OR Medical Resource Utilization and Health Economics
........................................................................................................................... 
 
10 STATISTICAL CONSIDERATIONS .................................................................... 
 
10.1 Sample Size Determination ............................................................................. 
 
10.2 Analysis Sets ................................................................................................... 
 
10.3 Statistical Analyses ......................................................................................... 
 
10.3.1 General Considerations ......................................................................... 
 
10.3.2 Efficacy Analyses ................................................................................... 
 
10.3.3 Safety Analyses....................................................................................... 
 
 
 
10.4 Interim Analyses ............................................................................................. 
 
11 REFERENCES ........................................................................................................ 
 
12 APPENDICES ......................................................................................................... 
 
APPENDIX 1 ABBREVIATIONS............................................................................... 
 
APPENDIX 2 STUDY GOVERNANCE CONSIDERATIONS ................................. 
 
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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 ECOG PERFORMANCE STATUS ..................................................... 
 
APPENDIX 6 RESPONSE EVALUATION CRITERIA IN SOLID TUMORS 
GUIDELINES (VERSION 1.1) WITH BMS MODIFICATIONS ........................ 
 
APPENDIX 7 NEW YORK HEART ASSOCIATION FUNCTIONAL 
CLASSIFICATION ................................................................................................ 
 
APPENDIX 8 PROTOCOL AMENDMENT SUMMARY OF CHANGE HISTORY
................................................................................................................................. 
 
 
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PROTOCOL SUMMARY
Protocol Title:
A Phase 2, Open-label, Randomized Study of MORAb-202 (Farletuzumab Ecteribulin), a Folate 
Receptor Alpha-targeting Antibody-Drug Conjugate, in Participants with Metastatic Non-Small 
Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) After Progression on Prior Therapies
Brief Title: Phase 2 Study of MORAb-202 in Previously Treated Metastatic NSCLC AC
Rationale:
Patients with non-small cell lung cancer (NSCLC) adenocarcinoma (AC) who have experienced 
disease progression after prior approved therapies with platinum-doublet chemotherapy and
immune checkpoint inhibitors, or targeted therapies for actionable mutations, face a high unmet 
medical need. Effective treatment options after progression on standard-of-care therapies are 
urgently needed in this population. 
MORAb-202 (BMS-986445, farletuzumab ecteribulin) is a novel folate receptor alpha (FRα) 
targeting antibody-drug conjugate (ADC) comprising a humanized monoclonal antibody, 
farletuzumab, which binds to FRα-expressing tumor cells, conjugated to eribulin (E7389) mesylate 
via a cathepsin β-cleavable linker. The eribulin payload of MORAb-202 is a microtubule dynamics 
inhibitor that exerts its primary pharmacologic effects by preventing normal mitotic spindle 
formation, leading to irreversible mitotic blockage and subsequent cell death by apoptosis. FRα is 
highly expressed in NSCLC AC, whereas limited expression is seen in normal tissue.
The CA116003 study aims to further characterize the safety and efficacy of MORAb-202 in 
previously treated, metastatic NSCLC AC with the goal of selecting an optimal dose of 
MORAb-202 that can provide better outcomes compared with available treatment options in this 
study population.
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MORAb-202
Objectives and Endpoints: 
Objectives
Endpoints
Primary
Primary

To assess safety and tolerability of 
MORAb-202 in participants with previously 
treated, metastatic non-small cell lung cancer 
(NSCLC) adenocarcinoma (AC)

Incidence of treatment-related adverse events 
(TRAEs) leading to study treatment discontinuation

To assess tumor response of MORAb-202 in 
participants with previously treated, metastatic
NSCLC AC

Objective response rate (ORR) by Response 
Evaluation Criteria in Solid Tumors (RECIST) 1.1 
per investigator assessment
Secondary
Secondary

To assess safety and tolerability of 
MORAb-202 in participants with previously 
treated, metastatic non-small cell lung cancer 
(NSCLC) adenocarcinoma (AC)

Incidence and severity of adverse events 
(AEs)/serious AEs (SAEs), treatment related 
AEs/SAEs, AEs of special interest (AESI), deaths 
and laboratory abnormalities.

To evaluate progression-free survival (PFS) of 
MORAb-202 in participants with previously 
treated, metastatic NSCLC AC 

PFS by RECIST 1.1 per investigator assessment

To evaluate disease control rate (DCR) of 
MORAb-202 in participants with previously 
treated, metastatic NSCLC AC 

DCR by RECIST 1.1 per investigator assessment

To evaluate duration of response (DoR) of 
MORAb-202 in participants with previously 
treated, metastatic NSCLC AC who achieved 
a complete response (CR) or partial response 
(PR)

DoR by RECIST 1.1 per investigator assessment
Overall Design:
CA116003 is a Phase 2 open-label, randomized, multicenter study assessing the safety, efficacy,
and tolerability of MORAb-202 in participants with previously treated, metastatic NSCLC AC. 
Participants will receive MORAb-202 at a dose of 25 mg/m2
 every 3 weeks. 
 
 
(see details below).

Participants must have received prior treatment, including platinum-based chemotherapy, and

If without actionable genetic alterations or unknown genetic alterations status, treatment 
with anti-PD-1/PD-L1
OR

If with known actionable genetic alterations, treatment with at least 1 targeted therapy

No more than 3 prior lines of systemic therapy in the metastatic setting
Note: Participants with resectable or stage 3 locally advanced disease that has recurred or 
progressed within 1 year from the start of treatment with platinum-based chemotherapy and 
anti-PD-1/PD-L1 are not required to be retreated in the metastatic setting to be eligible.
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survival were or are expected to be collected if this is not the same. A participant is considered to 
have completed the study if he/she has completed all survival follow-up visits.
Study Intervention: 
Name
Intervention Name/ Unit Dose Strength(s)
MORAb-202 (BMS-986445)/ [
mg/ml]
Type 
Drug
Dose Formulation
Lyophilized powder in a single use vial
Dosage Level(s)
25 mg/m2 Q3W
Route of Administration
IV infusion
Use
Experimental
IMP and NIMP/AxMP
IMP
Sourcing
Provided centrally by the Sponsor
Abbreviations: AxMP, auxiliary medicinal product; IMP, investigational medicinal product; IV, intravenous; NIMP, 
non-investigational medicinal product; Q3W, every 3 weeks.
Statistical Methods:
The primary endpoints are being assessed based on a targeted 
 
 The primary analysis will 
be performed when all participants in each arm have been followed up for a minimum of 6 months
or discontinued earlier from treatment. 
Data Monitoring Committee: No
A Data Monitoring Committee will not be used in the study.
Other Committee: Yes
A SC, 
, and SSC will be used in this study.
Brief Summary:
The purpose of CA116003 study is to assess the safety and efficacy of MORAb-202 in previously 
treated, metastatic NSCLC AC. The study hypothesis is that the study intervention will 
demonstrate anti-tumor activity, as measured by ORR, and a manageable safety profile.
Study visits will occur on Day 1, Day 8 and Day 15 of Cycle 1 and Day 1 of each 
 cycle
thereafter.
The study intervention duration is up to 2 years of treatment or until disease progression, 
unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
The duration of the study is up to 2 years of treatment and until the last participant has completed 
2 years of survival follow-up. 
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SCHEDULE OF ACTIVITIES
The following schedule of activities are provided:
Table 2-1: Screening Procedural Outline (CA116003).
Table 2-2: On Treatment Procedural Outline (CA116003).
Table 2-3: Follow-up Procedural Outline (CA116003).
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Table 2-1:
Screening Procedural Outline (CA116003)
Procedurea
Screeningb
(Day-28 to 1)
Notes
All windows are based on calendar days
Eligibility Assessments
Informed Consent (IC)c
X
A participant is considered enrolled only when a protocol-specific IC is signed. IC 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 pre-
treatment failure. If re-enrolled, the participant must be reconsented and assigned a new 
participant number from Interactive Response Technology (IRT). 
IRT Registration
X
Register in IRT system to obtain participant number after the IC is obtained.
Inclusion/Exclusion Criteria
X
Must be confirmed prior to treatment assignment (within IRT). See Section 6.1 and Section 
6.2.
Medical History
X
All general medical history, as well as any relevant history of the disease under study, 
including American Joint Committee on Cancer (AJCC) stage (per 8th edition), histology, 
all prior therapy, and other relevant history.
Safety Assessments
Physical Examination (PE) and 
Measurements
X
Includes height and weight. Must be collected within 14 days prior to treatment assignment. 
If the screening PE is performed within 24 hours prior to dosing on Day 1 then a single 
exam may count as both the screening and predose evaluation.
Performance Status (PS)
X
Eastern Cooperative Oncology Group (ECOG) PS within 14 days prior to treatment 
assignment (see Appendix 5).
Vital Signs
X
Includes body temperature, respiratory rate, seated blood pressure (BP), and heart rate (HR). 
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 treatment assignment.
Concomitant Medication Use
X
Within 14 days prior to treatment assignment. 
NOTE: Treatment with any live/attenuated vaccine use within 30 days prior to first study 
treatment is prohibited.
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Table 2-1:
Screening Procedural Outline (CA116003)
Procedurea
Screeningb
(Day-28 to 1)
Notes
All windows are based on calendar days
Pulmonary Function Tests (PFTs)
X
PFTs include forced vital capacity (FVC), total lung capacity (TLC), forced expiratory 
volume during first second of forced breath (FEV1), diffusing capacity of the lungs for 
carbon monoxide (DLCO; %) within 28 days prior to treatment assignment. May be 
repeated during the screening period if necessary (Section 6.4.1).
Pulse Oximetry
X
Oxygen saturation 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 treatment 
assignment.
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 treatment assignment.
Adverse Event Reporting
Assessment of Signs/Symptoms/Clinical 
Complaints
X
Within 14 days of treatment assignment.
Monitor for Serious Adverse Events 
(SAEs)
X
All 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 adverse events (AEs; SAEs or non-serious AEs) associated with severe acute respiratory 
syndrome coronavirus 2 (SARS-CoV-2) infection must be collected from the start of the 
participant’s written consent.
AEs/SAEs must be graded by using National Cancer Institute (NCI) Common Terminology 
Criteria for Adverse Events version 5 (CTCAE v5.0).
Laboratory Tests
See Section 9.4.4.
Clinical Laboratory Assessments
X
Includes blood and urine samples. On-site/local laboratory testing must be performed within 
14 days prior to treatment assignment.
Pregnancy Test (For Women of 
childbearing Potential [WOCBP] only)
X
Serum or urine pregnancy test (minimum sensitivity equivalent units 25 IU/L or equivalent 
units of human chorionic gonadotropin [HCG]). If a urine test cannot be confirmed as 
negative (eg, an ambiguous result), a serum pregnancy test is required. To be conducted at 
screening visit and repeated within 24 hours prior to first dose of study treatment. See 
Appendix 4.
Follicle-stimulating Hormone
X
Required to confirm menopause in women < 55 years of age. See Appendix 4.
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Table 2-1:
Screening Procedural Outline (CA116003)
Procedurea
Screeningb
(Day-28 to 1)
Notes
All windows are based on calendar days
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
(see Section 6.2).
Must be performed within 28 days of treatment assignment.
Baseline Tumor Assessments
Body Imaging
X
Contrast enhanced 
, abdomen, pelvis, and all other 
known and/or suspected sites of disease within 28 days prior to first dose. See Section 9.1.1
for further details.
Brain Imaging
X
Magnetic resonance imaging (MRI) of the brain (without and with contrast) is required for 
ALL participants during screening, within 28 days prior to first dose. CT of the brain 
(without and with contrast) can be performed if MRI is medically contraindicated. See 
Section 9.1.1 for further details and exceptions.
Study Intervention
Contact IRT for Treatment and Vial 
Assignment
X
Participant must receive the first dose of study medication within 3 calendar days from 
treatment assignment and vial allocation in IRT.
a Some of the assessments referred to in this section may not be captured as data in the case report form (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.
b Screening safety, laboratory, and clinical outcomes assessments that are performed within 3 days prior to dosing on Cycle 1 Day 1 and prior to treatment 
assignment, unless otherwise specified above, do not need to be repeated at the Cycle 1 Day 1 visit 
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c For participants who may take part remotely, prescreening will be done remotely via a telephone call, and the informed consent will be obtained remotely using 
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 will be provided in a separate document.
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Table 2-2:
On Treatment Procedural Outline (CA116003)
Procedurea
Cycle 1
(
)
Cycle 2 
onwards
End of 
treatment 
(EOT)b
Notesc
Day 1
- 3 days
Day 8
± 3 days
Day 15
± 3 days
Day 1
± 3 days
Eligibility Assessments
Inclusion/Exclusion Criteria
X
Safety Assessments
Targeted Physical 
Examination (PE)
X
X
X
X
X
If the screening full PE is performed within 24 hours prior to 
dosing on Day 1, then a single exam may count as both the 
screening and predose evaluation.
Vital Signs and Performance 
Status
X
X
X
X
X
Includes blood pressure (BP), heart rate (HR), temperature, and 
performance status. BP and HR should be measured after the 
participant has been resting quietly for at least 5 minutes.
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).
12-Lead Electrocardiogram 
(ECGs)
As clinically indicated
X
ECGs should be recorded after the participant has been supine 
for at least 5 minutes. Refer to Section 9.4.3 for more details on 
frequency of ECG measurements.
Concomitant Medication Use
Continuously
Review/document all concomitant medications.
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Table 2-2:
On Treatment Procedural Outline (CA116003)
Procedurea
Cycle 1
Cycle 2 
onwards
End of 
treatment 
(EOT)b
Notesc
Day 1
- 3 days
Day 8
± 3 days
Day 15
± 3 days
Day 1
± 3 days
Adverse Event Reporting
Monitor for Serious and Non-
Serious Adverse Events (AEs) 
Continuously
All serious AEs (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. See Section 9.2.1 and 
Appendix 3.
Record at each visit all AEs (SAEs or non-serious AEs), 
including those associated with severe acute respiratory 
syndrome coronavirus 2 (SARS-CoV-2) infection. All 
AEs/SAEs must be graded using Common Terminology 
Criteria for Adverse Events version 5 (CTCAE v5.0).
Interstitial Lung Disease 
(ILD)/Pneumonitis 
Signs/Symptoms Assessment 
Continuously
Laboratory Tests
See Section 9.4.4.
Clinical Laboratory 
Assessments
X
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 of Cycle 1 Day 1 and the results 
are available and have been reviewed for eligibility.
Refer to Section 9.4.4 for the list of laboratory tests to be 
conducted.
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BMS-986445
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Table 2-2:
On Treatment Procedural Outline (CA116003)
Procedurea
Cycle 1
Cycle 2 
onwards
End of 
treatment 
(EOT)b
Notesc
Day 1
- 3 days
Day 8
± 3 days
Day 15
± 3 days
Day 1
± 3 days
Pregnancy Test (Women of 
Childbearing Potential 
[WOCBP] only) 
X
See Notes
X
Serum or urine pregnancy test (minimum sensitivity equivalent 
units 25 IU/L or equivalent units of human chorionic 
gonadotropin [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. Refer to 
Appendix 4 for further information.
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BMS-986445
MORAb-202
Table 2-2:
On Treatment Procedural Outline (CA116003)
Procedurea
Cycle 1
Cycle 2 
onwards
End of 
treatment 
(EOT)b
Notesc
Day 1
- 3 days
Day 8
± 3 days
Day 15
± 3 days
Day 1
± 3 days
Efficacy Assessments
Body Imaging
See Notes
Contrast enhanced CT of the 
, abdomen, pelvis, and all 
other known and/or suspected sites of disease should occur 
every 6 weeks (± 7 days) starting from first dose for the first 36 
weeks, then every 12 weeks (± 7 days) until investigator-
assessed disease progression and 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 and exceptions. 
Brain Imaging 
See Notes
Participants with a history of brain metastasis or symptoms 
should have a surveillance magnetic resonance imaging (MRI; 
without and with contrast) per standard of care (approximately 
every 12 weeks), or sooner if clinically indicated. CT of the 
brain without and with contrast can be performed if MRI is 
contraindicated. See Section 9.1.1 for further details.
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Table 2-2:
On Treatment Procedural Outline (CA116003)
Procedurea
Cycle 1
Cycle 2 
onwards
End of 
treatment 
(EOT)b
Notesc
Day 1
- 3 days
Day 8
± 3 days
Day 15
± 3 days
Day 1
± 3 days
Study Intervention
Contact Interactive Response 
Technology (IRT) for 
Treatment and Vial 
Assignment/Dispense/
Administer/Deliver Study 
Intervention 
X
X
Participants must receive the first dose of study treatment 
(MORAb-202) within 3 calendar days from treatment 
assignment in IRT, unless previously discussed with Medical 
Monitor (or designee).
See Section 7.1.1 for details on administration.
Contact IRT
X
Register EOT visit.
a Some of the assessments referred to in this section may not be captured as data in the case report form. 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.
b EOT is defined as the date at which the decision is made to discontinue the participant from study treatment. The EOT visit should be performed ≤ 7 days from
the treatment discontinuation decision. Evaluations will be performed prior to study discharge or for participants who are prematurely discontinued. 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 Screening safety, laboratory, and clinical outcomes assessments that are performed within 3 days prior to dosing on Cycle 1 Day 1 and prior to treatment 
assignment, unless otherwise specified, do not need to be repeated at the Cycle 1 Day 1 visit.
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Table 2-3:
Follow-up Procedural Outline (CA116003)
Procedure
Safety Follow-
up Visita
Survival 
Follow-up
Notes
Efficacy Assessments
Body Imaging
See Notes
Only for participants who discontinue study treatment prior to documented 
radiographic progression per Response Evaluation Criteria in Solid Tumors 
(RECIST) 1.1 (see Appendix 6).
Contrast enhanced computed tomography (CT) of the 
 abdomen, pelvis, and
all other known and/or suspected sites of disease should occur every 6 weeks 
(± 7 days) starting from first dose for the first 36 weeks, then every 12 weeks (± 7 
days) until investigator assessed disease progression. See Section 9.1.1 for further 
details.
Brain Imaging
See Notes
Only for participants who discontinue study treatment prior to documented 
radiographic progression per RECIST 1.1 (see Appendix 6).
Participants with a history of brain metastasis or symptoms should have a 
surveillance magnetic resonance imaging (MRI; without and with contrast) per 
standard of care (approximately every 12 weeks), or sooner if clinically 
indicated. CT of the brain without and with contrast can be performed if MRI is 
contraindicated. See Section 9.1.1 for further details.
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Table 2-3:
Follow-up Procedural Outline (CA116003)
Procedure
Safety Follow-
up Visita
Survival 
Follow-up
Notes
Survival Follow-up
Survival Statusb
X
X
Participant disease and survival status, and subsequent cancer therapy will be 
assessed by a documented clinic visit, email, or telephone contact every 3 months 
(± 14 days) from the safety follow-up visit until the last participant has completed
2 years of survival follow-up, or until death, loss to follow-up, withdrawal of 
consent, or conclusion of the study, whichever occurs first. Include response to 
subsequent anticancer therapy and any details relevant to the participant’s disease 
status.
 
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 the last dose or can be performed on the date of discontinuation if that date is greater than 30 days after last dose.
b Survival follow-up visits may be conducted in clinic or by telephone or via digital technology (including email and participant portal). BMS 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.
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3
INTRODUCTION
CA116003 is a Phase 2 open-label, multicenter study assessing the safety, tolerability, and efficacy 
of MORAb-202 (BMS-986445, farletuzumab ecteribulin), a folate receptor alpha (FRα)-targeting 
antibody-drug conjugate (ADC) in participants with previously treated, metastatic non-small cell 
lung cancer (NSCLC) adenocarcinoma (AC). The goal of the study is to optimize dose and 
appropriate study population and potentially provide better outcomes compared with available 
treatment options.
Worldwide, lung cancer is the second most diagnosed cancer but is the leading cause of cancer-
related deaths in both men and women, claiming approximately 1.8 million deaths in the year 
2020, due to a high fatality rate. NSCLC accounts for about 85% of all primary lung cancers 
diagnosed, with AC the major subtype.1
Lung AC mostly originates in the peripheral lung tissue from the mucous producing epithelial, 
alveolar type 2 cells.2 and strongly correlates with prior smoking history. The majority of patients 
present with Stage IV disease at initial diagnosis and have a very poor prognosis.3,4,5 The most 
common clinical symptoms at presentation are cough, dyspnea, hemoptysis, pain, or other 
symptoms associated with spread to most common metastatic sites: lung, brain, bone, adrenal 
glands, and liver.5
With the approval of immune checkpoint inhibitors as single agents or in combination with 
chemotherapy in the first line setting and as second line monotherapy for metastatic NSCLC AC
after platinum doublet chemotherapy, the treatment paradigm has changed significantly with 
improved 5-year overall survival (OS) rates reaching to about 20% in these patients. In patients 
with molecular alterations as well, approved targeted therapies have increased long term survival
rates.6 Despite these advances, once patients progress on these therapies, treatment options remain 
very limited and prognosis very poor.7,8,9
3.1
Study Rationale
Patients with NSCLC who have experienced disease progression after prior approved therapies with 
platinum-doublet chemotherapy, anti-programmed cell death protein 1 (PD-1)/ programmed death-
ligand 1 (PD-L1) inhibitors or target therapies face a high unmet medical need, with median OS of 
9.4 to 11.3 months despite treatment with the current option of single-agent chemotherapy.7,8,9
Effective treatment options after progression on standard of care therapies are urgently needed. This 
phase 2 study aims to investigate a novel therapeutic approach, MORAb-202, for these patients 
with previously treated, metastatic NSCLC. A randomized, parallel dose-ranging study design was 
initially selected using a 
 approach for MORAb-202. The 
 approach has the advantage of scaling the dose/exposures more evenly across
ranges.
maintains exposures in the lower
quartiles,
similar to that of
, while reducing exposure in the highest
quartiles. Dose selection 
for MORAb-202 was based on a detailed assessment of pharmacokinetics (PK) and exposure-
response (E-R) safety (interstitial lung disease [ILD]/pneumonitis) across multiple tumor types 
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see Section 5.5.
Farletuzumab ecteribulin (also known as MORAb-202, BMS-986445) is an ADC that has 3 
components, a humanized monoclonal antibody, farletuzumab, the mitotic inhibitor payload, 
eribulin, and a cathepsin β-cleavable linker that binds them. MORAb-202 has high affinity to FRα
expressed on the membrane of tumor cells and leverages the FRα transport mechanism to enter the 
cells. Once internalized, the cathepsin β-cleavable linker of the ADC is cleaved inside the 
lysosomal compartment and free eribulin is released which elicits cytotoxic effects directly to the 
tumor cells. The eribulin payload of MORAb-202 is a first-in-class halichondrin B-based 
microtubule dynamics inhibitor that exerts its primary pharmacologic effects by preventing normal
mitotic spindle formation, leading to irreversible mitotic blockage and subsequent cell death by 
apoptosis.10,11,12 Eribulin mesylate binds with high affinity to the plus ends of microtubules, where 
it suppresses the growth phase of microtubules without affecting the corresponding shortening 
phase.13,14 In addition, eribulin mesylate induces formation of nonproductive tubulin aggregates, 
lowering concentrations of free tubulin available for polymerization and thus further inhibiting 
microtubule growth. 
Preclinical data show the pleiotropic effects of MORAb-202 are also evident from the bystander 
antiproliferative activity on surrounding tumor cells and remodeling of tumor microenvironment 
(TME) by unconjugated eribulin released into the TME after cancer cell death.15 In in vitro cell
culture studies, MORAb-202 exhibited anticancer effects on FRα-negative cells, when co-cultured 
with FRα-positive cells.15
Of note, the mechanisms of eribulin-mediated changes to the TME and tumor are not linked to its 
antimitotic effects. These additional effects of eribulin include: (i) tumor vasculature remodeling 
whereby inner tumor cores become better perfused and less hypoxic, and (ii) promotion of cellular 
differentiation processes resulting in shifts from more aggressive to less aggressive phenotypes, 
either via reversal of the epithelial-mesenchymal transition (EMT) in carcinomas or tissue-specific 
differentiation of sarcomas. These data indicate that eribulin mesylate induces beneficial changes 
in tumor biology or tumor-host interactions that are over and above those which can be attributed 
to direct antiproliferative activities of eribulin mesylate against tumor cells alone.16,17,18
FRα is a glycosylphosphatidylinositol-linked protein, highly expressed in a variety of cancers, 
such as 
 as well as lung cancer. Although FRα expression is limited in normal lung 
tissue, approximately 74% of NSCLC ACs express FRα.19 The differential distribution of FRα 
expression, coupled with its ability to internalize large molecules, allows for effective drug 
delivery. Thus, FRα is ideally suited for MORAb-202-based therapeutic approach.20 Although 
clinical activity was observed with MORAb-202 across FRα expression levels in MORAb-202-
J081-101 (hereafter referred to as Study 101), 
 
.15 Thus, the role of FRα expression levels in NSCLC AC and its association with 
MORAb-202 activity require further investigation in order to understand which patients may 
derive greater benefit from treatment with MORAb-202.
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MORAb-202 is being clinically evaluated in 2 clinical studies: Study 101, a study being conducted 
in Japan, and MORAb-202-G000-201 (hereafter referred to as Study 201) being conducted under 
Eisai IND 132,199 (EudraCT Number: 2019-003600-12) across several primary solid tumors that 
express FRα (eg, 
). As of the cutoff date of 31-Aug-2021, 107 
participants have been treated with MORAb-202 across both trials, including 20 participants with 
. 
 have received 
MORAb-202 in Study 201 after the data cutoff date of 31-Aug-2021.
Study 101 is a first-in-human, open-label, dose-escalation, and expansion study. The primary 
objective is to evaluate the safety, tolerability, and pharmacokinetics of MORAb-202 as a single 
agent administered by intravenous (IV) injection every 3 weeks (Q3W) in Japanese participants 
with solid tumors (Part 1: Dose Escalation part) or platinum-resistant ovarian carcinoma (PROC) 
 (Part 2: Dose Expansion part). Of the 82 participants, 4 participants 
 
were enrolled in the 0.68 mg/kg (n = 3), or 0.9 mg/kg (n = 1) dose escalation cohort and 15
participants 
 were enrolled in the 0.9 mg/kg dose expansion cohort. Overall, the 
investigator-assessed objective response rate (ORR) was 45% (10/22 participants) for the dose 
escalation cohort and 30.0% (8/60 participants) for the dose expansion cohort. Across both parts 
of Study 101, 79/82 (96.3%) participants treated with single-agent MORAb-202 experienced at 
least 1 treatment-emergent adverse event (TEAE), and the most frequently (> 25%) reported 
TEAEs were ILD/pneumonitis, and alanine aminotransferase (ALT) increased. In all participants 
in the dose expansion part of Study 101, 28/60 events of ILD/pneumonitis were reported by 
investigators and an additional 7 events identified by the ILD expert committee only. The 
maximum tolerated dose (MTD) was not reached in Study 101.
Study 201 is an open-label study with a two-dose level escalation part followed by a dose 
confirmation part, evaluating the safety, tolerability, and efficacy of MORAb-202 in participants 
with select tumor types (
) in the United States (US) population. In 
the dose escalation part, 25 participants have been exposed to MORAb-202 at dose levels of 0.9 
and 1.2 mg/kg. Of the 25 participants exposed, 1 participant with 
 was enrolled in the 
0.9 mg/kg dose cohort. The investigator-assessed 
 
 
 
 
participants.
 
 
The dose confirmation part of Study 201 includes sequential 
 of MORAb-202 
at 25 mg/m2
 
 A total of 
 participants have been enrolled and treated 
with MORAb-202 in the dose confirmation part, with 
 
 
 
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weeks or longer. 
In the 
 
 
 
 
Based on the emerging data for MORAb-202 at the 
 in Study 201, notably a 
 
 
 
 continue in 
 patients in Study 201. Please refer to Section 
for additional 
details.
See Section 3.2.7 Summary of Clinical Safety and the current MORAb-202 Global Investigator’s 
Brochure (IB)15 for additional details on safety.
 
 
MORAb-202 has shown clinical activity in participants with 
, 
including notable disease control in heavily pretreated participants, warranting further clinical 
exploration.
 
 
 this study implements multiple risk mitigation measures as outlined in 
Section 3.3 and Table 3.3.1-1.
The CA116003 study aims to further characterize the safety and efficacy of MORAb-202 in 
previously treated, metastatic NSCLC AC with the goal of selecting an optimal dose of 
MORAb-202 that can provide better outcomes compared with available treatment options in this 
study population.
 
.
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3.1.1
Research Hypothesis
MORAb-202 (farletuzumab ecteribulin) will demonstrate anti-tumor activity (as measured by 
ORR) with a manageable safety profile in participants with previously treated, metastatic NSCLC 
AC who have progressed during or after treatment with standard-of-care therapies.
3.2
Background
3.2.1
Metastatic Non-Small Cell Lung Cancer
NSCLC remains the leading cause of cancer-related mortality worldwide, accounting for 
approximately 18% of all cancer deaths.21 There are 3 major histological subtypes of NSCLC: AC, 
squamous cell carcinoma, and large cell carcinoma, with AC being the most common histologic 
subtype accounting for over 60% of NSCLC cases.22,23 Most NSCLC ACs are diagnosed at an 
advanced stage (stage III or IV) with a poor overall prognosis. The standard approach to treatment 
of advanced NSCLC AC includes platinum-based chemotherapy, immune checkpoint inhibitors, 
targeted therapy for tumors with driver mutations, and combination therapy. However, most 
patients with advanced disease experience disease progression within 12 to 24 months from the 
initial diagnosis of metastatic NSCLC, requiring further treatment. Per the National 
Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO) 
Clinical Practice Guidelines for NSCLC, the current standard of care in patients progressing on 
standard first- and second-line approved therapies is salvage chemotherapy, such as docetaxel. 
Outcomes with docetaxel are poor, with response rates of 6.8% to 14%, median progression-free 
survival (PFS) of 3.0 to 4.2 months, and median OS of 9.4 to 11.3 months.8,9
Identification of targetable alterations (ie, epidermal growth factor receptor [EGFR], ALK, 
PI3K/AKT/mTOR, RAS-MAPK, RET, MET, BRAF, and NTRK/ROS1) in patients with 
advanced NSCLC has evolved its treatment paradigm.24 In lung AC, actionable driver mutations 
are present in approximately 30% to 35% of the patients. These mutations confer sensitivity to 
small-molecule tyrosine kinase inhibitors, resulting in high response rates (ranging from 60% to 
80%), longer PFS (8 to 13 months),25,26 significant improvements in OS, and more favorable 
toxicity profiles compared with chemotherapy. Nevertheless, while targeted therapy in NSCLC 
has significantly improved disease control in patients with actionable mutations, the tumors 
inevitably develop drug resistance and progress, indicating the need for identifying effective 
therapies to continue improving lung cancer treatment.27
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3.2.3
MORAb-202 Mechanism of Action
MORAb-202 is a novel ADC consisting of farletuzumab, a humanized monoclonal antibody that 
binds to FRα-expressing tumor cells, conjugated to eribulin (E7389) mesylate, a microtubule 
dynamics inhibitor, via a cathepsin β-cleavable linker. When MORAb-202 binds to the 
FRα-expressing tumor cell, the ADC is internalized, which results in lysosomal cleavage of the 
cathepsin β-cleavable linker and intracellular release of eribulin.
Unconjugated eribulin elicits its antitumor activity by inhibiting the growth of microtubules, which 
cause irreversible mitotic arrest and cell death. In addition, unconjugated eribulin exhibits a 
bystander effect through non-mitotic effects, which include (i) the inhibition of cell migration, 
(ii) the induction of tumor vasculature remodeling whereby inner tumor cores become better 
perfused and less hypoxic, and (iii) the promotion of cellular differentiation processes resulting in 
shifts from more aggressive to less aggressive phenotypes via reversal of the EMT.39,40,41 The 
release of unconjugated eribulin from cells undergoing cell death also potentially has effects on 
adjacent tumor and stromal cells in the TME, which may allow MORAb-202 to effectively target 
tumors with heterogenous FRα expression and modify the TME.15 Thus, it is postulated that 
eribulin may induce beneficial changes in tumor biology or tumor-host interactions in addition to 
direct cytotoxic effects.
3.2.4
Summary of Key Preclinical Data with MORAb-202
Preclinical data support clinical exploration of MORAb-202 in NSCLC AC, as proposed in this 
study. MORAb-202 is selectively cytotoxic to FRα-positive cells, with low levels of off-target 
killing. It demonstrates a clear in vitro bystander effect in mixed tumor cell populations of 
FRα-positive and FRα-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 FRα-expression positive NSCLC tumor cell 
line-derived and patient-derived xenograft (PDX)19 models of human cancer with a single 
administration at 5 mg/kg.42
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Please refer to the current MORAb-202 Global IB for additional details.15
These results suggest that MORAb-202 may have antitumor activity against FRα-positive 
 
and warrants clinical investigation.
3.2.5
MORAb-202 Clinical Data
Across both Study 101 and Study 201 (data cutoff of 31-Aug-2021), a total of 107 participants 
 have been treated with MORAb-202.15
 
 have received MORAb-202 in Study 201 after the data 
cutoff date of 31-Aug-2021. Study 101 is a first-in-human, open-label, dose-escalation and 
expansion study with a primary objective of evaluating the safety, tolerability, and PK of MORAb-
202 as a single agent administered by IV injection Q3W in participants with solid tumors (Part 1: 
Dose escalation) or PROC 
 (Part 2: Dose expansion), with no requirement for FRα
expression in the Japanese population. Preliminary efficacy of MORAb-202 was also evaluated in 
Study 201, an open-label study with a 2-dose level escalation part, followed by a dose confirmation 
part, which evaluated the safety, tolerability, and efficacy of MORAb-202 in participants with 
select tumor types (
), with no minimum requirement for FRα
expression in the US population. 
In Study 101, 82 participants have been exposed to MORAb-202 across 5 dose levels in the dose 
escalation and dose expansion parts. Twenty-two participants with solid tumors were enrolled in 
the dose escalation part across 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, including 4 participants 
 
(n = 3 at 0.68 mg/kg; n = 1 at 0.9 mg/kg). Sixty participants were enrolled in the dose expansion 
part, including 15 participants 
 in the 0.9 mg/kg dose cohort and 45 participants with 
OC in the 0.9 mg/kg and 1.2 mg/kg dose cohorts. 
In the dose escalation part of Study 201, 25 participants have been exposed to MORAb-202 at 
dose levels of 0.9 mg/kg and 1.2 mg/kg. Of the 25 participants exposed to MORAb-202 in Study 
201, 1 participant 
 was enrolled in the 0.9 mg/kg dose cohort.
The dose confirmation part of Study 201 includes 
 
and the study has opened recruitment globally. A total 
of 
 participants have been enrolled and treated with MORAb-202 in the dose confirmation part, 
with  participants
 in the 
 
and  participants
 
. However, based on the 
emerging data for MORAb-202 at the 
 
 in Study 201, notably 
 
 
 
 
 in the study at the 
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. Enrollment at the 
dose level will continue in 
 patients in Study 201. Please refer to Section 
for additional 
details.
3.2.6
Summary of Clinical Efficacy
Clinical efficacy data is presented as of the cutoff date of 31-Aug-2021, unless otherwise specified. 
Please refer to the current MORAb-202 Global IB15 for complete information on clinical efficacy.
In both Study 101 and Study 201,
 
 Anti-tumor 
activity was evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for all 
participants in Studies 101 and 201.
3.2.6.1
Study 101
Across Study 101 dose escalation cohorts, the investigator-assessed ORR was 45% (10/22 
participants). Responses included 1 CR (
 at 0.9 mg/kg) and 9 partial responses (PRs); 
1 participant (
) at 0.3 mg/kg, 4 participants (
) at 0.68 mg/kg, 
2 participants (
) at 0.9 mg/kg, and 2 participants (
) at 1.2 mg/kg. The disease control rate 
(DCR) was 82% (18/22 participants). Of note, the 2 PRs reported for participants 
 at 
0.6 mg/kg were not confirmed on subsequent scans and both were later declared as SD.
3.2.6.2
Study 201
Across Study 201 dose-escalation cohorts, the investigator-assessed 
 
 
 
 
3.2.6.3
Key Differences Between Study 101 and Study 201
Encouraging efficacy was observed in participants with non-high-grade serous (HGS) PROC in 
both the dose-escalation and expansion parts of Study 101 (0.9 mg/kg dose: ORR of 31.5%,
duration of response [DoR] of 10.6 months; 1.2 mg/kg dose: ORR of 50%, DoR of 8.0 months). 
However, 
 was observed in the PROC cohorts in Study 201 (0.9 mg/kg dose: ORR 
of 
 
 
. Evaluation of differences in participant populations enrolled across the 2 studies 
. 
Number of prior lines of therapy and baseline tumor burden are well established prognostic factors 
associated with response in PROC.43 In Study 201, 
 of participants of PROC received > 3 
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prior lines of therapy (as permitted by the eligibility criteria). In contrast, only 
 of 
 
participants in Study 101 had > 3 prior lines of treatment.
At the 
 dose level in Study 201, mean sum of diameters of target lesions at baseline was 
 mm (range, 
 mm), whereas in Study 101 (at the same dose level), participants had 
relatively lower disease burden at baseline with a mean sum of diameters of target lesions of 
mm (range,
 mm). At the 
 dose level, the mean sum of diameters of target 
lesions were similar between Study 201 and 101 (
 mm 
 mm] 
 mm 
 mm],
.
The high neutrophil-to-lymphocyte ratio (NLR), which is also associated with poorer outcomes, 
was also different between the 2 study populations.44
 
. Finally, baseline 
 g/dL) 
 
 g/dL). Low albumin levels are associated with 
 
 and are also considered to be an independent predictor of worse prognosis.15,45
Taken together, these observations indicate that participants in Study 201 had 
 
 
 with participants in 
Study 101. These factors could account for 
 
 
with 
MORAb-202. 
In summary, encouraging efficacy with MORAb-202 was observed in both studies across tumor 
types, including notable 
 in participants with 
 is a significant 
predictor of survival outcomes46 indicating that further dose optimization is warranted in this 
population.
3.2.7
Summary of Clinical Safety
Clinical safety data are presented as of the cutoff date of 31-Aug-2021, unless otherwise specified.
Please refer to the current MORAb-202 Global IB for complete information on clinical safety.15
3.2.7.1
Study 101
Across both parts of Study 101, 79/82 (96.3%) participants treated with single-agent MORAb-202 
experienced at least 1 TEAE, and the most frequently (> 20%) reported TEAEs were 
ILD/pneumonitis (26.8%), increased ALT (26.8%), increased aspartate aminotransferase 
(AST; 23.2%), nausea (23.2%), and pyrexia (23.2%). The 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%) 
participants. Serious TEAEs were reported in 2/22 (9.1%) participants, of which 1/22 (4.5%) 
participant had a treatment-related event. There were no reported treatment-related deaths at the 
time of data cutoff. Five (5/22; 22.7%) events of ILD/pneumonitis/pneumonia/traumatic lung 
injury were reported, including 1 in 0.68 mg/kg, 3 in 0.9 mg/kg, and 1 in 1.2 mg/kg cohorts (3
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Grade 1 and 2 Grade 2 events), which were identified by the investigators and confirmed by the 
ILD expert committee.
In the dose expansion part of Study 101, Grade ≥ 3 TEAEs were reported in 15/60 (25%) 
participants. Serious TEAEs were reported in 12/60 (20.0%) participants, of which 7/60 (11.7%) 
participants had treatment-related events. The most frequent treatment-related SAEs were 
pneumonitis and ILD. In the 
 0.9 mg/kg expansion cohort, serious TEAEs (Grade 3) were 
reported in 2/15 (13.3%) participants, and both were pneumonitis.
In all participants (n = 60) in the Study 101 dose expansion, 28 (46.7%) events of ILD/pneumonitis 
were reported by the investigators and an additional 7 events identified by the ILD expert 
committee only (total of 35 events; 58.3%). In participants 
 in Study 101 
dose expansion, ILD/pneumonitis events were reported for 8 (53.3%) participants, including 
5 participants diagnosed by the investigators (4 Grade 1 and 1 Grade 2 events), and 3 additional 
participants identified by the ILD expert committee (National Cancer Institute [NCI] Common 
Terminology Criteria for Adverse Events version 5 [CTCAE v5.0] grade not assigned). There were 
no confirmed high-grade (Grade ≥ 3) ILD events in participants 
.
Serious Adverse Events:
Of the 82 participants exposed in Study 101 (cutoff date, 31-Aug-2021), 14 participants (17.1%) 
experienced at least 1 treatment-emergent SAE. Of the 14 SAEs reported in participants who 
received MORAb-202, 8 were assessed by the investigator as related to study treatment and 6 were 
assessed as unrelated to study treatment. The most frequent treatment-related SAEs were 
pneumonitis and ILD.
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3.2.8
Summary of Clinical Safety in 
As of cutoff date 31-Aug-2021, in Study 101, 
 participants with metastatic 
 were 
treated with Q3W MORAb-202 across both the dose escalation part (  at 0.9 mg/kg and  at 
0.68 mg/kg dose) and expansion part (
 at 0.9 mg/kg dose). In Study 201, 
 with 
 was treated at the 0.9 mg/kg dose.
In the dose expansion cohort of Study 101
 participants with 
 were treated
with MORAb-202 at 0.9 mg/kg Q3W. Any 
 were reported in 
 participants, respectively. Overall, 
were reported and there were 
 
 participants 
 as assessed by investigator; 
additional 
 based on the clinical 
information and
. Among the 
participants with 
, the time to onset from first dose of MORAb-202 ranged from 
 
. As of the cutoff date, the reported 
 
 
Based on the totality of the data, the clinical safety profile of MORAb-202 in 
participants with NSCLC appear to be consistent with that observed in other tumors in both studies.
3.2.9
Summary of Data from Subjects who Resumed Treatment After 
 
Clinical experience with MORAb-202 suggest that resuming treatment 
 
Pooled analysis of 
 events from Study 101 and Study 201 show that 
 
In Study 101, 
, 
 
 
 
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In the Study 201 dose-confirmation part, participant treated in the MORAb-202 
cohort 
with 
 
 
 
 
(MORAb-202 at 
), 
 
 
In CA116003, treatment with MORAb-202 is held for 
 and prompt 
treatment with 
 is recommended. Treatment with MORAb-202 at a dose level -1 
can be resumed only if 
 improves or resolves. 
See Section 7.4 for recommendations on management of ILD/pneumonitis events.
Please refer to the current MORAb-202 Global IB for complete information on clinical safety.
3.2.10
Clinical Pharmacology
MORAb-202 is an immunoglobulin G1 (IgG1) antibody (farletuzumab) conjugated to the 
microtubule inhibitor eribulin via a cathepsin β-cleavable linker 
 
. Eribulin mesylate, marketed as Halaven®, is approved in the US and European Union for 
the treatment of metastatic breast cancer and for unresectable or metastatic liposarcoma.47
3.2.10.1
Pharmacokinetics
The PK of MORAb-202 was evaluated after IV administration at Q3W 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 (n = 3) in Part 1 (dose 
escalation), and at Q3W doses of 0.9 mg/kg (n = 39) and 1.2 mg/kg (n = 21) in Part 2 (dose 
expansion) in Study 101 (Japanese population). PK was also evaluated at Q3W doses of 0.9 mg/kg 
(n = 9) and 1.2 mg/kg (n = 6) in Study 201 (non-Japanese population). The PK of MORAb-202, 
total antibody and released eribulin have been previously described over the escalation dose range 
of 0.3 to 1.2 mg/kg Q3W in Study 101.48 From noncompartmental analysis (NCA), the PK of 
MORAb-202 was near dose-proportional from 0.3 mg/kg 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 
the Cycle 1 dose. Concentration versus time profiles were similar for MORAb-202 and total 
antibody levels, with low levels of released eribulin near the assay limit of quantitation, indicating 
that 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 US Prescribing 
Information (USPI) approved dose of 1.4 mg/m2 IV on Days 1 and 8 of a 21-day cycle.47,
348
8
 
 
 
. Based on human metabolism studies conducted with 14C-eribulin, as 
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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, 
consistent with 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 BW on clearance (CL) and volume of 
distribution of the central compartment (V) and baseline albumin levels on CL. This results in 
participants with higher baseline BW having higher CL and V, and participants with low albumin 
having higher CL, which is consistent with that observed for other monoclonal antibodies.49
3.2.10.2
Exposure-response Analysis of Efficacy (ORR) and Safety (ILD)
There was a dose and E-R relationship observed for ORR in Study 101 over the dose range 
0.68 to 1.2 mg/kg Q3W in participants with 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 
when data were combined across tumor types from Studies 101 and 201 (N = 96 total; n = 81,
Study 101 and 
). The highest tested dose of 1.2 mg/kg Q3W in Study 101 
(including both escalation and expansion) had the highest ORR of 54.2% (13/24) in PROC and 
highest ILD rate of 58.3% (14/24) across tumor types. The next lower dose level, 0.9 mg/kg Q3W, 
led to a lower ORR of 32.1% (9/28) and ILD rate of 37.0% (17/46) in Study 101. 
An E-R efficacy (ORR) analysis was conducted with participants with PROC from Study 101 
(n = 58). Across the dose range of 0.3 to 1.2 mg/kg Q3W, 21 participants had a PR, and 
2 participants had a CR with an ORR of 39.7% (23/58). 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.50 Age, weight, non-HGS (vs HGS OC), and 
Eastern Cooperative Oncology Group performance status (ECOG PS; 1 vs 0) were not significant 
predictors of an OR. Higher doses above 1.2 mg/kg Q3W would be expected to result in a higher 
probability of an OR, given linear PK and lack of saturation of OR across the current dose range. 
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. 
 
 
 
 
An E-R analysis of all grade 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. In a 
multivariate analysis, AUC and age were significant predictors of ILD, with both higher AUC and 
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higher age predicting a higher probability of ILD.50
 
 
 
3.2.10.4
Corrected QT Interval Assessment
 
 
 msec. 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) of 11.4 msec (19.5) in 26 patients with solid tumors, there was 
no concentration effect identified. 51 The total dose of eribulin (unconjugated) 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. These data combined with plasma levels of 
released eribulin from MORAb-202 that are approximately 300-fold lower than with single-agent 
eribulin, indicate a low risk of QTc prolongation for MORAb-202. Therefore, for all treated
participants, electrocardiograms (ECGs) will only be required at baseline and at end of treatment 
(EOT). During study treatment and safety follow-up, ECGs should be performed as clinically 
indicated.
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. 
 
 
(see Section 3.2.6). As described in Section 3.2.6, clinical activity with MORAb-202 treatment
was observed across multiple FR-expressing tumor types. Across Studies 101 and 201, 
107 participants were exposed to MORAb-202 as of the cutoff date of 31-Aug-2021, including 20 
participants with 
 
 participants 
 have 
received MORAb-202 in Study 201 in the dose confirmation part, after the data cutoff date of 31-
Aug-2021. Clinical responses were observed in participants with 
, and 
tumors across FR-expression levels at different MORAb-202 dose range levels; however, 
lower rates of all grade ILD have been observed with lower doses while a trend was observed for
higher grade ILD in participants with higher BW. In order to reduce the overall rate of ILD and 
high-grade ILD,
 
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 for Study CA116003 to be evaluated in parallel. The 
extensive PK analyses performed for MORAb-202 (see Section 3.2.10.1 and Section 5.5)
 
dosing in this advanced NSCLC AC setting where outcomes remain poor.
As described in Section 
emerging data for MORAb-202 
 
 
 
 
 
 
 
Based on clinical study experience to date, ILD/pneumonitis associated with MORAb-202 appears 
to be responsive to treatment with corticosteroids.52 For some participants who experienced 
. AEs due to steroid use in 
Study 101 were generally not reported, which is in line with current clinical experience with steroid 
use as a treatment for AEs in cancer patients.53,54
 
 
 
. 
Lastly, the recommendations for monitoring and management of ILD/pneumonitis included in this 
study have been revised since 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 (refer to Section 7.4.1 for ILD/pneumonitis management 
recommendations). 
 
 
 
 
 
 
 
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 See Section 3.2.8 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 current MORAb-202 Global IB.15
The global coronavirus disease 2019 (COVID-19) pandemic has been identified as a potential risk 
to clinical study participants in general and may particularly affect individuals with underlying 
chronic diseases on immunomodulatory therapies. In general, participants with lung cancer are at 
an increased risk for respiratory compromise. As described in the Global IB and informed consent 
form (ICF), MORAb-202 is an immunomodulatory Investigational Medicinal Product (IMP) with 
the potential for immunosuppressive effects. Based on the mechanism of action, infections are a 
potential risk. It is not known whether taking MORAb-202 increases the risk of severe acute 
respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, or the duration or severity of 
COVID-19 disease. The inclusion criteria (Section 6.1) have been designed to exclude people with 
current and recent infections. Testing to exclude asymptomatic SARS-CoV-2 prior to enrollment 
should follow local standard practice. The study has been designed with study visits that allow for 
close monitoring of participants’ safety throughout the clinical study (Section 2), and participants 
are encouraged to contact the investigator if an intercurrent illness develops between study visits. 
Testing for COVID-19 to inform decisions about clinical care during the study should follow local 
standard practice. In addition, the Sponsor has also developed guidance for investigators on how 
to manage a participant with a clinical suspicion of, or a diagnosis of, COVID-19. This includes 
criteria for temporarily interrupting or permanently discontinuing IMP (Section 8.1), and criteria 
for reinitiating IMP on resolution of a COVID-19 infection (Section 8.1). In order to facilitate 
enhanced reporting of COVID-19 events that occur during the study, all AEs and SAEs reported 
after the time of consent that are related to SARS-CoV-2 or COVID-19 infection must be reported 
(Section 9.2). Individual benefit-risk considerations remain the responsibility of the investigator. 
Investigators should apply clinical judgment and these risks should be considered when enrolling 
a participant. With respect to the benefit/risk of receiving COVID-19 vaccinations during 
treatment with MORAb-202, non-live COVID-19 vaccination is considered a concomitant 
medication within the study. However, the efficacy and safety of non-live vaccines (including 
non-live COVID-19 vaccines) in participants receiving MORAb-202 is unknown.
Refer to the risk assessment Section 3.3.1 for identified risks and mitigation strategy.
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Table 3.3.1-1:
Risk Assessment
Potential Risk of Clinical Significance
Summary of Data/
Rationale for Risk
Mitigation Strategy
Study Procedures
Blood draws/use of intravenous catheter 
for laboratory assessments (eg, pain, 
bruising, bleeding, infection, fainting)
Per institutional protocol/investigator discretion.
CT scan/ magnetic resonance imaging
(MRI) radiation exposure
Per institutional protocol/investigator discretion.
Allergy to contrast agent for CT scan/MRI 
(eg, allergic reaction, anaphylaxis)
Contrast United 
States Prescribing 
Information and 
Summary of Product 
Characteristics
Prophylaxis and/or treatment per institutional protocol/investigator discretion.
Other (if applicable)
Severe acute respiratory syndrome 
coronavirus 2 (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), rescreening criteria (Section 6.4.1) and dose 
modifications (Section 7.4.1) sections for SARS-CoV-2 Safety Surveillance Plan.
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 study can continue should the 
hospital be subject to increased demands/restrictions due to the pandemic (travel 
restrictions, remote access / monitoring, preventative measures, etc).
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3.3.2
Benefit Assessment
There is currently an unmet medical need for safe and effective therapy for patients with advanced 
NSCLC who have progressed on currently approved therapies. Existing data suggest promising 
clinical activity with MORAb-202 in participants with FRα-expressing advanced cancers. Safety 
and efficacy are primary endpoints of this study. Safety will be monitored on an ongoing basis by 
the clinical study team, the pharmacovigilance team and various oversight committees. 
MORAb-202 may address this high unmet need for patients with NSCLC AC, given its unique, 
tumor-specific mechanism (ie, FRα-directed ADC), the high prevalence of FRα overexpression in 
lung cancer, and the preclinical and clinical activity seen to date (see Section 5.4.1). See Section
5.4.2 for further details on clinical efficacy in MORAb-202 studies.
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 AEs. 
3.3.3
Overall Benefit/Risk Conclusion
Considering the measures taken to minimize risk to participants in this study, the potential risks 
identified in association with MORAb-202 ILD/pneumonitis are justified by the anticipated 
benefits that may be afforded to participants with previously treated, metastatic NSCLC AC.
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 where 
character, severity, and/or frequency suggest that participants would be exposed to an 
unreasonable and significant risk of illness or injury; (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 communicate 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.
In conclusion, the overall benefit/risk of MORAb-202 in participants with previously treated,
metastatic NSCLC AC is assessed to be acceptable and is described further in the following 
sections.
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4
OBJECTIVES AND ENDPOINTS
Table 4-1:
Objectives, Endpoints and Estimands
Objectives
Endpoints
Primary
Primary

To assess safety and tolerability of MORAb-202 in participants with 
previously treated, metastatic non-small cell lung cancer (NSCLC)
adenocarcinoma (AC)

Incidence of treatment-related adverse events (TRAEs) leading to study 
treatment discontinuation
Main Estimand for the Primary Objectivea

Treatment: MORAb-202, 25 mg/m2

Population: Participants with previously treated, metastatic NSCLC AC

Variable: Occurrence of TRAEs leading to study treatment discontinuation

Intercurrent events: Early discontinuation of study treatment due to reasons other than TRAE leading to treatment discontinuation

Strategy to handle intercurrent events: While on treatment (early discontinuation of treatment due to reasons other than TRAEs would not be counted 
towards population-level summary)

Population-level summary: Adverse event (AE) incidence rate; 
 
 

To assess tumor response of MORAb-202 in participants with previously 
treated, metastatic NSCLC AC 

Objective response rate (ORR) by Response Evaluation Criteria in Solid 
Tumors (RECIST) 1.1 per investigator assessment
Main Estimand for the Primary Objectivea

Treatment: MORAb-202, 25 mg/m2

Population: Participants with previously treated, metastatic NSCLC AC with evaluable baseline tumor assessment

Variable: Best overall response (BOR), defined as the best response, as determined by investigator, recorded between the date of first dose and the date of 
first objectively documented progression per RECIST 1.1

Intercurrent events: Early discontinuation of study treatment 

Strategy to handle intercurrent events: Treatment policy (all post-baseline tumor assessment regardless of on-treatment status will contribute to BOR 
determination)

Intercurrent events: Initiation of subsequent anticancer therapy (excluding allowed palliative radiotherapy/surgery to non-target/non-thoracic sites)

Strategy to handle intercurrent events: Treatment policy (all post-baseline tumor assessment regardless of initiation of subsequent anticancer therapy 
will contribute to BOR determination)
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Table 4-1:
Objectives, Endpoints and Estimands
Objectives
Endpoints

Population-level summary: ORR, defined as the number of participants who achieve a BOR of confirmed complete response (CR) or confirmed partial 
response (PR) based on investigator assessments (using RECIST 1.1) divided by the number of all response-evaluable participants, with two-sided 95% 
exact confidence interval (CI); 
.
Secondary
Secondary

To assess safety and tolerability of MORAb-202 in participants with 
previously treated, metastatic NSCLC adenocarcinoma (AC)

Incidence and severity of AEs/serious AEs (SAEs), TRAEs/SAEs, AEs 
of special interest (AESI), deaths and laboratory abnormalities
Main Estimand for the Secondary Objectivea

Treatment: MORAb-202, 25 mg/m2

Population: Participants with previously treated, metastatic NSCLC AC

Variable: Occurrence of the AEs/SAEs, TRAEs/SAEs, AESI, deaths and laboratory abnormalities

Intercurrent events: Early discontinuation of study treatment 

Strategy to handle intercurrent events: while on treatment (only treatment-emergent AEs between first study dose date and 30 days from last study dose 
will be counted)

Population-level summary: AE incidence rate

To evaluate progression-free survival (PFS) of MORAb-202 in 
participants with previously treated, metastatic NSCLC AC 

PFS by RECIST 1.1 per investigator assessment
Main Estimand for the Secondary Objectivea

Treatment: MORAb-202, 25 mg/m2

Population: Participants with previously treated, metastatic NSCLC AC

Variable: PFS, defined as the time between the date of first dose and the first date of documented progression, determined by investigator assessments (using 
RECIST 1.1), or death due to any cause, whichever occurs first

Intercurrent events: Early discontinuation of study treatment 

Strategy to handle intercurrent events: treatment policy (consider time of first PD or death as PFS event regardless of treatment discontinuation)

Intercurrent events: Initiation of subsequent anticancer therapy (excluding allowed palliative radiotherapy/surgery to non-target/non-thoracic sites)

Strategy to handle intercurrent events: treatment policy (consider time of first PD or death as PFS event regardless of initiation of subsequent anticancer
therapy)

Population-level summary: Kaplan Meier (KM) estimated median survival time and landmark survival rate of PFS
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Table 4-1:
Objectives, Endpoints and Estimands
Objectives
Endpoints

To evaluate DCR of MORAb-202 in participants with previously treated, 
metastatic NSCLC AC

DCR by RECIST 1.1 per investigator assessment
Main Estimand for the Secondary Objectivea

Treatment: MORAb-202, 25 mg/m2

Population: Participants with previously treated, metastatic NSCLC AC with evaluable baseline tumor assessment

Variable: BOR, defined as the best response, as determined by investigator, recorded between the date of first dose and the date of first objectively 
documented progression per RECIST 1.1

Intercurrent events: Early discontinuation of study treatment 

Strategy to handle intercurrent events: treatment policy (all post-baseline tumor assessment regardless of on-treatment status will contribute to BOR 
determination)

Intercurrent events: Initiation of subsequent anticancer therapy (excluding allowed palliative radiotherapy/surgery to non-target/non-thoracic sites)

Strategy to handle intercurrent events: treatment policy (all post-baseline tumor assessment regardless of initiation of subsequent anticancer therapy 
will contribute to BOR determination)

Population-level summary: DCR, defined as the number of participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based 
on investigator assessments (using RECIST 1.1) divided by the number of all response evaluable participants, with two-sided 95% exact CI

To evaluate duration of response (DoR) of MORAb-202 in participants 
with previously treated, metastatic NSCLC AC who achieved a CR or PR

DoR by RECIST 1.1 per investigator assessment
Main Estimand for the Secondary Objectivea

Treatment: MORAb-202, 25 mg/m2

Population: Participants with previously treated, metastatic NSCLC AC with a best overall response as PR or CR 

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 1.1), or death due to any cause, whichever occurs first. DoR will be 
evaluated for responders (confirmed CR or PR) only

Intercurrent events: Early discontinuation of study treatment 

Strategy to handle intercurrent events: Treatment policy (consider time of first PD or death as DoR event regardless of treatment discontinuation)

Intercurrent events: Initiation of subsequent anticancer therapy (excluding allowed palliative radiotherapy/surgery to non-target/non-thoracic sites)

Strategy to handle intercurrent events: Treatment policy (consider time of first PD or death as DoR event regardless of initiation of subsequent 
anticancer therapy)
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Table 4-1:
Objectives, Endpoints and Estimands
Objectives
Endpoints

Population-level summary: KM estimated median response time and landmark response rate of DoR
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Table 4-1:
Objectives, Endpoints and Estimands
Objectives
Endpoints
a Sensitivity estimators of the main estimand and supplemental estimands will be defined in the Statistical Analysis Plan, where applicable. 
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5
STUDY DESIGN
5.1
Overall Design
CA116003 is a Phase 2 open-label, multicenter study assessing the safety, efficacy, and tolerability 
of MORAb-202 in participants with previously treated, metastatic NSCLC AC. Participants will 
receive MORAb-202 at a dose of 25 mg/m2
every 3 weeks. The 
 

Eligible participants must have received prior treatment, including platinum-based 
chemotherapy and:

If without actionable genetic alterations or unknown genetic alterations status, treatment 
with anti-PD-1/PD-L1
OR 

If with known actionable genetic alterations, treatment with at least 1 targeted therapy 

Participants must have received no more than 3 prior lines of systemic therapy in the metastatic 
setting
NOTE: Participants with resectable or stage 3 locally advanced disease that has recurred or 
progressed within 1 year from the start of treatment with platinum-based chemotherapy and 
anti-PD-1/PD-L1 are not required to be retreated in the metastatic setting to be eligible.
The full eligibility criteria are described in Section 6. 
Approximately 
participants will receive treatment in 
 (25 mg/m2 Q3W). Protocol 
Amendment 03 
 
) but continues  
 
 
. Participants already 
treated in 
 and may choose to 
continue MORAb-202 treatment at a dose of 25 mg/m2
 
 Please refer to Section 3.3 for a description of the rationale to 
.
Participants will enroll through IRT (see Section 7.2) and will be assigned to treatment 
 at 
25 mg/m2.
All screening assessments to determine participant eligibility must be performed within 28 days 
prior to treatment assignment (see Section 2). 
 
 
 
 
 FRα expression levels will be analyzed by immunohistochemistry (IHC) on 
an ongoing basis. There is no minimum requirement for FRα expression (%). A tumor sample of 
sufficient quality and quantity is highly recommended. An archival sample resubmission beyond 
the screening period for participants without tumor sample of sufficient quality and quantity who 
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are otherwise eligible for the study is highly recommended 
 Additional details 
on tumor sample quality and quantity metrics and logistics will be provided in the laboratory 
manual. 
All participants will be treated until disease progression per RECIST 1.1 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; however, continuous safety and tumor assessment evaluation will guide the 
Sponsor’s decision for a participant to be treated with additional cycles of study therapy beyond 
2 years, if the participant has confirmed clinical benefit (see Section 7.8).
 
All 
relevant data (safety, efficacy, PK, and pharmacodynamics) will inform the Sponsor’s decision on 
subsequent clinical development, including enrollment of additional participants into an expansion 
cohort to assess the relationship with FRα expression through a protocol amendment or continuing 
development in a separate study (see Section 10.1).
The primary analysis will be performed when all participants have been followed up for a 
minimum of 6 months or discontinued earlier from treatment. One dose level of MORAb-202 will 
be selected at the primary analysis to continue further evaluation. The dose selection will be based 
on the totality of efficacy and safety data and as described in Section 10.1. Safety follow-up visits
will be conducted 30 days after the last study drug administration. All ongoing treatment-related 
SAEs and ILD/pneumonitis events will be followed until resolution or stabilization. All 
participants discontinuing treatment for reasons other than disease progression will be followed 
for continued tumor imaging assessments until investigator-assessed disease progression per 
RECIST 1.1, death, or withdrawal of consent for tumor assessment, whichever occurs first. All 
participants will be followed for survival every 3 months until the last participant has completed
2 years of survival follow-up.
The study design schematic is presented in Figure 5.1-1.
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. The SC will re-evaluate 
the benefit/risk profile of the drug and the totality of the data and assess whether termination or 
resumption of the cohort/study is appropriate. Following each meeting, the SC will recommend 
continuation, modification, or discontinuation of a dose based on observed benefit/risk profile.
Information reviewed at each time point may include disposition, demographics, AEs, SAEs, 
treatment-related AEs (TRAEs), TRAEs leading to discontinuation, AESIs, 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 each 
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 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 Committee Charter.
5.1.1.2
ILD Expert Review Committee
An external independent ILD Expert Review Committee will be established for this study. 
 
 
 
 
 
5.1.1.3
Study Steering Committee
A Study Steering Committee (SSC), consisting of investigators and members representing the 
Sponsor of the study, will be established to provide scientific guidance for the protocol and conduct 
of the study. Details of the SSC responsibilities and procedures will be specified in the SSC charter.
5.2
Number of Participants
Approximately 
participants will receive treatment with MORAb-202 at a dose of 25 mg/m2
 Q3W. It is estimated that approximately 
participants will be enrolled to achieve 
approximately 
treated participants in 
 assuming a screen failure rate of 
 
 
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5.3
End of Study Definition
The start of the study is defined as the first participant first visit. End of study is defined as all
treated participants who complete their last visit or scheduled procedure shown in the Schedule of 
Activities (including survival follow-up). Study completion is defined as the final date on which 
data for the endpoint of OS were or are expected to be collected if this is not the same.
A participant is considered to have completed the study if he/she has completed all survival 
follow-up visits.
5.4
Scientific Rationale for Study Design
This study is a multicenter, open-label, Phase 2 study, evaluating safety, tolerability, and efficacy 
of MORAb-202 in participants with NSCLC AC who progressed after receiving up to 3 prior lines
of therapy, including platinum-based chemotherapy and checkpoint inhibitors, or up to 3 prior 
lines of therapy, including targeted therapy in those with actionable mutations. The treatment 
option for these patients listed in the NCCN and ESMO treatment guidelines is salvage therapy,
such as docetaxel, which has very poor outcomes. 
NSCLC AC tumors have high expression of FRα that can be targeted by the ADC, MORAb-202. 
Upon binding to FRα, the ADC is internalized into the tumor cell by endocytosis and is transported 
into the lysosome, where the cathepsin β-cleavable linker in the ADC is enzymatically cleaved to 
release the payload eribulin.
 
 
 
 
The study will evaluate the
 of MORAb-
202 at 25 mg/m2 Q3W
 which corresponds to 0.68 mg/kg, a dose that has shown clinical 
activity. The MORAb-202 dose of 
 has been 
 
. Refer to Section 3.3 for further details on the 
.
The study design allows for adequate characterization of the benefit/risk profile of MORAb-202
and selection of a dose that maximizes tolerability, safety and efficacy in patients with NSCLC 
AC, in line with Food and Drug Administration’s (FDA’s) current initiative of oncology drug dose 
optimization.55,56 To ensure safety of all participants, the study will be closely monitored by a 
Safety Committee and is designed with prospectively established stopping rules for higher 
incidence of severe ILD cases. 
5.4.1
Rationale for Choice of Endpoints
ORR is an accepted Phase 2 endpoint in NSCLC 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.57 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 1.1 to avoid delays in implementation of subsequent intervention in this advanced cancer 
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setting. The tumor response will be further described by the durability of responses. Safety and 
tolerability are a co-primary endpoint to allow selection of the dose with the optimal benefit/risk 
profile.
5.4.2
Participant Considerations and Input Into Study Design
5.4.2.1
Racial and Ethnic Disparity in Lung Cancer Diagnosis, Treatment and 
Outcomes
There are differences in the incidence and mortality rates of lung cancer between racial and ethnic 
groups globally, which may be associated with socioeconomic status.58 In the United States, black 
men and women are more likely to develop and die from lung cancer than persons of any other 
racial or ethnic group. For example, black Americans with lung cancer are 18% less likely to be 
diagnosed early, 23% less likely to receive surgical treatment, 9% more likely to receive no 
treatment and 21% less likely to survive 5 years compared with white Americans.59 Similar 
differences are also observed for Latino patients with lung cancer, who are 16% less likely to be 
diagnosed early, 26% more likely to receive no treatment and 16% less likely to survive 5 years 
compared with white Americans. Given the racial and ethnic disparities in lung cancer diagnosis, 
treatment, and outcomes, this study plans to enroll and evaluate MORAb-202 in a diverse and 
representative patient population with lung cancer.
5.4.2.2
Patient Voice Interviews
Input into the study design was obtained from Patient Voice interviews (a process within BMS, 
with a goal of improving patient experience and engagement). Patients living with advanced 
NSCLC are uniquely positioned to help in the drug development process. Patients who participated 
in Patient Voice opted-in to being interviewed to provide BMS with their patient and treatment 
journey, as well as their perspectives on clinical trials. BMS learned that patients with advanced 
NSCLC generally viewed clinical trials favorably, and their participation helps to advance the 
development of novel treatments for the broader population of patients with NSCLC in the future.
Patients are open to considering treatment options that provide a better quality of life over those 
with debilitating side effects. Patients noted that the provision of clear information regarding the 
side-effect profile and management is important to assess their interest in participating in a trial. 
Patients generally considered the CA116003 study design to be realistic for advanced NSCLC. 
Specific input from patients that aligned with protocol are listed below:

Some patients thought that weekly clinic visits for the first 9 weeks could be a deterrent to 
participation for those patients with a long distance commute to a study site. In response to this 
feedback and after careful reassessment of scheduled visits, the requirement for weekly clinic
visits was reduced from the first 9 weeks to the first 3 weeks. Safety of the patients will 
continue to be monitored during this time through weekly phone calls to patients during 
Cycle 2. Patients will have site contact information and a participant alert card.

The 2-year treatment period was considered reasonable when the patients were provided with 
the option for continued access to study medication at the conclusion of the trial by Patient 
Voice. If participants are clinically benefiting from treatment after the 2-year treatment period, 
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consideration will be given on an individual basis to allow continuation of study treatment (see 
Section 7.8).

To help minimize the potential burden of participation, Patient Voice recommended strategies 
to include the use of decentralized capabilities, such as telemedicine visits when appropriate, 
flexible methods to complete questionnaires, and expense re-imbursement. As such, telehealth 
visits may be implemented on this study. Clinical outcome assessments will be completed 
electronically and eConsent will be an option. The eConsent platform will minimize in-person 
clinic visits and allow for less burdensome participation. 
5.5
Justification for Dose
A MORAb-202 dose of 25 mg/m2 Q3W (0.68 mg/kg equivalent) was selected for this study. The 
dose was based on a detailed assessment of PK and E-R safety (ILD/pneumonitis) across multiple 
tumor types 
). 
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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 legally acceptable representatives (LAR, see Appendix 2; where acceptable
per local guidelines) must have signed and dated an Institutional Review Board 
(IRB)/Independent Ethics Committee (IEC)-approved written ICF in accordance with 
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.
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
The investigator shall evaluate the effectiveness of the contraceptive method in relationship to 
the first dose of study intervention.

Local laws and regulations may require the use of alternative and/or additional contraception 
methods.
a) Female Participants:
i)
Female participants who are not of childbearing potential must have documented proof 
in their medical documents.
ii) Women who are not of childbearing potential are exempt from contraceptive 
requirements.
iii) WOCBP must have a negative highly sensitive serum or urine pregnancy test 
(minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin 
[hCG]) within 24 hours prior to the start of study intervention.
(1) 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.
(2) Additional requirements for pregnancy testing during and after study intervention 
are located in Section 2, Schedule of Activities.
(3) The investigator is responsible for review of medical history, menstrual history, and 
recent sexual activity to decrease the risk for inclusion of a woman with an early 
undetected pregnancy.
iv) WOCBP must agree to follow instructions for method(s) of contraception defined in 
Appendix 4, described below and included in the ICF.
o
WOCBP are permitted to use hormonal contraception methods.
v) 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) Not applicable per Protocol Amendment 02
(3) Is a WOCBP and using a contraceptive method that is highly effective (with a 
failure rate of < 1% per year), with low user dependency, as described in 
Appendix 4 during the intervention period and for at least 28 days before dosing 
and throughout the study and for 7 months after MORAb-202 discontinuation and 
agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the 
same time period.
b) Male Participants:
Males who are sexually active with WOCBP must agree to follow instructions for method(s) 
of contraception as defined in Appendix 4 and as described below.
i)
Azoospermic males are not exempt from contraceptive requirements and will be 
required to always use a latex or other synthetic condom during any sexual activity 
(eg, vaginal, anal, oral) with WOCBP, even if the participant has undergone a 
successful vasectomy or if the partner is pregnant.
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ii) Not applicable per Protocol Amendment 02
iii) Not applicable per Protocol Amendment 02
iv) Not applicable per Protocol Amendment 02
v) Not applicable per Protocol Amendment 02
vi) Breastfeeding partners should be advised to consult their health care providers about 
using appropriate highly effective contraception during the time the participant is 
required to use condoms.
vii)Male participants will be required to always use a latex or other synthetic condom 
during any sexual activity (eg, vaginal, anal, oral) with WOCBP, even if the 
participants have undergone a successful vasectomy or if their partner is already 
pregnant or breastfeeding. Males should continue to use a condom during the 
intervention period and for at least 28 days before dosing and throughout the study and 
4 months after MORAb-202 discontinuation. 
viii)
Female partners of males participating in the study should be advised to use highly 
effective methods of contraception during the intervention period and for at least 4 
months after the last dose of study intervention in the male participant.
ix) Male participants with a pregnant or breastfeeding partner must agree to remain 
abstinent from sexual activity or use a male condom during any sexual activity 
(eg, vaginal, anal, oral), even if the participants have undergone a successful 
vasectomy, during the intervention period and for at least 4 months after the last dose 
of study intervention.
x) Male participants must refrain from donating sperm during the intervention period and 
for at least 4 months after the last dose of study intervention.
6.2
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
1) Medical Conditions
a) NSCLC histologies other than AC (ie, squamous cell carcinoma, large cell carcinoma).
b) Not applicable per Protocol Amendment 02
c) Significant third-space fluid retention (eg, ascites or pleural effusion) that requires repeated 
drainage.
d) Clinically significant pericardial effusion requiring drainage.
e) Prior pneumonectomy. Prior lobectomy and segmentectomy are allowed > 12 months
before treatment.
f)
Recent chest radiotherapy. Participants with chest or chest wall radiation may be permitted 
if chest radiation is documented > 6 months before starting study treatment.
g) Current infectious pneumonia (including COVID-19-related infection), history of viral 
pneumonia with evidence of persistent radiologic abnormalities.
i)
Previous SARS-CoV-2 infection, either suspected or confirmed, within 4 weeks prior 
to treatment assignment. Additionally, acute symptoms must have completely resolved 
and based on investigator assessment in consultation with the BMS Medical Monitor 
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(or designee), there are no sequelae that would place the participant at a higher risk of 
receiving investigational treatment.
ii) Participants currently in interventional trials for coronavirus disease 2019 
(COVID-19), may not participate in BMS clinical studies until the specific washout 
period is achieved. If a study participant has received an investigational COVID-19 
vaccine or other IP designed to treat or prevent COVID-19 prior to screening, 
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).
NOTE: COVID-19 polymerase chain reaction (PCR) viral testing61 may be required prior 
to treatment assignment 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.
h) Investigator assessed current ILD/pneumonitis, or ILD/pneumonitis is suspected at 
screening or history of ILD/pneumonitis of any severity including ILD/pneumonitis from 
prior anticancer therapy. 
i)
Spinal cord compression or untreated, symptomatic central nervous system (CNS) 
metastases (brain or leptomeningeal). Participants are eligible if CNS metastases are 
asymptomatic and do not require immediate treatment or if these have been treated and 
there is no magnetic resonance imaging (MRI) or CT evidence of progression for at least 
4 weeks after treatment is complete and within 28 days prior to first dose of study treatment 
and participants have neurologically returned to baseline (except for residual signs or 
symptoms related to the CNS treatment). In addition, participants must have discontinued
anticonvulsant therapy and must have discontinued corticosteroids, or be 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.
j)
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 (< 5 days) course of steroids up to 7 days prior to initiating study 
treatment is permitted.
k) Evidence of active infection including tuberculosis and uncontrolled infection requiring
systemic antibacterial, antiviral, or antifungal therapy ≤ 14 days prior to treatment.
l)
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 8), pericarditis, or myocarditis.
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ii) Ongoing symptomatic cardiac dysrhythmias, history of clinically significant 
arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de 
pointes). 
m) Clinically significant ECG abnormality, including marked prolonged baseline QTcF 
(repeated demonstration of a QTcF interval > 500 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.
n) Evidence of active bleeding or medically significant hemorrhage within 3 months prior to 
enrollment.
o) Not applicable per Protocol Amendment 02
p) Any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, 
Sjögren’s syndrome, sarcoidosis, etc) where there is documented (or suspicion of) 
pulmonary involvement. Participants with an active, known, or suspected autoimmune 
disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone 
replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic 
treatment, or conditions not expected to recur in the absence of an external trigger are 
permitted to enroll.
q) Concurrent malignancy (present during screening) requiring treatment, or history of prior 
malignancy active within 2 years prior to treatment assignment, except for the NSCLC 
under study (ie, participants with a history of prior malignancy are eligible if treatment was 
completed at least 2 years before treatment assignment 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 (ie, superficial bladder cancer, carcinoma in situ of the 
prostate, cervix, or breast) that have undergone definitive treatment at any time are also 
eligible.
r)
Any condition including medical, emotional, psychiatric, or logistical that, in the opinion 
of the investigator, would preclude the participant from adhering to the protocol or would 
increase the risk associated with study participation or study drug administration or 
interfere with the interpretation of safety results.
s) Pulmonary function test (PFT) abnormalities: Forced expiratory volume during first second 
of forced breath (FEV1) < 70%, or forced vital capacity (FVC) < 60%, and diffusing 
capacity of the lung for carbon monoxide (DLCO) < 70%.
t)
History of deep vein thrombosis (DVT) within 6 weeks prior to enrollment. Participants 
who completed at least 2 weeks of anticoagulation prior to starting study treatment and 
continue while on study are eligible.
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.
2) Prior/Concomitant Therapy
a) Participants who have received prior investigational treatment with FRα-targeting agent, 
or FRα-targeting ADCs including MORAb-202.
b) Any condition requiring folate supplementation (eg, folate deficiency).
c) Participants with known intolerance to components of the study drug.
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d) Currently enrolled in another clinical study or used any investigational drug or device, 
which in the opinion of the Sponsor may interfere with the study treatment, within the past 
28 days or 5 times the half-life of the investigational drug (whichever is longer) prior to 
the start of the study treatment.
e) 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.
f)
Treatment with any live/attenuated vaccine within 30 days of first study treatment.
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
(2) Hgb < 9.0 g/dL
(3) Platelet count < 75 × 109/L
NOTE: Supportive therapies 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) ALT and aspartate aminotransferase (AST) > 3× ULN (in the case of liver 
metastases > 5× ULN). 
iv) Participants with alkaline phosphatase (ALP) > 3× ULN, unless they are known to have 
bone metastases in which case higher ALP values will also be allowed.
v) Serum albumin < 3.0 g/dL.
b) Known human immunodeficiency virus (HIV) positive with an AIDS defining 
opportunistic infection within the last year, or a current CD4 count < 350 cells/μL. 
Participants with HIV are eligible if:
i)
They have received antiretroviral therapy (ART) for at least 4 weeks prior to treatment 
assignment 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.
c) Active viral hepatitis B or C as evidenced by the following:
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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.
4) Allergies and Adverse Drug Reaction
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).
5) Other Exclusion Criteria
a) 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 BMS approval is required.)
b) Participants who are compulsorily detained for treatment of either a psychiatric or physical 
illness (eg, infectious disease)
Eligibility criteria for this study have been carefully considered to ensure the safety of the study 
participants and that the results of the study can be used. It is imperative that participants fully 
meet all eligibility criteria.
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 assigned to treatment 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 AEs.
6.4.1
Retesting During Screening or Lead-in Period
Participant re-enrollment: This study permits the re-enrollment of a participant who has 
discontinued the study as a pretreatment failure (ie, participant has not been assigned to 
treatment/has not been treated). If re-enrolled, the participant must be reconsented and will be 
issued a new patient identification number.
Retesting of laboratory parameters, PFTs and/or other assessments within any single screening 
visit will be permitted (in addition to any parameters that require a confirmatory value).
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The most current result prior to treatment assignment 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 IMP in some regions, is defined 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 from the 
authorized form, or 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 as 
IPs/AxMPs.
7.1
Study Interventions Administered
Table 7.1-1:
Study Interventions
Name
Intervention Name/ Unit Dose Strength(s)
MORAb-202/ 
 mg/ml
Type 
Drug
Dose Formulation
Lyophilized powder in a Single Use Vial
Dosage Level(s)
25 mg/m2 Q3W
Route of Administration
IV infusion
Use
Experimental
IMP and NIMP/AxMP
IMP
Sourcing
Provided centrally by the Sponsor
7.1.1
MORAb-202 Administration 
Participants will receive MORAb-202 at a dose of 25 mg/m2 in 
 Q3W (± 3 days), for a 
maximum treatment duration of 2 years or, as described in Section 7.8, until disease progression, 
unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
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Doses of MORAb-202 may be reduced, interrupted, delayed, or discontinued depending on how 
well the participant tolerates the treatment (see Table 7.4.1-1 for dose modifications for 
management of TRAEs). Dosing visits are not skipped, only delayed.
Please refer to the current MORAb-202 Global IB 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.
7.2
Method of Study Intervention Assignment
All participants will be centrally assigned to treatment with MORAb-202 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). 
Enrolled participants, including those not dosed, will be assigned sequential participant numbers 
starting with 
 Sequential numbering may restart at 
 for each participating site because the distinct patient identification number will ultimately 
comprise the site number and participant number 
 Those enrolled participants 
meeting inclusion and exclusion criteria will be eligible to receive treatment with MORAb-202. 
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 BMS.
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After enrollment in the IRT, participants who have met all eligibility criteria will be assigned to 
treatment through the IRT. 
7.3
Blinding
Not applicable as this is an open-label study; it has been determined that blinding is not required 
to meet study objectives and access to treatment assignment information is unrestricted. The 
specific treatment to be taken by a participant will be assigned using IRT. The site will contact the 
IRT 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. 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 
CRF (eCRF).
Participants will be evaluated for AEs at each visit with the CTCAE v5.0 as a guide for the grading 
of severity.
7.4.1
Dosage Modifications for MORAb-202
Dosage modifications for MORAb-202 and recommended management of TEAEs are shown in 
Table 7.4.1-1.
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Table 7.4.1-1:
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 
Section 7.4.2.
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Table 7.4.1-1:
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 7.4.1-1:
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 7.4.1-1:
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 7.4.1-1:
Recommended Dose Modifications and Management for MORAb-202 Treatment-related Adverse 
Events
Drug-Related 
Adverse Event
per CTCAE v5.0
Severity
Action Taken
Hematologic
Neutrophil count 
decreased
Grade ≥ 3
Hold MORAb until absolute neutrophil count (ANC) is ≥1000/μL.
Grade 4
Dose reduce 1 level (Table 7.4.2-1) if lasting > 7 days.
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Table 7.4.1-1:
Recommended Dose Modifications and Management for MORAb-202 Treatment-related Adverse 
Events
Drug-Related 
Adverse Event
per CTCAE v5.0
Severity
Action Taken
Febrile neutropenia
Grade ≥ 3
Hold MORAb-202 until < 38°C (100.4°F) + ANC ≥1000/μL.
Dose reduce 1 level (Table 7.4.2-1) if Grade ≥3 febrile neutropenia (fever > 38°C [100.4°F] + ANC < 1000/μL).
Platelet count 
decreased
Grade ≥ 2
Hold MORAb-202 until platelet count is ≥75,000/μL.
Dose reduce 1 level (Table 7.4.2-1) 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.
Non-hematologic
All other lab 
abnormalities
(both symptomatic 
and asymptomatic)
Grade ≥ 3

Hold MORAb-202 until resolution to Grade ≤ 1 or baseline.

Dose reduce 1 level (Table 7.4.2-1).

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.
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7.4.2
Dosage Modifications 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 7.4.2-1). 
Consultation with the study Medical Monitor is required prior to dose reduction. Once a dose is 
decreased, it cannot be increased again. 
Table 7.4.2-1:
MORAb-202 Dose Level
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.
7.4.3
Criteria to Resume Treatment
To start the next cycle of MORAb-202 administration, participants must meet the minimum 
requirements below and be appropriate for additional cycles per investigator judgment:

ANC ≥1000/μL

Platelet count ≥75,000/μL

All non-hematologic toxicity has resolved to Grade ≤ 1 or baseline.

All Grade ≥3 laboratory abnormalities even if asymptomatic must be corrected to Grade ≤1 
or baseline

Meet the requirements for dosing as per management of infusion reactions and 
ILD/pneumonitis events (Table 7.4.1-1).
7.4.4
Dose Delays
MORAb-202 administration in subsequent cycles may be postponed for up to 
 from the 
subsequent scheduled dose to recover from any toxicities. Treatment delays of 
 are
allowed in participants with ILD/pneumonitis to permit recovery. Disease assessment should 
continue as per the protocol-mandated schedule (see Table 2-2). Study treatment should not be 
reinitiated in participants with disease progression.
If the treatment has been held and the next cycle is delayed, Day 1 of the next cycle will be defined 
as the first day that study treatment is resumed. Cycles will not be skipped; treatment will resume 
at the next planned cycle.
7.5
Preparation/Handling/Storage/Accountability
The IP/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/AxMP is only dispensed to study 
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participants. The IP/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 BMS. If 
concerns regarding the quality or appearance of the study intervention arise, the study intervention
should not be dispensed, and BMS should be contacted immediately.
Study intervention not supplied by BMS will be stored in accordance with the package insert.
IP/AxMP documentation (whether supplied by BMS or not) must be maintained that includes all 
processes required to ensure the drug is accurately administered. This includes documentation of 
drug storage, administration and, as applicable, storage temperatures, reconstitution, and use of 
required processes (eg, required diluents, administration sets).

The investigator or designee must confirm 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.

The investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study intervention accountability, reconciliation, and record maintenance 
(ie, receipt, reconciliation, and final disposition 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 MORAb-202 Global 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, BMS 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 BMS 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
Treatment Compliance
Study intervention compliance will be periodically monitored by drug accountability. 
Treatment compliance will be monitored by drug accountability as well as the participant’s 
medical record and eCRF. This will be source data verified by the BMS 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 
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in the clinic will be recorded in the source documents and recorded in the CRF. The dose of study 
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, 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
Palliative Local Therapy
Palliative local therapy, including palliative radiation therapy and palliative surgical resection, to 
symptomatic non-target lung lesions (ie, causing hemoptysis or obstruction), bone lesions, skin 
lesions, or CNS lesions is permitted prior to discontinuation of study treatment for participants 
who do not have evidence of overall clinical or radiographic progression, per RECIST 1.1. Any 
palliative radiation therapy where the radiation field involves the lung (ie, chest wall, thoracic 
spine, mediastinum, esophagus, lung, etc), should first be discussed with and approved by the 
Medical Monitor/designee.
Participants requiring palliative local therapy should be evaluated for objective evidence of disease 
progression prior to the initiation of such therapy. If progression, per RECIST 1.1 by investigator 
assessment, is identified on any tumor assessments prior to the initiation of palliative local therapy, 
then participants must discontinue study drug treatment.
The potential for overlapping toxicities with radiotherapy and MORAb-202 currently is not 
known. As concurrent radiotherapy and MORAb-202 have not been evaluated, in cases where 
palliative radiotherapy is required for a tumor lesion, then it is recommended that MORAb-202
dosing is held prior to initiation of radiation therapy. Participants should be closely monitored for 
any potential toxicity during and after receiving radiotherapy, and AEs should resolve to 
Grade ≤1 prior to resuming study drug.
7.7.2
Supportive Therapies and COVID-19 Vaccines

Supportive therapies as blood/platelet transfusion, hematopoietic stimulating agent including 
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 7 days 
prior to initiating/resuming study treatment.

COVID-19 vaccines that are NOT live are allowed and should be handled in the same manner 
as other vaccines. Administration may occur during the study, including during the
administration of the BMS study treatment and after the last administration of the BMS study 
treatment.
7.7.3
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 studies on drug-drug interactions conducted for 
MORAb-202. Farletuzumab, the antibody portion of MORAb-202, is not expected to impact 
cytochrome P450 (CYP)-mediated metabolism since its mechanism of action does not involve 
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increases in proinflammatory cytokines that historically have been linked to antibody-based 
modulation of CYPs. As described in the Halaven® USPI, drug-drug interaction studies have been 
conducted for eribulin; 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 
CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A enzymes, or induce CYP1A2, 
CYP2C9, CYP2C19 or CYP3A4 enzymes at relevant clinical concentrations. Since eribulin did 
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.
7.7.4
Prohibited and/or Restricted Treatments
The following medications and treatments are prohibited during the study (unless utilized to treat 
a treatment-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 systemic anti-neoplastic therapy (eg, systemic chemotherapy, hormonal 
therapy, immunotherapy, non-palliative radiotherapy, tumor debulking surgery or standard or 
investigational agents for treatment of malignancy). Medical Monitor approval in writing for 
any localized use of systemic anticancer. However, the continued use of drugs for bone 
diseases (such as bisphosphonates and anti-receptor activator of nuclear factor kappa-B ligand 
[RANKL] monoclonal antibody) that were already being used by the participant prior to the 
initial study treatment is permitted. The use of such agents can be discussed with the Sponsor 
Medical Monitor as needed.

Any non-palliative radiation therapy. Radiation therapy administered with palliative intent as 
described in Section 7.7.1.

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.
7.7.5
Other Restrictions and Precautions
Participants are prohibited from joining another clinical study while they are participating in this 
study.
7.7.5.1
Imaging Restriction 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 
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considered in this assessment. Participants with renal insufficiency are to be assessed as to whether 
or not they should receive contrast and if so, which contrast agent and dose is appropriate. Specific 
to 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. This will be outlined in the imaging manual.
Gentle hydration before and after IV contrast should follow local standard of care. The ultimate 
decision to perform MRI in an individual participant 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 conclusion of the study, if the study intervention is not available as an approved treatment 
in the local country, participants who continue to demonstrate clinical benefit may be eligible to 
receive BMS-supplied study intervention, as specified in Section 7.1. If the study treatment is not 
available as an approved and available treatment, study intervention may be provided via an 
extension of the study, a rollover study requiring approval by the responsible Health Authority and 
ethics committee, or through another mechanism at the discretion of BMS.
BMS reserves the right to terminate access to BMS-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; c) the participant can obtain medication from a government-
sponsored or other health program. In all cases, BMS will follow local regulations.
8
DISCONTINUATION CRITERIA
8.1
Discontinuation From Study Intervention
Participants MUST discontinue IP (and Non-IP/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 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 BMS

Loss of ability to freely provide consent through imprisonment or involuntarily incarceration 
for treatment of either a psychiatric or physical (eg, infectious disease) illness. (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 
BMS approval is required.)

Pregnancy (refer to Section 9.2.5)
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
Documented disease progression per RECIST 1.1, as assessed by the investigator 

Clinical deterioration while receiving 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 8.

Any dosing delays lasting 
from the subsequent scheduled dose with the following 
exception:

Treatment delays of 
are allowed in participants with ILD/pneumonitis to
permit recovery
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 Schedule of Activities (Section 2) 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. 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 and 
 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 (in this study or a rollover study) for collection of outcome, disease response (until 
investigator assessed disease progression by RECIST 1.1), and/or survival follow-up data as 
required and in line with Section 5 until death or the conclusion of the study.
8.1.2
Long-term Survival Follow-up
Survival follow-up visits will occur every 3 months (± 14 days) from the safety follow-up visit, 
until the last participant has completed 2 years of survival follow-up, or until death, loss to follow-
up, withdrawal of consent, or conclusion of the study, whichever occurs first. The survival visit 
may be conducted in the clinic, by telephone, or via digital technology (including email and 
participant portal). 
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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 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 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.

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, or 
compliance. 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 Section 2 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 both from the study intervention and from 
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 
three (3) documented phone calls, faxes, or emails, as well as lack of response by participant
to one (1) registered mail letter. All attempts should be documented in the participant’s medical 
records.
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
If it is determined that the participant has died, the site will use permissible local methods to 
obtain date and cause of death.

If the investigator’s use of 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 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, in order 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.
9
STUDY ASSESSMENTS AND PROCEDURES

Study procedures and timing are summarized in Section 2. 

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 treatment assignment. 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).

Evaluate the participant immediately to rule out pulmonary toxicity if the participant shows 
pulmonary-related signs (eg, abnormalities on 
 hypoxia) 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
Images will be submitted to a central imaging vendor and may undergo blinded independent 
central review (BICR) at any time during the study (Refer to Section 9.4.5
 
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. 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. 
Screening and on-study images should be acquired as outlined in Section 2 Schedule of Activities. 
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 1.1 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.
9.1.1
Efficacy Assessment
Contrast-enhanced CT of the 
, abdomen, pelvis, and all 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). As 
imaging will also be 
, sites are encouraged to obtain 
 with a 
minimal slice thickness of 2 mm (Refer to Section 9.4.5 for 
 
Every attempt should be made to image each participant using an identical 
acquisition protocol on 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 IV contrast, then a non-contrast CT of the 
 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 IV contrasts, then a non-contrast CT 
of the 
 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 IV contrast, then a non-contrast CT of the 
, abdomen, pelvis, and other 
known/suspected sites of disease is acceptable.
Use of CT component of a positron emission 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 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 1.1 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 1.1 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.
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9.1.2
Imaging Assessments
Screening and on study images should be acquired as outlined in Section 2 Schedule of Activities.
On-treatment images should be assessed by the local team for 
 
 
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 1.1 tumor 
assessment and submit to the imaging vendor. Tumor assessments should continue on the protocol-
defined imaging schedule, regardless of whether dosing is delayed or discontinued, until 
investigator-assessed disease progression by RECIST 1.1. Changes in tumor measurements and 
tumor responses will be assessed by the same investigator or designee using RECIST 1.1 criteria. 
Investigators will report the number and size of new lesions that appear while on study. The 
timepoint of tumor assessments will be reported on the eCRF based on the investigator’s 
assessment using RECIST 1.1 criteria (see Appendix 6 for specifics of RECIST 1.1 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 BOR of SD requires a minimum of 35 days on study from first dose to the date 
of the first imaging assessment.
Refer to Section 9.4.5 for details of 
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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, or a surrogate).
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.
CTCAE v5.0 definitions and grading should be used for safety reporting of all AE and SAEs on 
the CRF.
9.2.1
Time Period and Frequency for Collecting AE and SAE Information
All SAEs must be collected from the time of signing the consent, including those thought to be 
associated with protocol-specified procedures, and within 30 days following discontinuation of 
dosing.
The investigator must report any SAE that occurs after these time periods and that is believed to 
be related to study intervention or protocol-specified procedure (eg, a follow-up skin biopsy).

Medical occurrences that begin before the start of study intervention but after obtaining 
informed consent will be recorded on the appropriate section of the CRF module.

All SAEs will be recorded and reported to Sponsor or designee within 24 hours, 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.
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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 
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.
Collect all nonserious AEs (not only those deemed to be treatment related) continuously during 
the treatment period and for a minimum of 30 days following discontinuation of study treatment.
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 judgement in the context of known 
AEs, when appropriate for the program or protocol.
9.2.3
Follow-up of AEs and SAEs

Nonserious 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 nonserious AEs that cause interruption, delays or discontinuation 
of study intervention and for those present at the end of study intervention as appropriate.

All identified nonserious AEs must be recorded and described on the nonserious AE page of 
the CRF (paper or electronic). Completion of supplemental CRFs may be requested for AEs 
and/or laboratory abnormalities that are reported/identified during the course of the study.
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts. All SAEs, and nonserious AESIs; as defined in Section 9.2) 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). Any serious/nonserious 
ILD/pneumonitis event (AESIs, as defined in Section 9.2.6) must be followed with 
 
approximately Q3W 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).
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 
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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. 
Further information on follow-up procedures is given in Appendix 3.
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 current MORAb-202 Global IB 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 SUSAR (suspected, unexpected serious 
adverse reaction) 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
If, following initiation of the study intervention, it is subsequently discovered that a participant is 
pregnant or may have been pregnant at the time of study exposure, including during at least for 7 
months after study product administration (for MORAb-202), the investigator must immediately 
notify the BMS Medical Monitor/designee of this event and complete and forward a Pregnancy 
Surveillance Form to the BMS designee within 24 hours of awareness of the event and in 
accordance with SAE reporting procedures described in Appendix 3.
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 on the participant.
Any pregnancy that occurs in a female partner of a male study participant should be reported to 
the Sponsor or designee. In order for the Sponsor or designee to collect any pregnancy surveillance 
information from the female partner, the female partner must sign an ICF for disclosure of this 
information. Information on this pregnancy will be collected on the Pregnancy Surveillance Form.
If any sexual activity involving penile intercourse (eg, vaginal, anal, oral) has occurred between a 
male participant and a pregnant partner(s) without the use of a condom during and at least for
90 days after study product administration, the information should be reported to the Sponsor or 
designee, even if the male participant has undergone a successful vasectomy.
9.2.6
Adverse Events of Special Interest - Infusion-related Reactions and 
ILD/Pneumonitis
Administration of MORAb-202 could be associated with immune-mediated responses. These 
immune-mediated AEs may occur shortly after administration of the first dose or might have a 
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delayed presentation. Signs and symptoms associated with these reactions are listed in 
Table 9.2.6-1 and, if they occur after administration of MORAb-202, should be classified as 
AESIs.
Table 9.2.6-1:
Adverse Events of Special Interest
Category
Adverse Events
Infusion Reactionsa
Allergic reaction
Anaphylaxis
Cytokine release syndrome
Angioedema
Chills/Rigors
Sweating/diaphoresis
Urticaria
Pruritus/itching
Bronchospasm/wheezing
Bronchial edema
Interstitial Lung Disease
(ILD)/Pneumonitis eventsb
Pneumonitis
ILD
Pulmonary fibrosis
a When single/multiple signs or symptoms concomitantly occur; each sign/symptom should be reported on the eCRF 
and the investigator should also record whether they correspond to “infusion reaction” on the eCRF. In case of each 
sign/symptom judged as an “infusion reaction,” their onset/outcome date and time should be recorded on the 
adverse event eCRF.
b ILD/pneumonitis events of Grade 3 or above should be immediately reported as an important medical event by a 
completed serious adverse event form. 
AESIs that are Grade ≥3 in severity will be immediately reported by a completed SAE form. The 
AESIs will be clarified on AE form in eCRF.
Any ILD/pneumonitis events of Grade ≥3 should always be considered as serious important 
medical events, entered in the Adverse Event eCRF, and reported using the procedures detailed in 
Section 9.2.3 and Appendix 3. 
9.2.7
Laboratory Test Result Abnormalities
The following laboratory test result abnormalities should be captured on the nonserious AE CRF 
page or SAE eCRF, as appropriate. 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 required the participant to have study intervention
discontinued or interrupted

Any laboratory test result abnormality that required the participant to receive specific 
corrective therapy
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It is expected that, wherever possible, the clinical rather than laboratory term would be used by the 
reporting investigator (eg, anemia vs low hemoglobin value).
9.2.8
Potential Drug-induced Liver Injury
Wherever possible, timely confirmation of initial liver-related laboratory 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 9.2.8 and 
Appendix 3 for reporting details).
Potential DILI is defined as: 

Aminotransferase (AT; ALT or AST) elevation > 3× ULN

AND

Total bilirubin > 2× ULN, without initial findings of cholestasis (elevated serum alkaline 
phosphatase)

AND

No other immediately apparent possible causes of AT 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.
9.2.9
Other Safety Considerations
Any significant worsening of conditions noted during interim or final physical examinations, ECG, 
x-ray filming, or any other potential safety assessment required or not required by the protocol 
should also be recorded as a nonserious AE or SAE, as appropriate, and reported accordingly.
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 SAE will be reported as an SAE (see Appendix 3).
In the event of an overdose, the investigator should:

Contact the Medical Monitor immediately

Closely monitor the participant for AEs/SAEs and laboratory 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
Decisions regarding dose interruptions, delays or modifications will be made by the investigator 
in consultation with the Medical Monitor based on the clinical evaluation of the participant.
9.4
Safety
Planned time points for all safety assessments are listed in the Schedule of Activities (Section 2).
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9.4.1
Physical Examinations
Refer to Schedule of Activities (Section 2).
9.4.2
Vital signs
Includes pulse oximetry and ECOG PS. Refer to Schedule of Activities (Section 2).
9.4.3
Electrocardiograms
Refer to Schedule of Activities (Section 2).
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).
A local laboratory will perform the analyses and will provide reference ranges for these tests.
Results of clinical laboratory tests must be available prior to study intervention administration.
Table 9.4.4-1:
Clinical Laboratory Assessments
Hematology
Hemoglobin
Hematocrit
Total leukocyte count, including differential
Red blood cell (RBC) count
Platelet count
Chemistry
Amylase and/or lipase
Aspartate aminotransferase (AST)
Alanine aminotransferase (ALT)
Total bilirubin (T.bili)
Direct bilirubin (reflex)a
Alkaline phosphatase (ALP)
Lactate dehydrogenase (LDH)
Creatinine
Blood urea nitrogen or urea per local guidance
Uric acid
Glucose
Total protein
Albumin
Sodium
Potassium
Chloride
Calcium
CO2
Phosphorus
Magnesium
Folate
Creatine kinase
(Urine) Creatinine clearance (CrCL) - 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 (screening only)
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Table 9.4.4-1:
Clinical Laboratory Assessments
Hepatitis B/C (Hepatitis B surface antigen [HBsAG], hepatitis C virus (HCV) indicating presence of active viral 
replication (detectable HCV ribonucleic acid [RNA]) - screening only. Human immunodeficiency virus (HIV)-1 
and HIV-2 antibody - screening only (as mandated by local requirement)
Other Analyses
Pregnancy test (minimum sensitivity equivalent units 25 IU/L; women of childbearing potential only: screening, 
predose, discharge).
Follicle stimulating hormone (screening only for confirmation of menopause in women age < 55 years)
a Reflex testing to be performed only if T.bili test is abnormal.
9.4.5
ILD/Pneumonitis Assessments
ILD/pneumonitis is a known TRAE associated with MORAb-202 (see Section 3.2.8. 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 all 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 participants may be 
asymptomatic 
Signs/symptoms potentially 
consistent with ILD/pneumonitis may include but are not limited to the following:

Dyspnea (at rest and/or with ordinary physical activity)

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)
All 
 for all participants 
 
 
 See Table 7.4.1-1 for 
 
 
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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 as per standard 
medical/clinical judgment.
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9.9
Additional Research
This protocol will include residual sample storage for additional research.
For All Sites:
Additional research is required for all study participants, except where prohibited by IRBs/ethics 
committees, 
prohibited 
by 
local 
laws 
or 
regulations, 
or 
academic/institutional 
requirements. Where 1 or more of these exceptions occurs, participation in the additional research 
should be encouraged but will not be a condition of overall study participation.

If the IRB/ethics committees and site agree to the mandatory additional research retention 
and/or collection, then the study participant must agree to the mandatory additional research 
as a requirement for inclusion in the study.

If optional participation is permitted and approved, then the study participants may opt out of 
the additional research retention and/or collection.
Sample Collection and Storage
Samples kept for future research will be stored at the 
, or 
an independent, BMS-approved storage vendor.
 
Transfers of samples by research Sponsor to third parties will be subject to the recipient’s 
agreement to establish similar storage procedures.
Samples will be stored in a coded fashion, and no researcher will have access to the key. The key 
is securely held by the Investigator at the clinical site, so there is no direct ability for a researcher 
to connect a sample to a specific individual.
Further details of sample collection and processing will be provided to the site in the procedure 
manual.
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Table 9.9-1:
Residual Sample Retention for Additional Research Schedule
Timepoints for which residual samples will be retained
All
All
All
All
All
All
9.10
Other Assessments
Not applicable.
9.11
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.
10
STATISTICAL CONSIDERATIONS
10.1
Sample Size Determination 
Approximately 
participants will be assigned to receive MORAb-202 at a dose of 25 mg/m2
every 3 weeks
 
 
The sample size of 
is calculated to assess preliminary safety and efficacy objectives
 
 
 
 
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All relevant data (eg, safety, efficacy, 
) will guide subsequent 
development. 
 
 
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A final analysis will be performed
 
 
 
Details of other analyses will be included in study statistical analysis 
plan (SAP) and will be finalized prior to database lock.
10.2
Analysis Sets
For the purposes of analysis, the following populations are defined:
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 Treated
All participants who received at least 1 dose of study intervention. This will 
be the primary analysis set for safety objectives.
All Response Evaluable
All treated participants with baseline tumor assessment. This will be the 
primary analysis set for efficacy objectives.
10.3
Statistical Analyses
10.3.1
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. 
The 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. 
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10.3.2
Efficacy Analyses
Endpoint
Statistical Analysis Methods
Primary Analyses
ORR by 
Response 
Evaluation 
Criteria in Solid 
Tumors 
(RECIST) 1.1 
per investigator 
assessment
Objective Response Rate (ORR) is defined as the number of participants who achieve a best 
overall response (BOR) of confirmed complete response (CR) or confirmed partial response 
(PR), based on investigator assessments (using RECIST 1.1), divided by the number of all 
response-evaluable participants. BOR is defined as the best response, as determined by the 
investigator, recorded between the date of first dose and the date of first objectively documented 
progression per RECIST 1.1. 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 (complete 
response [CR], partial response [PR], stable disease [SD], progressive disease [PD], or unable 
to determine [UTD]) will be presented. Estimates of response rate, along with its exact two-
sided 95% confidence interval (CI) by Clopper and Pearson70 will be presented.
Secondary/
Analyses
PFS by 
RECIST 1.1 per 
investigator 
assessment
PFS is defined as the time between the date of first dose and the first date of documented 
progression, per investigator assessments (using RECIST 1.1), 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 first dose. 
The PFS function will be estimated using the KM product limit method and will be displayed 
graphically. A two-sided 95% CI for median PFS 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 Kaplan Meier estimate and corresponding CIs will be derived based on 
Greenwood’s71 formula for variance derivation and the log-log transformation applied on the 
survivor function72.
DCR by 
RECIST 1.1 per 
investigator 
assessment
Disease Control Rate (DCR) is defined as the number of participants who achieve a BOR of 
confirmed CR, confirmed PR, or stable disease (SD), based on investigator assessments (using 
RECIST 1.1) divided by the number of all response-evaluable participants.
Estimates of DCR, along with its exact two-sided 95% CI by Clopper and Pearson.
DoR by 
RECIST 1.1 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 1.1), 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.
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10.3.3
Safety Analyses
Endpoint
Statistical Analysis Methods
Primary Analyses
Safety
Incidence of AEs leading to study treatment discontinuation. 
Safety analysis will be performed in all treated participants. Descriptive statistics of AE 
incidence rate will be presented.
Secondary 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. All on-study AEs, drug-related AEs, SAEs, and drug-
related SAEs will be tabulated using worst grade per NCI CTCAE v5.0 criteria by system organ 
class and preferred term. On-study lab parameters including hematology, chemistry, liver 
function and renal function will be summarized using worst grade per NCI CTCAE v5.0 criteria.
10.4
Interim Analyses 
Not applicable. 
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11
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39 Yoshida T, Ozawa Y, Kimura T, et al. Eribulin mesilate suppresses experimental metastasis of 
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mesenchymal-epithelial transition (MET) states. Br J Cancer 2014;110(6):1497-505.
40 Funahashi Y, Okamoto K, Adachi Y, et al. Eribulin mesylate reduces tumor microenvironment 
abnormality by vascular remodeling in preclinical human breast cancer models. Cancer Sci 
2014;105(10):1334-42. 
41 Kawano S, Asano M, Adachi Y, et al. Antimitotic and non-mitotic effects of eribulin mesilate 
in soft tissue sarcoma. Anticancer Res 2016;36(4):1553-61.
42 Cheng X, Li J, Tanaka K, et al. MORAb-202, an antibody–drug conjugate utilizing humanized 
anti-human FRα farletuzumab and the microtubule-targeting agent eribulin, has potent 
antitumor activity. Mol Cancer Ther 2018;17(12):2665-75.
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43 Pujade-Lauraine E, Banerjee S, Pignata S. Management of platinum-resistant, relapsed 
epithelial ovarian cancer and new drug perspectives. J Clin Oncol 2019;37(27):2437-48.
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in advanced non–small-cell lung cancer: Results from Southwest Oncology Group randomized 
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patients with locally advanced or metastatic breast cancer previously treated with 
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assessment of eribulin mesylate in patients with advanced solid tumors. Invest New Drugs. 
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52 Modi S, Saura C, Yamashita T, et al. Trastuzumab deruxtecan in previously treated HER2-
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less is more. N Engl J Med 2021;385:1445-7.
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56 FDA Oncology “Beyond Breakthrough” Project Takes Shape: Review of Decade-Old Program 
To Result In “Menu” Of Benefits, Process For Rescinding Designation. May 24, 2021. 
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designation. Accessed March 24, 2022.
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2022 May 23]. Available from: https://www.lung.org/research/state-of-lung-cancer/racial-
and-ethnic-disparities.
60 Goldstraw P, Chansky K, Crowley J, et al; International Association for the Study of Lung 
Cancer Staging and Prognostic Factors Committee, Advisory Boards, and Participating 
Institutions; International Association for the Study of Lung Cancer Staging and Prognostic 
Factors Committee Advisory Boards and Participating Institutions. The IASLC Lung Cancer 
Staging Project: Proposals for Revision of the TNM Stage Groupings in the Forthcoming 
(Eighth) Edition of the TNM Classification for Lung Cancer. J Thorac Oncol. 2016;11(1):39-
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That 
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overview.html. Accessed 10-Jan-2023.
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70 Clopper C, Pearson ES. The use of confidence or fiducial limits illustrated in the case of the 
binomial. Biometrika 1934;26:404-13.
71 Greenwood, M. The errors of sampling of the survivorship tables. Reports on public health and 
statistical subjects 1926;33, Appendix 1, HMSO, London.
72 Kalbfleisch JD, Prentice RL. (1980) The Statistical Analysis of Failure Time Data, New York: 
John Wiley & Sons.
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12
APPENDICES
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APPENDIX 1
ABBREVIATIONS
Abbreviation
Term
AC
adenocarcinoma
ADC
Antibody-drug conjugate
AE
adverse event
AESI
adverse events of special interest
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
AT
Aminotransferase
AUC
area under the concentration-time curve
AxMP
Auxiliary Medicinal Product
BMS
Bristol-Myers Squibb
BOR
best overall response
BP
blood pressure
BW
body weight
CI
confidence interval
CL
clearance
CNS
central nervous system
CONSORT
Consolidated Standards of Reporting Trials
COVID-19
coronavirus disease 2019
CR
complete response
CRA
Clinical Research Associate
CrCL
creatinine clearance
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Abbreviation
Term
CRF
Case Report Form
CSR
Clinical Study Report
CT
computed tomography
CTAg
Clinical Trial Agreement
CTCAE v5.0
Common Terminology Criteria for Adverse Events version 5
CYP
cytochrome P450
DCR
disease control rate
DCT
Decentralized Clinical Trial
DILI
drug-induced liver injury
DLCO
diffusing capacity of the lungs for carbon monoxide
DoR
duration of response
DVT
deep vein thrombosis
EBRT
external beam radiotherapy
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group 
eCOA
electronic Clinical Outcomes Assessments
eCRF
electronic Case Report Form
EDC
electronic data capture
EGFR
epidermal growth factor receptor
EMT
epithelial-mesenchymal transition
EOS
end of study
EOT
end of treatment
E-R
exposure-response
ESMO
European Society for Medical Oncology
F2F
face-to-face
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Abbreviation
Term
FDA
Food and Drug Administration
FDG
fluorodeoxyglucose
FEV1
forced expiratory volume during first second of forced breath
FRα
a folate receptor alpha
FSH
follicle-stimulating hormone
FVC
forced vital capacity
GCP
Good Clinical Practice
G-CSF
granulocyte colony stimulating factor
HBV
hepatitis B virus
HCG
human chorionic gonadotropin
HCV
hepatitis C virus
Hgb
hemoglobin
HGS
high-grade serous
HIPAA
Health Insurance Portability and Accountability Act
HIV
human immunodeficiency virus
HR
heart rate
HRT
hormone replacement therapy
IB
Investigator’s Brochure
IC
Informed consent
ICF
informed consent form
ICH
International Council for Harmonisation
ICMJE
International Committee of Medical Journal Editors
IEC
Independent Ethics Committee
IgG1
immunoglobulin G1
IHC
immunohistochemistry
ILD
interstitial lung disease
IMP
Investigational Medicinal Product
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Abbreviation
Term
IP
Investigational Product
IRB
Institutional Review Board
IRT
Interactive Response Technology
IV
intravenous
KM
Kaplan Meier
LAM
lactational amenorrhea method
MRI
magnetic resonance imaging
MTD
maximum tolerated dose
NCA
noncompartmental analysis
NCCN
National Comprehensive Cancer Network
NCI
National Cancer Institute
NLR
neutrophil-to-lymphocyte ratio
NSCLC
non-small cell lung cancer
OR
objective response
ORR
objective response rate
OS
overall survival
PCR
polymerase chain reaction
PD-1
programmed cell death protein 1
PD-L1
programmed death-ligand 1
PDX
patient-derived xenograft
PE
physical examination
PET
positron emission tomography
PFS
progression-free survival
PFT
pulmonary function test
PK
pharmacokinetic
PO
per os (by mouth route of administration)
PR
partial response
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Abbreviation
Term
PROC
platinum resistant ovarian cancer
PS
performance status
Q3W
every 3 weeks
QTc
corrected QT interval
QTcF
Fridericia corrected QTc
RBC
red blood cell
RECIST
Response Evaluation Criteria in Solid Tumors
RF
radiofrequency
RNA
ribonucleic acid
SAEs
serious adverse events
SAP
statistical analysis plan
SARS-CoV-2
severe acute respiratory syndrome coronavirus 2
SC
Safety Committee
SD
stable disease
SSC
Study Steering Committee
TEAE
treatment-emergent adverse event
TLC
total lung capacity
TME
tumor microenvironment
TRAE
treatment-related adverse event
UK
United Kingdom
ULN
upper limit of normal
US
United States
USPI
United States Prescribing Information
V
volume of distribution of the central compartment
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 
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, one or more of the following: (1) the rights, physical safety or mental 
integrity of one 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 Code of Federal Regulations, Title 21, Part 50 (21CFR50)

European Union Directive 2001/20/EC; or

European Regulation 536/2014 for clinical studies (if applicable), 

European Medical Device Regulation 2017/745 for clinical device research (if applicable),

the IRB/IEC

and 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, also 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:

IRB/IEC

Regulatory authority(ies), if applicable by 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, also by the local Health Authority, must be sent to Bristol-Myers 
Squibb (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 course of the study and 
for 1 year after completion of the study.
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. 
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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 and answer all questions regarding the study.

Inform participant that his/her participation is voluntary. Participant will be required to sign a 
statement of informed consent that meets the requirements of 21 CFR 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 participant to inquire about the details of the study.
Obtain an ICF signed and personally dated by participant and by the person who conducted the 
informed consent discussion. 

Include a statement in participant’s medical record that written informed consent was obtained 
before 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 participant to the most current version of the ICF(s) during his/her participation in 
the study, as applicable.
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 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. 
In situations where consent cannot be given by participants, their legally acceptable representatives 
(as 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. 
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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. 
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 
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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 CRF (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.

Definitions of what constitutes source data can be found in systems that may include, but are 
not limited to, electronic medical/health records (EMRs/EHRs), adverse event (AE) 
tracking/reporting, protocol required assessments, and/or drug accountability records.

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. 
STUDY INTERVENTION RECORDS
Records for study intervention MORAb-202 (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.
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If
Then
Supplied by BMS (or its vendors):
Records or logs must comply with applicable 
regulations and guidelines and should include:

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

nonstudy 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, as per the Delegation 
of Authority Form
Sourced by site and not supplied by BMS 
or its vendors (examples include IP 
sourced 
from 
the 
sites 
stock or 
commercial supply or a specialty 
pharmacy)
The investigator or designee accepts responsibility 
for documenting traceability and study treatment 
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 
understanding of product safety. CRFs may be requested for AEs and/or laboratory abnormalities 
that are reported or identified during the course of 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 SAEs and pregnancy, which will be 
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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 noncompliance 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. 
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.
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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 TREATMENT
For this study, study treatments (those supplied by BMS or a vendor or sourced by the 
investigator), such as partially used study treatment containers, vials, and syringes, may be 
destroyed on site. 
If
Then
Study treatments 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 treatments 
containers must be immediately destroyed as 
required for safety, or to meet local regulations 
(eg, cytotoxics or biologics).
Partially used study interventions and/or 
empty containers may be destroyed after 
proper reconciliation and documentation. But 
unused IMP must be reconciled by site 
monitor/Clinical Research Associate prior to 
destruction.
If study treatments will be returned, the return 
will be arranged by the responsible Study 
Monitor.
Study treatments sourced by site, not supplied 
by BMS (or its vendors; eg, study treatments 
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.

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.
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
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 treatments provided by BMS (or its vendors). Destruction of non-study 
treatments 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:

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 recruitment of participants by the investigator

Discontinuation of further study intervention development
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 
regulatory requirements. The investigator shall promptly inform the participant and should assure 
appropriate participant therapy and/or follow-up.
DISSEMINATION OF CLINICAL STUDY DATA
In order to benefit potential study participants, patients, healthcare 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 as 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.
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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 their 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 time 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 BMS is aligned with the criteria of the International Committee of 
Medical Journal Editors (ICMJE, www.icmje.org). Authorship selection is based upon 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); AND
2) Drafting the work or revising it critically for important intellectual content; AND
3) Final approval of the version to be published; AND
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 BMS 
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.
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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)
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 or electronic Clinical Outcomes Assessments (eCOA) to improve patient 
access, increase patient engagement and reduce both site and patient burden. For example, within 
the DCT platform TeleVisit, eCOAs and 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).
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 and eCOAs 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 non-
treatment study visits to a TeleVisit to help ease the study burden for participants and hence 
minimize participant drop-out.
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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 Table 2-3 in the protocol 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 participant’s 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. 
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.
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eCOA
This trial will deploy eCOA using provisions that allow participants to complete eCOAs at the 
research site or at home. This flexible, customizable, and easy to use system, helps to simplify 
instrument and survey completion for participants. 
Preprogrammed completion windows, along with built-in reminders (with flexibility in the 
options, such as push notifications, SMS, email) ensure that eCOAs are completed at the right time 
in line with the protocol requirements, whilst also enabling some flexibility for participants to 
personalize alarm times within that window to suit their lifestyle. 
Alerts to sites will be deployed based on incoming symptom data to ensure that potential safety 
concerns are flagged in a timely manner, prior to the next scheduled study visit. Alerts to sites have 
been configured based on specific study parameters to notify sites when participants have a drop 
in compliance with eCOA and enable follow-up with the participant to remedy any problems. 
Data collected from participants via remote assessments will be collected electronically within 
purpose-built technology and will be monitored remotely by the Sponsor or designee 
representatives, where allowed by applicable country law and regulation. Survival follow-up visits 
using TeleVisits will be handled similarly to a traditional model, with the participant contacting 
study personnel. 
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.
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 in a clinical investigation participant administered study 
treatment that does not necessarily have a causal relationship with this treatment. 
An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory 
finding), symptom, or disease temporally associated with the use of study treatment, whether or 
not considered related to the study treatment.
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 signs 
measurements), including those that worsen from baseline, considered clinically significant 
in the medical and scientific judgment of the investigator. Note that abnormal lab tests or 
other safety assessments 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 
it may have been present before the start of the study.

Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction.

Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 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).
DEFINITION OF SAE
If an event is not an AE per definition above, then it cannot be an SAE, even if serious conditions 
are met.
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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 which 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 Bristol-Myers Squibb (BMS) clinical 
studies: 

A visit to the emergency room or other hospital department < 24 hours that does not result 
in admission (unless considered an important medical or life-threatening event).

Elective surgery, planned prior to signing consent.

Admissions as 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 entry into 
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 result 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 room 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 
medical event. (See Section 9.2.7 for the definition of potential DILI.) 
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Pregnancy and DILI must follow the same transmission timing and processes to BMS as used for 
SAEs. (See Section 9.2.5 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 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 one 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 v5.0).
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 predefined 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 treatment or if new 
information becomes available, the SAE report must be updated and submitted within 24 hours 
to BMS (or designee) using the same procedure used for transmitting the initial SAE report.
All 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 treatment, and pregnancies must be reported 
to BMS (or designee) immediately within 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 designee).
In this case, the paper form is transmitted via email or confirmed facsimile 
transmission.
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 facsimile transmission.
SAE Email Address: worldwide.safety@BMS.com
SAE Facsimile 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 Woman of Childbearing 
Potential 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 of the protocol. Only the contraception methods as described in 
Section 6.1 are acceptable for this study.
DEFINITIONS
Woman 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

Premenopausal female with 1 of the following:

Documented hysterectomy

Documented bilateral salpingectomy

Documented bilateral oophorectomy
Note: Documentation can come from the site personnel’s review of the participant’s medical 
records, medical examination, or medical history interview.

Postmenopausal female

A postmenopausal state is defined as 12 months of amenorrhea in a woman over age 
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 in order 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 judgement 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 timepoint where the Investigational Medicinal Product 
(IMP) or any active major metabolites have decreased to a concentration that is no longer 
considered to be 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 IMP 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 where 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 where 
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 where hormonal contraception is permitted by the study protocol.)b

Intrauterine device.
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
Intrauterine hormone-releasing system (IUS). (This method of contraception can only be 
used by WOCBP participants in studies where 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.
Male participants will be required to always use a latex or other synthetic condom during any 
sexual activity (eg, vaginal, anal, oral) with WOCBP, even if the participants have undergone a 
successful vasectomy or if their partner is already pregnant or breastfeeding.

Sexual abstinence.
Sexual abstinence is considered a highly effective method only if defined as refraining from 
heterosexual intercourse during the entire period of risk associated with the study treatment. 
The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study 
and the preferred and usual lifestyle of the participant.

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.

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, postovulation 
methods), withdrawal (coitus interruptus), spermicides only, and lactational 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 treatment, which may reduce the 
efficacy of the contraceptive method. Hormonal contraception is permissible only when there is sufficient 
evidence that the IMP 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 .Sections 6.1 INCLUSION CRITERIA and 7.7.4 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 
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study regarding permissibility of hormonal contraception, refer to .Sections 6.1 INCLUSION CRITERIA and 
7.7.4 PROHIBITED AND/OR RESTRICTED TREATMENTS of the protocol..
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 where hormonal contraception is prohibited.)
Unacceptable Methods of Contraception

Periodic abstinence (calendar, symptothermal, postovulation 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 and Appendix 3.
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APPENDIX 5
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 6
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 1.1) 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 5mm.
Malignant lymph nodes: To be considered pathologically enlarged and measurable, a lymph node 
must be ≥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 which 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 
≥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 ≥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 ≥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 which 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 
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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.
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 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 
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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 
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 
fluorodeoxyglucose (FDG)- positron emission tomography (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 
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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.
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
CR = complete response, PR = partial response, SD = stable disease, PD = progressive disease and NE = not evaluable
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
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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
Unequivocal PD
Yes or No
PD
Any
Yes
PD
CR = complete response, PD = progressive disease and NE = not evaluable.
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 
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 
.
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 increase in 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
CR
NE
SD provided minimum criteria for SD duration met, otherwise, 
NE
PR
CR
PR
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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
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
CR = complete response, PR = partial response, SD = stable disease, PD = progressive disease, and NE = not 
evaluable.
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 7
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.
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APPENDIX 8
PROTOCOL AMENDMENT SUMMARY OF CHANGE HISTORY
Overall Rationale for Protocol Amendment 02, 06-Feb-2023
The main purpose of this Protocol Amendment is to make updates based on 
 
, investigator feedback, and updates to Sponsor guidelines.
Summary of Changes for Protocol Amendment 02
Section Number & 
Title
Description of Change
Brief Rationale
Protocol Summary
Protocol Summary 
Study Design Schema
Section 5.1: Overall 
Design
Figure 5.1-1: Study 
Design Schema
Section 6.1: Inclusion 
Criteria
Updated the prior therapy requirements.
Inclusion criteria 2)b) and 2)c) were noted as not 
applicable per Protocol Amendment 02 and new criteria 
2)j) and 2)k) were added.
Expanded inclusion of 
prior therapy to include 
neoadjuvant and 
adjuvant therapy, and 
allow 1 additional line of 
systemic therapy to 
better reflect the actual 
patient population
Protocol Summary
Section 5.2: Number of 
Participants
Updated:
“Randomized participants who discontinue before 
receiving their first dose of MORAb-202 will be replaced” 
to 
“Additional participants will be randomized to account for 
participants who are randomized but discontinue before 
receiving their first dose of MORAb-202.”
Updated for clarity.
Table 2-1: Screening 
Procedural Outline 
(CA116003)
Section 6.4.1: Retesting 
During Screening or 
Lead-in Period
Updated pulmonary function tests (PFTs) to be conducted 
within 28 days prior to randomization and may be repeated 
during the screening period if necessary.
Clarified that PFTs could be retested during the screening 
period.
Expanded time to 
perform PFTs from 14 to 
28 days. Clarified that 
PFTs could be retested 
during the screening 
period if initially not 
within eligible 
parameters.
Table 2-1: Screening 
Procedural Outline 
(CA116003)
Section 5.1: Overall 
Design
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