Clinical trial NCT04319224
Conditions: Cancer
Keywords: JTX-2011 Vopratelimab Ipilimumab Nivolumab ICOS Anti-CTLA-4 PD-1 PD-L1 Immunotherapy Immuno-oncology Cancer
Sponsor: Jounce Therapeutics, Inc.
Start date: 2020-03-10; Completion date: 2023-01-03
Enrollment: 4 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
JTX-2011-R01 is an open label, multicenter, rollover study that is designed to provide continued access to vopratelimab for eligible subjects with advanced solid tumor malignancies who have previously participated in a vopratelimab study (the parent study).

Detailed description:
Vopratelimab is an agonist monoclonal antibody that specifically binds to the Inducible Co-Stimulator of T cells (ICOS) to generate an anti-tumor immune response. This is an open label, roll over study to evaluate the long-term safety of continued treatment with vopratelimab monotherapy or combination treatment.

Arms: arm 1: Participants will continue to receive vopratelimab monotherapy per parent protocol. arm 2: Participants will continue to receive vopratelimab in combination with ipilimumab per parent protocol. arm 3: Participants will continue to receive vopratelimab in combination with nivolumab per parent protocol.
Interventions: intervention 1: Vopratelimab intervention 2: Ipilimumab intervention 3: Nivolumab
Intervention descriptions: intervention 1: Specified dose on specified days intervention 2: Specified dose on specified days intervention 3: Specified dose on specified days

Protocol documents:
Prot_000.pdf: 
DocuSign Envelope ID: AE7A8A9B-006B-4E55-9B9D-DB15E9B29947 
 
 
 
 
 
CLINICAL STUDY PROTOCOL 
 
Protocol Title: 
An Open-label, Multi-center, Rollover Study in Subjects with Advanced 
Solid Tumor Malignancies After Participation in a Vopratelimab 
(JTX-2011) Clinical Study 
 
Product: 
Vopratelimab (JTX-2011) 
 
Protocol Number: 
JTX-2011-R01 
 
Protocol Version: 
2.0 (Amendment 1), 03 August 2021 
 
IND Number: 
127929 
 
NCT: 
04319224 
 
Sponsor: 
Jounce Therapeutics, Inc. 
780 Memorial Drive 
Cambridge, MA 02139 
T (857) 999-2963 M (339) 832-5531 
 
Medical Monitor: 
Ellen Hooper, MD 
Medical Director 
Jounce Therapeutics, Inc. 
780 Memorial Drive 
Cambridge, MA 02139 
(w) 857-320-2548 
(m) 914-439-2240 
ehooper@jouncetx.com 
 
 
IQVIA Biotech, LLC Safety and Pharmacovigilance 
Fax number: 1-866-761-1274 
E-mail: Safety-Inbox.Biotech@IQVIA 
 
 
 
The experimental protocol for this study has been designed in accordance with the general ethical principles outlined in the 
Declaration of Helsinki. The review of this protocol by the Institutional Review Board and the performance of all aspects of the 
study, including the methods used for obtaining informed consent, must also be in accordance with principles enunciated in such 
declaration, the ICH E6 guidelines of Good Clinical Practice, 21 Code of Federal Regulations (CFR) 21.50 Protection of Human 
Patients and 21 CFR 21.56 Institutional Review Boards, and all other applicable regulatory authority requirements. 


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Jounce Therapeutics, Inc. 
Protocol JTX-2011-R01 
Version 2.0, 03 August 2021 
 
SPONSOR PROTOCOL APPROVAL PAGE 
 
 
 
 
 
 
 
An Open-label, Multi-center, Rollover Study in Subjects with Advanced Solid Tumor 
Malignancies After Participation in a Vopratelimab (JTX-2011) 
Clinical Study 
 
Protocol Number: JTX-2011-R01 
 
Protocol Version 2.0 (Amendment 1), 03 August 2021 
 
 
 
 
 
 
 
Approved by: 
 
Sponsor’s Responsible Medical Officer: 
 
Signature  
 
 
 
 8/11/2021 
 
Date 
 
Johan Baeck, MD 
Senior Vice President, Clinical Development & 
Medical Affairs, on behalf of 
 
Elizabeth Trehu, MD, FACP 
Chief Medical Officer 


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Jounce Therapeutics, Inc. 
Protocol JTX-2011-R01 
Version 2.0, 03 August 2021 
 
INVESTIGATOR SIGNATURE OF AGREEMENT PAGE 
 
Protocol Title: 
An Open-label, Multi-center, Rollover Study in Subjects with 
Advanced Solid Tumor Malignancies After Participation in a 
Vopratelimab (JTX-2011) Clinical Study 
 
Protocol Number:   JTX-2011-R01 
 
AGREEMENT 
 
CONFIDENTIALITY STATEMENT: This and related documents from Jounce Therapeutics, 
Inc., contain privileged information that is confidential and may not be disclosed unless such 
disclosure is required by federal laws or regulations. In any event, persons to whom the information 
is disclosed must be informed that it is privileged and/or confidential and may not be further 
disclosed by them. Information from this study may not be reproduced in any form without the 
written permission of Jounce Therapeutics, Inc. 
 
PROTOCOL COMPLIANCE: The signature of the Principal Investigator below constitutes 
his/her agreement to comply with the contents of this Protocol and to conduct this study according 
to Good Clinical Practices (GCP) and applicable requirements. 
 
 
 
Principal Investigator’s Name 
Principal Investigator’s Title 
 
 
 
 
 
 
 
 
Principal Investigator’s Address 
 
 
 
 
 
 
Principal Investigator’s Signature 
Date 


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Jounce Therapeutics, Inc. 
Protocol JTX-2011-R01 
Version 2.0, 03 August 2021 
 
TABLE OF CONTENTS 
SPONSOR PROTOCOL APPROVAL PAGE ................................................................................. 2 
INVESTIGATOR SIGNATURE OF AGREEMENT PAGE ........................................................... 3 
TABLE OF CONTENTS ................................................................................................................ 4 
LIST OF TABLES .......................................................................................................................... 7 
LIST OF TERMS, ACRONYMS, AND ABBREVIATIONS ......................................................... 8 
PROTOCOL SYNOPSIS ................................................................................................................ 9 
1 
BACKGROUND AND RATIONALE FOR CLINICAL DEVELOPMENT ....................... 12 
2 
RATIONALE ....................................................................................................................... 12 
3 
STUDY DESIGN ................................................................................................................. 12 
4 
STUDY OBJECTIVES ........................................................................................................ 13 
4.1 
Primary Objective.............................................................................................................. 13 
4.2 
Secondary Objectives ........................................................................................................ 13 
4.3 
Exploratory Objectives ...................................................................................................... 13 
5 
POPULATION SELECTION CRITERIA ........................................................................... 13 
5.1 
Patient Population ............................................................................................................. 13 
5.2 
Inclusion Criteria ............................................................................................................... 14 
5.3 
Exclusion Criteria ...............................................................................................................14 
5.4 
Reproductive Restrictions ................................................................................................. 14 
6 
STUDY TREATMENTS AND ADMINISTRATION .......................................................... 15 
6.1 
Study Drug Dosage and Administration ............................................................................ 15 
6.1.1 
Contraindications ............................................................................................................ 16 
6.1.2 
Concomitant Medications ...............................................................................................16 
6.1.2.1 
Prohibited Concomitant Medications/Therapies. ........................................................ 16 
6.1.2.2 
Allowed Concomitant Medications ............................................................................. 16 
6.2 
Nivolumab Dosage and Administration ............................................................................ 16 
6.3 
Ipilimumab Dosage and Administration .............................................................................17 
6.4 
Study Drug Procurement. .................................................................................................. 17 
6.4.1 
Drug Ordering ................................................................................................................ 17 
6.4.2 
Drug Accountability ........................................................................................................17 
6.5 
Subject Numbering and Treatment Assignment ................................................................ 18 
7 
DOSE MODIFICATION AND PATIENT WITHDRAWAL ................................................ 18 
7.1 
Criteria for Dose Modification. ......................................................................................... 18 
7.1.1 
Delayed Cycles ............................................................................................................... 18 
7.1.2 
Dose Interruptions .......................................................................................................... 18 
7.1.3 
Dose Hold ....................................................................................................................... 18 
7.1.4 
Dose Modifications ........................................................................................................ 18 
7.1.4.1 
Dose Modifications for Vopratelimab ......................................................................... 18 


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Protocol JTX-2011-R01 
Version 2.0, 03 August 2021 
7.1.4.2 
Dose Modifications and Toxicity Management for Vopratelimab in Combination with 
Nivolumab. .................................................................................................................. 27 
7.1.4.3 
Dose Modifications and Toxicity Management for Vopratelimab in Combination with 
Ipilimumab .................................................................................................................. 27 
7.2 
Infusion-Related Reactions ................................................................................................27 
7.2.1 
Grade 2 Infusion-Related Reactions ...............................................................................27 
7.2.2 
Grade 3 Infusion-Related Reactions ...............................................................................27 
7.2.3 
Infusion-Related Reaction Prophylaxis .......................................................................... 28 
8 
WITHDRAWAL OF SUBJECTS ......................................................................................... 28 
8.1 
Criteria for Withdrawal ......................................................................................................28 
9 
OVERALL STUDY ASSESSMENTS ................................................................................. 29 
9.1 
Rollover Entry/Cycle 1 Day 1 ........................................................................................... 29 
9.2 
Day 1 (± 3 Days) of Subsequent Cycles.............................................................................30 
9.2.1 
Subsequent Dosing Days ................................................................................................ 30 
9.2.2 
Approximately Every 3 Months (± 4 Weeks) ................................................................ 30 
9.2.3 
Every 6 Months (± 3 Weeks) ......................................................................................... 30 
9.3 
End of Study ...................................................................................................................... 31 
10 
DESCRIPTION OF STUDY ASSESSMENTS.................................................................... 31 
10.1 
Physical Examination. ........................................................................................................31 
10.2 
Vital Signs ......................................................................................................................... 31 
10.3 
Weight ............................................................................................................................... 31 
10.4 
Response Assessment. ....................................................................................................... 32 
10.5 
Clinical Laboratory Evaluations .........................................................................................32 
10.6 
Biomarkers ........................................................................................................................ 32 
10.6.1 
Retention of Samples ..................................................................................................... 32 
10.7 
Pregnancy Test .................................................................................................................. 33 
10.8 
Adverse Events and Serious Adverse Events. .................................................................... 33 
10.8.1 
Definition of an Adverse Event (AE) ..............................................................................33 
10.8.2 
Observation and Recording of AEs. ............................................................................... 33 
10.8.3 
Grading and Severity ...................................................................................................... 34 
10.8.4 
Relationship Categorization ........................................................................................... 35 
10.8.5 
Outcome Categorization ..................................................................................................35 
10.8.6 
Clinical Laboratory Evaluations ......................................................................................35 
10.8.7 
Pregnancy ....................................................................................................................... 36 
10.9 
Serious Adverse Event Reporting .......................................................................................36 
10.9.1 
Definition of a Serious Adverse Event (SAE) .................................................................36 
10.9.2 
SAE Classifications .........................................................................................................37 
10.9.3 
Protocol-Specified Expected Events ...............................................................................37 
10.9.4 
Observation and Recording of SAEs ............................................................................. 37 


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Jounce Therapeutics, Inc. 
Protocol JTX-2011-R01 
Version 2.0, 03 August 2021 
10.9.5 
E-mail: Safety-Inbox.Biotech@IQVIA .......................................................................... 37 
10.9.6 
Regulatory Authorities and Institutional Review Boards ................................................ 38 
10.9.7 
Drug Safety Contact Information .................................................................................... 39 
11 
STATISTICAL ANALYSES ................................................................................................ 39 
11.1 
Endpoints ............................................................................................................................ 39 
11.2 
Statistical Basis for Sample Size. ....................................................................................... 39 
11.3 
Statistical Analysis ............................................................................................................. 39 
11.3.1 
Determination of Sample Size ........................................................................................ 39 
11.3.2 
Analysis Set ..................................................................................................................... 40 
12 
DATA QUALITY ASSURANCE ..........................................................................................40 
12.1 
Data Collection ................................................................................................................... 40 
12.2 
Clinical Data Management ................................................................................................. 40 
13 
ADMINISTRATIVE PROCEDURES ................................................................................. 41 
13.1 
Institutional Review Board (IRB) ...................................................................................... 41 
13.2 
Informed Consent. .............................................................................................................. 41 
13.3 
Subject Privacy ................................................................................................................... 42 
13.4 
Study Monitoring ............................................................................................................... 42 
13.5 
Modification of Protocol .................................................................................................... 43 
13.6 
Suspension or Termination of Study .................................................................................. 43 
13.7 
Departure from Protocol..................................................................................................... 43 
13.8 
Recording, Access and Retention of Source Data .............................................................. 44 
13.8.1 
Case Report Forms .......................................................................................................... 44 
13.9 
Good Clinical Practice (GCP) Compliance ........................................................................ 45 
13.9.1 
Quality Control and Quality Assurance........................................................................... 45 
13.9.2 
Publications ..................................................................................................................... 46 
13.9.3 
Confidentiality ................................................................................................................. 46 
13.9.4 
Audit/Inspection .............................................................................................................. 46 
14 
APPENDICES .......................................................................................................................47 
Appendix 1: Schedule of Events (Every 6 Week Administration) ................................................ 47 
Appendix 2: Schedule of Events (Every 3 Week Administration) ................................................ 48 
Appendix 3: Web Links ................................................................................................................ 49 
Appendix 4: RECIST .................................................................................................................... 50 
15 
REFERENCE LIST ..............................................................................................................51 


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Jounce Therapeutics, Inc. 
Protocol JTX-2011-R01 
Version 2.0, 03 August 2021 
LIST OF TABLES 
Table 1: Dose Modifications and Toxicity Management for Vopratelimab, Nivolumab, and 
Ipilimumab ...................................................................................................................... 19 
Table 2: Grading for Events Not Covered By the CTCAE ........................................................... 34 
Table 3: Guidance in Determining the Relationship of an Adverse Event .................................... 35 


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Jounce Therapeutics, Inc. 
Protocol JTX-2011-R01 
Version 2.0, 03 August 2021 
 
LIST OF TERMS, ACRONYMS, AND ABBREVIATIONS 
Abbreviation 
Definition 
ADL 
Activities of daily living 
AE 
Adverse event 
ALT 
Alanine Transaminase (SGPT) 
AST 
Aspartate Transaminase (SGOT) 
CFR 
Code of Federal Regulations 
CRO 
Contract Research Organization 
CT 
Computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
CTLA-4 
Cytotoxic T-lymphocyte antigen 4 
DSUR 
Drug Safety Update Report 
EC 
Ethics Committee 
eCRF 
Electronic case report form 
FDA 
Food and Drug Administration (US) 
GCP 
Good Clinical Practice 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use 
ICOS 
Inducible CO-Stimulator of T cells 
IgG1 
Immunoglobulin G1 
IND 
Investigational New Drug (Application) 
irAE 
Immune-related adverse event(s) 
IRB 
Institutional Review Board 
kg 
Kilogram 
mg 
Milligram 
NCI 
National Cancer Institute 
OS 
Overall survival 
PBMC 
Peripheral blood mononuclear cell 
PFS 
Progression-free survival 
PD-1 
Programmed cell death protein 1 
PI 
Principal Investigator 
PK 
Pharmacokinetic(s) 
RECIST 
Response Evaluation Criteria in Solid Tumors 
SAE 
Serious adverse event 
SAF 
Safety Population 
US 
United States 


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Jounce Therapeutics, Inc. 
Protocol JTX-2011-R01 
Version 2.0, 03 August 2021 
 
PROTOCOL SYNOPSIS 
 
Study Title: 
An Open-label, Multi-center, Rollover Study in Subjects with Advanced Solid 
Tumor Malignancies After Participation in a Vopratelimab (JTX-2011) Clinical 
Study 
Protocol 
Number: 
JTX-2011-R01 
Sponsor: 
Jounce Therapeutics, Inc. 
Study type: 
Interventional 
Study Purpose 
and Rationale 
JTX-2011-R01 is a rollover study that is designed to provide continued access to 
vopratelimab for eligible subjects with advanced solid tumor malignancies who 
have previously participated in a vopratelimab study (the parent study). In 
addition to providing continued access to study treatment for subjects who have 
received clinical benefit in the parent study, this study will enable evaluation of 
the long-term safety and efficacy of vopratelimab when administered as either a 
single agent or in combination with other anticancer agents in accordance with 
the dosing regimens administered under the parent study protocols or those 
approved by the medical monitor as based on other dosing regimens that have 
been shown to be safe and well tolerated. Assessments in this rollover study will 
be more limited than those in the parent study and will allow for incorporation 
of institutional standard of care guidelines. 
Primary 
Objective 
Evaluate the long-term safety of continued treatment with vopratelimab 
monotherapy or combination treatment 
Secondary 
Objectives 
Evaluate the progression-free survival (PFS) in subjects treated with 
vopratelimab monotherapy or combination therapy 
Exploratory 
Objectives 
Examine changes from baseline in parent protocol in pharmacodynamic 
biomarkers including but not limited to phenotypes of immune cell subsets after 
treatment with vopratelimab monotherapy or vopratelimab in combination with 
nivolumab or in sequence with ipilimumab 
Examine the correlation between pharmacodynamic biomarkers and duration of 
response and PFS 


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Protocol JTX-2011-R01 
Version 2.0, 03 August 2021 
 
Study Design 
This rollover study is designed to provide continued access to vopratelimab for 
eligible subjects with advanced solid tumor malignancies who have previously 
participated in a vopratelimab clinical study after closure of the parent study. 
Eligible subjects must have tolerated vopratelimab in the parent study without 
significant toxicities that otherwise would preclude further dosing in the opinion 
of the Investigator and/or Sponsor. Subjects must also be expected to receive 
continued benefit from treatment with vopratelimab in the opinion of the 
Investigator and/or Sponsor. 
Subjects will continue to receive vopratelimab at the same dose and schedule 
received in the parent study. Any changes to the dose and schedule of 
vopratelimab must be in accordance with a dose and schedule previously shown 
to be safe and well tolerated and must be discussed with the medical monitor. 
Subjects who received combination treatment on the parent study will also 
continue to receive the partner drug (e.g., nivolumab or ipilimumab) at the same 
dose and schedule as in the parent study. Any changes to the dose and schedule 
of nivolumab or ipilimumab must be discussed with the medical monitor. 
Safety will be evaluated continuously for the duration of a subject’s 
participation. Imaging for disease status will be performed in accordance with 
institutional standard of care guidelines and must be performed at least every 
6 months (± 3 weeks). 
All subjects must sign a new informed consent form to be enrolled in the 
rollover study. Subjects may continue to receive study treatment until loss of 
clinical benefit or unacceptable toxicity as defined by the Investigator and/or 
Sponsor, withdrawal of consent, loss to follow-up, or death. 
Study Drugs 
Vopratelimab is a humanized IgG1K monoclonal antibody that is an agonist of 
Inducible CO-Stimulator of T cells (ICOS). 
Nivolumab, marketed as Opdivo®, is a human IgG4K anti-PD-1 monoclonal 
antibody manufactured by Bristol-Myers Squibb. 
Ipilimumab, marketed as Yervoy®, is a human IgG1K cytotoxic T-lymphocyte 
antigen 4 (CTLA-4)-blocking antibody manufactured by Bristol-Myers Squibb. 
Inclusion 
Criteria 
Subject is currently receiving and tolerating vopratelimab therapy and receiving 
clinical benefit from study treatment in the opinion of the Investigator and/or 
Sponsor. 
Subject has demonstrated compliance with the parent study requirements, as 
assessed by the Investigator and/or Sponsor, and is able and willing to comply 
with the necessary visits and assessments as part of the rollover study. 
Written informed consent must be obtained prior to enrolling in the rollover 
study and receiving study treatment. If consent cannot be expressed in writing, it 
must be formally documented and witnessed, ideally via an independent trusted 
witness. 
Women of childbearing potential and males with partners of child-bearing 
potential must agree to use adequate birth control throughout their participation 
and for 5 months following the last study treatment. 


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Jounce Therapeutics, Inc. 
Protocol JTX-2011-R01 
Version 2.0, 03 August 2021 
 
Exclusion 
Criteria 
Subject was permanently discontinued from the parent study due to 
unacceptable toxicity, non-compliance with study procedures, withdrawal of 
consent, or any other reason. 
Subject is receiving concurrent anticancer treatment (excluding combination 
drugs such as nivolumab or ipilimumab as a component of the combination 
dosing regimen used in the parent study). 
Women who are pregnant or breastfeeding. 
Subject has any medical or social condition that, in the opinion of the 
Investigator, might place a subject at increased risk, affect compliance, or 
confound safety or other clinical study data interpretation. 
Efficacy 
Assessments 
The antitumor activity of study treatment will be assessed using Response 
Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the 
local Investigator and based on imaging performed according to institutional 
standard of care guidelines, but at least every 6 months (± 3 weeks). 
Safety 
Assessments 
Safety will be monitored through adverse event (AE) documentation, clinical 
laboratory evaluations, physical examinations, and vital signs performed at 
every visit. Safety and tolerability will be assessed by the incidence and severity 
of AEs and serious adverse events (SAEs) as determined by the current version 
of the Common Terminology Criteria for Adverse Events (CTCAE). Immune- 
related AEs will also be assessed. 
Biomarker 
Assessments 
Pharmacodynamic biomarkers in peripheral blood, including peripheral blood 
mononuclear cell (PBMC)-based assays of immune cell phenotype, will be 
assessed approximately every 3 months (± 4 weeks) and at the end of treatment 
and correlated with efficacy outcomes, if sufficient samples are available. 
Sample collection may be discontinued at any time per the Sponsor’s discretion. 
Sample Size 
Determination 
and Statistical 
Analyses 
Patients on study treatment in a Jounce-sponsored clinical study and eligible for 
rollover may be enrolled. For the study objectives, no prospective sample size 
determination is required. Data will be summarized descriptively as appropriate. 


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Protocol JTX-2011-R01 
Version 2.0, 03 August 2021 
 
1 BACKGROUND AND RATIONALE FOR CLINICAL DEVELOPMENT 
 
Please refer to the current vopratelimab Investigator’s Brochure for background information and 
clinical experience with vopratelimab administered as a single agent and in combination with 
nivolumab or in sequence with ipilimumab. 
 
2 RATIONALE 
 
JTX-2011-R01 is a rollover study that is designed to provide continued access to vopratelimab for 
eligible subjects with advanced solid tumor malignancies who have previously participated in a 
vopratelimab study (the parent study). In addition to providing continued access to study treatment 
for subjects who have received clinical benefit in the parent study, this study will enable evaluation 
of the long-term safety and efficacy of vopratelimab when administered as either a single agent or 
in combination with other anticancer agents in accordance with the dosing regimens administered 
under the parent study protocols. Any changes to the dose and schedule of the study drugs must be 
discussed with the medical monitor. Assessments in this rollover study will be more limited than 
those in the parent study and will allow for incorporation of institutional standard of care 
guidelines. 
 
3 STUDY DESIGN 
 
JTX-2011-R01 is a rollover study that is designed to provide continued access to vopratelimab for 
eligible subjects with advanced solid tumor malignancies who have previously participated in a 
vopratelimab study (the parent study) after closure of the parent study. 
 
Eligible subjects must have tolerated vopratelimab in the parent study without significant toxicities 
that otherwise would preclude further dosing in the opinion of the Investigator and/or Sponsor. 
Subjects must also be expected to receive continued benefit from treatment with vopratelimab in 
the opinion of the Investigator and/or Sponsor. 
 
Subjects will continue to receive vopratelimab at the same dose and schedule received in the parent 
study, and ideally will experience no treatment interruption between the end of participation in the 
parent study and entry into the rollover study. Any changes to the dose and schedule of 
vopratelimab must be in accordance with a dose and schedule previously shown to be safe and 
well tolerated and must be discussed with the medical monitor. Subjects who received combination 
treatment on the parent study will also continue to receive the partner drug (e.g., nivolumab or 
ipilimumab) at the same dose and schedule as in the parent study. Any changes to the dose and 
schedule of nivolumab or ipilimumab must be discussed with the medical monitor. 


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Protocol JTX-2011-R01 
Version 2.0, 03 August 2021 
 
Safety will be evaluated continuously for the duration of a subject’s participation. Imaging for 
disease status will be performed in accordance with institutional standard of care guidelines and 
must be performed at least every 6 months (± 3 weeks). 
 
All subjects must sign a new informed consent form to be enrolled in the rollover study. Subjects 
may continue to receive study treatment until loss of clinical benefit or unacceptable toxicity as 
defined by the Investigator and/or Sponsor, withdrawal of consent, loss to follow-up, or death. 
 
4 STUDY OBJECTIVES 
 
4.1 
Primary Objective 
 
Evaluate the long-term safety of continued treatment with vopratelimab monotherapy or 
combination treatment 
 
4.2 
Secondary Objectives 
 
Evaluate the progression free survival (PFS) in subjects treated with vopratelimab monotherapy or 
combination therapy 
 
4.3 
Exploratory Objectives 
 
Examine changes from baseline in parent protocol in pharmacodynamic biomarkers including but 
not limited to phenotypes of immune cell subsets after treatment with vopratelimab monotherapy 
or vopratelimab in combination with nivolumab or in sequence with ipilimumab. 
 
Examine the correlation between pharmacodynamic biomarkers and duration of response and PFS. 
 
5 POPULATION SELECTION CRITERIA 
 
5.1 
Patient Population 
 
This rollover study will enroll subjects who have been treated as part of a vopratelimab clinical 
study that has closed. At the time of rollover study entry, subjects must be continuing to receive 
study drug(s) as part of the active parent study. Subjects must not have any ongoing, significant 
toxicities at the time of rollover study entry that would preclude further dosing in the opinion of 
the Investigator and/or Sponsor. 


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Jounce Therapeutics, Inc. 
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Version 2.0, 03 August 2021 
 
5.2 
Inclusion Criteria 
 
• Subject is currently receiving and tolerating vopratelimab therapy and receiving clinical 
benefit from study treatment in the opinion of the Investigator and/or Sponsor. 
• Subject has demonstrated compliance with the parent study requirements, as assessed by 
the Investigator and/or Sponsor, and is able and willing to comply with the necessary visits 
and assessments as part of the rollover study. 
• Written informed consent must be obtained prior to enrolling in the rollover study and 
receiving study treatment. If consent cannot be expressed in writing, it must be formally 
documented and witnessed, ideally via an independent trusted witness. 
• Women of childbearing potential and males with partners of child-bearing potential must 
agree to use adequate birth control throughout their participation and for 5 months 
following the last study treatment. 
 
5.3 
Exclusion Criteria 
 
• Subject was permanently discontinued from the parent study due to unacceptable toxicity, 
non-compliance with study procedures, withdrawal of consent, or any other reason. 
• Subject is receiving concurrent anti-cancer treatment (excluding combination drugs such 
as nivolumab or ipilimumab as a component of the combination dosing regimen used in 
parent study). 
• Women who are pregnant or breastfeeding. 
• Subject has any medical or social condition that, in the opinion of the Investigator, might 
place a subject at increased risk, affect compliance, or confound safety or other clinical 
study data interpretation. 
 
5.4 
Reproductive Restrictions 
 
There are no data regarding the effect of vopratelimab on the unborn fetus. Vopratelimab should 
not be administered to pregnant women. Embryo-fetal toxicity is a labeled warning for nivolumab 
and ipilimumab (Opdivo® Full Prescribing Information {Bristol-Myers Squibb Company 2021}, 
Yervoy® Full Prescribing Information {Bristol-Myers Squibb Company 2021}). Women of 
childbearing potential must have a negative serum or urine pregnancy test prior to administration 
of each dose of vopratelimab throughout the study. Women of childbearing potential and males 
with partners of childbearing potential must agree to use adequate birth control throughout their 
participation and for 5 months following the last study treatment. 


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Protocol JTX-2011-R01 
Version 2.0, 03 August 2021 
 
6 STUDY TREATMENTS AND ADMINISTRATION 
 
6.1 
Study Drug Dosage and Administration 
 
For this study, the investigational drug refers to vopratelimab, which will be supplied by the 
Sponsor, Jounce Therapeutics. Study drug(s) refer to vopratelimab and any partner drugs 
administered in the parent study (e.g., nivolumab, ipilimumab). 
 
All dosages prescribed and dispensed to subjects and all dose changes during the study must be 
recorded on the Dosage Administration Record electronic case report form (eCRF). 
 
For all study medication administration, a physician must be present at the site or immediately 
available to respond to emergencies during all administrations of all study medications. Note that 
the infusion time is not inclusive of the flush post study drug administration. 
 
Vopratelimab is administered as a single agent or in combination with nivolumab or in sequence 
with ipilimumab at a subject’s prior identified tolerable dose regimen and schedule. Any changes 
to the dose and schedule of the study agents must be discussed with the medical monitor as stated 
in Section 3. 
 
When vopratelimab is administered on the same day as nivolumab, vopratelimab should be dosed 
first with a 30-minute (-5/+10 minutes) evaluation period prior to administration of combination 
therapy. In instances where an infusion reaction occurs during dosing of vopratelimab, 
administration of combination therapy may be delayed beyond the 30-minute (-5/+10 minutes) 
evaluation period. 
 
If treating in sequence with ipilimumab, continue to follow dosing guidelines from the parent study 
for up to 4 doses. Administer ipilimumab as a 90-minute IV infusion or per the approved label 
infusion time (-5/+10 minutes) at a dose of 3 mg/kg q6w for up to 4 doses. Note that the approved 
schedule for ipilimumab administration is q3w; this protocol administers ipilimumab at a less 
frequent schedule. Additional doses of ipilimumab beyond 4 doses total may be considered on a 
patient by patient basis in consultation with the medical monitor. 
 
Further instructions for the preparation and dispensation of vopratelimab, nivolumab, and 
ipilimumab are described in the Study Pharmacy Manual. 


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Jounce Therapeutics, Inc. 
Protocol JTX-2011-R01 
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6.1.1 Contraindications 
Based on the immune-stimulatory mechanism of action of vopratelimab, it should not be 
administered to subjects with any of the following: 
 
Active disease requiring systemic immunosuppressive therapy. Exceptions allowed on a patient 
by patient basis upon discussion with the medical monitor; 
Any known primary or acquired diagnosis of immunodeficiency, or treatment with systemic 
steroids or any other form of immunosuppressive therapy. Exception: inhaled or topical steroids 
and adrenal replacement doses are permitted in the absence of active autoimmune disease. 
Please refer to the respective prescribing information for contraindications to nivolumab and 
ipilimumab. 
6.1.2 Concomitant Medications 
Concomitant medication use will be assessed at each visit. 
 
6.1.2.1 Prohibited Concomitant Medications/Therapies 
 
• Concurrent anticancer treatment (exceptions below) 
• Systemic steroids or any other form of immunosuppressive therapy 
6.1.2.2 Allowed Concomitant Medications 
 
Subjects may continue to receive any medications/therapies that were administered during the 
parent study. 
 
• Inhaled, topical or oral steroids and adrenal replacement doses are permitted. 
• Palliative radiation to non-target lesions only is allowed during study treatment in 
consultation with the medical monitor. 
• One-time dose of immunosuppressive agents used prophylactically for contrast allergies 
• Steroids administered prophylactically for infusion related reactions in subjects who have 
demonstrated infusion related reactions to study drug on a prior dose 
• Vaccines 
6.2 
Nivolumab Dosage and Administration 
 
Nivolumab, marketed as Opdivo®, is a human immunoglobulin IgG4K anti-PD-1 monoclonal 
antibody manufactured by Bristol-Myers Squibb for the treatment of cancer. Nivolumab acts as an 
immunomodulator by blocking ligand activation of the PD-1 receptor on activated T cells. Please 
refer to the Pharmacy Manual for vopratelimab and most recent package insert for Opdivo® Full 
Prescribing Information for more information {Bristol-Myers Squibb Company 2021}. 


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Jounce Therapeutics, Inc. 
Protocol JTX-2011-R01 
Version 2.0, 03 August 2021 
 
6.3 
Ipilimumab Dosage and Administration 
 
Ipilimumab, marketed as Yervoy®, is a human IgG1K CTLA-4-blocking antibody manufactured 
by Bristol-Myers Squibb for the treatment of melanoma. Ipilimumab binds to CTLA-4 and blocks 
the interaction of CTLA-4 with its ligands, CD80/CD86. Ipilimumab will be administered using 
the dose and schedule from the parent study. Please refer to the Pharmacy Manual and most recent 
package insert for Yervoy® Full Prescribing Information for more information {Bristol-Myers 
Squibb Company 2021}. 
 
6.4 
Study Drug Procurement 
6.4.1 Drug Ordering 
The initial shipment of study drug(s) to a clinical site will occur after all essential regulatory 
documents are collected for that site. Please refer to the Pharmacy Manual for information on 
re-supply shipments. 
6.4.2 Drug Accountability 
Each Investigator/designee is responsible for taking an inventory of each shipment of study drug 
supplied by the Sponsor received and comparing it with the accompanying accountability form. 
 
Study drug(s) must be used only as directed in this protocol. The Investigator/designee must keep 
accurate written records of all study drug received from Jounce/Sponsor Representative. 
Additionally, the Investigator/designee must keep accurate records of study drug(s) dispensed to 
subjects in this protocol including the number of vials used to prepare subject doses, lot number, 
date dispensed, subject identification number, dose administered, balance forward, and the initials 
of the person dispensing the medication. Based on the entries in the site drug accountability forms, 
it must be possible to reconcile drug product delivered with that used. All study drug must be 
accounted for and all discrepancies investigated and documented appropriately. 
 
Study drug stock may not be removed from the investigative site where originally shipped without 
prior knowledge and consent of Jounce or their delegated Contract Research Organization (CRO). 
 
At the end of the study, all unused vials of study drug will be destroyed by the investigative site 
according to that site’s drug destruction procedures or processed through a “buy-back” procedure 
through the depot, as applicable. Jounce will indicate which steps should be taken by each site at 
the end of the study. All certificates of delivery/drug receipts must be signed prior to shipment. 


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Jounce Therapeutics, Inc. 
Protocol JTX-2011-R01 
Version 2.0, 03 August 2021 
 
6.5 
Subject Numbering and Treatment Assignment 
 
Each subject is identified in the study by a number that is assigned when the subject is first enrolled 
in the rollover protocol. The subject number is retained as the primary identifier for the subject 
throughout participation in the rollover study. The subject number consists of the center number 
assigned by the Sponsor, cohort identifier, and a sequential subject number suffix so that each 
subject is numbered uniquely across the entire database. Subject numbers will be assigned by the 
Sponsor at the time of rollover entry. 
The subject identifier, along with the dose and date of last study treatment(s), from the parent study 
will be captured in the relevant eCRF for the rollover study. 
 
7 DOSE MODIFICATION AND PATIENT WITHDRAWAL 
 
7.1 
Criteria for Dose Modification 
7.1.1 Delayed Cycles 
A change in the start of a cycle of +3 days for social reasons (e.g., holidays) is permitted if 
unavoidable. Subjects who require frequent treatment delays should be discussed with the Medical 
Monitor. 
If a cycle delay of >14 days not due to treatment-related toxicity occurs, the circumstances 
surrounding the delay will be discussed with the Medical Monitor prior to dosing the subject for 
the next cycle. 
7.1.2 Dose Interruptions 
Same day dose interruptions may occur; however, the study drug should be infused within 4 hours 
of the interruption. If the interruption is due to toxicity, please refer to Section 7.1.4 for dose 
modifications. 
7.1.3 Dose Hold 
Dose holds will be documented. 
 
7.1.4 Dose Modifications 
Any changes to the dose and schedule of the study agents must be discussed with the medical 
monitor as stated in Section 3. 
 
7.1.4.1 Dose Modifications for Vopratelimab 
 
Dose modifications and management of toxicity for vopratelimab are provided in Table 1. 


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Table 1: Dose Modifications and Toxicity Management for Vopratelimab, Nivolumab, and Ipilimumab 
 
Adverse Event 
Toxicity Grade 
Dose Modification 
Recommended Managementa 
Diarrhea or 
Colitis 
Grade 2 
• Withhold study drug(s) until resolution to Grade 
0-1. 
• When symptoms resolve to Grade 0-1, resume 
vopratelimab only. If symptoms do not recur after 
1 cycle of vopratelimab, resume combination 
therapy.b 
• If symptoms persist 2' 6 weeks, or subject is 
unable to reduce the corticosteroid dose to less 
than 7.5 mg prednisone or equivalent per day, 
discuss subject continuation with the Medical 
Monitor.b 
If symptoms persist > 5 days or recur: 0.5 to 1 mg/kg/day 
prednisone equivalents followed by steroid tapera 
Grade 3 
• Permanently discontinue ipilimumab/nivolumab. 
• Withhold vopratelimab until resolution to Grade 
0-1. When symptoms resolve to Grade 0-1, 
resume vopratelimab.b 
• If symptoms persist 2' 6 weeks, or subject is 
unable to reduce the corticosteroid dose to less 
than 7.5 mg prednisone or equivalent per day, 
discuss subject continuation with the Medical 
Monitor.b 
1-2 mg/kg/day prednisone equivalents followed by steroid 
tapera 
If symptoms persist 2' 3-5 days or recur after improvement, 
consider administering IV 
corticosteroid or noncorticosteroida 
Grade 4 
• Permanently discontinue study drug(s). 
1-2 mg/kg/day prednisone equivalents followed by steroid 
tapera 
Administer IV corticosteroid until symptoms improve to 
grade 1a 
Consider early infliximab 5-10 mg/kg if symptoms 
refractory to corticosteroid within 2-3 daysa 


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Adverse Event 
Toxicity Grade 
Dose Modification 
Recommended Managementa 
Pneumonitis 
Grade 2 
• Withhold study drug(s) until resolution to Grade 
0-1. 
• When symptoms resolve to Grade 0-1, resume 
vopratelimab only. If symptoms do not recur after 
1 cycle of vopratelimab, resume combination 
therapy.b 
• Permanently discontinue ipilimumab/nivolumab if 
symptoms last 6 weeks or longer. 
1-2 mg/kg/day prednisone 
equivalents followed by steroid tapera 
Grade 3 or 4 
• Permanently discontinue study drug(s). 
1-2 mg/kg/day prednisone equivalents followed by steroid 
taper 
If no improvement after 48 hours, may add infliximab 5 
mg/kg or mycophenolate mofetil IV 1 g twice a day or IVIG 
for 5 days or cyclophosphamidea 
Empirical antibiotics 
Hepatitis 
Grade 2 AST/ALT 
(>3 to 5 × ULN) or 
bilirubin (1.5 to 3 × 
ULN)b 
• Withhold study drug(s) until resolution to Grade 
0-1. 
• When symptoms resolve to Grade 0-1, resume 
vopratelimab only. If symptoms do not recur after 
1 cycle of vopratelimab, resume combination 
therapy.b 
• Permanently discontinue ipilimumab/nivolumab if 
symptoms last 6 weeks or longer. 
0.5 to 1 mg/kg/day prednisone equivalents or investigator 
discretiona 
Grade 3 or 4 
AST/ALT (>5 × 
ULN) or bilirubin 
(>3 x ULN)b 
• Permanently discontinue study drug(s). 
1-2 mg/kg/day prednisone equivalents or investigator 
discretiona 
If corticosteroid refractory or no improvement after 3 days, 
may offer mycophenolate mofetil or azathioprine 
Hypophysitis 
Grade 2 or 3 
• Withhold study drug(s) until patient is stabilized 
on replacement hormone and discuss resuming 
combination therapy with medical monitor. 
Hormonal supplementation as needed (e.g., hydrocortisone 
10-20 mg orally in the morning, 5-10 mg orally in early 
afternoon; levothyroxine by weight). 
Continue hormonal replacement as medically indicated 
Grade 4 
• Withhold study drug(s) until patient is stabilized 
on replacement hormone and discuss resuming 
combination therapy with medical monitor. 
Hormonal supplementation as above. Consider initial pulse 
dose therapy with prednisone 1-2 mg/kg oral daily (or 
equivalent) tapered over at least 1-2 weeks. 
Continue hormonal replacement as medically indicated 


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Adverse Event 
Toxicity Grade 
Dose Modification 
Recommended Managementa 
Adrenal 
insufficiency 
Grade 2 
• Withhold study drug(s) until patient is stabilized 
on replacement hormone and discuss resuming 
combination therapy with medical monitor. 
Initiate outpatient treatment at 2 to 3 times maintenance (if 
prednisone, 20 mg daily; if hydrocortisone, 20-30 mg in the 
morning, and 10-20 mg in the afternoon) to manage acute 
symptoms. 
Taper maintenance doses over 5-10 days. 
May require fludrocortisone (0.1 mg/day) for 
mineralocorticoid replacement in primary adrenal 
insufficiency. 
Continue hormonal replacement as medically indicated. 
Grade 3 or 4 
• Withhold study drug(s) until patient is stabilized 
on replacement hormone and discuss resuming 
combination therapy with medical monitor. 
See in clinic or, for after hours, make an emergency 
department referral for normal saline (at least 2L) and IV 
stress-dose corticosteroids on presentation (hydrocortisone 
10 mg or dexamethasone 4 mg (if the diagnosis is not clear 
and stimulation testing will be needed). 
Taper stress-dose corticosteroids down to maintenance doses 
over 7-14 days after discharge. 
Maintenance therapy as in Grade 2 above 
Thyroid 
disorders 
Hypothyroidism 
• Withhold study drug(s) until symptoms return to 
baseline and discuss resuming combination 
therapy with medical monitor. 
Hormone replacement therapy. 
Continue hormonal replacement as medically indicated. 
Hyperthyroidism 
• Withhold study drug(s) until symptoms return to 
baseline and discuss resuming combination 
therapy with medical monitor. 
Beta-blocker (e.g. – atenolol, propranolol) for symptomatic 
relief. 
For severe symptoms or concern for thyroid storm, 
hospitalize subject and initiate prednisone 1-2 mg/kg/day or 
equivalent tapered over 1-2 weeks. 
Consider also use of potassium iodide oral solution or 
thionamide (methimazole or propylthiouracil) 


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Adverse Event 
Toxicity Grade 
Dose Modification 
Recommended Managementa 
Type 1 
Diabetes 
Mellitus 
Grade 1 
hyperglycemia 
Grade 1: 
Asymptomatic or 
mild symptoms; 
fasting glucose 
value >ULN 
(160 mg/dL); fasting 
glucose value > 
ULN (8.9 mmol/L); 
no evidence of 
ketosis or laboratory 
evidence of T1DM 
• May continue study drug(s) with close clinical 
follow-up and laboratory evaluation. 
Grade 1: May initiate oral therapy for those with new onset 
T2DM 
Screen for T1DM if appropriate, for example, acute onset 
with prior normal values or clinical concern for ketosis 
Grade 2 
hyperglycemia 
Grade 2: Moderate 
symptoms, able to 
perform ADL, 
fasting glucose 
value > 160- 
250 mg/dL; fasting 
glucose value > 8.9- 
13.9 mmol/L, 
ketosis or evidence 
of T1DM at any 
glucose level 
• Hold study drug(s) until glucose control obtained; 
resume study drug(s) when hyperglycemia 
resolves to Grade 0 or 1 
Grade 2: Moderate symptoms, able to perform ADL, fasting 
glucose value . 160-250 mg/dL; fasting glucose value 8.9- 
13.9 mmol/L, with ketosis or evidence of T1DM at any 
glucose level 
Titrate oral therapy or add insulin for worsening control in 
T2DM 
Should administer insulin for T1DM (or as default therapy if 
there is confusion about type) 
Urgent endocrine consultation for any subject with T1DM; 
in the absence of endocrinology, internal medicine may 
suffice 
Consider admission for T1DM if early outpatient evaluation 
is not available or signs of ketoacidosis are present 
Grade 3 or 4 
hyperglycemia 
• Withhold study drug(s) until metabolic control is 
achieved with insulin. Resume vopratelimab upon 
resolution of hyperglycemia to Grade 0-1. If 
symptoms do not recur after 1 cycle of 
vopratelimab, resume ipilimumab/nivolumab 
therapy. 
Administer insulin until metabolic control is achieved. 
Continue insulin as medically indicated 
Admit for inpatient management: concerns for developing 
diabetic ketoacidosis, symptomatic subjects regardless of 
diabetes type, new onset T1DM unable to see endocrinology 


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Adverse Event 
Toxicity Grade 
Dose Modification 
Recommended Managementa 
Nephritis and 
Renal 
Dysfunction 
Grade 2: serum 
creatinine (>1.5 to 3 
× ULN) 
• Withhold study drug(s) until resolution to Grade 
0-1. 
• When resolved to Grade 0-1, resume 
vopratelimab. If increase in serum creatinine does 
not recur after 1 cycle of vopratelimab, resume 
ipilimumab/nivolumab therapy.b 
0.5 to 1 mg/kg/day prednisone equivalents followed by 
steroid taper. If worsening or no improvement occurs iQ ”  
days, increase dose of corticosteroids to 1-2 mg/kg/day 
prednisone equivalents and permanently discontinue study 
drug(s).a 
Evaluate for other causes (recent IV contrast, medications, 
fluid status, etc) 
Grade 3: serum 
creatinine (> 3 to 6 
× ULN) 
• Permanently discontinue study drug(s). 
1-2 mg/kg/day prednisone equivalentsa 
Consult nephrology 
Evaluate for other causes (recent IV contrast, medications, 
fluid status, etc) 
If improved to Grade 1, taper corticosteroids over at least 4 
weeks 
If elevation persists >3-5 days or worsen, consider additional 
immunosuppression (e.g. – mycophenolate) 
Grade 4: serum 
creatinine (> 6 × 
ULN) 
• Permanently discontinue study drug(s). 
1-2 mg/kg/day prednisone equivalentsa 
Consult nephrology 
Evaluate for other causes (recent IV contrast, medications, 
fluid status, etc) 
If improved to Grade 1, taper corticosteroids over at least 4 
weeks 
If elevations persist >2-3 days or worsen, consider additional 
immunosuppression (e.g. – mycophenolate) 
Rash 
Grade 2 
• Withhold study drug(s). When symptoms resolve 
to Grade 0-1, resume vopratelimab. If symptoms 
do not recur after 1 cycle of vopratelimab, resume 
ipilimumab/nivolumab.b 
Should treat skin with topical emollients, oral antihistamines, 
and medium- to high-potency topical corticosteroids. 
0.5 to 1 mg/kg/day prednisone equivalentsa 
Grade 3 
• Withhold study drug(s) until resolution to Grade 
0-1. 
• When symptoms resolve to Grade 0-1, resume 
vopratelimab only; permanently discontinue 
ipilimumab/nivolumab. 
Should treat skin with topical emollients, oral antihistamines, 
and high-potency topical corticosteroids. 
1-2 mg/kg/day prednisone equivalentsa 
Grade 4 
• Permanently discontinue study drug(s). 
1-2 mg/kg/day prednisone equivalentsa 
Admit for inpatient management 


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Adverse Event 
Toxicity Grade 
Dose Modification 
Recommended Managementa 
Neuropathy 
Grade 2 
• Withhold study drug(s) until resolution to Grade 
0-1; if symptoms persist 2' 6 weeks, discuss 
subject continuation with the Medical Monitor. 
• When symptoms resolve to Grade 0-1, resume 
vopratelimab. If symptoms do not recur after 1 
cycle of vopratelimab, resume 
ipilimumab/nivolumab therapy.b 
• Permanently discontinue study drug(s) for related 
reactions lasting 6 weeks or longer or if the 
subject is unable to reduce the corticosteroid dose 
to less than 7.5 mg prednisone or equivalent per 
day. 
(peripheral neuropathy) 
Initial observation OR initiate prednisone 0.5-1 mg/kg (if 
progressing from mild). Neurontin, pregabalin, or duloxetine 
for pain 
(Autonomic neuropathy) 
Initial observation OR initiate prednisone 0.5-1 mg/kg (if 
progressing from mild). Neurologic consultation 
Grade 3 or 4 
• Permanently discontinue study drug(s). 
(Peripheral neuropathy) 
Neurologic consultation 
Initiate IV methylprednisolone 2-4 mg/kg 
Monitor pulmonary function, concurrent autonomic 
dysfunction, neuropathic pain, constipation/ileus. 
Offer frequent neurochecks 
(Autonomic neuropathy) 
Initiate methylprednisolone 1g IV daily for 3 days followed 
by oral corticosteroid taper Neurologic consultation 
Encephalitis 
New-onset moderate 
or severe neurologic 
signs or symptoms 
• Permanently discontinue study drug(s). 
If etiologies other than immune-mediated adverse events are 
ruled out, permanently discontinue study drug(s) and 
administer 1-2 mg/kg/day prednisone equivalentsa 
Administer concurrent IV acyclovir until PCR results 
obtained and negative 
Immune-mediated 
encephalitis 
• Permanently discontinue study drug(s). 
1-2 mg/kg/day prednisone equivalentsa 
If limited or no improvement, may offer rituximab or 
plasmapheresis 


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Adverse Event 
Toxicity Grade 
Dose Modification 
Recommended Managementa 
Uveitis, iritis 
Grade 2 
• Withhold study drug(s). 
• When symptoms resolve to Grade 0-1, resume 
study drug(s) only if local immunosuppressive 
therapy was used. Permanently discontinue 
ipilimumab/nivolumab if systemic therapy was 
required. 
Urgent ophthalmology referral. Topical corticosteroids, 
cycloplegic agents, systemic corticosteroids. May resume 
vopratelimab once off systemic corticosteroids, which are 
purely indicated for ocular adverse effects or once 
corticosteroids for other concurrent systemic irAEs are 
reduced to :S 10 mg; continued topical/ocular corticosteroids 
are permitted when resuming vopratelimab to manage and 
minimize local toxicity 
Grade 3 or 4 
• Permanently discontinue study drug(s). 
Emergent ophthalmology referral. Systemic corticosteroids 
(IV prednisone 1-2 mg/kg or methylprednisolone 0.8- 
1.6 mg/kg) and intravitreal/periocular/topical corticosteroids 
per ophthalmologist opinion 
Episcleritis 
Grade 2 
• Temporarily withhold study drug(s) until after 
ophthalmology consult. 
Urgent ophthalmology referral 
Topical corticosteroids, cycloplegic agents, systemic 
corticosteroids 
Grade 3 or 4 
• Permanently discontinue study drug(s). 
Emergent ophthalmology referral. Systemic corticosteroids 
and topical corticosteroids with cycloplegic agents 
Other 
Grade 2 adverse 
reactions 
• Withhold study drug(s) until resolved to Grade 0- 
1. 
• When symptoms resolve to Grade 0-1, resume 
vopratelimab only. If symptoms do not recur after 
1 cycle of vopratelimab, resume 
ipilimumab/nivolumab. 
• If symptoms persist 2' 6 weeks or unable to reduce 
the corticosteroid dose to less than 7.5 mg 
prednisone or equivalent per day, subject 
continuation must be discussed between the 
Investigator and Medical Monitor 
If symptoms persist > 5 days or recur, consider 0.5- 
1 mg/kg/day prednisone equivalent followed by 
corticosteroid taper 
If symptoms persist 2' 6 weeks obtain organ class 
consultation 


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Adverse Event 
Toxicity Grade 
Dose Modification 
Recommended Managementa 
Other Grade 3 
adverse reaction 
• Permanently discontinue ipilimumab/nivolumab. 
• Withhold vopratelimab until resolution to Grade 
0-1. 
• When symptoms resolve to Grade 0-1, resume 
vopratelimab only. 
Consider 1-2 mg/kg/day prednisone equivalentsa 
Recurrence of same 
Grade 3 adverse 
reaction 
• Discuss subject continuation with the Medical 
Monitor. 
1-2 mg/kg/day prednisone equivalentsa 
Persistent Grade 3 
adverse reaction 
lasting 2' 1 weeks 
• Permanently discontinue study drug(s). 
1-2 mg/kg/day prednisone equivalentsa 
Urgent organ class consultation 
Consider additional immunosuppressive agents (e.g. – 
mycophenolate) 
Life-threatening or 
Grade 4 adverse 
reaction 
• Permanently discontinue study drug(s). 
1-2 mg/kg/day prednisone equivalentsa 
Emergent organ class consultation 
Consider additional immunosuppressive agents (e.g. – 
mycophenolate) 
Requirement for 10 
mg prednisone per 
day or greater 
prednisone or 
equivalent for > 3 
months 
• Permanently discontinue study drug(s). 
Urgent organ class consultation 
Consider additional immunosuppressive agents (e.g. – 
mycophenolate) 
Abbreviations: ADL = activities of daily living; ALT = alanine aminotransferase; AST = aspartate aminotransferase; IV = intravenous; T1DM = Type 1 diabetes mellitus; 
T2DM = Type 2 diabetes mellitus; ULN = upper limit of normal. 
Toxicity graded per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) 
a If steroids have been administered, taper steroids over the course of at least 4 to 6 weeks or per institution guidelines. 
b Subjects must have partial resolution of symptoms (Grade 0-1) and must be receiving < 7.5 mg of prednisone or equivalent per day in order to resume study treatment. 


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7.1.4.2 Dose Modifications and Toxicity Management for Vopratelimab in Combination with 
Nivolumab 
 
For dose modifications for nivolumab please follow the prescribing information (Opdivo® Full 
Prescribing Information {Bristol-Myers Squibb Company 2021}). In the event of a toxicity that 
requires that study treatment be withheld until resolution to Grade 0 or 1, the first administration 
of study drug after resolution of toxicity should be vopratelimab alone. Nivolumab may be added 
at the next dose, at the discretion of the investigator and the medical monitor, if the toxicity does 
not recur with vopratelimab monotherapy. 
 
7.1.4.3 Dose Modifications and Toxicity Management for Vopratelimab in Combination with 
Ipilimumab 
 
For dose modifications for ipilimumab please follow the prescribing information (Yervoy® Full 
Prescribing Information {Bristol-Myers Squibb Company 2021). In the event of a toxicity that 
requires that study treatment be withheld until resolution to Grade 0 or 1, the first administration 
of study drug after resolution of toxicity should be vopratelimab alone. Ipilimumab may then be 
added in sequence at the next dose, at the investigator’s discretion, if the toxicity does not recur 
with vopratelimab monotherapy. 
 
7.2 
Infusion-Related Reactions 
 
Post-infusion observation is per institutional guidelines. Signs and symptoms of an infusion 
reaction may include the following: headache, fever, facial flushing, pruritus, myalgia, nausea, 
chest tightness, dyspnea, vomiting, erythema, abdominal discomfort, diaphoresis, shivers, 
hypertension, hypotension, lightheadedness, palpitations, urticaria and somnolence. Although 
unlikely, serious allergic reactions (e.g., anaphylaxis) may occur at any time during the infusion. 
7.2.1 Grade 2 Infusion-Related Reactions 
In the case of Grade 2 occurrence of signs and symptoms consistent with infusion related reaction, 
follow institutional protocol and reduce the rate of infusion of vopratelimab to half the initial rate; 
consider interrupting infusion of vopratelimab if symptoms do not respond to medical intervention. 
If signs and symptoms resolve with intervention including interruption of, vopratelimab infusion 
may be restarted at half the initial rate. 
7.2.2 Grade 3 Infusion-Related Reactions 
In the case of Grade 3 or greater occurrence of signs and symptoms consistent with infusion related 
reaction, discontinue infusion of vopratelimab. 


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7.2.3 Infusion-Related Reaction Prophylaxis 
For subjects who experience a Grade 2 or 3 infusion-related reaction and remain on treatment, 
institutional practice for prevention of infusion reactions may be followed for all subsequent 
cycles. 
 
8 WITHDRAWAL OF SUBJECTS 
 
A subject is free to withdraw from treatment at any time for any reason without prejudice to their 
future medical care by the physician or at the institution. However, subjects who withdraw from 
treatment should be encouraged to return for the End-of-study visit and complete all safety 
assessments. If a subject refuses to undergo the End-of-study procedures, the reason for refusal 
should be fully documented in the subject’s eCRF. 
 
The Investigator or Jounce may also withdraw the subject from treatment at any time in the interest 
of his or her safety. The primary reason for withdrawal must be recorded in the subject’s medical 
record and on the withdrawal form in the eCRF. If a subject is withdrawn for more than one reason, 
each reason should be documented in the source document and the most medically significant 
reason should be entered on the eCRF. 
 
The withdrawal of a subject from treatment should be discussed where possible with the Medical 
Monitor before the subject stops taking study drug. If study treatment is discontinued, the final 
evaluations will be performed as completely as possible. 
 
The reason for termination, date of stopping study treatment and the total treatment period must 
be recorded in the eCRF and source documents. 
 
8.1 
Criteria for Withdrawal 
 
The Medical Monitor may be contacted on a case-by-case basis if clarification is required. Reasons 
for withdrawal include: 
 
• Withdrawal of consent by the subject or refusal by the subject to continue treatment and/or 
procedures/observations; 
• In the case of radiographic progression accompanied by clinical progression. However, in 
the case of radiographic progression where the subject is clinically stable, it is 
recommended to continue treatment as long as, in the investigator’s opinion, the subject is 
clinically stable; 
• Occurrence of unmanageable adverse events (AEs) in the judgment of the Investigator or 
subject, justifies withdrawal due to its severity, nature, or requirement for treatment, 
regardless of the causal relationship to study drug; 


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• Pregnancy; 
• If the Investigator feels it is in the subject’s best interest to withdraw; 
• Other reasons (e.g., significant protocol violation, non-compliance, loss to follow-up); 
• Termination of the study by Sponsor. 
9 OVERALL STUDY ASSESSMENTS 
 
Duration of participation on this study will be dependent on the amount of time a subject derives 
clinical benefit. An End-of-study visit will be performed 28 days (± 7 days) after the last dose of 
study treatment. 
 
9.1 
Rollover Entry/Cycle 1 Day 1 
 
Enrollment into the rollover study should occur upon exit from the parent study to avoid any 
interruptions in study treatment administration. 
 
All assessments should be performed prior to vopratelimab dosing, unless otherwise noted. 
 
• Signing of informed consent form. 
• Review eligibility criteria to determine whether a subject may enter the rollover study. 
• Physical examination. 
• Vital signs pre-and post-infusion. 
• Weight. 
• Serum or urine pregnancy test for women of childbearing potential. The pregnancy test 
will not be required for women who are surgically sterile or who are greater than 1 year 
post-menopausal. 
• Laboratory assessments including hematology and chemistry; additional laboratory 
measurements may be performed in accordance with institutional guidelines. 
• Pharmacodynamic biomarkers; Collection of samples may be discontinued at any time per 
the Sponsor’s discretion. 
• Record ongoing concomitant medications and AEs. 
• Study treatment (vopratelimab ± partner drug) administration on the same dose and 
schedule as a subject was receiving at the time of discontinuation from the parent study. 
Study drug administration between the parent and rollover study should be maintained per 
the dose and schedule on the parent study. Any changes to the dose and schedule of 
vopratelimab must be in accordance with a dose and schedule previously shown to be safe 
and well tolerated and must be discussed with the medical monitor. Any changes to the 
dose and schedule of nivolumab or ipilimumab must be discussed with the medical monitor. 


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9.2 
Day 1 (± 3 Days) of Subsequent Cycles 
 
The following evaluations and procedures will be performed on Day 1 of subsequent cycles. All 
assessments should be performed prior to vopratelimab dosing, unless otherwise noted. 
 
• Physical examination. 
• Vital signs pre-and post-infusion. 
• Weight. 
• Pregnancy test for women of childbearing potential. 
• Laboratory assessments including hematology and chemistry; additional laboratory 
measurements may be performed in accordance with institutional guidelines. 
• Concomitant medication review. 
• AE assessment. 
• Study treatment (vopratelimab ± partner drug) administration on the same dose and 
schedule as a subject was receiving at the time of discontinuation from the parent study. 
Any changes to the dose and schedule of vopratelimab must be in accordance with a dose 
and schedule previously shown to be safe and well tolerated and must be discussed with 
the medical monitor. Any changes to the dose and schedule of nivolumab or ipilimumab 
must be discussed with the medical monitor. 
• Disease imaging (e.g., CT scan) for response assessment in accordance with Section 9.2.3. 
9.2.1 Subsequent Dosing Days 
Subjects should continue to receive study drug administration dosing within every cycle per the 
dose and schedule administered in the parent study. Any changes to the dose and schedule of 
vopratelimab must be in accordance with a dose and schedule previously shown to be safe and 
well tolerated and must be discussed with the medical monitor. Any changes to the dose and 
schedule of nivolumab or ipilimumab must be discussed with the medical monitor. 
9.2.2 Approximately Every 3 Months (± 4 Weeks) 
A visit should be performed approximately every 3 months (± 4 weeks) to align with a scheduled 
study drug administration or other clinic visit. At this time, peripheral blood sampling should be 
performed for pharmacodynamic biomarkers. Collection of samples may be discontinued at any 
time per the Sponsor’s discretion. 
9.2.3 Every 6 Months (± 3 Weeks) 
Disease imaging (e.g., computed tomography [CT] scan) should be performed for response 
assessment in accordance with institutional standard of care guidelines, but at least every 6 months 
(± 3 weeks). 


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9.3 
End of Study 
 
At the end of study (within 28 days ± 7 days after last dose of study drug): 
• Physical examination. 
• Vital signs. 
• Weight. 
• Laboratory assessments including hematology and chemistry; additional laboratory 
measurements may be performed in accordance with institutional guidelines 
• Peripheral blood sampling for pharmacodynamic biomarkers; Collection of samples may 
be discontinued at any time prior to end of study per the Sponsor’s discretion. 
• In the case of progressive disease, disease imaging (e.g., CT scan) for response assessment 
in accordance with institutional standard of care guidelines, but at least every 6 months (± 
3 weeks). 
• Concomitant medication review. 
• AE assessment. 
10 DESCRIPTION OF STUDY ASSESSMENTS 
 
Demographic and medical history information for individual subjects will be transferred from the 
parent study. 
 
10.1 Physical Examination 
 
At all visits, a targeted physical examination will be performed per institutional guidelines. 
Clinically significant physical examination data will be recorded on the eCRF as AEs, as 
appropriate. 
 
10.2 Vital Signs 
 
Measurements of vital signs include blood pressure, temperature, heart rate, respiratory rate, and 
oxygen saturation. Vital signs should be taken prior to and at the end of each vopratelimab infusion. 
Clinically significant vital sign data will be recorded on the eCRF as AEs, as appropriate. 
 
10.3 Weight 
 
The determination of vopratelimab dose will be based on the subject’s weight. Weight will be 
recorded on the eCRF at each visit. 


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10.4 Response Assessment 
 
The anti-tumor activity of study treatment will be assessed using Response Evaluation Criteria in 
Solid Tumors (RECIST) version 1.1 as assessed by study investigators. Imaging for efficacy 
assessments will be performed in accordance with institutional standard of care guidelines, but at 
least every 6 months (± 3 weeks) and will be recorded on the eCRF. 
 
10.5 Clinical Laboratory Evaluations 
 
Clinical laboratory assays will include chemistry and hematology, as well as any other 
measurements according to institutional standard of care guidelines, performed at local 
laboratories according to the laboratory’s normal procedures Abnormal laboratory values that are 
unexpected and not explained by the subject’s clinical condition should be repeated until 
confirmed, explained, or resolved. In the judgment of the Investigator, any clinically significant 
changes will be recorded on the eCRF as an AE. 
 
10.6 Biomarkers 
 
Pharmacodynamic biomarkers in peripheral blood, including peripheral blood mononuclear cell 
(PBMC)-based assays of immune cell phenotype, will be assessed approximately every 3 months 
(± 4 weeks) and at the end of treatment to determine the effect on peripheral T cells. Biomarker 
sampling will be recorded on the eCRF. Sample collection may be discontinued at any time per 
the Sponsor’s discretion. 
 
Please refer to the separate Laboratory Manual detailing the biomarker sample collection times, 
preparation, storage and shipping process. 
10.6.1 Retention of Samples 
If allowable by local guidelines and/or policies, all blood and PBMC samples will be retained for 
potential additional testing at a later date or to enable development of a companion diagnostic that 
would help to identify subjects most likely to benefit from vopratelimab in the future. 
 
Samples will be retained at a secure storage facility (to be selected, qualified, and contracted by 
Jounce Therapeutics) in case there is need for retesting. At the end of ten (10) years after the final 
clinical study report is written (or some other period based on local guidelines and/or policies), or 
if Jounce no longer requires the samples, they will be destroyed. Analyses may be conducted by 
Jounce Therapeutics, Inc. or by a designated lab at their discretion. 


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Biospecimens will not be labeled with any personal identifiers (e.g., date of birth, initials). They 
will be labeled with the subject’s study number to allow for future exploratory research analyses 
to be correlated to the study data and treatment/dose assignments. 
 
10.7 Pregnancy Test 
 
A serum or urine pregnancy test must be performed and reviewed on all women of childbearing 
potential prior to every dose of study drug. Test results will be recorded on the eCRF. 
 
10.8 Adverse Events and Serious Adverse Events 
 
The investigator is responsible for the detection and documentation of events meeting the criteria 
and definition of an AE or serious adverse event (SAE) as provided in this protocol. 
10.8.1 Definition of an Adverse Event (AE) 
An AE is any untoward medical occurrence in a clinical investigation subject administered a 
pharmaceutical product and which does not necessarily have to have a causal relationship with this 
treatment. 
 
An AE can therefore be any unfavorable and unintended sign (including clinically significant 
abnormal laboratory finding), symptom, disease, or exacerbation of a pre-existing condition 
temporally associated with the use of study drug, whether or not related to the study drug. 
 
Disease progression should not be recorded as an AE/SAE. New or increasing symptoms related 
to disease progression should be reported as an AE or AEs. When possible, the primary diagnosis 
of the event meeting SAE criteria should be recorded as the AE/SAE term. (For instance, if a 
subject is hospitalized for shortness of breath and it is confirmed that this is a symptom of a 
malignant pleural effusion, then malignant pleural effusion should be reported as the event term, 
rather than disease progression). 
10.8.2 Observation and Recording of AEs 
AEs that occur on the parent study and are ongoing at the time of entry into the rollover study will 
be recorded as medical history. Any such AE that worsens on the rollover study should be recorded 
as a new AE at the worsened severity. 
 
Study personnel will assess AEs at every visit. The date of onset and resolution (if applicable) of 
the AE will be documented in the source documents and on the appropriate eCRF page. The 
Investigator will monitor all AEs to the final study visit or to a satisfactory resolution if the AE is 
ongoing. 


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All AEs will be recorded from the time of signed informed consent until the End-of-study visit (28 
days ± 7 days after the last dose of study drug[s]) and are to be recorded on the appropriate AE 
pages in the eCRF and in source documents. AEs for the End-of-study visit may be collected by a 
telephone contact if the subject is not able to attend an on-site End-of-study visit. Where possible, 
a diagnosis rather than a list of symptoms should be recorded. If a diagnosis has not been made, 
then each symptom should be listed individually. 
 
All study drug related AEs/SAEs (see Section 10.8.4 for definition) will be followed to resolution 
(the subject’s health has returned to his/her baseline status or all variables have returned to normal), 
or until new therapy initiated. Where appropriate, medical tests and examinations will be 
performed to document resolution of the event(s). 
 
SAEs will be reported as outlined in Section 10.9 and recorded in the AE eCRF. 
 
10.8.3 Grading and Severity 
Grade refers to the severity of the AE/SAE. Severity will be assessed in this study using the 
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), 
version 5.0 (see Appendix 3). 
 
In the event that an AE is not covered by the CTCAE, the assessment of severity will be determined 
by using the CTCAE general guideline: 
 
Table 2: Grading for Events Not Covered By the CTCAE 
Grade 1 
Mild; asymptomatic or mild symptoms; clinical or diagnostic 
observations only; intervention not indicated. 
Grade 2 
Moderate; minimal, local or noninvasive intervention indicated; 
limiting age-appropriate instrumental ADL*. 
Grade 3 
Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of 
hospitalization indicated; disabling; limiting self-care ADL**. 
Grade 4 
Life-threatening consequences; urgent intervention indicated. 
Grade 5 
Death related to AE 
Activities of Daily Living (ADL) 
*Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc. 
**Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. 
 
The Investigator will evaluate all AEs as to their severity. 
 
• An AE that is assessed as severe should not be confused with an SAE. Severity is a category 
used for rating the intensity of an event; both AEs and SAEs can be assessed as severe. An 
event is described as ‘serious’ when it meets one of the pre-defined outcomes as described 
in Section 10.9. 


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Worsening of a pre-treatment event, after initiation of study drug(s) must be recorded as a new AE. 
 
10.8.4 Relationship Categorization 
An Investigator qualified in medicine must make the determination of relationship to study drug 
for each AE/SAE. The Investigator should decide whether, in his or her medical judgment there is 
a reasonable possibility that the event may have been caused by the study drug. If no valid reason 
exists for suggesting a relationship, the AE/SAE should be classified as “definitely not”. If there 
is a valid reason, even if undetermined or untested, for suspecting a possible cause-and-effect 
relationship between the study drug and the occurrence of the AE/SAE, the AE/SAE should be 
considered “possibly related”. Table 3 should be used for guidance in the determination of 
relationship: 
 
Table 3: Guidance in Determining the Relationship of an Adverse Event 
 
Relationship 
Definition 
Unrelated 
There is no association between study drug and the reported event. 
Related 
The event follows a reasonable temporal sequence from the time of study drug 
administration and/or follows a known response pattern to the study drug, but could also 
have been produced by other factors. 
A causal relationship also exists between study drug administration and the AE if other 
conditions (e.g., concurrent illness, progression/expression of disease state, or concurrent 
medication reaction) do not appear to explain the event. 
 
If the causal relationship between an AE/SAE and study drug(s) is determined to be possibly or 
probably related, the event will be considered to be related to vopratelimab per investigator 
assessment for the purposes of expedited regulatory reporting. Note: “Cannot be ruled out” is not 
a basis for the assessment of possibly or probably related. 
10.8.5 Outcome Categorization 
Outcome of an AE/SAE may be classified as resolved, resolved with sequelae, unresolved, or fatal. 
Death is an outcome of an event. The event that resulted in death must be recorded on the 
appropriate eCRF. 
10.8.6 Clinical Laboratory Evaluations 
A clinical laboratory AE is any laboratory value that is considered clinically significant by the 
Investigator and has caused a medical intervention or accompanied by clinical symptoms. 
Laboratory abnormalities that have not required medical intervention should not be recorded as 
AEs and will be captured and reported in the laboratory section of the clinical study report. If a 


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medical intervention occurs, it should be recorded as a treatment with the abnormal laboratory 
finding as the AE. 
 
The Investigator should decide, based upon the AE criteria and the clinical condition of the subject, 
whether a change in a laboratory parameter is clinically significant and therefore represents an AE. 
10.8.7 Pregnancy 
Pregnancy will not be considered an SAE. Any report of pregnancy recorded for any female study 
participant or a female partner of a male study participant should be reported immediately by 
completing a Pregnancy Report Form and submitted by e-mail or fax to IQVIA’s Drug Safety (see 
Section 10.9.4). 
 
If the outcome of the pregnancy meets serious criteria (miscarriage or congenital anomaly/birth 
defect), it should be reported as an SAE. 
 
The pregnant female study participant must be withdrawn from the study. Every effort should be 
made to gather information regarding the pregnancy outcome until 8 weeks post-partum. It is the 
responsibility of the Investigator to obtain all pregnancy information. 
 
10.9 Serious Adverse Event Reporting 
10.9.1 Definition of a Serious Adverse Event (SAE) 
An SAE is any untoward medical occurrence (whether considered to be related to study drug or 
not, except for those events described in Section 10.9.2) that at any dose: 
• Results in death; 
• Is life-threatening (the term “life-threatening” in the definition of “serious” refers to an 
event which the subject 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 (at least 24 hours inpatient) or prolongation of existing 
hospitalization; 
• Results in persistent or significant disability/incapacity; 
• Is a congenital abnormality/birth defect; 
• Is an Important Medical Event. 
Medical and scientific judgment should be exercised in deciding whether expedited reporting is 
appropriate in other situations, such as important medical events that may not be immediately life- 
threatening or result in death or hospitalization but may jeopardize the subject or may require 
intervention to prevent one of the other outcomes listed in the definition of a serious adverse event 
above, as these events may be considered serious. 


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Examples of such events are intensive treatment in an emergency room or at home for allergic 
bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization. 
10.9.2 SAE Classifications 
Elective or previously scheduled hospitalizations for pre-existing conditions which have not 
worsened after initiation of treatment should not be classified as SAEs. For example, an admission 
for a previously scheduled ventral hernia repair would not be classified as an SAE. 
10.9.3 Protocol-Specified Expected Events 
Subjects with advanced solid malignancies are at risk for many AEs as a consequence of prior 
therapy and as a result of their disease. 
 
Subjects receiving immune therapies are at risk for immune-related AEs. Immune-related AEs 
(irAEs) are typically responsive to interruption or discontinuation of the immunotherapy in 
combination with immunosuppressive drugs such as steroids or occasionally tumor necrosis factor- 
blocking  antibodies. At  present,  there  is  no  clear  preventive  strategy  to  avoid  irAEs 
{Michot 2016}. 
 
10.9.4 Observation and Recording of SAEs 
All SAEs must be reported to IQVIA within 24 hours of first awareness of the event. 
 
 
10.9.5 E-mail: Safety-Inbox.Biotech@IQVIA 
Additional follow-up information, if required, or available, should be recorded on a follow-up SAE 
Report Form and faxed to IQVIA Drug Safety within one business day of discovery by site. 
 
All SAEs, whether related or unrelated to study drug, will be recorded from the time of signed 
informed consent until resolution or new therapy initiated or for 28 days post final dose if no new 
therapy is initiated. Any SAEs considered to have at least a possible relationship to the study drug 
and discovered by the Investigator at any time period after the subject’s study treatment has ended 
should be reported according to the timeframe described above. 
 
Study drug-related SAEs will be followed until resolution, stabilization or subject receives new 
therapy. 
SAE Reporting Contact Information 
IQVIA Biotech, LLC Safety and Reporting 
Fax number: 1-866-761-1274 
Phone number: 1-866-758-2798 


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At a minimum, the site number, Investigator’s name, subject number, event name, the date of onset, 
a short description of the event and the Investigator’s preliminary assessment of causality must be 
provided at the time of the initial SAE report. 
 
The onset date of the SAE is defined as the onset date of signs and symptoms or a change in 
baseline when the SAE met seriousness criteria. 
 
The resolution date of the SAE is defined as the date in which the criteria of seriousness is no 
longer applicable (e.g., discharge from hospitalization). 
 
All SAEs that are ongoing events at the time of death should be considered not resolved at time of 
death. 
 
The Investigator is encouraged to discuss with the Medical Monitor any SAEs for which the issue 
of reportability is unclear or in question. 
 
The Investigator must review, sign, and date the SAE Report Form to confirm the accuracy of the 
information recorded on the SAE Report Form along with the corresponding source 
documentation. 
10.9.6 Regulatory Authorities and Institutional Review Boards 
Jounce or its designee is responsible for notifying the investigational sites and all heath authorities 
(e.g., United States [US] Food and Drug Administration [FDA]) of all expedited SAEs. 
 
The Investigator will notify his or her Institutional Review Board (IRB)/Ethics Committee (EC) 
of serious, related and unexpected AE(s) or significant risks to subjects. The Investigator must 
keep copies of all AE information, including correspondence with Jounce or local ECs on file. 
 
It is the responsibility of the Principal Investigator (PI) to notify the IRB/EC of all SAEs that occur 
at his or her site as per site guidelines. Investigators will be notified of all suspected, unexpected 
SAEs (7/15 Day Safety Reports) that occur during any clinical studies that are using the 
investigative compound. Each site is responsible for notifying its IRB/EC of these additional SAEs. 


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10.9.7 Drug Safety Contact Information 
 
 
Medical Monitor: 
Ellen Hooper, MD 
Senior Medical Director 
Jounce Therapeutics 
780 Memorial Drive 
Cambridge, MA 02139 
(w) 857-320-2548 
(m) 914-439-2240 
ehooper@jouncetx.com 
Back-up Medical Monitor: 
Johan Baeck, MD 
Senior Vice President, Clinical 
Development and Medical Affairs 
Jounce Therapeutics 
780 Memorial Drive 
Cambridge, MA 02139 
(w) 857-320-2573 
(m) 862-926-8158 
jbaeck@jouncetx.com 
 
 
 
11 STATISTICAL ANALYSES 
 
11.1 Endpoints 
 
Safety and efficacy endpoints, including exposure to the investigational study drug, incidence and 
severity of treatment-emergent serious and non-serious AEs, investigational study drug 
discontinuation reason, and death, will be derived. 
 
11.2 Statistical Basis for Sample Size 
 
Patients on study treatment in a Jounce-sponsored clinical study and eligible for rollover may be 
enrolled. For the study objectives, no prospective sample size determination is required. 
 
11.3 Statistical Analysis 
 
Study data collected will be summarized descriptively as per the requirements of the 
Investigational New Drug (IND) annual report or Drug Safety Update Report (DSUR). Additional 
analyses of safety and efficacy data may be performed, if the updates are clinically meaningful, 
following the pertinent statistical analysis methods specified in the original protocol. 
11.3.1 Determination of Sample Size 
Not applicable 
IQVIA Biotech, LLC Safety and Reporting 
Fax number: 1-866-761-1274 
E-mail: Safety-Inbox.Biotech@IQVIA 


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11.3.2 Analysis Set 
The Safety Population (SAF) will include all subjects who have been treated with at least one dose 
of study drug. 
 
12 DATA QUALITY ASSURANCE 
 
This study will be organized, performed, and reported in compliance with Jounce/CRO’s Standard 
Operating Procedures, protocols and working practice documents, and the requirements of 
International Conference on Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals for Human Use (ICH)/Good Clinical Practice (GCP) guidelines. Compliance will 
be achieved through a combination of study specific audits of investigative sites and audits at 
regular intervals of the Jounce /CRO’s systems for data handling, analysis, and reporting. 
 
12.1 Data Collection 
 
Investigators or designees will enter the information required by the protocol onto the eCRFs. Each 
investigative site will be visited as frequently as documented in the monitoring plan by the CRO 
on behalf of Jounce to review the eCRFs for completeness and accuracy. The CRO representative 
will highlight any discrepancies found between source documents and the completed eCRFs and 
ensure that appropriate site personnel address the discrepancies. When a discrepancy results in 
corrected eCRF data, the correction will be reviewed again against the correct source 
documentation. Uniform procedures will be discussed at the Site Initiation Visit. 
 
12.2 Clinical Data Management 
 
Data from eCRFs and other external data will be entered into a clinical database as specified in the 
CRO’s data management plan. Quality control and data validation procedures will be applied to 
ensure the validity and accuracy of the clinical database. 
 
Data from eCRFs and other external data will be reviewed and checked for omissions, apparent 
errors, and values requiring further clarification using computerized and manual procedures. Only 
authorized personnel will make corrections to the eCRF and all corrections will be documented in 
an audit trail. 
 
This study will be conducted in compliance with regulations contained within 21Code of Federal 
Regulations (CFR) Part 11, electronic records/electronic signatures regulations. 


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13 ADMINISTRATIVE PROCEDURES 
 
The procedures set out in this study protocol, pertaining to the conduct, evaluation, and 
documentation of this study, are designed to ensure that Jounce and Investigators abide by GCP as 
described in the ICH Harmonised Tripartite Guideline E6: GCP: Consolidated Guideline, and 21 
CFR Parts 50, 54, 56, and 312. Compliance with these regulations also constitutes compliance with 
the ethical principles described in the current revision of the Declaration of Helsinki. The study 
will also be carried out in keeping with local legal and regulatory requirements. 
 
13.1 Institutional Review Board (IRB) 
 
It is the responsibility of the Investigator to submit this protocol, the informed consent document 
(approved by Jounce or its designate), relevant supporting information and all types of subject 
recruitment information to the IRB/EC for review, and all must be approved prior to site initiation. 
Prior to implementing changes in the study, Jounce and the IRB/EC must also approve any revised 
informed consent documents and amendments to the protocol. 
 
On the approval letter, the study reference, the date of review and actions taken should be clearly 
stated. Investigational Product will not be released and the subject recruitment will not begin until 
this written approval has been received by Jounce or its designee. 
 
The Investigator is responsible for keeping the IRB/EC apprised of the progress of the study and 
of any changes made to the protocol. The Investigator must also keep the IRB/EC informed of any 
serious and significant AEs. 
 
13.2 Informed Consent 
 
It is the responsibility of the Investigator to obtain written Informed Consent from subjects. All 
consent documentation must be in accordance with applicable regulations and GCP. Each subject 
or the subject’s legally authorized representative is requested to sign the Informed Consent Form 
(ICF) after the subject has received and read the written subject information and received an 
explanation of what the study involves, including but not limited to: the objectives, potential 
benefits and risk, inconveniences and the subject’s rights and responsibilities. A copy of the 
informed consent documentation (consent form or subject information sheet and the consent form, 
as applicable) must be given to the subject or the subject’s legally authorized representative. If 
applicable, it will be provided in a certified translation of the subject’s local language. Signed 
consent forms must remain in each subject’s study file and must be available for verification by 
study monitors at any time. 


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Each PI will provide Jounce with a copy of the IRB/EC approved consent forms, and a copy of the 
IRB/EC written approval, prior to the start of the study. Additionally, if the IRB/EC required 
modification of the sample subject information and consent document provided by Jounce, the 
documentation supporting this requirement must be provided to Jounce. 
 
Jounce reserves the right to delay initiation of the study at a site where the informed consent forms 
do not meet the standards of applicable regulations and ICH GCP. 
 
13.3 Subject Privacy 
 
Jounce and the Investigator affirm and uphold the principle for the subject’s right to protection 
against invasion of privacy. Throughout this study, all data collected and analyzed by Jounce (or 
designee) will be identified by an identification number. 
 
To verify compliance with this protocol, Jounce will require that the Investigator permit its monitor 
to review those portions of the subject’s primary medical records that directly concern this study 
(including but not limited to laboratory test results, electrocardiogram reports, and hospital and 
outpatient records). Should access to such medical records require a waiver or authorization 
separate from the statement of informed consent, the Investigator will obtain such permission in 
writing from the subject before the subject is entered into the study. 
 
13.4 Study Monitoring 
 
Monitoring of the study will be performed by a representative of Jounce’s CRO. At the monitoring 
visits, the progress of the study will be discussed with the Investigator, or his/her representative. 
The ICFs will be reviewed for signatures and the eCRFs checked for completeness and accuracy. 
Subject source data must be available for review. The Investigator and his/her staff are expected 
to cooperate with the study monitor and be available during at least a portion of the monitoring 
visit to review the eCRFs and any queries/resolutions, answer questions, and provide any missing 
information. 
 
The study monitor will record the date of each visit together with a summary of the status and 
progress of the study. Proposed actions will be confirmed with the Investigator in writing. 
 
Telephone contact will be made with the Investigator as necessary during the data collection period 
and during the data and report writing periods. 


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13.5 Modification of Protocol 
 
All amendments to the protocol must be documented in writing, reviewed, and approved by the 
Investigator and Jounce, and submitted to the IRB/EC for approval prior to initiation, except in 
cases where required for subject safety. If the protocol amendment substantially alters the study 
design or potential risk to the subject, new written informed consent for continued participation in 
the study must be obtained from each subject. 
 
13.6 Suspension or Termination of Study 
 
Should conditions requiring further clarification arise before the decision to proceed with or 
terminate the study can be reached, the study will be suspended until the situation has been 
resolved. 
 
Jounce has the right to terminate this study and remove all study material from the site at any time. 
Examples of where this might occur include but are not limited to: 
 
• It becomes apparent that subject enrollment is unsatisfactory with respect to quality and/or 
quantity or data recording is inaccurate and/or incomplete on a chronic basis; 
• The incidence and/or severity of AEs in this study indicate a potential health hazard caused 
by treatment with the study medication. 
 
13.7 Departure from Protocol 
 
No deviation may be made from the protocol unless an amendment has been agreed to in writing 
by both the Investigator and Jounce and approved by the IRB/EC. Investigative sites will contact 
the medical monitor to request clarifications regarding any aspect of the clinical study or eligibility 
of subjects. Any study-wide updates may be released via administrative memo from the Sponsor 
when appropriate. 
 
When an emergency occurs that requires a departure from the protocol for an individual, a 
departure will be only for that subject. The Investigator or other physician in attendance in such 
an emergency will, if circumstances and time permit, contact Jounce or their representatives, 
immediately by telephone. Such contacts will be made as soon as possible to permit a decision as 
to whether or not the subject (for whom the departure from protocol was affected) is to continue 
in the study. The source documents will completely describe the departure from the protocol and 
state the reasons for such departure. In addition, the IRB/EC will be notified in writing of such 
departure from protocol. 


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13.8 Recording, Access and Retention of Source Data 
 
The Investigator must permit authorized representatives of Jounce, the regulatory authorities, the 
IRB/EC, auditors and interested commercial parties to inspect facilities and records relevant to this 
study. Source data to be reviewed during this study will include, but are not limited to: subject’s 
medical file, original laboratory reports, X-rays/scans, pathology reports, electrocardiograms, etc. 
All key data must be recorded in the subject’s source documents. 
 
The monitor (auditors, IRB/EC or regulatory inspectors) may check the eCRF entries against the 
source documents. The consent form will include a statement by which the subjects allow the 
monitor/auditor/inspector from Jounce or its representatives, regulatory authorities or the IRB/EC 
access to source data which substantiate information recorded in the eCRFs. These personnel, 
bound by professional secrecy, will not disclose any personal information or personal medication 
information. 
 
As described in the ICH GCP Guidelines, ‘essential documents’, including eCRFs, source 
documents, consent forms, laboratory test results and the investigational product inventory 
records, should be retained by the Investigator until at least two years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated marketing 
applications in an ICH region or at least two years have elapsed since the formal discontinuation 
of clinical development of the investigational product. These documents should be retained for a 
longer period however if required by the applicable regulatory requirements or by an agreement 
with Jounce. It is the responsibility of the Sponsor to inform the investigator/institution as to when 
these documents no longer need to be retained. The Investigator must obtain written permission 
from Jounce prior to the destruction of any study document. 
 
These records must be made available at reasonable times for inspection and duplication, if 
required, by a properly authorized representative of the US FDA in accordance with the US 
21 CFR 312.68 or other regulatory authorities in accordance with regulatory requirements. 
13.8.1 Case Report Forms 
Electronic CRFs will be used for data collection for this study. 
 
The Investigator is responsible for maintaining adequate and accurate source documents from 
which accurate information will be transcribed into eCRFs which have been designed to capture 
all observations and other data pertinent to the clinical investigation. eCRFs should be completed 
by the Investigator or delegate as stated on the Delegation of Authority Log. Overwriting of 
information or use of liquid correcting fluid is not allowed in the source document. 


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The eCRFs must be reviewed and electronically signed and dated by the Investigator once all data 
has been entered and all queries resolved. Once the Study Monitor has verified the contents of the 
completed eCRF against the source data, queries may be raised if the data are unclear or 
contradictory. The Investigator must address all queries. 
 
13.9 Good Clinical Practice (GCP) Compliance 
 
The Investigator must undertake to perform the study in accordance with, ICH GCP Guideline E6, 
local IRB/EC requirements, and 21 CFR. 
 
It is the Investigator’s responsibility to ensure that adequate time and appropriate resources are 
available at the study site prior to commitment to participate in this study. The Investigator should 
also be able to estimate or demonstrate a potential for recruiting the required number of suitable 
subjects within the agreed recruitment period. 
 
The Investigator will maintain a list of appropriately qualified persons to whom the Investigator 
has delegated significant study-related tasks. An up-to-date copy of the curriculum vitae for the 
Investigator and sub-Investigator(s) will be provided to Jounce (or designee) before starting the 
study. 
 
If the subject has a primary physician the Investigator should, with the subject’s consent, inform 
them of the subject’s participation in the study. 
13.9.1 Quality Control and Quality Assurance 
A site monitoring plan will be developed to ensure the human subject protection, study procedures, 
laboratory, study intervention administration, and data collection processes are of high quality and 
meet Jounce, GCP/ICH, and regulatory guidelines. 
 
The Investigator will permit authorized representatives of Jounce and the respective regulatory 
authorities to inspect facilities and records relevant to this study if needed. 
 
Initial site training will be provided by Jounce. Training for new staff will be provided by current 
study nurses and study coordinators under the supervision of the PI. Additional training will be 
provided by Jounce as needed. 
 
The Data Management Team will implement quality control procedures beginning with the data 
entry system and generate data quality control checks that will be run on the database. Any missing 
data or data anomalies will be communicated to the site(s) for clarification/resolution. 


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13.9.2 Publications 
All manuscripts, abstracts or other modes of presentation arising from the results of the study must 
be reviewed and approved in writing by Jounce, in advance of submission. The review is aimed at 
protecting Jounce’s proprietary information existing either at the date of the commencement of the 
study or generated during the study. 
 
The detailed obligations regarding the publication of any data, material results or other 
information, generated or created in relation to the study must be carried out in accordance with 
the Clinical Study Agreement. 
13.9.3 Confidentiality 
Data collected during this study may be used to support the development, registration, or marketing 
of vopratelimab. After subjects have consented to take part in the study their medical records and 
the data collected during the study will be reviewed by Jounce and/or its representatives. These 
records and data may, in addition, be reviewed by the following: independent auditors who validate 
the data on behalf of Jounce; third parties with whom Jounce may develop, register or market 
vopratelimab; national or local regulatory authorities and the IRB/EC(s) that gave approval for this 
study to proceed. 
 
Although subjects will be known by a unique number, their date of birth will also be collected and 
used to assist Jounce to verify the accuracy of the data, for example, that the laboratory results are 
assigned to the correct subject. 
13.9.4 Audit/Inspection 
To ensure compliance with relevant regulations, data generated by this study must be available for 
inspection upon request by representatives of, for example, the US FDA (as well as other national 
and local regulatory authorities), Jounce or its representatives, interested commercial parties and 
the IRB/EC for each study site. 


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CONFIDENTIAL 
Page 47 of 51 
 
 
 
14 APPENDICES 
 
Appendix 1: Schedule of Events (Every 6 Week Administration) 
 
Rollover 
Entry/Cycle 1 
Day 1 1 
Day 1 (± 3 days) 
of Subsequent 
Cycles 2 
Rollover End of 
Study 
Timing of Visit 
Every 6 Weeks 
28 ± 7 days 
after last dose 
Informed Consent 
X 
Eligibility Criteria 
X 
Physical Examination3 
X 
X 
X 
Weight (kg) 
X 
X 
X 
Vital Signs4 
X 
X 
X 
Pregnancy Test5 
X 
X 
Hematology 
X 
X 
X 
Chemistry 
X 
X 
X 
Other Laboratory Assessments per Standard of Care 
X 
X 
X 
Blood Samples for Pharmacodynamic Biomarkers 
X 
X6 
X 
Study Treatment Administration7 
X 
X 
Disease Imaging (e.g., CT scan) 
X8 
X8 
Concomitant Medications 
X 
X 
X 
Adverse Events 
X 
X 
X 
Abbreviations: CT = computed tomography; ; RECIST = Response Evaluation Criteria in Solid Tumors 
Footnotes: 
1 Enrollment into the rollover study should occur upon exit from the parent study to avoid any interruptions in study 
treatment administration. 
2 All assessments should be performed prior to vopratelimab dosing, unless otherwise noted. 
3 Targeted physical examination is required at each study administration visit and at the End-of-study visit;. 
4 Vital signs to include temperature, heart rate, respiratory rate, blood pressure, and oxygen saturation. Vital signs should be 
taken prior to and at the end of each vopratelimab infusion. 
5 Negative serum or urine pregnancy test for women of childbearing potential prior to administration of vopratelimab on 
Day 1 of each treatment cycle. 
6 Blood sampling for exploratory analyses of pharmacodynamic biomarkers should be collected approximately every 
3 months (± 4 weeks) at the time of a scheduled clinic visit. Sample collection may be discontinued at any time per the 
Sponsor’s discretion. Please refer to the Study Laboratory Manual for more details. 
7 Study treatment (vopratelimab ± partner drug) should be administered on the same dose and schedule as a subject was 
receiving at the time of discontinuation from the parent study. Any changes to the dose and schedule of vopratelimab must 
be in accordance with a dose and schedule previously shown to be safe and well tolerated and must be discussed with the 
medical monitor. Any changes to the dose and schedule of nivolumab or ipilimumab must be discussed with the medical 
monitor. 
8 Disease imaging will be performed in accordance with institutional standard of care guidelines, but at least every 6 months 
(± 3 weeks). Response will be determined by RECIST (Version 1.1). 


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Appendix 2: Schedule of Events (Every 3 Week Administration) 
 
Rollover Entry/ 
Cycle 1 Day 11 
Day 1 (± 3 days) 
of Subsequent 
Cycles 2 
Rollover End 
of Study 
Timing of Visit 
Every 3 Weeks 
28 ± 7 days 
after last dose 
Informed Consent 
X 
Eligibility Criteria 
X 
Physical Examination3 
X 
X 
X 
Weight (kg) 
X 
X 
X 
Vital Signs4 
X 
X 
X 
Pregnancy Test5 
X 
X 
Hematology 
X 
X 
X 
Chemistry 
X 
X 
X 
Other Laboratory Assessments per Standard of Care 
X 
X 
X 
Blood Samples for Pharmacodynamic Biomarkers 
X 
X6 
X 
Study Treatment Administration7 
X 
X 
Disease Imaging (e.g., CT scan) 
X8 
X8 
Concomitant Medications 
X 
X 
X 
Adverse Events 
X 
X 
X 
Abbreviations: CT = computed tomography; RECIST = Response Evaluation Criteria in Solid Tumors 
Footnotes: 
1 Enrollment into the rollover study should occur upon exit from the parent study to avoid any interruptions in study 
treatment administration. 
2 All assessments should be performed prior to vopratelimab dosing, unless otherwise noted. 
3 Targeted physical examination is required on study administration days and at the End-of-study visit; 
4 Vital signs to include temperature, heart rate, respiratory rate, blood pressure, and oxygen saturation. Vital signs should be 
taken prior to and at the end of vopratelimab infusion. 
5 Negative serum or urine pregnancy test for women of childbearing potential prior to administration of vopratelimab on 
Day 1 of each treatment cycle. 
6 Blood sampling for exploratory analyses of pharmacodynamic biomarkers should be collected approximately every 
3 months (± 4 weeks) at the time of a scheduled clinic visit. Sample collection may be discontinued at any time per the 
sponsor’s discretion. Please refer to the Study Laboratory Manual for more details. 
7 Study treatment (vopratelimab ± partner drug) should be administered on the same dose and schedule as a subject was 
receiving at the time of discontinuation from the parent study. Any changes to the dose and schedule of vopratelimab must 
be in accordance with a dose and schedule previously shown to be safe and well tolerated and must be discussed with the 
medical monitor. Any changes to the dose and schedule of nivolumab or ipilimumab must be discussed with the medical 
monitor. 
8 Disease imaging will be performed in accordance with institutional standard of care guidelines, but at least every 6 months 
(± 3 weeks). Response will be determined by RECIST (Version 1.1). 


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Appendix 3: Web Links 
 
CTCAE 
 
The link to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 is: 
 
https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quic 
k_Reference_8.5x11.pdf 
 
FDA Guidance for Investigators 
 
The below links are to the Guidance Documents for Investigators Responsibilities and Safety 
Reporting Requirements for INDs: 
 
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidance 
s/UCM227351.pdf 
 
http://www.fda.gov/downloads/Drugs/.../Guidances/UCM187772.pdf 


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Appendix 4: RECIST 
 
See Laboratory Manual for more information 
http://ctep.cancer.gov/protocolDevelopment/docs/recist_guideline.pdf 
{Eisenhauer, 2009} 


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15 REFERENCE LIST 
 
Opdivo® Prescribing Information. September 2021, Bristol-Myers Squibb Company. 
https://packageinserts.bms.com/pi/pi_opdivo.pdf 
 
Yervoy® Prescribing Information. September 2021, Bristol-Myers Squibb Company. 
https://packageinserts.bms.com/pi/pi_yervoy.pdf 
 
E. A. Eisenhauer, P. Therasse, J. Bogaerts, L. H. Schwartz, D. Sargent, R. Ford, J. Dancey, S. 
Arbuck, S. Gwyther, M. Mooney, L. Rubinstein, L. Shankar, L. Dodd, R. Kaplan, D. 
Lacombe, and J. Verweij, New response evaluation criteria in solid tumours: revised RECIST 
guideline (version 1.1). Eur J Cancer, 2009. 45(2): p. 228-47. 
 
J. M. Michot, C. Bigenwald, S. Champiat, M. Collins, F. Carbonnel, S. Postel-Vinay, A. 
Berdelou, A. Varga, R. Bahleda, A. Hollebecque, C. Massard, A. Fuerea, V. Ribrag, A. 
Gazzah, J. P. Armand, N. Amellal, E. Angevin, N. Noel, C. Boutros, C. Mateus, C. Robert, J. 
C. Soria, A. Marabelle, and O. Lambotte, Immune-related adverse events with immune 
checkpoint blockade: a comprehensive review. Eur J Cancer, 2016. 54: p. 139-48. 

SAP_001.pdf: 
DocuSign Envelope ID: 5695F0E8-C5EE-493C-8A1E-394E9112C773 
 
 
 
 
 
 
 
 
 
 
Statistical Analysis Plan 
 
 
 
 
Protocol: JTX-2011-R01 
 
An Open-label, Multi-center, Rollover Study in Subjects with Advanced Solid Tumor 
Malignancies After Participation in a Vopratelimab 
(JTX-2011) Clinical Study 
 
 
 
 
 
 
Sponsor: 
 
Jounce Therapeutics, Inc. 
780 Memorial Drive 
Cambridge, MA 
02139 
 
NCT: 04319224 
 
 
 
Confidentiality Statement 
This document and the information it contains is confidential and the proprietary 
property of Jounce Therapeutics. The information is not to be disclosed or transmitted 
to any party without the express approval of Jounce Therapeutics, or its agents, and any 
such unauthorized use or disclosure is expressly prohibited. 


DocuSign Envelope ID: 5695F0E8-C5EE-493C-8A1E-394E9112C773 
Version and Date: V1.0 01Dec2022 
Page 2 of 15 
 
 
 
Statistical Analysis Plan Version draft 
Protocol JTX-2011-R01 
 
SIGNATURE PAGE 
Upon review of this document, the undersigned approves this version of the Statistical 
Analysis Plan, which authorizes that the content is acceptable based on the current 
planned protocol. 
 
 
 
 
7:54 AM EST 
 
 
 
 
 
 
 
 
 
 
 
 
| 4:21 PM EST 
 
 
 
 
 
 
 
 
 
12:24 PM PST 
Name 
Signature 
Date 
Author: 
Bo Chao 
02 De ember 2022 |
Position 
Associate Director, Biostatistician 
Company 
Jounce Therapeutics, Inc. 
Approved by: 
Di Li 
02 De ember 2022 
Position 
Vice President, Biostatistics and Programming 
Company 
Jounce Therapeutics, Inc. 
Approved by: 
Elizabeth Trehu 
01 De ember 2022 |
Position 
Chief Medical Officer, Clinical Development 
Company 
Jounce Therapeutics, Inc. 


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Version and Date: V1.0 01Dec2022 
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Statistical Analysis Plan Version draft 
Protocol JTX-2011-R01 
 
TABLE OF CONTENTS 
SIGNATURE PAGE ............................................................................................................. 2 
ABBREVIATIONS 5 
TRADEMARK INFORMATION ............................................................................................. 6 
1. 
INTRODUCTION ........................................................................................................ 7 
2. 
STUDY OBJECTIVES ................................................................................................... 7 
2.1 
Primary Objective .......................................................................................... 7 
2.2 
Secondary Objectives ..................................................................................... 7 
2.3 
Exploratory Objectives .................................................................................. 7 
3. 
STUDY ENDPOINTS ................................................................................................... 7 
3.1 
Primary Endpoint ........................................................................................... 7 
3.2 
Secondary Endpoints ..................................................................................... 7 
3.3 
Exploratory Endpoints ................................................................................... 7 
4. 
STUDY DESIGN ......................................................................................................... 8 
4.1 
Treatment Assignment and Blinding ............................................................. 8 
5. 
SAMPLE SIZE CONSIDERATION .................................................................................. 9 
6. 
STATISTICAL METHODS ............................................................................................ 9 
6.1 
General Considerations .................................................................................. 9 
Baseline .......................................................................................................... 9 
6.2 
Analysis Populations ...................................................................................... 9 
6.3 
Treatment Misallocations ............................................................................... 9 
6.4 
Study Subjects ................................................................................................ 9 
Subject Disposition and Completion Status ................................................... 9 
Demographics , Baseline Characteristics ..................................................... 10 
Study Drug Exposure ................................................................................... 10 
Concomitant Medications ............................................................................ 10 
Medical History ........................................................................................... 11 


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Statistical Analysis Plan Version draft 
Protocol JTX-2011-R01 
6.5 
Efficacy Analyses ........................................................................................ 11 
Progression-free Survival ............................................................................. 11 
Duration of Response ................................................................................... 11 
Overall Survival ........................................................................................... 12 
6.6 
Safety Analyses ............................................................................................ 12 
Adverse Events ............................................................................................ 12 
Laboratory Data ........................................................................................... 14 
Vital Signs and ECG .................................................................................... 14 
Table 1 
Normal Range of Vital Signs ......................................................................... 14 
Electrocardiogram (ECG) ............................................................................ 14 
Physical Exams ............................................................................................ 14 
Eastern Cooperative Oncology Group Performance Status ......................... 14 
6.7 
Exploratory Biomarker Analysis .................................................................. 14 
7. 
INTERIM ANALYSIS ................................................................................................. 15 
8. 
REFERENCES ........................................................................................................... 15 
9. 
VERSION HISTORY .................................................................................................. 15 


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Statistical Analysis Plan Version draft 
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ABBREVIATIONS 
 
 
AE 
Adverse event 
CR 
Complete Response 
CRF 
Case Report Form 
DOR 
Duration of Response 
ECGs 
Electrocardiograms 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
irAEs 
Immune related adverse events 
IRRs 
Infusion related reactions 
MedDRA 
Medical Dictionary for Regulatory Activities 
NE 
Non-evaluable 
OS 
Overall Survival 
PD 
Progressive Disease 
PFS 
Progression Free Survival 
PR 
Partial Response 
PT 
Preferred Term 
RECIST 
Response Evaluation Criteria in Solid Tumors 
SAE 
SAF 
Serious Adverse Event 
Safety Population 
SAP 
Statistical Analysis Plan 
SAS 
Statistical Analysis Software 


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Statistical Analysis Plan Version draft 
Protocol JTX-2011-R01 
Version and Date: V1.0 01Dec2022 
Page 6 of 15 
 
 
 
 
SOC 
System Organ Class 
SD 
Stable Disease 
TEAE 
treatment-emergent adverse events 
 
TRADEMARK INFORMATION 
 
 
SAS 
SAS (Statistical Analysis Software) is a registered trademark of SAS 
Institute Inc. 


DocuSign Envelope ID: 5695F0E8-C5EE-493C-8A1E-394E9112C773 
Statistical Analysis Plan Version draft 
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Page 7 of 15 
 
 
 
1. 
INTRODUCTION 
This document describes the details of statistical analysis methodology for protocol JTX- 
2011-R01 (2.0, 03 August 2021), An Open-label, Multi-center, Rollover Study in Subjects 
with Advanced Solid Tumor Malignancies After Participation in a Vopratelimab (JTX-2011) 
Clinical Study. As background information, an overview of the study design is provided. 
Details of the summary and listings to be done are outlined in this document. Note: in this 
document any text taken directly from the protocol is italicised. 
 
2. 
STUDY OBJECTIVES 
2.1 
PRIMARY OBJECTIVE 
The primary objective is to evaluate the long-term safety of continued treatment with 
vopratelimab monotherapy or combination treatment. 
2.2 
SECONDARY OBJECTIVES 
The secondary objective is to evaluate the progression free survival (PFS) in subjects treated 
with vopratelimab monotherapy or combination therapy. 
2.3 
EXPLORATORY OBJECTIVES 
The exploratory objectives are as follows: 
• Examine changes from baseline in parent protocol in pharmacodynamic biomarkers 
including but not limited to phenotypes of immune cell subsets after treatment with 
vopratelimab monotherapy or vopratelimab in combination with nivolumab or in 
sequence with ipilimumab. 
• Examine the correlation between pharmacodynamic biomarkers and duration of 
response and PFS. 
 
3. 
STUDY ENDPOINTS 
3.1 
PRIMARY ENDPOINT 
• Incidence and severity of treatment-emergent adverse events (TEAEs), serious 
TEAEs, and discontinuation due to adverse events (AEs)evaluated using National 
Cancer Institute (NCI) Common Technology Criteria for Adverse Events (CTCAE) 
version 5.0 and death 
3.2 
SECONDARY ENDPOINTS 
• 
Progression free survival (PFS), duration of response (DOR) as per RECIST version 
1.1 and overall survival (OS) 
 
3.3 
EXPLORATORY ENDPOINTS 
• Changes from baseline in parent protocol in pharmacodynamic biomarkers including 
but not limited to phenotypes of immune cell subsets after treatment with 


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vopratelimab monotherapy or vopratelimab in combination with nivolumab or in 
sequence with ipilimumab. 
 
4. 
STUDY DESIGN 
This is a rollover study that is designed to provide continued access to vopratelimab for 
eligible subjects with advanced solid tumor malignancies who have previously participated 
in a vopratelimab study (the parent study) after closure of the parent study. 
Eligible subjects must have tolerated vopratelimab in the parent study without significant 
toxicities that otherwise would preclude further dosing in the opinion of the Investigator 
and/or Sponsor. Subjects must also be expected to receive continued benefit from treatment 
with vopratelimab in the opinion of the Investigator and/or Sponsor. 
Subjects will continue to receive vopratelimab at the same dose and schedule received in the 
parent study, and ideally will experience no treatment interruption between the end of 
participation in the parent study and entry into the rollover study. Any changes to the dose 
and schedule of vopratelimab must be in accordance with a dose and schedule previously 
shown to be safe and well tolerated and must be discussed with the medical monitor. 
Subjects who received combination treatment on the parent study will also continue to 
receive the partner drug (e.g., nivolumab or ipilimumab) at the same dose and schedule as 
in the parent study. Any changes to the dose and schedule of nivolumab or ipilimumab must 
be discussed with the medical monitor. 
Safety will be evaluated continuously for the duration of a subject’s participation. Imaging 
for disease status will be performed in accordance with institutional standard of care 
guidelines and must be performed at least every 6 months (± 3 weeks). 
All subjects must sign a new informed consent form to be enrolled in the rollover study. 
Subjects may continue to receive study treatment until loss of clinical benefit or unacceptable 
toxicity as defined by the Investigator and/or Sponsor, withdrawal of consent, loss to follow- 
up, or death. 
 
4.1 
TREATMENT ASSIGNMENT AND BLINDING 
Treatment Assignment 
 
There is no new treatment assignment in the rollover study. Patients in rollover study will 
continue to receive vopratelimab and any partner drugs administered in the parent study (e.g., 
nivolumab, ipilimumab). 
 
Blinding 
 
The study is not blinded. 


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5. SAMPLE SIZE CONSIDERATION 
Not appliable. Patients on study treatment in a Jounce-sponsored clinical study and eligible 
for rollover may be enrolled. For the study objectives, no prospective sample size 
determination is required. 
 
6. STATISTICAL METHODS 
6.1 
GENERAL CONSIDERATIONS 
Individual subject listings will be presented for data collected for rollover study. Data listings 
will be sorted by parent study id, subject number and date collected where applicable. 
 
Table summary may be provided as appropriate. Categorical data will be summarized by 
frequency distribution (number and percentage of subjects falling within each category). 
Continuous variables will be summarized by descriptive statistics including N, mean, 
standard deviation, median, and range (minimum and maximum). 
 
Data analyses will be conducted using the SAS® System (SAS Institute, Inc., Cary, NC, 
USA) Version 9.4 or above. 
 
BASELINE 
 
Baseline for subjects in the rollover study is defined as the baseline in the parent study. 
 
For deriving time-to-event efficacy endpoints (PFS, OS, DOR), starting date from parent 
study will be used with details as follows: 
 
• PFS/OS will be calculated from date of the first dose study drug from parent study. 
• DOR will be calculated from date of first confirmed response from parent study. 
 
6.2 
ANALYSIS POPULATIONS 
Enrolled subjects will include all subjects who have signed the ICF for rollover study. 
 
The Safety Population (SAF) will include all subjects who have been treated with at least one 
dose of study drug in the rollover study. 
6.3 
TREATMENT MISALLOCATIONS 
Not applicable. 
 
6.4 
STUDY SUBJECTS 
SUBJECT DISPOSITION AND COMPLETION STATUS 


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Subject disposition summary will be provided for all subjects categorized by parent study. 
The summary will include subjects treated, disposition of subjects with respect to treatment 
discontinuation and end of study status for the rollover study including reasons for treatment 
discontinuation and study exit will be provided. Deaths within 30 days of last dose and death 
beyond 30 days of last dose will be summarized separately along with primary cause of 
death. 
 
Subject disposition listing will also be provided. 
DEMOGRAPHICS , BASELINE CHARACTERISTICS 
Subject listing for demographics and baseline disease characteristics will be provided. 
 
STUDY DRUG EXPOSURE 
Individual listing for study drug administration will be provided for vopratelimab and any 
partner drugs administered in the parent study (e.g., nivolumab, ipilimumab) for each dose 
administration with information regarding intended dose/actual dose, dose modification (and 
reason if any). 
 
Duration of exposure (days) in rollover study will be defined for each subject and also 
separately for each study drug as follows: 
 
Duration on study drug X (days)= last dose date of study drug X in rollover study– first dose 
date of study drug X in rollover study +1 
 
Duration on treatment (days)=max(last dose date of each study drug in rollover study) – 
min(first dose date of each study drug in rollover study) +1 
 
In addition, overall duration of exposure (overall duration of each study drug and duration of 
treatment) will also be calculated similarly as above counting from first dose in parent study. 
 
Number of treatment cycles in rollover study and total number of treatment cycles (including 
parent study and rollover study) will be derived for each subject. 
 
For each study drug, cumulative dose received in rollover study and total cumulative dose 
received (including parent study and rollover study) will be calculated for each subject. 
 
Duration of exposure (in rollover study and overall), number of treatment cycles (in rollover 
study and total), cumulative dose received cycles (in rollover study and total) will be 
provided in data listings. 
 
CONCOMITANT MEDICATIONS 


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Individual listings will be provided for concomitant medications. Concomitant medications 
will be coded by WHO Drug Dictionary. Concomitant medications will include all 
concomitant medications taken on or after the date of first dose of study drug or any 
concomitant medication started prior to first dose of study drug that continued beyond the 
date of first dose of study drug in rollover study. 
 
MEDICAL HISTORY 
Medical history will be coded according to the Medical Dictionary for Regulatory Activities 
(MedDRA) dictionary v23.0 or higher and will be listed. 
 
6.5 
EFFICACY ANALYSES 
The efficacy endpoints include progression-free survival (PFS), duration of response (DOR) 
and overall survival (OS), all relative to C1D1 of the parent study. 
 
PROGRESSION-FREE SURVIVAL 
Progression-free survival (PFS) is defined as the time from the first dose of study drug from 
parent study until the first documentation of a disease progression or death due to any cause, 
whichever occurs first regardless of whether the subject receives subsequent anticancer 
therapy prior to progression. Patients who have no documented progression and are still alive 
at the time of analysis will be censored at the time of the latest date of assessment from their 
last evaluable RECIST 1.1 assessment. PFS is defined in months as follows: 
 
PFS (months) = (Date of PD/death or censoring – Date of the first dose study drug from 
parent study + 1) / (365.25/12) 
 
Individual subject listing will be provided for PFS including PFS time, event/censor date and 
event/censoring description. 
 
DURATION OF RESPONSE 
Duration of response (DOR) is defined as the time from the first documentation of a 
subsequently confirmed objective response from parent study until the first documentation of 
disease progression or death due to any cause, whichever occurs first regardless of whether 
the subject receives subsequent anticancer therapy prior to progression. For subjects who are 
alive and progression-free at the time of data cut-off for analysis, DOR will be censored at 
the last tumor assessment date. Only subjects who have achieved objective response 
(confirmed CR or confirmed PR) will be evaluated for DOR. DOR is defined in months as 
follows: 


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DOR (months) = (Date of PD/death or censoring – Date of first confirmed response from 
parent study + 1) / (365.25/12), 
 
The date of PD/death or censoring is the same as defined for PFS. 
 
Individual subject listing will be provided including DOR, BOR, start date of response, 
event/censoring date and event/censoring description. Start date of subsequent anticancer 
therapy will be also be included when applicable. 
 
OVERALL SURVIVAL 
Overall survival (OS) is defined as the time from the first dose of study product from parent 
study until death due to any cause. For patients who are alive at the time of analysis, OS will 
be censored on the last date when patients are known to be alive. 
 
OS is defined in months as follows: 
 
OS (months) = (Date of death or censoring – Date of the first dose of study drug from parent 
study + 1) / (365.25/12). 
 
Individual subject listing will be provided. 
 
6.6 
SAFETY ANALYSES 
The safety listings will include the evaluation of the following data: 
 
• Adverse events (AEs) 
• Laboratory results 
• Vital signs: pulse rate, respiration rate, temperature, systolic and diastolic blood 
pressure, and weight 
• Electrocardiograms (ECGs) 
• Physical exams 
• ECOG Status 
The SAF will be used for displaying safety outputs unless otherwise specified. Data will be 
provided in subject listings. 
 
ADVERSE EVENTS 


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6.6.1.1 
ADVERSE EVENT DEFINITIONS 
 
Adverse events will be coded into standardized terminology according to the Medical 
Dictionary for Regulatory Activities (MedDRA) dictionary v23.0 or higher. Severity of AE 
will be graded according to National Cancer Institute Common Terminology Criteria for 
Adverse Events Version 5.0 (NCI CTCAE, v5.0). 
 
• Treatment-Emergent Adverse Events (TEAEs) are designated as events that occur 
after the start of study drug(s), and were not observed prior to start of treatment; Or if 
the event was observed prior to the start of study drug but worsened after the start of 
study drug in the rollover study. 
 
• Treatment Related TEAEs will include those TEAEs which are considered related to 
study drugs as designated by the investigator and/or Sponsor. 
 
• Serious adverse events (SAEs) will include all events classified as serious on the 
eCRF. The electronic database used to enter data at the site will be deemed as the 
source of record for adverse event information. The safety and pharmacovigilance 
database will be reconciled against the EDC. 
 
• Immune-related adverse events (irAEs) are unique side effects typically seen after 
dosing with checkpoint inhibitors and are derived based on eCRF irAE flag. Some of 
the most common irAEs include: pneumonitis, colitis, hepatitis, endocrinopathy , 
adrenal insufficiency, hypothyroidism and hyperthyroidism, , nephritis, dermatitis, 
and neuropathy Summary of Adverse Events 
 
6.6.1.2 
SUMMARY OF ADVERSE EVENTS 
 
Adverse events (AEs) will be listed. Listings will be created by categories for AEs as outlined 
below: 
• All adverse events (AEs) with flags for treatment emergent adverse events 
(TEAEs) and flags of relatedness to study drug(s) 
• SAEs with flags for treatment emergent adverse events (TEAEs) and flags of 
relatedness to study drug(s) 
• Immune related adverse events (irAEs) 
• Infusion related reactions (IRRs) 
• TEAEs leading to death 
• TEAEs leading to study drug interruption, reduction, hold or permanent study 
drug discontinuation 


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A general overview summary table will also be provided include frequencies by category of 
AE (as listed above) and will also include TEAE by severity grade and relationship to study 
drugs. 
LABORATORY DATA 
Laboratory data will be listed separately for hematology, chemistry, coagulation and 
urinalysis panels with lab results, normal ranges, CTCAE grade (as applicable). 
 
VITAL SIGNS AND ECG 
Individual data listings will be provided for vital sign parameters: systolic and diastolic 
blood pressure (mmHg), respiratory rate (breaths per minute), body temperature (C◦), weight 
(kg) and pulse rate (beats per minute). 
 
TABLE 1 NORMAL RANGE OF VITAL SIGNS 
Parameter 
Units 
Normal Range 
Systolic Blood Pressure 
mmHg 
90 - 120 
Diastolic Blood Pressure 
mmHg 
60 - 80 
Pulse Rate 
Beats per minute 
60-100 
Respiratory Rate 
Breaths per minute 
12 – 20 
Temperature 
◦C 
36.1 – 37.2 
 
 
ELECTROCARDIOGRAM (ECG) 
Individual data listings will be provided, including observed and change from baseline 
values will be presented for ECG measures of PR interval, QRS duration, QT interval, QTc 
interval and overall interpretation. 
PHYSICAL EXAMS 
Physical exam data will be presented in a data listing. 
 
EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS 
The Eastern Cooperative Oncology Group (ECOG) performance status data will be 
presented in subject listings. 
 
6.7 EXPLORATORY BIOMARKER ANALYSIS 
 
Exploratory pharmacodynamic biomarkers collected in rollover studies will be listed when 
available. 
 
There is no additional analysis planned for exploratory biomarkers for this study.. 


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7. INTERIM ANALYSIS 
Not applicable. 
 
8. REFERENCES 
E. A. Eisenhauer, P. Therasse, J. Bogaerts, L. H. Schwartz, D. Sargent, R. Ford, J. Dancey, S. 
Arbuck, S. Gwyther, M. Mooney, L. Rubinstein, L. Shankar, L. Dodd, R. Kaplan, D. 
Lacombe, and J. Verweij, New response evaluation criteria in solid tumours: revised 
RECIST guideline (version 1.1). Eur J Cancer, 2009. 45(2): p. 228-47. 
 
FDA Guidance for Industry: Clinical Trial Endpoints for the Approval of Non-Small Cell 
Lung Cancer Drugs and Biologics. April 2015. 
 
 
 
 
9. VERSION HISTORY 
 
Version 
Date 
Summary of Changes 
Reason for Change 
1.0 
01Dec2022 
Initial document 
Initial document