Vopratelimab and a CTLA-4 Inhibitor in PD-1/PD-L1 Inhibitor Experienced Subjects With NSCLC or Urothelial Cancer

INTRODUCTION

Org Study ID: JTX-2011-201
Secondary ID: N/A
NTC ID: NCT03989362
Sponsor: Jounce Therapeutics, Inc.

JTX-2011-201 is a Phase 2, open label clinical study of vopratelimab (JTX-2011) and
ipilimumab in adult subjects with non-small cell lung cancer (NSCLC) or urothelial cancer to
evaluate safety and efficacy.

Vopratelimab (JTX-2011) 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
a Phase 2, open label study to evaluate the safety and efficacy of vopratelimab in
combination with ipilimumab in adult subjects with advanced and/or refractory non-small cell
lung cancer and urothelial cancer.

Overall Status
Recruiting
Start Date
June 6, 2019
Phase
Phase 2
Study Type
Interventional

Primary Outcome 1 - Measure: % subjects with overall response (OR)

Primary Outcome 1 - Timeframe: 34 months

Cancer

Inclusion Criteria:

1. Willing and able to participate and comply with all trial requirements and able to
provide signed and dated informed consent prior to initiation of any trial procedures

2. Male or female ≥ 18 years of age

3. Locally advanced, inoperable or metastatic NSCLC or urothelial cancer, with evaluable
or measurable disease, according to RECIST v1.1, with at least one measurable lesion

4. Prior treatment with a PD-1/PD -L1 inhibitor for at least 3 months

5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

6. Predicted life expectancy ≥ 3 months

7. Have laboratory values in accordance with the study protocol

8. If medical history of the following, case should be reviewed with the Medical Monitor:
prior biliary tract disorders (as based on Hepatobiliary system organ class high level
terms of obstructive bile duct disorders, hepatic vascular disorders, structural and
other bile duct disorders) or portal hypertension and/or hepatic vascular disorders

9. Women of child-bearing potential (WOCBP): negative serum pregnancy test within 72
hours prior to planned C1D1 and a negative urine pregnancy test on C1D1 and any
subsequent study drug administration day

10. WOCBP and males whose partners are WOCBP must agree to use a highly effective method
of birth control throughout their participation and for 5 months following the last
study drug administration. Highly effective methods of birth control are defined as
those, alone or in combination, that result in a low failure rate (i.e., less than 1
percent per year) when used consistently and correctly. For subjects using a hormonal
contraceptive method, information regarding the product under evaluation and its
potential effect on the contraceptive should be addressed.

Exclusion Criteria:

1. Concurrent anticancer treatment (either approved or investigational, excluding
radiation therapy)

2. Prior anticancer therapies within the timeframes specified below, or ongoing toxicity
from prior therapy > Grade 1 according to the Common Terminology Criteria for Adverse
Events (CTCAE) v5.0. Exceptions include > Grade 1 toxicities that, in the opinion of
the Investigator, should not exclude the subject (e.g., alopecia) and are approved by
the Medical Monitor:

1. Biologic therapy, including immunotherapy, within 21 days prior to C1D1

2. Chemotherapy within 21 days (42 days for mitomycin or nitrosoureas) prior to C1D1

3. Anti-CTLA-4 or anti-ICOS therapy at any time

4. Chimeric antigen receptor T-cell therapy at any time

5. Organ transplantation, including allogeneic or autologous stem-cell
transplantation, at any time

3. Major surgery (excluding minor procedures, e.g., placement of vascular access, biopsy,
etc.) within 4 weeks prior to C1D1

4. Live vaccines within 30 days prior to C1D1 (inactivated vaccines are allowed; seasonal
vaccines should be up to date prior to C1D1)

5. History of immune-related adverse events (irAEs) leading to treatment discontinuation.
Subjects who discontinued prior immunotherapies for irAEs that are well controlled
with appropriate treatment may be enrolled if approved by the Medical Monitor

6. Any active disease, including primary or acquired immunodeficiency, requiring systemic
immunosuppressive therapy equivalent to ≥10 mg prednisone per day within 7 days prior
to C1D1. Exception: inhaled or topical steroids and adrenal replacement doses are
permitted in the absence of active autoimmune disease as well as a one-time dose of
immunosuppressive agents used prophylactically for contrast allergies

7. Known severe intolerance to or life-threatening hypersensitivity reactions to
humanized monoclonal antibodies or intravenous immunoglobulin preparations; history of
anaphylaxis; or known allergy to any of the study medications, their analogues, or
excipients in the various formulations of any agent

8. Brain metastases, leptomeningeal disease, or spinal cord compression not definitively
treated with surgery or radiation

9. Prior whole brain radiation

10. Concurrent second malignancy at other sites that requires treatment or, in the
judgment of the Investigator, may require treatment within the next year. Concurrent
malignancies that do not require treatment and are clinically stable are allowed.
Prior malignancies are allowed as long as the subject is not receiving specific
treatment other than hormonal therapy and, in the judgment of the Investigator, is
unlikely to have a recurrence

11. Active and clinically relevant bacterial, fungal, or viral infection, including known
Hepatitis A, B, or C or human immunodeficiency virus (HIV) (testing not required)

12. Women who are pregnant or breastfeeding

13. History of symptomatic cardiac disease that is unresponsive to surgical or medical
management

14. 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
trial data interpretation.

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

Name: Ellen Hooper, MD, FAAP

Role: Study Director

Affiliation: Jounce Therapeutics, Inc.

Name: Ellen Hooper, MD, FAAP

Phone: N/A

Email: EMERGE@jouncetx.com

Facility	Status	Contact
Facility: Beverly Hills Cancer Center Beverly Hills, California 90211 United States	Status: Recruiting	Contact: David Berz dberz@bhcancercenter.com
Facility: University of Southern California Medical Center Los Angeles, California 90033 United States	Status: Recruiting	Contact: Bing Xia, MD
Facility: Christiana Care Health Services Newark, Delaware 19713 United States	Status: Recruiting	Contact: Michael Guarino, MD michael.j.guarino@christianacare.org
Facility: Massachusetts General Hospital Boston, Massachusetts 02114 United States	Status: Recruiting	Contact: Justin Gainor, MD jgainor@partners.org
Facility: Washington University School of Medicine Saint Louis, Missouri 63110 United States	Status: Recruiting	Contact: Ramaswamy Govindan, MD rgovindan@wustl.edu
Facility: The Valley Hospital Ridgewood, New Jersey 07450 United States	Status: Recruiting	Contact: Eli Kirshner, MD kirsel@valleyhealth.com
Facility: Weill Cornell Medical College New York, New York 10065 United States	Status: Recruiting	Contact: Ronald Scheff, MD rjs2002@med.cornell.edu
Facility: University of Rochester Rochester, New York 14642 United States	Status: Recruiting	Contact: Adrienne Victor, MD adrienne_victor@urmc.rochester.edu
Facility: Southeastern Medical Oncology Center Clinton, North Carolina 28328 United States	Status: Recruiting	Contact: Samer Kasbari, MD skasbari@cancersmoc.com
Facility: Cleveland Clinic Foundation Cleveland, Ohio 44195 United States	Status: Recruiting	Contact: Nathan Pennell, MD
Facility: Allegheny Health Network Research Institute Pittsburgh, Pennsylvania 15212 United States	Status: Recruiting	Contact: Gene Finley, MD gene.finley@ahn.org
Facility: Lifespan Cancer Institute Providence, Rhode Island 02903 United States	Status: Recruiting	Contact: Christopher Azzoli, MD CAzzoli@Lifespan.org
Facility: Sarah Cannon Research Institute Nashville, Tennessee 37203 United States	Status: Recruiting	Contact: Melissa Johnson, MD melissa.johnson@sarahcannon.com
Facility: University of Texas MD Anderson Cancer Center Houston, Texas 77030 United States	Status: Recruiting	Contact: Mehmet Altan, M.D. maltan@mdanderson.org
Facility: University of The Texas Health Science Center at San Antonio San Antonio, Texas 78229 United States	Status: Recruiting	Contact: Gina Alvarez 210-450-5893 alvarezg1@uthscsa.edu
Facility: University of Virginia Health System Charlottesville, Virginia 22908 United States	Status: Recruiting	Contact: Gracie Hockenberry 434-297-7784 mgt4n@virginia.edu
Facility: University Health Network - Princess Margaret Cancer Centre Toronto, Ontario M5G 2M9 Canada	Status: Recruiting	Contact: Dianne Zawisza 416-946-2913 Dianne.zawisza@uhn.ca
Facility: The Research Institute of the McGill University Health Montréal, Quebec H4A 3J1 Canada	Status: Recruiting	Contact: Scott Owen, MD scott.owen@mcgill.ca
Facility: University Institute of Cardiology and Respirology of Quebec Québec, G1V 4G5 Canada	Status: Recruiting	Contact: Brigitte Fortin 418-656-8711 brigitte.fortin@criucpq.ulaval.ca

Brief Title: Vopratelimab and a CTLA-4 Inhibitor in PD-1/PD-L1 Inhibitor Experienced Subjects With NSCLC or Urothelial Cancer

Phase 2 Multicenter Trial of ICOS Agonist Monoclonal Antibody (mAb) Vopratelimab (JTX -2011) and a CTLA-4 Inhibitor in PD-1/PD-L1 Inhibitor Experienced Adult Subjects With Non-small Cell Lung Cancer or Urothelial Cancer

INTRODUCTION

BRIEF SUMMARY

DETAILED DESCRIPTION

PRIMARY OUTCOMES

CONDITION

ELIGIBILITY

OFFICIAL INFORMATION

Overall Contact

LOCATION

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