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BRIEF TITLE: Trial of ICOS Agonist Monoclonal Antibody (mAb) JTX -2011 and a CTLA-4 Inhibitor in PD-1/PD-L1 Inhibitor Experienced Adult Subjects With Urothelial Cancer

Phase 2 Multicenter Trial of ICOS Agonist Monoclonal Antibody (mAb) 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


  • Org Study ID: JTX-2011-201
  • Secondary ID:
  • NCT ID: NCT03989362
  • NCT Alias:
  • Sponsor: Jounce Therapeutics, Inc. - Industry
  • Source: Jounce Therapeutics, Inc.

Brief Summary

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.

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 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.

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

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: 34 months

Condition:

  • Cancer

Eligibility

Criteria:
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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Ellen Hooper, MD, FAAP

Role: Study Director

Affiliation: Jounce Therapeutics, Inc.

Overall Contact

Name: Rachel McComb

Phone:

Email: EMERGE@jouncetx.com

Locations

Facility Status Contact
Beverly Hills Cancer Center
Beverly Hills, California 90211
United States
Recruiting David Berz

dberz@bhcancercenter.com
Florida Cancer Specialists Sarasota Cattlemen
Sarasota, Florida 34232
United States
Recruiting Judy Wang, MD

JSWang@flcancer.com
Washington University School of Medicine
Saint Louis, Missouri 63110
United States
Recruiting Ramaswamy Govindan, MD

rgovindan@wustl.edu
The Valley Hospital
Ridgewood, New Jersey 07450
United States
Not yet recruiting Eli Kirshner, MD

kirsel@valleyhealth.com
Lifespan Cancer Institute
Providence, Rhode Island 02903
United States
Recruiting Christopher Azzoli, MD

CAzzoli@Lifespan.org
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Recruiting Melissa Johnson, MD

melissa.johnson@sarahcannon.com
University of The Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
Recruiting Gina Alvarez
210-450-5893
alvarezg1@uthscsa.edu
University of Virginia Health System
Charlottesville, Virginia 22908
United States
Recruiting Gracie Hockenberry
434-297-7784
mgt4n@virginia.edu
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
Canada
Recruiting Dianne Zawisza
416-946-2913
Dianne.zawisza@uhn.ca
The Research Institute of the McGill University Health
Montréal, Quebec H4A 3J1
Canada
Recruiting Scott Owen, MD

scott.owen@mcgill.ca
University Institute of Cardiology and Respirology of Quebec
Québec, G1V 4G5
Canada
Not yet recruiting Brigitte Fortin
418-656-8711
brigitte.fortin@criucpq.ulaval.ca