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

Cancer Clinical Trial

— EMERGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03989362
• Other study ID #: JTX-2011-201
• Status: Completed
• Phase: Phase 2
• Start date: June 6, 2019
• Est. completion date: March 15, 2022

Study information

• Verified date: April 2022
• Source: Jounce Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Vopratelimab
Specified dose on specified days
• Ipilimumab
Specified dose on specified days

Locations

Country	Name	City	State
Canada	The Research Institute of the McGill University Health	Montréal	Quebec
Canada	University Institute of Cardiology and Respirology of Quebec	Québec
Canada	University Health Network - Princess Margaret Cancer Centre	Toronto	Ontario
United States	University of Maryland - Marlene and Stewart Greenebaum Cancer Center	Baltimore	Maryland
United States	Beverly Hills Cancer Center	Beverly Hills	California
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Southeastern Medical Oncology Center	Clinton	North Carolina
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	University of Southern California Medical Center	Los Angeles	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Weill Cornell Medical College	New York	New York
United States	Christiana Care Health Services	Newark	Delaware
United States	Allegheny Health Network Research Institute	Pittsburgh	Pennsylvania
United States	Lifespan Cancer Institute	Providence	Rhode Island
United States	The Valley Hospital	Ridgewood	New Jersey
United States	University of Rochester	Rochester	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of The Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Florida Cancer Specialists Sarasota Cattlemen	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Jounce Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% subjects with overall response (OR)		34 months
Secondary	% subjects with adverse events (AEs)		34 months
Secondary	% subjects with serious adverse events (SAEs)		34 months
Secondary	% subjects with clinically significant change from baseline in clinical laboratory tests		34 months
Secondary	% subjects with anti-drug antibodies (ADA) to treatment		34 months
Secondary	% of subjects with neutralizing antibodies (NAb) to treatment		34 months
Secondary	% of subjects with clinically significant changes in electrocardiogram (ECG) measurements		34 months
Secondary	Percent change in target lesions from baseline		34 months
Secondary	Apparent volume of distribution during specific time points		34 months
Secondary	Median duration of response (DOR)		34 months
Secondary	Disease control rate (DCR)		34 months
Secondary	Landmark progression free survival (PFS)		34 months
Secondary	Median PFS		34 months
Secondary	Median overall survival (OS)		34 months