Vopratelimab and a CTLA-4 Inhibitor in PD-1/PD-L1 Inhibitor Experienced Subjects With NSCLC or Urothelial Cancer
EMERGE
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
1 other identifier
interventional
61
2 countries
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 cancer
Started Jun 2019
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 6, 2019
CompletedFirst Submitted
Initial submission to the registry
June 13, 2019
CompletedFirst Posted
Study publicly available on registry
June 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2022
CompletedSeptember 10, 2022
April 1, 2022
2.8 years
June 13, 2019
September 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
% subjects with overall response (OR)
34 months
Secondary Outcomes (13)
% subjects with adverse events (AEs)
34 months
% subjects with serious adverse events (SAEs)
34 months
% subjects with clinically significant change from baseline in clinical laboratory tests
34 months
% subjects with anti-drug antibodies (ADA) to treatment
34 months
% of subjects with neutralizing antibodies (NAb) to treatment
34 months
- +8 more secondary outcomes
Study Arms (8)
LM1
EXPERIMENTALPhase 2 study of vopratelimab by intravenous (IV) infusion administered in combination with ipilimumab by IV infusion in NSCLC
LT1
EXPERIMENTALPhase 2 study of vopratelimab by IV infusion administered in combination with ipilimumab by IV infusion in NSCLC
UM1
EXPERIMENTALPhase 2 study of vopratelimab by IV infusion administered in combination with ipilimumab by IV infusion in urothelial cancer
UT1
EXPERIMENTALPhase 2 study of vopratelimab by IV infusion administered in combination with ipilimumab by IV infusion in urothelial cancer
LM2
EXPERIMENTALPhase 2 study of vopratelimab by intravenous (IV) infusion in administered in sequence with ipilimumab by IV infusion in NSCLC
LT2
EXPERIMENTALPhase 2 study of vopratelimab by intravenous (IV) infusion in administered in sequence with ipilimumab by IV infusion in NSCLC
UM2
EXPERIMENTALPhase 2 study of vopratelimab by intravenous (IV) infusion in administered in sequence with ipilimumab by IV infusion in urothelial cancer
UT2
EXPERIMENTALPhase 2 study of vopratelimab by intravenous (IV) infusion in administered in sequence with ipilimumab by IV infusion in urothelial cancer
Interventions
Eligibility Criteria
You may qualify if:
- 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
- Male or female ≥ 18 years of age
- 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
- Prior treatment with a PD-1/PD -L1 inhibitor for at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Predicted life expectancy ≥ 3 months
- Have laboratory values in accordance with the study protocol
- 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
- 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
- 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.
You may not qualify if:
- Concurrent anticancer treatment (either approved or investigational, excluding radiation therapy)
- 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:
- Biologic therapy, including immunotherapy, within 21 days prior to C1D1
- Chemotherapy within 21 days (42 days for mitomycin or nitrosoureas) prior to C1D1
- Anti-CTLA-4 or anti-ICOS therapy at any time
- Chimeric antigen receptor T-cell therapy at any time
- Organ transplantation, including allogeneic or autologous stem-cell transplantation, at any time
- Major surgery (excluding minor procedures, e.g., placement of vascular access, biopsy, etc.) within 4 weeks prior to C1D1
- Live vaccines within 30 days prior to C1D1 (inactivated vaccines are allowed; seasonal vaccines should be up to date prior to C1D1)
- 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
- 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
- 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
- Brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation
- Prior whole brain radiation
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Beverly Hills Cancer Center
Beverly Hills, California, 90211, United States
University of Southern California Medical Center
Los Angeles, California, 90033, United States
Christiana Care Health Services
Newark, Delaware, 19713, United States
Florida Cancer Specialists Sarasota Cattlemen
Sarasota, Florida, 34232, United States
University of Maryland - Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
Weill Cornell Medical College
New York, New York, 10065, United States
University of Rochester
Rochester, New York, 14642, United States
Southeastern Medical Oncology Center
Clinton, North Carolina, 28328, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania, 15212, United States
Lifespan Cancer Institute
Providence, Rhode Island, 02903, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of The Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
The Research Institute of the McGill University Health
Montreal, Quebec, H4A 3J1, Canada
University Institute of Cardiology and Respirology of Quebec
Québec, G1V 4G5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ellen Hooper, MD
Jounce Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2019
First Posted
June 18, 2019
Study Start
June 6, 2019
Primary Completion
March 15, 2022
Study Completion
March 15, 2022
Last Updated
September 10, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share