Vopratelimab and a CTLA-4 Inhibitor in PD-1/PD-L1 Inhibitor Experienced Subjects With NSCLC or Urothelial Cancer (EMERGE)
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| ClinicalTrials.gov Identifier: NCT03989362 |
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Recruitment Status :
Completed
First Posted : June 18, 2019
Last Update Posted : September 10, 2022
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Sponsor:
Jounce Therapeutics, Inc.
Information provided by (Responsible Party):
Jounce Therapeutics, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer | Drug: Vopratelimab Drug: Ipilimumab | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 61 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | June 6, 2019 |
| Actual Primary Completion Date : | March 15, 2022 |
| Actual Study Completion Date : | March 15, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
Drug Information available for:
Ipilimumab
| Arm | Intervention/treatment |
|---|---|
|
Experimental: LM1
Phase 2 study of vopratelimab by intravenous (IV) infusion administered in combination with ipilimumab by IV infusion in NSCLC
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Drug: Vopratelimab
Specified dose on specified days
Other Name: JTX-2011 Drug: Ipilimumab Specified dose on specified days
Other Name: Yervoy |
|
Experimental: LT1
Phase 2 study of vopratelimab by IV infusion administered in combination with ipilimumab by IV infusion in NSCLC
|
Drug: Vopratelimab
Specified dose on specified days
Other Name: JTX-2011 Drug: Ipilimumab Specified dose on specified days
Other Name: Yervoy |
|
Experimental: UM1
Phase 2 study of vopratelimab by IV infusion administered in combination with ipilimumab by IV infusion in urothelial cancer
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Drug: Vopratelimab
Specified dose on specified days
Other Name: JTX-2011 Drug: Ipilimumab Specified dose on specified days
Other Name: Yervoy |
|
Experimental: UT1
Phase 2 study of vopratelimab by IV infusion administered in combination with ipilimumab by IV infusion in urothelial cancer
|
Drug: Vopratelimab
Specified dose on specified days
Other Name: JTX-2011 Drug: Ipilimumab Specified dose on specified days
Other Name: Yervoy |
|
Experimental: LM2
Phase 2 study of vopratelimab by intravenous (IV) infusion in administered in sequence with ipilimumab by IV infusion in NSCLC
|
Drug: Vopratelimab
Specified dose on specified days
Other Name: JTX-2011 Drug: Ipilimumab Specified dose on specified days
Other Name: Yervoy |
|
Experimental: LT2
Phase 2 study of vopratelimab by intravenous (IV) infusion in administered in sequence with ipilimumab by IV infusion in NSCLC
|
Drug: Vopratelimab
Specified dose on specified days
Other Name: JTX-2011 Drug: Ipilimumab Specified dose on specified days
Other Name: Yervoy |
|
Experimental: UM2
Phase 2 study of vopratelimab by intravenous (IV) infusion in administered in sequence with ipilimumab by IV infusion in urothelial cancer
|
Drug: Vopratelimab
Specified dose on specified days
Other Name: JTX-2011 Drug: Ipilimumab Specified dose on specified days
Other Name: Yervoy |
|
Experimental: UT2
Phase 2 study of vopratelimab by intravenous (IV) infusion in administered in sequence with ipilimumab by IV infusion in urothelial cancer
|
Drug: Vopratelimab
Specified dose on specified days
Other Name: JTX-2011 Drug: Ipilimumab Specified dose on specified days
Other Name: Yervoy |
Primary Outcome Measures :
- % subjects with overall response (OR) [ Time Frame: 34 months ]
Secondary Outcome Measures :
- % subjects with adverse events (AEs) [ Time Frame: 34 months ]
- % subjects with serious adverse events (SAEs) [ Time Frame: 34 months ]
- % subjects with clinically significant change from baseline in clinical laboratory tests [ Time Frame: 34 months ]
- % subjects with anti-drug antibodies (ADA) to treatment [ Time Frame: 34 months ]
- % of subjects with neutralizing antibodies (NAb) to treatment [ Time Frame: 34 months ]
- % of subjects with clinically significant changes in electrocardiogram (ECG) measurements [ Time Frame: 34 months ]
- Percent change in target lesions from baseline [ Time Frame: 34 months ]
- Apparent volume of distribution during specific time points [ Time Frame: 34 months ]
- Median duration of response (DOR) [ Time Frame: 34 months ]
- Disease control rate (DCR) [ Time Frame: 34 months ]
- Landmark progression free survival (PFS) [ Time Frame: 34 months ]
- Median PFS [ Time Frame: 34 months ]
- Median overall survival (OS) [ Time Frame: 34 months ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Concurrent anticancer treatment (either approved or investigational, excluding radiation therapy)
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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
- Active and clinically relevant bacterial, fungal, or viral infection, including known Hepatitis A, B, or C or human immunodeficiency virus (HIV) (testing not required)
- Women who are pregnant or breastfeeding
- History of symptomatic cardiac disease that is unresponsive to surgical or medical management
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03989362
Locations
Show 21 study locations
Sponsors and Collaborators
Jounce Therapeutics, Inc.
Investigators
| Study Director: | Ellen Hooper, MD | Jounce Therapeutics, Inc. |
| Responsible Party: | Jounce Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT03989362 |
| Other Study ID Numbers: |
JTX-2011-201 |
| First Posted: | June 18, 2019 Key Record Dates |
| Last Update Posted: | September 10, 2022 |
| Last Verified: | April 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Jounce Therapeutics, Inc.:
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ICOS ICOS agonist monoclonal antibody JTX-2011 Vopratelimab Anti-CTLA-4 Ipilimumab |
EMERGE Immunotherapy Immuno-Oncology Cancer Non-small Cell Lung Cancer Urothelial Cancer |
Additional relevant MeSH terms:
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Ipilimumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |