Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer | Drug: Vopratelimab Drug: Ipilimumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 452 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 |
Estimated Primary Completion Date : | April 30, 2022 |
Estimated Study Completion Date : | July 31, 2022 |
Arm | Intervention/treatment |
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Experimental: LM1
Phase 2 study of vopratelimab by intravenous (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: 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
|
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
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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:
Study Director: | Ellen Hooper, MD | Jounce Therapeutics, Inc. |
Tracking Information | |||||
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First Submitted Date ICMJE | June 13, 2019 | ||||
First Posted Date ICMJE | June 18, 2019 | ||||
Last Update Posted Date | April 12, 2021 | ||||
Actual Study Start Date ICMJE | June 6, 2019 | ||||
Estimated Primary Completion Date | April 30, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
% subjects with overall response (OR) [ Time Frame: 34 months ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Vopratelimab and a CTLA-4 Inhibitor in PD-1/PD-L1 Inhibitor Experienced Subjects With NSCLC or Urothelial Cancer | ||||
Official Title ICMJE | 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 | ||||
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 (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 ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Cancer | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
452 | ||||
Original Estimated Enrollment ICMJE |
226 | ||||
Estimated Study Completion Date ICMJE | July 31, 2022 | ||||
Estimated Primary Completion Date | April 30, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03989362 | ||||
Other Study ID Numbers ICMJE | JTX-2011-201 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Jounce Therapeutics, Inc. | ||||
Study Sponsor ICMJE | Jounce Therapeutics, Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Jounce Therapeutics, Inc. | ||||
Verification Date | April 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |