Vopratelimab (JTX-2011) Alone and in Combination With Anti-Programmed Cell Death Protein 1 (PD-1) or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) in Subjects With Advanced and/or Refractory Solid Tumors
NCT ID: NCT04319224
Last Updated: 2024-05-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
4 participants
INTERVENTIONAL
2020-03-10
2023-01-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vopratelimab
Participants will continue to receive vopratelimab monotherapy per parent protocol.
Vopratelimab
Specified dose on specified days
Vopratelimab with ipilimumab
Participants will continue to receive vopratelimab in combination with ipilimumab per parent protocol.
Vopratelimab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Vopratelimab with nivolumab
Participants will continue to receive vopratelimab in combination with nivolumab per parent protocol.
Vopratelimab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Interventions
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Vopratelimab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has demonstrated compliance with the parent study requirements, as assessed by the Investigator and/or Sponsor, and is able and willing to comply with the necessary visits and assessments as part of the rollover study.
* Written informed consent must be obtained prior to enrolling in the rollover study and receiving study treatment. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
* Women of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 5 months following the last study treatment
Exclusion Criteria
* Subject is receiving concurrent anti-cancer treatment (excluding combination drugs such as nivolumab or ipilimumab as a component of the combination dosing regimen used in parent study).
* Women who are pregnant or breastfeeding.
* Subject has 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 study data interpretation.
18 Years
ALL
No
Sponsors
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Jounce Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stew Kroll
Role: STUDY_DIRECTOR
Jounce Therapeutics, Inc.
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
The University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
University of Virginia Health Systems
Charlottesville, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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JTX-2011-R01
Identifier Type: -
Identifier Source: org_study_id
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