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Vopratelimab (JTX-2011) Alone and in Combination With Anti-PD-1 or Anti-CTLA-4 in Subjects With Advanced and/or Refractory Solid Tumors

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ClinicalTrials.gov Identifier: NCT04319224
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Jounce Therapeutics, Inc.

Brief Summary:
JTX-2011-R01 is an open label, multicenter, rollover study that is designed to provide continued access to vopratelimab for eligible subjects with advanced solid tumor malignancies who have previously participated in a vopratelimab study (the parent study).

Condition or disease Intervention/treatment Phase
Cancer Drug: Vopratelimab Drug: Ipilimumab Drug: Nivolumab Phase 1 Phase 2

Detailed Description:
Vopratelimab 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 an open label, roll over study to evaluate the long-term safety of continued treatment with vopratelimab monotherapy or combination treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center, Rollover Study in Subjects With Advanced Solid Tumor Malignancies After Participation in a Vopratelimab (JTX-2011) Clinical Study
Actual Study Start Date : March 10, 2020
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vopratelimab
Participants will continue to receive vopratelimab monotherapy per parent protocol.
Drug: Vopratelimab
Specified dose on specified days
Other Name: JTX-2011

Experimental: Vopratelimab with ipilimumab
Participants will continue to receive vopratelimab in combination with ipilimumab per parent protocol.
Drug: Vopratelimab
Specified dose on specified days
Other Name: JTX-2011

Drug: Ipilimumab
Specified dose on specified days
Other Name: Yervoy

Experimental: Vopratelimab with nivolumab
Participants will continue to receive vopratelimab in combination with nivolumab per parent protocol.
Drug: Vopratelimab
Specified dose on specified days
Other Name: JTX-2011

Drug: Nivolumab
Specified dose on specified days
Other Name: Opdivo




Primary Outcome Measures :
  1. % subjects with adverse events (AEs) [ Time Frame: 48 months ]
  2. % subjects with serious adverse events (SAEs) [ Time Frame: 48 months ]
  3. % subjects with clinically significant change from baseline in clinical laboratory tests [ Time Frame: 48 months ]

Secondary Outcome Measures :
  1. Median progression free survival (PFS) [ Time Frame: 48 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:

  • Subject is currently receiving and tolerating vopratelimab (JTX-2011) therapy and receiving clinical benefit from study treatment in the opinion of the Investigator and/or Sponsor.
  • 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 was permanently discontinued from the parent study due to unacceptable toxicity, non-compliance with study procedures, withdrawal of consent, or any other reason.
  • 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.

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): NCT04319224


Contacts
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Contact: Nancy Mota Vopra_Rollover@jouncetx.com

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Russell Pachynski, MD       rkpachynski@wustl.edu   
Principal Investigator: Russell Pachynski, MD         
United States, Texas
The University of Texas - MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Timothy Yap, MD    877-632-6789      
Principal Investigator: Timothy Yap, MD         
Sponsors and Collaborators
Jounce Therapeutics, Inc.
Investigators
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Study Director: Ellen Hooper, MD Jounce Therapeutics, Inc.
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Responsible Party: Jounce Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04319224    
Other Study ID Numbers: JTX-2011-R01
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jounce Therapeutics, Inc.:
JTX-2011
Vopratelimab
Ipilimumab
Nivolumab
ICOS
Anti-CTLA-4
PD-1
PD-L1
Immunotherapy
Immuno-oncology
Cancer
Additional relevant MeSH terms:
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Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action