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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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An Open-label, Multi-center, Rollover Study in Subjects With Advanced Solid Tumor Malignancies After Participation in a Vopratelimab (JTX-2011) Clinical Study

Conditions
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Cancer

Intervention / Treatment
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* Drug: Vopratelimab
* Drug: Ipilimumab
* Drug: Nivolumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vopratelimab<br>Participants will continue to receive vopratelimab monotherapy per parent protocol. | Drug: Vopratelimab<br>* Specified dose on specified days<br>* Other names: JTX-2011;|
| Experimental: Vopratelimab with ipilimumab<br>Participants will continue to receive vopratelimab in combination with ipilimumab per parent protocol. | Drug: Vopratelimab<br>* Specified dose on specified days<br>* Other names: JTX-2011;Drug: Ipilimumab<br>* Specified dose on specified days<br>* Other names: Yervoy;|
| Experimental: Vopratelimab with nivolumab<br>Participants will continue to receive vopratelimab in combination with nivolumab per parent protocol. | Drug: Vopratelimab<br>* Specified dose on specified days<br>* Other names: JTX-2011;Drug: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % subjects with adverse events (AEs) |  | 48 months | 
| % subjects with serious adverse events (SAEs) |  | 48 months | 
| % subjects with clinically significant change from baseline in clinical laboratory tests |  | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median progression free survival (PFS) |  | 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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JTX-2011, Vopratelimab, Ipilimumab, Nivolumab, ICOS, Anti-CTLA-4, PD-1, PD-L1, Immunotherapy, Immuno-oncology, Cancer