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

Jounce Therapeutics

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Cancer

Treatments: Drug: Vopratelimab; Drug: Nivolumab; Drug: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04319224

JTX-2011-R01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 3 patient groups

Vopratelimab

Experimental group

Description:

Participants will continue to receive vopratelimab monotherapy per parent protocol.

Treatment:

Drug: Vopratelimab

Vopratelimab with ipilimumab

Experimental group

Description:

Participants will continue to receive vopratelimab in combination with ipilimumab per parent protocol.

Treatment:

Drug: Ipilimumab

Drug: Vopratelimab

Vopratelimab with nivolumab

Experimental group

Description:

Participants will continue to receive vopratelimab in combination with nivolumab per parent protocol.

Treatment:

Drug: Nivolumab

Drug: Vopratelimab