Clinical trial NCT04319224: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Cancer
Keywords: JTX-2011
Vopratelimab
Ipilimumab
Nivolumab
ICOS
Anti-CTLA-4
PD-1
PD-L1
Immunotherapy
Immuno-oncology
Cancer
Lead sponsor: Jounce Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-24
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of Subjects With Adverse Events (AEs)
timeFrame: Approximately 34 months
measure: Percentage of Subjects With Serious Adverse Events (SAEs)
timeFrame: Approximately 34 months
measure: Percentage of Subjects With Clinically Significant Change From Baseline in Clinical Laboratory Tests
timeFrame: Approximately 34 months
Secondary outcomes:
measure: Median Progression Free Survival (mPFS)
timeFrame: Approximately 34 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Houston
country: United States
facility: The University of Texas - MD Anderson Cancer Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health Systems
state: Virginia
Study officials:
affiliation: Jounce Therapeutics, Inc.
name: Stew Kroll
role: STUDY_DIRECTOR
References: