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

NCT04319224 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: JTX-2011-R01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

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).

Conditions

Cancer

Keywords

JTX-2011; Vopratelimab; Ipilimumab; Nivolumab; ICOS; Anti-CTLA-4; PD-1; PD-L1; Immunotherapy; Immuno-oncology; Cancer

Outcome Measures

Primary Outcomes (3)

• Percentage of Subjects With Adverse Events (AEs)

  Percentage of subjects with at least one AE

  Approximately 34 months

• Percentage of Subjects With Serious Adverse Events (SAEs)

  Percentage of subjects with at least one SAE

  Approximately 34 months

• Percentage of Subjects With Clinically Significant Change From Baseline in Clinical Laboratory Tests

  Percentage of subjects with at least one clinically significant change from baseline in clinical laboratory tests (i.e., change requiring adjustment of dose, clinical intervention or administration of concomitant medication)

  Approximately 34 months

Secondary Outcomes (1)

• Median Progression Free Survival (mPFS)

  Approximately 34 months

Study Arms (3)

Vopratelimab

EXPERIMENTAL

Participants will continue to receive vopratelimab monotherapy per parent protocol.

Drug: Vopratelimab

Vopratelimab with ipilimumab

EXPERIMENTAL

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

Drug: Vopratelimab; Drug: Ipilimumab

Vopratelimab with nivolumab

EXPERIMENTAL

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

Drug: Vopratelimab; Drug: Nivolumab

Interventions

Vopratelimab DRUG

Specified dose on specified days

Also known as: JTX-2011

Vopratelimab; Vopratelimab with ipilimumab; Vopratelimab with nivolumab

Ipilimumab DRUG

Specified dose on specified days

Also known as: Yervoy

Vopratelimab with ipilimumab

Nivolumab DRUG

Specified dose on specified days

Also known as: Opdivo

Vopratelimab with nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jounce Therapeutics, Inc.: lead

Study Sites (3)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

The University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Virginia Health Systems

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Ipilimumab; Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Stew Kroll, Chief Development Officer
• Organization: Jounce Therapeutics, Inc.

skroll@jouncetx.com

(650) 576-9679

Study Officials

• Stew Kroll

  Jounce Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: March 10, 2020
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2023
• Last Updated: May 30, 2024
• Results First Posted: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)