NCT05572970

Brief Summary

This is an expanded access study for cancer treatment with balstilimab alone or in combination with zalifrelimab for an intermediate-size participant population. This study addresses the treatment needs of participants who have been previously and specifically treated with balstilimab alone or in combination with zalifrelimab in a clinical study, who have experienced a benefit from this treatment and/or wish to continue treatment, and who are eligible for treatment under this expanded access study.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
Last Updated

May 6, 2026

Status Verified

May 1, 2026

First QC Date

October 5, 2022

Last Update Submit

May 5, 2026

Conditions

Keywords

BalstilimabAGEN2034ZalifrelimabAGEN1884Monotherapy

Interventions

An anti-programmed death 1 (PD-1) monoclonal antibody.

Also known as: AGEN2034

An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody.

Also known as: AGEN1884

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must have completed predicate study protocol requirements, including prior treatment duration and follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

AVAILABLE

Arizona Oncology Associates

Tucson, Arizona, 85711, United States

AVAILABLE

Hoag Gynecologic Oncology

Newport Beach, California, 92663, United States

AVAILABLE

University of California, San Francisco Medical Center

San Francisco, California, 94158, United States

AVAILABLE

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43212, United States

AVAILABLE

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

AVAILABLE

Texas Oncology

Flower Mound, Texas, 75028, United States

AVAILABLE

MeSH Terms

Conditions

Neoplasms

Interventions

balstilimab

Study Officials

  • Medical Director

    Agenus Inc.

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2022

First Posted

October 10, 2022

Last Updated

May 6, 2026

Record last verified: 2026-05

Locations