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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.
This study will not exceed 100 participants. Participants will be reevaluated annually to assess the treatment benefit of zalifrelimab and/or balstilimab and thereby, continued eligibility for treatment. Under this program, treatment will be continued with balstilimab, as either monotherapy or as used in combination therapy with zalifrelimab, for participants that have previously received one or both of these investigational medicinal products in a clinical study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balstilimab | Drug | An anti-programmed death 1 (PD-1) monoclonal antibody. |
| |
| Zalifrelimab | Drug | An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody. |
|
Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agenus, Inc. | Contact | 781-674-4265 | clinicaltrialinfo@Agenusbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Agenus Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Available | Birmingham | Alabama | 35249 | United States | |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000720935 | balstilimab |
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| Arizona Oncology Associates |
| Available |
| Tucson |
| Arizona |
| 85711 |
| United States |
| Hoag Gynecologic Oncology | Available | Newport Beach | California | 92663 | United States |
| University of California, San Francisco Medical Center | Available | San Francisco | California | 94158 | United States |
| The Ohio State University Wexner Medical Center | Available | Columbus | Ohio | 43212 | United States |
| Women & Infants Hospital of Rhode Island | Available | Providence | Rhode Island | 02905 | United States |
| Texas Oncology | Available | Flower Mound | Texas | 75028 | United States |