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Expanded Access for Cancer Treatment With Balstilimab (AGEN2034) and Zalifrelimab (AGEN1884)

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ClinicalTrials.gov Identifier: NCT05572970
Expanded Access Status : Available
First Posted : October 10, 2022
Last Update Posted : October 10, 2022
Sponsor:
Information provided by (Responsible Party):
Agenus Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Cancer Drug: Balstilimab Drug: Zalifrelimab

Detailed Description:
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.
Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access for Cancer Treatment With Balstilimab (AGEN2034), Either as Monotherapy, or as Used in Combination With Zalifrelimab (AGEN1884)

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: Balstilimab
    An anti-programmed death 1 (PD-1) monoclonal antibody.
    Other Name: AGEN2034
  • Drug: Zalifrelimab
    An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody.
    Other Name: AGEN1884
Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05572970


Contacts
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Contact: Agenus, Inc. 781-674-4265 clinicaltrialinfo@Agenusbio.com

Sponsors and Collaborators
Agenus Inc.
Investigators
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Study Director: Medical Director Agenus Inc.
More Information
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Responsible Party: Agenus Inc.
ClinicalTrials.gov Identifier: NCT05572970    
Other Study ID Numbers: C-750-EAP-01
First Posted: October 10, 2022    Key Record Dates
Last Update Posted: October 10, 2022
Last Verified: October 2022
Keywords provided by Agenus Inc.:
Balstilimab
AGEN2034
Zalifrelimab
AGEN1884
Monotherapy