Study on Zimberelimab and Domvanalimab for Melanoma That Has Not Responded to PD-1 Treatment

Sponsor: Diwakar Davar

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05130177

Provider View

This clinical trial is testing a new combination of drugs, zimberelimab and domvanalimab, to see if they can help patients with melanoma that has not responded to previous PD-1 inhibitor treatments.

Patient Parameters

Program Overview

The main goal of this study is to find out how well the combination of zimberelimab and domvanalimab works in treating patients with advanced melanoma who have not responded to PD-1 inhibitor therapy. Patients will be screened for 28 days to ensure they are suitable for the study. Once enrolled, they will receive zimberelimab every three weeks and domvanalimab every three weeks. After three cycles of treatment, patients will have scans to check their response. If the treatment is working, they can continue receiving it for up to 24 months or until the disease progresses or side effects become too severe.

Description

This study involves patients with advanced melanoma who have not responded to previous PD-1 inhibitor treatments. Participants will first undergo a 28-day screening process, which includes scans, a tumor biopsy, and blood tests to confirm they are eligible. Once enrolled, they will receive zimberelimab and domvanalimab every three weeks. After three cycles, patients will have scans to assess their response to the treatment. If the treatment is effective, they can continue receiving it for up to 24 months or until the disease progresses or side effects become intolerable. The study aims to determine the effectiveness of this drug combination in shrinking tumors and improving patient outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older with a confirmed diagnosis of cutaneous melanoma.
  • Must agree to use contraception during the study and for 120 days after the last dose.
  • Must have previously received and progressed on PD-1/L1 inhibitor therapy.
  • Must have measurable disease and be able to provide a tumor biopsy.
  • Must have good overall health with an ECOG performance status of 0 or 1.
  • Must have adequate organ function as shown by specific blood tests.

Exclusion Criteria

  • Have received prior treatment targeting the TIGIT/CD226 pathway.
  • Have non-cutaneous melanoma types like mucosal or ocular melanoma.
  • Have an immune deficiency or are on immunosuppressive therapy.
  • Have not recovered from previous treatments or have had recent radiotherapy.
  • Have active infections or a history of severe allergic reactions to similar treatments.
  • Have other active cancers or untreated brain metastases.
  • Are pregnant, breastfeeding, or planning to conceive during the study.
  • Have a history of certain lung diseases or require high doses of steroids.
  • Have a history of HIV, active hepatitis B or C, or tuberculosis.

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