Study of Dapansutrile and Pembrolizumab for Advanced Melanoma Resistant to PD-1 Treatment

Sponsor: April Salama, M.D.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04971499

Provider View

This clinical trial is testing a new combination of drugs, dapansutrile and pembrolizumab, to see if they can help treat advanced melanoma that hasn't responded to previous PD-1 treatments. The study will first find a safe dose and then test how well the treatment works.

Patient Parameters

Program Overview

This study is divided into two parts. In the first part, researchers will determine the safest dose of dapansutrile when used with pembrolizumab for patients with melanoma that is resistant to PD-1 treatments. This involves starting with dapansutrile alone and then adding pembrolizumab. In the second part, the study will test how effective this combination is in treating the cancer. Participants will first take dapansutrile alone for two weeks before starting the combination therapy.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of melanoma.
  • Have advanced melanoma that cannot be removed by surgery.
  • Be 18 years or older.
  • Men must use reliable birth control during treatment and for 120 days after the last dose.
  • Women must not be pregnant or breastfeeding and must use reliable birth control if they are of childbearing potential.
  • Must have previously received and progressed on PD-1/PD-L1 therapy.
  • Must have measurable disease based on specific criteria.
  • Must provide a tumor tissue sample for analysis.
  • Must have a performance status that allows for daily activities.
  • Must have adequate organ function based on blood tests.
  • Must have resolved any side effects from previous cancer treatments to a mild level.

Exclusion Criteria

  • Have ocular or mucosal melanoma.
  • Be pregnant or breastfeeding.
  • Have received other cancer treatments recently.
  • Have active brain metastases or certain other medical conditions.
  • Have a history of severe allergic reactions to pembrolizumab.
  • Have active autoimmune diseases requiring treatment in the past two years.
  • Have active infections or certain viral infections like HIV or Hepatitis B/C.
  • Have a history of tuberculosis.
  • Have any condition that might interfere with the study or is not in the best interest of the participant.
  • Have a history of organ transplant.

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