Study on Dostarlimab Alone vs. Dostarlimab and Cobolimab Combination for Melanoma Before Surgery

Sponsor: Diwakar Davar

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04139902

Provider View

This clinical trial is testing two different treatments for melanoma that can be surgically removed. It compares the effects of using the drug Dostarlimab alone versus a combination of Dostarlimab and Cobolimab before surgery.

Patient Parameters

Program Overview

The purpose of this study is to see how effective Dostarlimab, either by itself or combined with Cobolimab, is in treating melanoma that can be operated on. The study will involve patients with certain types of melanoma who have not yet had surgery. Participants will receive the treatment for six weeks before their planned surgery and continue with Dostarlimab after surgery for about 48 weeks, totaling 54 weeks of treatment.

Description

This study is for patients with melanoma that can be surgically removed. It compares two treatments: Dostarlimab alone and a combination of Dostarlimab and Cobolimab. Patients with certain stages of melanoma, including those with lymph node involvement or small metastases, are eligible. Before surgery, patients will receive one of the treatments for six weeks. Surgery will take place 1-4 weeks after this pre-surgery treatment. After recovering from surgery, patients will continue to receive Dostarlimab for about 48 weeks. The total treatment period is approximately 54 weeks.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of certain types of melanoma, excluding uveal/choroidal and mucosal melanoma.
  • Have melanoma that is at a specific stage, which includes certain lymph node involvement or small metastases.
  • Have measurable disease based on specific criteria.
  • Provide a tumor sample from a recent biopsy.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Show adequate organ function in screening tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Men must agree to use contraception.

Exclusion Criteria

  • Have uveal or mucosal melanoma.
  • Are currently in another clinical trial or have been in one within the last four weeks.
  • Are taking medications that suppress the immune system for autoimmune diseases.
  • Have had severe immune-related side effects from previous treatments.
  • Have received certain cancer treatments within two weeks before the study.
  • Have active or untreated brain metastases.
  • Have another progressing cancer or one that needs treatment.
  • Have had invasive cancer diagnosed and treated less than two years ago.
  • Have lung disease or active lung inflammation.
  • Have an active infection needing treatment.
  • Have a condition or history that could interfere with the study.
  • Are pregnant or breastfeeding.
  • Have had a live vaccine within 30 days before starting the study.
  • Have had previous treatments with certain immune therapies.
  • Have allergies to the study drugs.
  • Have a history of HIV or active hepatitis B or C infections.

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