Study on Pembrolizumab and Lenvatinib with or without Healthy Donor Fecal Transplant in Treating Relapsed or Resistant Melanoma

Sponsor: Diwakar Davar

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06030037

Provider View

This clinical trial is exploring whether adding a healthy donor fecal transplant to the combination of pembrolizumab and lenvatinib can improve treatment outcomes for patients with melanoma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

This study is testing a new approach to treat melanoma that has come back or is not responding to treatment. It involves using pembrolizumab and lenvatinib, with or without a healthy donor fecal transplant, over a period of 104 weeks. The trial is for patients with advanced melanoma that has not responded to PD-1 treatments, except those who have previously used lenvatinib or similar drugs. The study aims to see if the gut microbiome, influenced by the fecal transplant, can improve the body's response to the treatment.

Description

Melanoma is a type of skin cancer that can be difficult to treat, especially when it returns or doesn't respond to initial treatments. This study is looking at a new treatment combination to help these patients. Pembrolizumab and lenvatinib are drugs that have shown promise in treating certain cancers. This trial is testing whether adding a healthy donor fecal transplant can enhance the effectiveness of these drugs in treating melanoma.

The fecal transplant involves introducing healthy bacteria from a donor into the patient's gut, which may help improve the body's immune response to cancer. The study will last for about two years, and patients will be closely monitored to see how well the treatment works and if it is safe.

Participants will need to meet certain criteria to join the study, such as having melanoma that has not responded to previous treatments and being willing to undergo the fecal transplant procedure. The study will also look at how the treatment affects the gut microbiome and whether it can help control the cancer more effectively.

Eligibility Criteria

Inclusion Criteria

  • Have cutaneous melanoma or melanoma of unknown origin. Patients with uveal, mucosal, or acral-lentiginous melanoma cannot participate.
  • Male participants must agree to use contraception during the study and for 120 days after the last treatment.
  • Female participants must not be pregnant or breastfeeding and must agree to use contraception if they are of childbearing potential.
  • Must have melanoma that has progressed after treatment with anti-PD-1 drugs.
  • Patients with stable brain metastases can participate if they meet specific conditions.
  • Must be willing to undergo fecal transplant procedures and understand the associated risks.
  • Must have measurable disease and be able to provide a tumor biopsy.
  • Must have adequate organ function and meet specific health criteria.
  • Patients with hepatitis B or C must have controlled viral loads and be on antiviral therapy.

Exclusion Criteria

  • Have non-cutaneous melanoma types like mucosal or ocular melanoma.
  • Have received prior treatments targeting the gut microbiome.
  • Have had recent chemotherapy, targeted therapy, or radiotherapy.
  • Have conditions that prevent the use of lenvatinib, such as certain heart or blood vessel issues.
  • Have severe allergies or conditions that prevent fecal transplant.
  • Have active infections or autoimmune diseases requiring treatment.
  • Have other active cancers or health conditions that could interfere with the study.
  • Are pregnant, breastfeeding, or planning to conceive during the study.
  • Have had an organ transplant.

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