Study on the Safety and Effectiveness of Pembrolizumab with Other Treatments or Alone for First-Time Advanced Melanoma

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04305054

Provider View

This clinical trial is exploring new treatment options for people with advanced melanoma who have not received any prior treatment. The study aims to find out if combining pembrolizumab with other investigational drugs can improve treatment outcomes.

Patient Parameters

Program Overview

This study is part of a larger research effort to find better ways to treat advanced melanoma that hasn't been treated before. Researchers are testing whether adding other treatments to pembrolizumab, a medication used to treat melanoma, can help control the disease. The study will look at how safe these combinations are and how well they work in shrinking or eliminating melanoma tumors. Different groups in the study will receive different combinations of pembrolizumab and other investigational drugs, and researchers will monitor their responses.

Description

With Amendment 5, participants receiving vibostolimab (Arm 1 and Arm 7) will discontinue treatment with vibostolimab and will be transitioned within their arm to pembrolizumab monotherapy. Participants receiving favezelimab (Arm 5, Arm 6, and Arm 7) may continue on study therapy until the end of study or may transition within their arm to pembrolizumab monotherapy. Participants with access to approved standard of care (SOC, pembrolizumab plus chemotherapy) should be considered for discontinuation from the study. Those benefiting from pembrolizumab with chemotherapy, but unable to access it as SOC outside the study, may continue on study and receive treatment with pembrolizumab plus chemotherapy until discontinuation criteria are met.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of melanoma.
  • Have advanced melanoma that cannot be removed by surgery.
  • Have not received any treatment for advanced melanoma.
  • Have provided a tumor sample for testing.
  • Men capable of fathering a child must agree to use contraception or remain abstinent during the study and for a specified time after the last dose.
  • Women must not be pregnant or breastfeeding and must use effective contraception if they are of childbearing potential.
  • Have good organ function and recovery from any previous treatments to a mild level.
  • Agree to follow the study's requirements for contraception based on the specific drugs used.

Exclusion Criteria

  • Have an immune system deficiency or are taking medications that suppress the immune system.
  • Have another cancer that is progressing or needs treatment.
  • Have cancer that has spread to the brain or spinal cord.
  • Have a type of melanoma affecting the eyes or mucous membranes.
  • Have an active autoimmune disease needing treatment in the past two years.
  • Have an active infection needing treatment.
  • Have a history of HIV, Hepatitis B, or Hepatitis C.
  • Have had lung inflammation or active tuberculosis.
  • Have received cancer treatment or radiation recently.
  • Have had major surgery recently.
  • Have received a live vaccine recently.
  • Have participated in another clinical trial recently.
  • Have had an organ transplant.
  • Have a psychiatric or substance abuse disorder affecting study participation.
  • Additional criteria for those receiving lenvatinib include:
    • Have severe gastrointestinal issues or bleeding.
    • Have significant heart disease recently.
    • Have high levels of protein in urine.
    • Have conditions affecting the absorption of lenvatinib.

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