Study on Nivolumab with Trametinib and Dabrafenib, or Encorafenib and Binimetinib for Treating Advanced Melanoma with BRAF Mutation

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT02910700

Provider View

This clinical trial is testing the effectiveness and safety of combining nivolumab with other drugs to treat patients with advanced melanoma that has a specific BRAF mutation. The study aims to find out if these combinations can better control the cancer that has spread or cannot be removed by surgery.

Patient Parameters

Program Overview

This study is exploring how well a combination of drugs, including nivolumab, trametinib, dabrafenib, encorafenib, and binimetinib, works in treating advanced melanoma with a BRAF mutation. Nivolumab is an immunotherapy that may help the immune system fight cancer, while the other drugs may stop cancer cells from growing. The study will compare different combinations to see which works best for patients whose melanoma has spread or cannot be surgically removed.

Description

The main goal of this study is to determine how safe and effective the drug combinations are in treating advanced melanoma with a BRAF mutation. Patients will be divided into different groups to receive various combinations of nivolumab with other drugs. The study will monitor how well the cancer responds to these treatments and how long the effects last.

Participants will receive treatment in cycles, with each cycle lasting 28 days. The treatment can continue for up to three years unless the cancer progresses or side effects become too severe. After completing the treatment, patients will have follow-up visits to monitor their health and the long-term effects of the treatment.

The study will also look at how the treatment affects the immune system and cancer cells, as well as overall survival and progression-free survival rates.

Eligibility Criteria

Inclusion Criteria

  • Have advanced melanoma (stage III or IV) with a BRAF V600 mutation that has spread or cannot be removed by surgery.
  • Have previously received treatment for melanoma, but not with BRAF or MEK inhibitors.
  • Have measurable disease that can be evaluated.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Patients with brain metastases are eligible if they meet specific conditions, such as having stable symptoms and no recent brain radiation.
  • Meet specific blood count and organ function requirements.
  • Women of childbearing potential must use effective birth control during the study and for a period after the last dose.
  • Men must use effective contraception if sexually active with women of childbearing potential.
  • Be able to understand and sign an informed consent document.

Exclusion Criteria

  • Have had severe immune-related side effects from previous treatments that required long-term steroid use.
  • Have a history of lung disease or pneumonitis.
  • Have known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • Have active autoimmune diseases, except for certain stable conditions.
  • Require high doses of steroids or other immunosuppressive medications.
  • Have active infections like hepatitis B, hepatitis C, or HIV.
  • Have allergies to the study drugs or similar medications.
  • Have had recent chemotherapy or radiation therapy and not fully recovered.
  • Have uncontrolled illnesses or conditions that could interfere with the study.
  • Pregnant or breastfeeding women are not eligible due to potential risks to the baby.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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