Study on Encorafenib, Binimetinib, and Pembrolizumab for Advanced or Metastatic Melanoma

Sponsor: Pfizer

Sponsor score: 60

ClinicalTrials ID:NCT04657991

This clinical trial is testing a combination of three medicines—encorafenib, binimetinib, and pembrolizumab—to treat melanoma that has spread or is advanced and has a specific BRAF gene mutation. The study aims to see if this combination is effective and safe for patients who have not received prior treatment.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effects of three medicines—encorafenib, binimetinib, and pembrolizumab—when used together to treat melanoma that is advanced or has spread to other parts of the body. This type of melanoma has a specific abnormal gene called BRAF. Participants will receive pembrolizumab through an IV at the clinic every three weeks. Half of the participants will also take encorafenib and binimetinib by mouth at home daily. Pembrolizumab may be given for up to two years, while the other two medicines can continue until the melanoma stops responding. Regular clinic visits will help monitor participants' progress.

Description

This study compares the effectiveness and safety of a combination of three medicines—encorafenib, binimetinib, and pembrolizumab—against a placebo plus pembrolizumab in patients with advanced melanoma that has a BRAF V600E/K mutation. Initially, a safety phase will determine the best dose for the combination. Then, in the main part of the study, participants will be randomly assigned to receive either the combination or the placebo. The study will include about 216 participants, with half receiving the combination and half receiving the placebo. Participants will be monitored for how well the treatment works and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Willing to attend all scheduled visits and follow the treatment plan.
  • Have advanced melanoma that cannot be removed by surgery or has spread, confirmed by medical tests.
  • Have at least one measurable tumor.
  • Have a performance status of 0 or 1, meaning fully active or restricted in strenuous activity but ambulatory.
  • Have a specific BRAF V600E or V600K mutation in the melanoma.
  • Provide a tumor sample for testing.
  • Have not received prior treatment for advanced melanoma.
  • Have adequate bone marrow, liver, and kidney function.
  • Able to give informed consent.

Exclusion Criteria

  • Have other medical or psychiatric conditions that may increase the risk of participating.
  • Have mucosal or ocular melanoma.
  • Have an active autoimmune disease requiring treatment in the past two years.
  • Have severe drug allergies or reactions.
  • Cannot swallow or absorb oral medications.
  • Have significant heart disease or recent blood clots.
  • Have a history of certain eye conditions.
  • Have lung conditions requiring steroids.
  • Have active hepatitis B, C, or HIV.
  • Have an active infection needing treatment.
  • Have brain metastases or other active CNS metastases.
  • Have had another cancer within the past two years, except for certain skin or prostate cancers.
  • Have previously stopped similar treatments due to severe side effects.
  • Are pregnant or breastfeeding.
  • Are involved in the study's conduct or have family members who are.

Locations

FACILITYZIPCITYSTATE
Adventist Health System/Sunbelt, Inc.32803OrlandoFlorida
AdventHealth Hematology and Oncology32804OrlandoFlorida
AdventHealth Orlando Infusion Center32804OrlandoFlorida
AdventHealth Orlando, Investigational Drug Services32804OrlandoFlorida
The University of Kansas Clinical Research Center66205FairwayKansas
The University of Kansas Cancer Center - Overland Park66210Overland ParkKansas
KU Eye Center66208Prairie VillageKansas
The University of Kansas Cancer Center - Investigational Drug Services66205WestwoodKansas
The University of Kansas Cancer Center66205WestwoodKansas
Massachusetts General Hospital02114BostonMassachusetts

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