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Protein Kinase Inhibitor

Drug Combinations for Advanced Melanoma

Phase 2

Waitlist Available

Led By Hussein A Tawbi

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula) (within one week prior to registration)

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two different combinations of drugs to treat patients with stage III-IV melanoma that has spread or can't be removed by surgery. The first combination is nivolumab with trametinib and dabrafenib. The second combination is encorafenib with binimetinib. The trial will compare how well the two combinations work and what side effects they cause.

Who is the study for?

This trial is for adults with stage III-IV melanoma that's spread or can't be surgically removed, specifically those with a BRAF V600 mutation. It includes patients who've had prior treatments except for BRAFi/MEKi and requires stable brain metastases if present. Participants must have good organ function, not need high steroid doses, and agree to contraception.

What is being tested?

The study tests how well nivolumab (an immunotherapy drug) works with trametinib and dabrafenib or encorafenib and binimetinib (targeted therapies) in treating advanced melanoma. The goal is to see which combination better inhibits tumor growth by blocking enzymes needed for cell growth.

What are the potential side effects?

Possible side effects include immune system changes leading to inflammation in various organs, potential skin reactions, fatigue, liver enzyme elevation indicating liver stress, blood-related issues like anemia or clotting problems, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function, measured by creatinine levels, is within the normal range.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Upper arm

Secondary study objectives

Complete response

Incidence of adverse events assessed using National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.0

Disease

+3 more

Other study objectives

Circulating and tumor markers

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C (NEB)Experimental Treatment5 Interventions

Patients receive nivolumab IV over 30 minutes on day 1 and 15, encorafenib PO QD on days 1-28, and binimetinib PO BID on days 1-28. Cycles repeats every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (NT, closed to accrual)Experimental Treatment4 Interventions

Patients receive nivolumab IV over 30 minutes on day 1 and 15, and trametinib PO QD on days 1-28. Cycles repeats every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity.

Group III: Arm A (NDT, CLOSED)Experimental Treatment5 Interventions

Patients receive nivolumab IV over 30 minutes on day 1, dabrafenib PO BID on days 1-28, and trametinib PO QD on days 1-28. Cycles repeats every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Binimetinib

2018

Completed Phase 3

~1250

Dabrafenib

2011

Completed Phase 3

~4120