Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma

Conditions

• Clinical Stage III Cutaneous Melanoma AJCC v8
• Clinical Stage IV Cutaneous Melanoma AJCC v8
• Malignant Solid Neoplasm
• Metastatic Melanoma
• Unresectable Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biopsy Procedure — PROCEDURE
  Undergo biopsy
• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Computed Tomography — PROCEDURE
  Undergo CT
• Dabrafenib — DRUG
  Given PO
• Echocardiography Test — PROCEDURE
  Undergo echocardiography
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Multigated Acquisition Scan — PROCEDURE
  Undergo multigated acquisition scan
• Navitoclax — BIOLOGICAL
  Given PO
• Pharmacological Study — OTHER
  Correlative studies
• Trametinib — DRUG
  Given PO

Study Details

This phase I/II trial studies the side effects and best dose of dabrafenib, trametinib, and navitoclax and to see how well they work in treating patients with BRAF mutant melanoma or solid tumors that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Navitoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of tumor cells by blocking Bcl-2, a protein needed for tumor cell survival. Giving navitoclax, dabrafenib, and trametinib may help shrink tumors in patients with melanoma.

Key Dates

Start date

Mar 24, 2014

Status verified

Feb 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

75 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (dabrafenib, trametinib)
  ARM I: Patients receive dabrafenib PO BID and trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA, MRI or CT, biopsy, and collection of blood samples throughout the trial.
• Experimental: Arm II (dabrafenib, trametinib, and navitoclax)
  Patients receive navitoclax PO QD days -7 to -1 of cycle 1 only. Patients also receive dabrafenib PO BID, trametinib PO QD, and navitoclax PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA, MRI or CT, biopsy, and collection of blood samples throughout the trial.

Primary Outcome Measure

Recommended phase II dose of the combination of dabrafenib, trametinib, and navitoclax (Phase I) [ Time Frame: Up to 28 days ]

Locations (49)

Find similar trials in Phoenix, AZ

Related Studies

• Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Project: Every Child for Younger Patients With Cancer
  Recruiting · Children's Oncology Group · Birmingham, Alabama
• Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas