Testing Dabrafenib and Trametinib With or Without Hydroxychloroquine in Stage IIIC or IV BRAF V600E/K Melanoma

Conditions

• Clinical Stage IV Cutaneous Melanoma AJCC v8
• Locally Advanced Melanoma
• Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
• Pathologic Stage IV Cutaneous Melanoma AJCC v8
• Unresectable Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dabrafenib mesylate — DRUG
  Given PO
• Hydroxychloroquine — DRUG
  Given PO
• Placebo Administration — DRUG
  Given PO
• Trametinib dimethyl sulfoxide — DRUG
  Given PO

Study Details

This phase II trial investigates how well adding hydroxychloroquine to the standard treatment of dabrafenib and trametinib works to overcome resistance and delay disease progression in treating patients with stage IIIC or IV BRAF V600E/K melanoma. Hydroxychloroquine may cause cell death in tumor cells that rely on a process called "autophagy" for survival. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving hydroxychloroquine together with dabrafenib and trametinib may work better than dabrafenib and trametinib alone to shrink and stabilize the cancer.

Key Dates

Start date

Jun 1, 2021

Status verified

May 2026

Primary completion

Jan 8, 2024

Completion

Jan 8, 2024

Study Design

Enrollment

5 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (dabrafenib, trametinib, hydroxychloroquine)
  Patients receive dabrafenib mesylate PO BID, trametinib dimethyl sulfoxide PO QD, and hydroxychloroquine sulfate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• Active Comparator: Arm B (dabrafenib, trametinib, placebo)
  Patients receive dabrafenib mesylate PO BID, trametinib dimethyl sulfoxide PO QD, and placebo PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

One-year Progression-free Survival Rate [ Time Frame: Assessed every 2 months until 6 months after completion of study treatment, up to 1 year ]

Locations (199)

Find similar trials in Anchorage, AK

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