Testing Trametinib and Dabrafenib as a Potential Targeted Treatment in Cancers With BRAF Genetic Changes (MATCH-Subprotocol H)

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04439292
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Lymphoma
  • Advanced Malignant Solid Neoplasm
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Refractory Lymphoma
  • Refractory Malignant Solid Neoplasm
  • Refractory Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This phase II MATCH treatment trial identifies the effects of trametinib and dabrafenib in patients whose cancer has genetic changes called BRAF V600 mutations. Dabrafenib may stop the growth of cancer by blocking BRAF proteins which may be needed for cell growth. Trametinib may stop the growth of cancer cells by blocking MEK proteins which, in addition to BRAF proteins, may also be needed for cell growth. Researchers hope to learn if giving trametinib with dabrafenib will shrink this type of cancer or stop its growth.

Key Dates

Start date
Jan 4, 2016
Status verified
Dec 2025
Primary completion
Nov 27, 2023
Completion
Dec 31, 2026

Study Design

Enrollment
44 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (dabrafenib, trametinib)
    Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration ]

Locations (1)

FacilityCityStateZIPSite coordinators
ECOG-ACRIN Cancer Research GroupPhiladelphiaPennsylvania19103-

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