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
- Dabrafenib Mesylate — DRUGGiven PO
- Trametinib Dimethyl Sulfoxide — DRUGGiven PO
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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | Philadelphia | Pennsylvania | 19103 | - |
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