Testing Trametinib and Dabrafenib for Cancers with BRAF Genetic Changes
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04439292
This study is exploring whether the combination of two drugs, trametinib and dabrafenib, can effectively treat cancers with specific genetic changes known as BRAF V600 mutations. These drugs work by blocking proteins that help cancer cells grow.
Patient Parameters
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Program Overview
This phase II clinical trial is testing the effects of two drugs, trametinib and dabrafenib, on patients with cancers that have a specific genetic change called BRAF V600 mutation. Dabrafenib works by blocking BRAF proteins, while trametinib blocks MEK proteins, both of which are involved in cancer cell growth. The study aims to find out if using these drugs together can shrink tumors or stop them from growing.
Description
The main goal of this study is to see how many patients with advanced cancers respond to the treatment with trametinib and dabrafenib. Researchers also want to know how long patients live without their cancer getting worse and to study any potential markers that might predict how well the treatment works.
Patients in the study will take dabrafenib twice a day and trametinib once a day in 28-day cycles. They will continue this treatment as long as it is effective and does not cause unacceptable side effects. After finishing the treatment, patients will have follow-up visits every three months for the first two years, and then every six months in the third year.
Eligibility Criteria
Inclusion Criteria
- Must meet the eligibility criteria of the main MATCH study before joining this sub-study.
- Must have a BRAF V600E, V600K, V600R, or V600D mutation, or another similar genetic change.
- Blood clotting tests must be within a safe range, even if taking blood thinners.
- Must have a heart test (ECHO or MUGA) showing normal heart function within four weeks before starting treatment.
- Must have a recent ECG showing no serious heart problems.
- Must not have high blood pressure that cannot be controlled with medication.
- Must have stopped any previous monoclonal antibody therapy at least eight weeks before starting this treatment.
Exclusion Criteria
- Cannot have certain types of cancer, including metastatic melanoma, papillary thyroid cancer, colorectal adenocarcinoma, or non-small cell lung cancer.
- Cannot have a history of lung diseases like interstitial lung disease or pneumonitis.
- Cannot be allergic to dabrafenib, trametinib, or similar substances.
- Cannot have a history or risk of a specific eye condition called retinal vein occlusion.
- Cannot have previously taken MEK or BRAF inhibitors.
- Cannot be using certain medications that affect how the body processes drugs.
- Cannot have a history of hepatitis B or C, unless the infection is cleared.
- Cannot have tumors with RAS mutations.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | 19103 | Philadelphia | Pennsylvania |
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