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OncoMatch/Clinical Trials/NCT05876806

Dabrafenib Plus Trametinib in Patients With Advanced Solid Tumor Having BRAF V600E Mutation or Clinically Actionable BRAF Gene Alterations

Is NCT05876806 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Dabrafenib and Trametinib for cancer.

Phase 2RecruitingSe Jun ParkNCT05876806Data as of May 2026

Treatment: Dabrafenib · TrametinibThis is a Phase II, open-label, non-randomized, multi-center study of oral Dabrafenib in combination with oral Trametinib in subjects with solid tumors with BRAF V600E mutation or clinically actionable BRAF gene alterations.

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Extracted eligibility criteria

Biomarker criteria

Required: BRAF V600E mutation

BRAF V600 mutated advanced solid tumor

Required: BRAF V600K mutation

BRAF V600 mutated advanced solid tumor

Required: BRAF other BRAF gene alterations that are regarded to be actionable by the KOSMOS MTB

Patients with other BRAF gene alterations that are regarded to be actionable by the KOSMOS MTB

Excluded: RAS activating mutation

History of malignancies with confirmed activating RAS mutation

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Cannot have received: braf inhibitor (dabrafenib, vemurafenib, encorafenib)

Cannot have received: mek inhibitor (trametinib, binimetinib, selumetinib, cobimetinib)

Cannot have received: erk inhibitor (ravoxertinib, ulixertinib, cc-90003, mk-8353)

Lab requirements

Blood counts

Adequate bone marrow function

Kidney function

Adequate organ function

Liver function

Adequate organ function

Cardiac function

No LVEF below institutional lower limit of normal, QTc < 480 msec, no clinically significant uncontrolled arrhythmias, no moderate valvular thickening, no intra-cardiac defibrillators, no acute coronary syndromes within 6 months, no congestive heart failure ≥ Class II (NYHA)

Adequate bone marrow and organ function. Current evidence of cardiovascular risk including any of the following: Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal, QT interval corrected for heart rate using Bazett's formula ≥ 480 msec, Clinically significant uncontrolled arrhythmias, Moderate valvular thickening documented by echocardiography, Presence of intra-cardiac defibrillators, Acute coronary syndromes (including myocardial infarction and unstable angina) which required coronary angioplasty or stenting within 6 months before enrollment, Congestive heart failure ≥ Class II as defined by New York Heart Association

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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