Trial Outcomes & Findings for Dabrafenib and Trametinib With Radiosurgery in Melanoma Brain Mets (NCT NCT01721603)

Last Updated: 2018-01-23

Results Overview

Determine whether dabrafenib combined with stereotactic radiosurgery (SRS) and trametinib improves the 6 month DBMFS rate of BRAFV600E melanoma patients for whom the standard of care is stereotactic radiosurgery (≤4 brain lesions and no lesion \> 3 cm) in comparison with similar historical controls treated with radiosurgery alone.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Up to 6 months after surgery

Results posted on

2018-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	Dabrafenib + Trametinib + Gamma Knife Radiosurgery 1 cycle = 28 days * Dabrafenib: 150mg capsule by mouth (PO), twice daily, continuous * Trametinib: 2 mg PO, once daily from beginning of cycle 3 Day 1,until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity. For patients with stable disease or partial tumor responses in the brain, Gamma Knife radiosurgery will be performed on treatment cycle 2, day 1 (+/- 3 days) using a stereotactic head frame and MRI imaging in accordance with FDA-approved procedures.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dabrafenib and Trametinib With Radiosurgery in Melanoma Brain Mets

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dabrafenib Given in Combination With Gamma Knife Radiosurgery n=2 Participants All patients will receive continuous, oral dosing of dabrafenib at a starting dose of 150 mg twice daily until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity Dabrafenib: 150mg capsule by mouth twice daily Gamma Knife Radiosurgery: This will be delivered using Gamma Knife technology. Patients will be fitted with a stereotactic head-frame for stereotactic localization of brain metastases.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Region of Enrollment United States	2 participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 6 months after surgery

Outcome measures

Outcome measures
Measure	Dabrafenib + Trametinib + Gamma Knife Radiosurgery n=2 Participants 1 cycle = 28 days * Dabrafenib: 150mg capsule by mouth (PO), twice daily, continuous * Trametinib: 2 mg PO, once daily from beginning of cycle 3 Day 1,until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity. For patients with stable disease or partial tumor responses in the brain, Gamma Knife radiosurgery will be performed on treatment cycle 2, day 1 (+/- 3 days) using a stereotactic head frame and MRI imaging in accordance with FDA-approved procedures.
Patients Reaching 6 Month Distant Brain Metastasis-free Survival (DBMFS)	1 Participants

SECONDARY outcome

Timeframe: From surgery up to 6 months

Determine whether dabrafenib combined with SRS and trametinib improves the 6-month local control rate of BRAFV600E melanoma brain metastases compared with historical controls treated with SRS.