Trial Outcomes & Findings for Testing Trametinib as a Potential Targeted Treatment in Cancers With BRAF Genetic Changes (MATCH-Subprotocol R) (NCT NCT04439279)

Last Updated: 2025-11-19

Results Overview

Overall response rate was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) among all eligible and treated patients. Best overall response was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. The 90% two-sided binomial exact confidence interval was calculated for ORR.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

assessed at baseline, then every 2 cycles until disease progression, up to 3 years post registration

Results posted on

2025-11-19

Participant Flow

Subprotocol R was activated on August 12, 2015. A total of 50 patients were assigned to this arm after screening, 48 from screening cohort and 2 from outside assay. Of the 50 patients, 35 patients were enrolled to arm R between December 4, 2015 and August 17, 2017.

To be assigned to a specific MATCH subprotocol, patients needed to submit a tumor biopsy for molecular characterization and those with molecular variants addressed by treatments included in the trial entered corresponding MATCH subprotocol. For the subprotocol R, patients had to have BRAF fusion or Non-V600E, Non-V600K mutations.

Participant milestones

Participant milestones
Measure	Subprotocol R Patients receive trametinib dimethyl sulfoxide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	35
Overall Study Started Protocol Therapy	35
Overall Study Eligible	33
Overall Study Reported Adverse Events Data	34
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Subprotocol R Patients receive trametinib dimethyl sulfoxide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study Adverse Event	7
Overall Study Death	4
Overall Study Disease progression	17
Overall Study Complicating disease	3
Overall Study Withdrawal by Subject	2
Overall Study Ineligible	1
Overall Study Treatment still ongoing	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subprotocol R n=33 Participants Patients receive trametinib dimethyl sulfoxide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Age, Continuous	65 years
Sex: Female, Male Female	19 Participants
Sex: Female, Male Male	14 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) White	31 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants

PRIMARY outcome

Timeframe: assessed at baseline, then every 2 cycles until disease progression, up to 3 years post registration

Population: eligible and treated patients

Outcome measures

Outcome measures
Measure	Subprotocol R n=33 Participants Patients receive trametinib dimethyl sulfoxide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Response Rate (ORR)	3 percentage of participants Interval 0.1 to 16.0

SECONDARY outcome

Timeframe: assessed at baseline, then every 2 cycles until disease progression, up to 3 years post registration

Population: eligible and treated patients

PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. The 6-month PFS rate was estimated using the Kaplan-Meier method which can provide a point estimate for any specific time point. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients.

Outcome measures

Outcome measures
Measure	Subprotocol R n=33 Participants Patients receive trametinib dimethyl sulfoxide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
6-month Progression-free Survival (PFS) Rate	20 percentage of participants Interval 10.0 to 33.0

SECONDARY outcome

Timeframe: assessed at baseline, then every 2 cycles until disease progression, up to 3 years post registration

Population: eligible and treated patients

PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients.

Outcome measures

Outcome measures
Measure	Subprotocol R n=33 Participants Patients receive trametinib dimethyl sulfoxide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Progression-free Survival	1.8 months Interval 1.6 to 3.4

Adverse Events

Subprotocol R

Serious events: 14 serious events

Other events: 29 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Subprotocol R n=34 participants at risk Patients receive trametinib dimethyl sulfoxide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	14.7% 5/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
General disorders Sudden death NOS	2.9% 1/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Skin and subcutaneous tissue disorders Pruritus	2.9% 1/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Skin and subcutaneous tissue disorders Rash acneiform	2.9% 1/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.9% 1/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	2.9% 1/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Gastrointestinal disorders Nausea	2.9% 1/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Gastrointestinal disorders Vomiting	2.9% 1/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Investigations Ejection fraction decreased	2.9% 1/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Investigations Lymphocyte count decreased	2.9% 1/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Metabolism and nutrition disorders Anorexia	2.9% 1/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Metabolism and nutrition disorders Dehydration	2.9% 1/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Metabolism and nutrition disorders Hypoalbuminemia	2.9% 1/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Metabolism and nutrition disorders Hyponatremia	2.9% 1/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.9% 1/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Vascular disorders Hypotension	2.9% 1/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Vascular disorders Thromboembolic event	2.9% 1/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.

Other adverse events

Other adverse events
Measure	Subprotocol R n=34 participants at risk Patients receive trametinib dimethyl sulfoxide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	29.4% 10/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	5.9% 2/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
General disorders Chills	5.9% 2/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
General disorders Edema limbs	35.3% 12/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
General disorders Fatigue	17.6% 6/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Skin and subcutaneous tissue disorders Alopecia	8.8% 3/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Skin and subcutaneous tissue disorders Dry skin	8.8% 3/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Skin and subcutaneous tissue disorders Pruritus	14.7% 5/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Skin and subcutaneous tissue disorders Rash acneiform	32.4% 11/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Skin and subcutaneous tissue disorders Rash maculo-papular	23.5% 8/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	20.6% 7/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Gastrointestinal disorders Abdominal pain	5.9% 2/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Gastrointestinal disorders Constipation	11.8% 4/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Gastrointestinal disorders Diarrhea	26.5% 9/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Gastrointestinal disorders Dry mouth	14.7% 5/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Gastrointestinal disorders Mucositis oral	14.7% 5/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Gastrointestinal disorders Nausea	38.2% 13/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Gastrointestinal disorders Vomiting	20.6% 7/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Infections and infestations Paronychia	5.9% 2/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Investigations Alanine aminotransferase increased	11.8% 4/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Investigations Alkaline phosphatase increased	14.7% 5/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Investigations Aspartate aminotransferase increased	29.4% 10/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Investigations Ejection fraction decreased	5.9% 2/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Investigations Lymphocyte count decreased	5.9% 2/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Investigations Platelet count decreased	11.8% 4/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Investigations White blood cell decreased	8.8% 3/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Metabolism and nutrition disorders Anorexia	11.8% 4/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Metabolism and nutrition disorders Hyperglycemia	5.9% 2/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Metabolism and nutrition disorders Hypoalbuminemia	17.6% 6/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Metabolism and nutrition disorders Hypocalcemia	5.9% 2/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Metabolism and nutrition disorders Hypomagnesemia	8.8% 3/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Nervous system disorders Dizziness	5.9% 2/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Respiratory, thoracic and mediastinal disorders Cough	8.8% 3/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.9% 2/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.
Vascular disorders Hypertension	8.8% 3/34 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All 35 patients enrolled to the trial were monitored for mortality, 34 patients were monitored for adverse events as one patient refused to submit adverse event data right after starting the protocol therapy.

Additional Information

Study Statistician

ECOG-ACRIN Cancer Research Group

Phone: 617-632-3012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60