Trial Outcomes & Findings for Capmatinib, Ceritinib, Regorafenib, or Entrectinib in Treating Patients With BRAF/NRAS Wild-Type Stage III-IV Melanoma (NCT NCT02587650)

Last Updated: 2020-01-27

Results Overview

Defined as a complete or partial response as per Response Evaluation Criteria in Solid Tumors version 1.1 criteria with confirmatory measurements a minimum of 4 weeks after the response-defining determination. Analysis of study results will include ORR estimations of ALK, NTRK, ROS1, RET, MET, and BRAF rearrangement-positive patients.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

24 weeks

Results posted on

2020-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A (Capmatinib) Patients with MET fusion receive capmatinib orally (PO), twice a day (BID) on day 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity. Capmatinib: Given orally Laboratory Biomarker Analysis: Correlative studies	Arm B (Ceritinib) Patients with ALK fusion receive ceritinib PO once a day (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity. Ceritinib: Given PO Laboratory Biomarker Analysis: Correlative studies	Arm C (Regorafenib) Patients with RET or BRAF fusion receive regorafenib PO QD on day 1-21. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity. Laboratory Biomarker Analysis: Correlative studies Regorafenib: Given PO	Arm D (Entrectinib) Patients with NTRK1, NTRK2, NTRK3, OR ROS1 fusion receive entrectinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity. Entrectinib: Given PO Laboratory Biomarker Analysis: Correlative studies
Overall Study STARTED	0	0	1	0
Overall Study COMPLETED	0	0	1	0
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Capmatinib, Ceritinib, Regorafenib, or Entrectinib in Treating Patients With BRAF/NRAS Wild-Type Stage III-IV Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm C (Regorafenib) n=1 Participants Participants with RET or BRAF mutations
Age, Customized 60-65 years	1 Participants n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	1 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	1 participants n=93 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Evaluable participants would be those with baseline staging, treatment for at least 8 weeks, and at least one post-baseline staging scan while on treatment. No participants meet the criteria to be considered evaluable for this analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: Evaluable patients would be those with baseline staging, treatment for at least 8 weeks, and at least one post-baseline staging scan while on treatment. No participants meet the criteria to be considered evaluable for this analysis.

Clinical benefit rate is defined as the proportion of patients achieving a complete response (CR) or partial response (PR) or stable disease (SD) for \> 24 weeks using the same RECIST 1.1 decision matrix used to calculate ORR. The CBR will be estimated for each arm along with a 95% confidence interval

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From treatment start to death, assessed up to 2 years

Overall defined as the time from treatment start to the progression or death and overall survival defined as the time from treatment start to death will be estimated using Kaplan-Meier methodology.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 2 years

Progression free survival (PFS) defined as the time from treatment start to the progression or death and overall survival defined as the time from treatment start to death will be estimated using Kaplan-Meier methodology

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Frequencies of toxicities will be tabulated according to CTCAE v4.03 to assess drug safety and tolerability

Outcome measures

Outcome data not reported

Adverse Events

Arm C (Regorafenib)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Arm C (Regorafenib) n=1 participants at risk Patients with RET or BRAF mutations
Infections and infestations Sepsis	100.0% 1/1 • Number of events 1 • Up to 3 months Analyses will be performed for all participants having received at least one dose of study drug. Only one participant was enrolled on this trial to Arm C (Regorafenib) for a total of 3 months. Adverse Events reported are for single accrued participant

Other adverse events

Other adverse events
Measure	Arm C (Regorafenib) n=1 participants at risk Patients with RET or BRAF mutations
Gastrointestinal disorders Diarrhea	100.0% 1/1 • Number of events 2 • Up to 3 months Analyses will be performed for all participants having received at least one dose of study drug. Only one participant was enrolled on this trial to Arm C (Regorafenib) for a total of 3 months. Adverse Events reported are for single accrued participant
Gastrointestinal disorders Nausea	100.0% 1/1 • Number of events 1 • Up to 3 months Analyses will be performed for all participants having received at least one dose of study drug. Only one participant was enrolled on this trial to Arm C (Regorafenib) for a total of 3 months. Adverse Events reported are for single accrued participant
General disorders Chills	100.0% 1/1 • Number of events 1 • Up to 3 months Analyses will be performed for all participants having received at least one dose of study drug. Only one participant was enrolled on this trial to Arm C (Regorafenib) for a total of 3 months. Adverse Events reported are for single accrued participant
Infections and infestations Skin infection	100.0% 1/1 • Number of events 1 • Up to 3 months Analyses will be performed for all participants having received at least one dose of study drug. Only one participant was enrolled on this trial to Arm C (Regorafenib) for a total of 3 months. Adverse Events reported are for single accrued participant
Metabolism and nutrition disorders Anorexia	100.0% 1/1 • Number of events 1 • Up to 3 months Analyses will be performed for all participants having received at least one dose of study drug. Only one participant was enrolled on this trial to Arm C (Regorafenib) for a total of 3 months. Adverse Events reported are for single accrued participant
Musculoskeletal and connective tissue disorders Arthralgia	100.0% 1/1 • Number of events 1 • Up to 3 months Analyses will be performed for all participants having received at least one dose of study drug. Only one participant was enrolled on this trial to Arm C (Regorafenib) for a total of 3 months. Adverse Events reported are for single accrued participant
Respiratory, thoracic and mediastinal disorders Dyspnea	100.0% 1/1 • Number of events 1 • Up to 3 months Analyses will be performed for all participants having received at least one dose of study drug. Only one participant was enrolled on this trial to Arm C (Regorafenib) for a total of 3 months. Adverse Events reported are for single accrued participant
Vascular disorders Hot flashes	100.0% 1/1 • Number of events 1 • Up to 3 months Analyses will be performed for all participants having received at least one dose of study drug. Only one participant was enrolled on this trial to Arm C (Regorafenib) for a total of 3 months. Adverse Events reported are for single accrued participant
Vascular disorders Hypertension	100.0% 1/1 • Number of events 3 • Up to 3 months Analyses will be performed for all participants having received at least one dose of study drug. Only one participant was enrolled on this trial to Arm C (Regorafenib) for a total of 3 months. Adverse Events reported are for single accrued participant

Additional Information

Dr. Adil Daud

University of California, San Francisco

Phone: (415) 353-7392

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place