Trial Outcomes & Findings for A Study of Binimetinib and Encorafenib in Advanced BRAF Mutant Cancers (NCT NCT03843775)

NCT ID: NCT03843775

Last Updated: 2024-10-21

Results Overview

National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 5,

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

17 participants

Primary outcome timeframe

1 year

Results posted on

2024-10-21

Participant Flow

Participant milestones

Participant milestones
Measure
Dose Level 1
Encorafenib 450 mg oral QD and Binimetinib 45 mg PO BID
Dose Level 2
Encorafenib 450 mg oral QD and Binimetinib 60 mg oral BID
Overall Study
STARTED
4
13
Overall Study
COMPLETED
1
5
Overall Study
NOT COMPLETED
3
8

Reasons for withdrawal

Reasons for withdrawal
Measure
Dose Level 1
Encorafenib 450 mg oral QD and Binimetinib 45 mg PO BID
Dose Level 2
Encorafenib 450 mg oral QD and Binimetinib 60 mg oral BID
Overall Study
Adverse Event
1
1
Overall Study
Lack of Efficacy
2
6
Overall Study
Withdrawal by Subject
0
1

Baseline Characteristics

A Study of Binimetinib and Encorafenib in Advanced BRAF Mutant Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Dose Level 1
n=4 Participants
Encorafenib 450 mg oral QD and Binimetinib 45 mg PO BID
Dose Level 2
n=13 Participants
Encorafenib 450 mg oral QD and Binimetinib 60 mg oral BID
Total
n=17 Participants
Total of all reporting groups
Age, Continuous
66 years
n=5 Participants
65 years
n=7 Participants
65 years
n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
6 Participants
n=7 Participants
8 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
7 Participants
n=7 Participants
9 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3 Participants
n=5 Participants
11 Participants
n=7 Participants
14 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
White
3 Participants
n=5 Participants
11 Participants
n=7 Participants
14 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
4 Participants
n=5 Participants
13 Participants
n=7 Participants
17 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: DLTs only evaluated for Dose Level 1 cohort

National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 5,

Outcome measures

Outcome measures
Measure
Dose Level 1
n=4 Participants
Encorafenib 450 mg oral QD and Binimetinib 45 mg PO BID
Dose Level 2
Encorafenib 450 mg oral QD and Binimetinib 60 mg oral BID
Dose-limiting Toxicities (DLTs)
0 DLTs

PRIMARY outcome

Timeframe: 1 year

Population: ORR was only assessed for the Dose Level 2 group

Per RECIST Version 1.1

Outcome measures

Outcome measures
Measure
Dose Level 1
Encorafenib 450 mg oral QD and Binimetinib 45 mg PO BID
Dose Level 2
n=13 Participants
Encorafenib 450 mg oral QD and Binimetinib 60 mg oral BID
Objective Response Rate (Phase II)
6.7 percentage of participants
Interval 0.3 to 31.9

Adverse Events

Dose Level 1

Serious events: 1 serious events
Other events: 4 other events
Deaths: 4 deaths

Dose Level 2

Serious events: 3 serious events
Other events: 13 other events
Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure
Dose Level 1
n=4 participants at risk
Encorafenib 450 mg oral QD and Binimetinib 45 mg PO BID
Dose Level 2
n=13 participants at risk
Encorafenib 450 mg oral QD and Binimetinib 60 mg oral BID
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
0.00%
0/4 • 1 year
7.7%
1/13 • 1 year
Gastrointestinal disorders
Gastric Hemorrhage
0.00%
0/4 • 1 year
7.7%
1/13 • 1 year
General disorders
Fever
25.0%
1/4 • 1 year
0.00%
0/13 • 1 year
Renal and urinary disorders
Acute Kidney Injury
0.00%
0/4 • 1 year
7.7%
1/13 • 1 year
Gastrointestinal disorders
Diarrhea
0.00%
0/4 • 1 year
7.7%
1/13 • 1 year
Gastrointestinal disorders
Vomiting
0.00%
0/4 • 1 year
7.7%
1/13 • 1 year

Other adverse events

Other adverse events
Measure
Dose Level 1
n=4 participants at risk
Encorafenib 450 mg oral QD and Binimetinib 45 mg PO BID
Dose Level 2
n=13 participants at risk
Encorafenib 450 mg oral QD and Binimetinib 60 mg oral BID
Gastrointestinal disorders
Nausea
25.0%
1/4 • 1 year
53.8%
7/13 • 1 year
Gastrointestinal disorders
Gastrointestinal hemorrhage
25.0%
1/4 • 1 year
15.4%
2/13 • 1 year
Eye disorders
Blurred vision
25.0%
1/4 • 1 year
7.7%
1/13 • 1 year
Gastrointestinal disorders
Diarrhea
50.0%
2/4 • 1 year
30.8%
4/13 • 1 year
Eye disorders
Dry eye
25.0%
1/4 • 1 year
0.00%
0/13 • 1 year
Gastrointestinal disorders
Flatulence
25.0%
1/4 • 1 year
0.00%
0/13 • 1 year
General disorders
Fever
25.0%
1/4 • 1 year
0.00%
0/13 • 1 year
Vascular disorders
Thrombotic event
25.0%
1/4 • 1 year
0.00%
0/13 • 1 year
Skin and subcutaneous tissue disorders
Rash maculopapular
25.0%
1/4 • 1 year
0.00%
0/13 • 1 year
Gastrointestinal disorders
Vomiting
0.00%
0/4 • 1 year
46.2%
6/13 • 1 year
Investigations
Alkaline phosphatase increased
0.00%
0/4 • 1 year
38.5%
5/13 • 1 year
Investigations
Creatinine phosphokinase increased
0.00%
0/4 • 1 year
30.8%
4/13 • 1 year
Eye disorders
Subretinal fluid
0.00%
0/4 • 1 year
30.8%
4/13 • 1 year
Investigations
AST increase
0.00%
0/4 • 1 year
30.8%
4/13 • 1 year
Investigations
ALT increase
0.00%
0/4 • 1 year
30.8%
4/13 • 1 year
Investigations
Creatinine kinase
0.00%
0/4 • 1 year
23.1%
3/13 • 1 year
General disorders
Fatigue
0.00%
0/4 • 1 year
23.1%
3/13 • 1 year
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/4 • 1 year
15.4%
2/13 • 1 year
Metabolism and nutrition disorders
Hypermagnesemia
0.00%
0/4 • 1 year
15.4%
2/13 • 1 year
Skin and subcutaneous tissue disorders
Pruritis
0.00%
0/4 • 1 year
7.7%
1/13 • 1 year
Eye disorders
Central serous chorioretinopathy
0.00%
0/4 • 1 year
7.7%
1/13 • 1 year
Skin and subcutaneous tissue disorders
Xeroderma
0.00%
0/4 • 1 year
7.7%
1/13 • 1 year
Skin and subcutaneous tissue disorders
Subcutaneous nodules
0.00%
0/4 • 1 year
7.7%
1/13 • 1 year
Skin and subcutaneous tissue disorders
Photosensitivity
0.00%
0/4 • 1 year
7.7%
1/13 • 1 year
Skin and subcutaneous tissue disorders
Impetigo
0.00%
0/4 • 1 year
7.7%
1/13 • 1 year
Gastrointestinal disorders
Constipation
0.00%
0/4 • 1 year
7.7%
1/13 • 1 year
Nervous system disorders
Headache
0.00%
0/4 • 1 year
7.7%
1/13 • 1 year
Blood and lymphatic system disorders
Anemia
0.00%
0/4 • 1 year
7.7%
1/13 • 1 year
Nervous system disorders
Dysgeusia
0.00%
0/4 • 1 year
7.7%
1/13 • 1 year
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/4 • 1 year
7.7%
1/13 • 1 year
Metabolism and nutrition disorders
Hypomagnesemia
0.00%
0/4 • 1 year
7.7%
1/13 • 1 year

Additional Information

Dr. Rona Yaeger MD

Memorial Sloan Kettering Cancer Center

Phone: 646-888-5109

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place