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
| 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
| 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
| 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 yearPopulation: DLTs only evaluated for Dose Level 1 cohort
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 5,
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 yearPopulation: ORR was only assessed for the Dose Level 2 group
Per RECIST Version 1.1
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
| 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
| 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
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place