Trial Outcomes & Findings for Safety and Efficacy in Participants With Metastatic BRAF-mutant Melanoma Treated With Encorafenib With and Without Binimetinib in Combination With Nivolumab and Low-dose Ipilimuma (NCT NCT04655157)
NCT ID: NCT04655157
Last Updated: 2024-05-23
Results Overview
Determination of recommended phase II dose (RP2D) of triple therapy in patients treated with 300mg encorafenib, 3mg/kg nivolumab and 1mg/kg ipilimumab via the frequency of DLTs that are classified as either possibly, probably, or definitely related to study treatment according to NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0). Number of distinct patients experiencing Adverse events and DLTs. This will be done with continuous Bayesian toxicity monitoring.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
2 participants
Primary outcome timeframe
Up to 6 weeks (DLT evaluation period)
Results posted on
2024-05-23
Participant Flow
Participant milestones
| Measure |
Phase 1 (Cohort 1): 300mg Encorafenib + 3mg/kg Nivolumab + 1 mg/kg Ipilimumab
Patients will be treated with 300mg encorafenib and 3mg/kg nivolumab and 1 mg/kg ipilimumab (triple therapy).
encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
|
Phase 1 (Cohort 2): 450mg Encorafenib + 45mg Binimetinib + 3mg/kg Nivolumab + 1mg/kg Ipilimumab
Patients will be treated with 450mg encorafenib, 45mg binimetinib, 3mg/kg nivolumab and 1mg/kg ipilimumab (quadruple therapy).
encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
binimetinib: A small molecule, selective inhibitor of MEK, a central kinase in the tumor-promoting MAPK pathway that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy in Participants With Metastatic BRAF-mutant Melanoma Treated With Encorafenib With and Without Binimetinib in Combination With Nivolumab and Low-dose Ipilimuma
Baseline characteristics by cohort
| Measure |
Phase 1 (Cohort 1): 300mg Encorafenib + 3mg/kg Nivolumab + 1 mg/kg Ipilimumab
n=1 Participants
Patients will be treated with 300mg encorafenib and 3mg/kg nivolumab and 1 mg/kg ipilimumab (triple therapy).
encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
|
Phase 1 (Cohort 2): 450mg Encorafenib + 45mg Binimetinib + 3mg/kg Nivolumab + 1mg/kg Ipilimumab
n=1 Participants
Patients will be treated with 450mg encorafenib, 45mg binimetinib, 3mg/kg nivolumab and 1mg/kg ipilimumab (quadruple therapy).
encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
binimetinib: A small molecule, selective inhibitor of MEK, a central kinase in the tumor-promoting MAPK pathway that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
n=5 Participants
|
65 years
n=7 Participants
|
48.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
PRIMARY outcome
Timeframe: Up to 6 weeks (DLT evaluation period)Population: Patients that received treatment
Determination of recommended phase II dose (RP2D) of triple therapy in patients treated with 300mg encorafenib, 3mg/kg nivolumab and 1mg/kg ipilimumab via the frequency of DLTs that are classified as either possibly, probably, or definitely related to study treatment according to NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0). Number of distinct patients experiencing Adverse events and DLTs. This will be done with continuous Bayesian toxicity monitoring.
Outcome measures
| Measure |
Phase 1 (Cohort 1): 300mg Encorafenib + 3mg/kg Nivolumab + 1 mg/kg Ipilimumab
n=1 Participants
Patients will be treated with 300mg encorafenib and 3mg/kg nivolumab and 1 mg/kg ipilimumab (triple therapy).
encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
|
Phase 1 (Cohort 2): 450mg Encorafenib + 45mg Binimetinib + 3mg/kg Nivolumab + 1mg/kg Ipilimumab
Patients will be treated with 450mg encorafenib, 45mg binimetinib, 3mg/kg nivolumab and 1mg/kg ipilimumab (quadruple therapy).
encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
binimetinib: A small molecule, selective inhibitor of MEK, a central kinase in the tumor-promoting MAPK pathway that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
|
|---|---|---|
|
Recommended Phase II Dose (RP2D) of Encorafenib + Nivolumab + Ipilimumab
|
NA mg
RP2D cannot be determined due to insufficient number of participants
|
—
|
PRIMARY outcome
Timeframe: Up to 6 weeks (DLT evaluation period)Population: Patients that received treatment
Determination of recommended phase II dose (RP2D) of quadruple therapy in patients treated with 450mg encorafenib, 45mg binimetinib, 3mg/kg nivolumab and 1mg/kg ipilimumab via the frequency of DLTs that are classified as either possibly, probably, or definitely related to study treatment according to NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0). Number of distinct patients experiencing Adverse events and DLTs. This will be done with continuous Bayesian toxicity monitoring.
Outcome measures
| Measure |
Phase 1 (Cohort 1): 300mg Encorafenib + 3mg/kg Nivolumab + 1 mg/kg Ipilimumab
n=1 Participants
Patients will be treated with 300mg encorafenib and 3mg/kg nivolumab and 1 mg/kg ipilimumab (triple therapy).
encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
|
Phase 1 (Cohort 2): 450mg Encorafenib + 45mg Binimetinib + 3mg/kg Nivolumab + 1mg/kg Ipilimumab
Patients will be treated with 450mg encorafenib, 45mg binimetinib, 3mg/kg nivolumab and 1mg/kg ipilimumab (quadruple therapy).
encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
binimetinib: A small molecule, selective inhibitor of MEK, a central kinase in the tumor-promoting MAPK pathway that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
|
|---|---|---|
|
Recommended Phase II Dose (RP2D) of Encorafenib + Binimetinib + Nivolumab + Ipilimumab
|
NA mg
RP2D cannot be determined due to insufficient number of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 15 monthsPopulation: Patients receiving at least one dose any drug and/or evaluable for response
Number of patients with Complete response \[CR\] + partial response \[PR\], per RECIST v1.1 criteria . Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. For non-target lesions: Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10mm short axis); PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase 1 (Cohort 1): 300mg Encorafenib + 3mg/kg Nivolumab + 1 mg/kg Ipilimumab
n=1 Participants
Patients will be treated with 300mg encorafenib and 3mg/kg nivolumab and 1 mg/kg ipilimumab (triple therapy).
encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
|
Phase 1 (Cohort 2): 450mg Encorafenib + 45mg Binimetinib + 3mg/kg Nivolumab + 1mg/kg Ipilimumab
n=1 Participants
Patients will be treated with 450mg encorafenib, 45mg binimetinib, 3mg/kg nivolumab and 1mg/kg ipilimumab (quadruple therapy).
encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
binimetinib: A small molecule, selective inhibitor of MEK, a central kinase in the tumor-promoting MAPK pathway that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
|
|---|---|---|
|
Response Rate Per RECIST v1.1 Criteria
Complete Response (CR)
|
0 Participants
|
0 Participants
|
|
Response Rate Per RECIST v1.1 Criteria
Partial Response (PR)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 15 monthsPopulation: Patients receiving at least one dose any drug and/or evaluable for response
Number of patients with Complete response \[CR\] + partial response \[PR\] + stable disease \[SD\] \>6 months) per RANO-BM criteria. Per RANO, CR: No lesion present; PR: ≥30% decrease in sum LD relative to baseline; SD: \<30% decrease relative to baseline, but \<20% increase in sum LD relative to nadir.
Outcome measures
| Measure |
Phase 1 (Cohort 1): 300mg Encorafenib + 3mg/kg Nivolumab + 1 mg/kg Ipilimumab
n=1 Participants
Patients will be treated with 300mg encorafenib and 3mg/kg nivolumab and 1 mg/kg ipilimumab (triple therapy).
encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
|
Phase 1 (Cohort 2): 450mg Encorafenib + 45mg Binimetinib + 3mg/kg Nivolumab + 1mg/kg Ipilimumab
n=1 Participants
Patients will be treated with 450mg encorafenib, 45mg binimetinib, 3mg/kg nivolumab and 1mg/kg ipilimumab (quadruple therapy).
encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
binimetinib: A small molecule, selective inhibitor of MEK, a central kinase in the tumor-promoting MAPK pathway that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
|
|---|---|---|
|
Central Nervous System (CNS) Clinical Benefit Rate (CBR)
Partial Reponse
|
0 Participants
|
0 Participants
|
|
Central Nervous System (CNS) Clinical Benefit Rate (CBR)
Complete Response
|
0 Participants
|
0 Participants
|
|
Central Nervous System (CNS) Clinical Benefit Rate (CBR)
Stable Disease
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months (per patient)Population: Patients receiving at least one dose of (any) study drug.
Number of (distinct) participants with ≤ Grade 3 Adverse Events or Serious Adverse Events that are possibly, probably or definitely related to study treatment per the Criteria for Adverse Events version 5 (CTCAEv5).
Outcome measures
| Measure |
Phase 1 (Cohort 1): 300mg Encorafenib + 3mg/kg Nivolumab + 1 mg/kg Ipilimumab
n=1 Participants
Patients will be treated with 300mg encorafenib and 3mg/kg nivolumab and 1 mg/kg ipilimumab (triple therapy).
encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
|
Phase 1 (Cohort 2): 450mg Encorafenib + 45mg Binimetinib + 3mg/kg Nivolumab + 1mg/kg Ipilimumab
n=1 Participants
Patients will be treated with 450mg encorafenib, 45mg binimetinib, 3mg/kg nivolumab and 1mg/kg ipilimumab (quadruple therapy).
encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
binimetinib: A small molecule, selective inhibitor of MEK, a central kinase in the tumor-promoting MAPK pathway that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
|
|---|---|---|
|
Adverse Events at Least Probably Related to Treatment
Fever
|
1 Participants
|
0 Participants
|
|
Adverse Events at Least Probably Related to Treatment
Hypertension
|
1 Participants
|
0 Participants
|
|
Adverse Events at Least Probably Related to Treatment
Arthralgia
|
1 Participants
|
0 Participants
|
|
Adverse Events at Least Probably Related to Treatment
Myalgia
|
1 Participants
|
0 Participants
|
|
Adverse Events at Least Probably Related to Treatment
Hypotension
|
1 Participants
|
0 Participants
|
|
Adverse Events at Least Probably Related to Treatment
Anemia
|
1 Participants
|
0 Participants
|
|
Adverse Events at Least Probably Related to Treatment
ALT Increased
|
1 Participants
|
0 Participants
|
|
Adverse Events at Least Probably Related to Treatment
Dyspnea
|
1 Participants
|
0 Participants
|
|
Adverse Events at Least Probably Related to Treatment
Hypokalemia
|
1 Participants
|
0 Participants
|
|
Adverse Events at Least Probably Related to Treatment
Lymphocyte decreased
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 15 monthsPopulation: Includes patients receiving at least one dose any drug and/or evaluable for response
The length of time during and after study treatment that each patient lived with cancer but it does not get worse. PFS is one way to assess how the treatment works. Per RECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, PD: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Phase 1 (Cohort 1): 300mg Encorafenib + 3mg/kg Nivolumab + 1 mg/kg Ipilimumab
n=1 Participants
Patients will be treated with 300mg encorafenib and 3mg/kg nivolumab and 1 mg/kg ipilimumab (triple therapy).
encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
|
Phase 1 (Cohort 2): 450mg Encorafenib + 45mg Binimetinib + 3mg/kg Nivolumab + 1mg/kg Ipilimumab
n=1 Participants
Patients will be treated with 450mg encorafenib, 45mg binimetinib, 3mg/kg nivolumab and 1mg/kg ipilimumab (quadruple therapy).
encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
binimetinib: A small molecule, selective inhibitor of MEK, a central kinase in the tumor-promoting MAPK pathway that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
6 months
|
3 months
|
Adverse Events
Phase 1 (Cohort 1): 300mg Encorafenib + 3mg/kg Nivolumab + 1 mg/kg Ipilimumab
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 1 (Cohort 2): 450mg Encorafenib + 45mg Binimetinib + 3mg/kg Nivolumab + 1mg/kg Ipilimumab
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1 (Cohort 1): 300mg Encorafenib + 3mg/kg Nivolumab + 1 mg/kg Ipilimumab
n=1 participants at risk
Patients will be treated with 300mg encorafenib and 3mg/kg nivolumab and 1 mg/kg ipilimumab (triple therapy).
encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
|
Phase 1 (Cohort 2): 450mg Encorafenib + 45mg Binimetinib + 3mg/kg Nivolumab + 1mg/kg Ipilimumab
n=1 participants at risk
Patients will be treated with 450mg encorafenib, 45mg binimetinib, 3mg/kg nivolumab and 1mg/kg ipilimumab (quadruple therapy).
encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
binimetinib: A small molecule, selective inhibitor of MEK, a central kinase in the tumor-promoting MAPK pathway that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
|
|---|---|---|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
100.0%
1/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
1/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
0.00%
0/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
100.0%
1/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
100.0%
1/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
100.0%
1/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
Other adverse events
| Measure |
Phase 1 (Cohort 1): 300mg Encorafenib + 3mg/kg Nivolumab + 1 mg/kg Ipilimumab
n=1 participants at risk
Patients will be treated with 300mg encorafenib and 3mg/kg nivolumab and 1 mg/kg ipilimumab (triple therapy).
encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
|
Phase 1 (Cohort 2): 450mg Encorafenib + 45mg Binimetinib + 3mg/kg Nivolumab + 1mg/kg Ipilimumab
n=1 participants at risk
Patients will be treated with 450mg encorafenib, 45mg binimetinib, 3mg/kg nivolumab and 1mg/kg ipilimumab (quadruple therapy).
encorafenib: A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
nivolumab: A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
ipilimumab: A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
binimetinib: A small molecule, selective inhibitor of MEK, a central kinase in the tumor-promoting MAPK pathway that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
1/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
0.00%
0/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
100.0%
1/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
0.00%
0/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
|
General disorders
Fever
|
100.0%
1/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
0.00%
0/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
|
Vascular disorders
Hypotension
|
100.0%
1/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
0.00%
0/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
0.00%
0/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
|
Investigations
ALT Increased
|
100.0%
1/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
0.00%
0/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
1/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
0.00%
0/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
100.0%
1/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
0.00%
0/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
|
Vascular disorders
Hypertension
|
100.0%
1/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
0.00%
0/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
|
Investigations
Lymphocyte decreased
|
100.0%
1/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
0.00%
0/1 • Adverse Events data were collected for up to 6 months per patient and up to 15 months overall duration for study.
|
Additional Information
Barbara M. Stadterman, MPH, MCCR
UPMC Hillman Cancer Center
Phone: 412-647-5554
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place