Trial Outcomes & Findings for Study of CDX-3379, a Human Monoclonal Antibody Targeting ERBB3, in Combination With the MEK Inhibitor, Trametinib, in Patients With Advanced Stage NRAS Mutant and BRAF/NRAS Wildtype (WT) Melanoma (NCT NCT03580382)
NCT ID: NCT03580382
Last Updated: 2020-05-20
Results Overview
response rate, will be compared with the historically reported response rate for the single agent trametinib in NRAS and BRAF/NRAS WT melenoma
TERMINATED
PHASE1/PHASE2
3 participants
48 Months
2020-05-20
Participant Flow
Participant milestones
| Measure |
NRAS Mutant Melanoma
C1D1-C1D21, CDX-3379 D1Trametinib daily Biopsy (days 14-16)
Trametinib daily Until PD: 1.0 mg daily
CDX-3379 (ERBB3 antibody): 15mg/kg IV Q3W
|
WT Melanoma
C1D1-C1D21, CDX-3379 D1Trametinib daily Biopsy (days 14-16)
Trametinib daily Until PD: 1.0 mg daily
CDX-3379 (ERBB3 antibody): 15mg/kg IV Q3W
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
NRAS Mutant Melanoma
C1D1-C1D21, CDX-3379 D1Trametinib daily Biopsy (days 14-16)
Trametinib daily Until PD: 1.0 mg daily
CDX-3379 (ERBB3 antibody): 15mg/kg IV Q3W
|
WT Melanoma
C1D1-C1D21, CDX-3379 D1Trametinib daily Biopsy (days 14-16)
Trametinib daily Until PD: 1.0 mg daily
CDX-3379 (ERBB3 antibody): 15mg/kg IV Q3W
|
|---|---|---|
|
Overall Study
Early Termination of Study
|
0
|
3
|
Baseline Characteristics
Study of CDX-3379, a Human Monoclonal Antibody Targeting ERBB3, in Combination With the MEK Inhibitor, Trametinib, in Patients With Advanced Stage NRAS Mutant and BRAF/NRAS Wildtype (WT) Melanoma
Baseline characteristics by cohort
| Measure |
NRAS Mutant Melanoma
C1D1-C1D21, CDX-3379 D1Trametinib daily Biopsy (days 14-16)
Trametinib daily Until PD: 1.0 mg daily
CDX-3379 (ERBB3 antibody): 15mg/kg IV Q3W
|
WT Melanoma
n=3 Participants
C1D1-C1D21, CDX-3379 D1Trametinib daily Biopsy (days 14-16)
Trametinib daily Until PD: 1.0 mg daily
CDX-3379 (ERBB3 antibody): 15mg/kg IV Q3W
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
—
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
—
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
—
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
—
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
—
|
3 participants
n=41 Participants
|
3 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 48 MonthsPopulation: Study was terminated prior to analysis.
response rate, will be compared with the historically reported response rate for the single agent trametinib in NRAS and BRAF/NRAS WT melenoma
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 48 MonthsPopulation: Study was terminated prior to analysis.
Survival data will be collectedvia telephone or clinic visits every 3 months (+10 days) from the date of last treatment, and median will be estimated using Kaplan-Meier approach
Outcome measures
Outcome data not reported
Adverse Events
WT Melanoma
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rachael Keller, Sr. Regulatory Specialist
NYU Langone Health - PCC CTO
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place