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
Part of paid clinical trials in New York, New York.
- Sponsor
- NYU Langone Health
- Study ID
- NCT03580382
- Phase
- PHASE1/PHASE2
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- Trametinib daily Until PD — DRUG1.0 mg daily
- CDX-3379 (ERBB3 antibody) — DRUG15mg/kg IV Q3W
Study Details
The main goal of this study is to test if it is safe and effective to give CDX-3379 together to treat advanced melanoma in patients with the NRAS mutation and BRAF/NRAS wildtype.
Key Dates
- Start date
- Jul 6, 2018
- Status verified
- May 2020
- Primary completion
- Sep 26, 2018
- Completion
- Sep 26, 2018
Study Design
- Enrollment
- 3 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: NRAS mutant melanomaC1D1-C1D21, CDX-3379 D1Trametinib daily Biopsy (days 14-16)
- Experimental: WT melanomaC1D1-C1D21, CDX-3379 D1Trametinib daily Biopsy (days 14-16)
Primary Outcome Measure
Objective Response Rate [ Time Frame: 48 Months ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | - |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | - |
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