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

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 melanoma
    C1D1-C1D21, CDX-3379 D1Trametinib daily Biopsy (days 14-16)
  • Experimental: WT melanoma
    C1D1-C1D21, CDX-3379 D1Trametinib daily Biopsy (days 14-16)

Primary Outcome Measure

Objective Response Rate [ Time Frame: 48 Months ]

Locations (2)

FacilityCityStateZIPSite coordinators
New York University School of MedicineNew YorkNew York10016-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

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