A Phase II Trial of Sunitinib and Nivolumab for KIT-mutated Advanced Melanoma

Part of paid clinical trials in San Francisco, California.

Sponsor
California Pacific Medical Center Research Institute
Study ID
NCT02400385
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • sunitinib — DRUG
    sunitinib 50mg/day po, 4 weeks on 2 weeks off
  • nivolumab — DRUG
    nivolumab 3mg/kg IV ever 2 weeks

Study Details

This will be a phase II trial of the combination of sunitinib and nivolumab in patients with advanced, measurable, metastatic melanoma who harbor mutations in the KIT gene in their tumors. It is a multi-center trial using the FDA-approved doses of both sunitinib and nivolumab. Sunitinib will be provided by Pfizer. Endpoint is RECIST response rate and PFS.

Key Dates

Start date
Oct 31, 2014
Status verified
Sep 2016
Primary completion
Dec 31, 2015
Completion
Dec 31, 2015

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Sunitinib 50mg/day, 4 weeks on and 2 weeks off, and concurrent nivolumab 3mg/kg iv every 2 weeks, both for three years if tolerated.

Primary Outcome Measure

Objective response by RECIST 1.1 [ Time Frame: 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
California Pacific Medical Center Research InstituteSan FranciscoCalifornia94115-

Find similar trials in San Francisco, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
California Pacific Medical Center Research Institute· San Francisco, CA

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