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

NCT02400385 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-02-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

sunitinib

sunitinib 50mg/day po, 4 weeks on 2 weeks off

DRUG

nivolumab

nivolumab 3mg/kg IV ever 2 weeks

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • California Pacific Medical Center Research Institute

    lead OTHER

Principal Investigators

  • David R Minor, M.D. · California Pacific Medical Center Research Institute

  • Kevin B Kim, MD · California Pacific Melanoma Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02400385 on ClinicalTrials.gov