This is an adaptive clinical trial that includes a dose escalation phase followed by a randomized controlled Phase 3 trial. The purpose of the dose escalation phase is to establish the Phase 3 dose of indoximod in combination with pembrolizumab or nivolumab in subjects with unresectable or metastatic melanoma and evaluate PK. Subsequently the efficacy, safety and tolerability of indoximod plus pembrolizumab or nivolumab versus placebo plus pembrolizumab or nivolumab will be studied in subjects with unresectable or metastatic melanoma in the Phase 3 portion of the trial. The phase 3 study will not proceed per Sponsor decision.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
21
Pembrolizumab will be administered intravenously every 3 weeks starting on day 1.
Nivolumab will be administered intravenously every 2 weeks starting on day 1.
Indoximod will be administered orally every 12 hours starting at Day 1
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Number of Participants With Regimen-limiting Toxicities (RLTs) of Indoximod in Combination With Pembrolizumab
Time frame: 28 Days
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