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Study of IDO Inhibitor in Combination With Checkpoint Inhibitors for Adult Patients With Metastatic Melanoma
Sponsor: NewLink Genetics Corporation
Summary
To evaluate the preliminary efficacy of the established dose of indoximod in combination with immune checkpoint inhibition as measured by the best overall response rate (ORR) (complete response (CR) + partial response (PR))across both standard of care agents administered sequentially in patients with unresectable stage III or stage IV melanoma
Official title: A Phase 1/2 Study of the Concomitant Administration of Indoximod Plus Immune Checkpoint Inhibitors for Adult Patients With Advanced or Metastatic Melanoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
131
Start Date
2014-07
Completion Date
2019-07-03
Last Updated
2026-05-29
Healthy Volunteers
No
Interventions
Indoximod
Initial dose of 600mg BID by mouth with escalation planned to 1200mg BID by mouth Dose escalation: * If 0 of the 3 subjects forming the first cohort experience RLT, 1200mg BID cohort will be enrolled * If 1 of the 3 subjects in any cohort experiences a RLT, then enrollment into that cohort will increase to a total of 6 subjects * If \> 1 of the 3-6 subjects experience a RLT, then the MTD has been exceeded and further enrollment into the cohort will cease * If \>1 subject at 600mg BID experiences a RLT, the dose will be de-escalated to 400mg BID. If \>1 subject at this level experiences a RLT, one additional de-escalation to 200mg BID is allowed Dosing cycles are 21 days in length during the combination immunotherapy component (first 4 cycles) and 28 days during indoximod monotherapy. Patients will continue until they experience disease progression or limiting toxicity Phase 2 Treatment Plan (Cohort 2) Will receive fixed dose of indoximod determined in phase 1
Ipilimumab
Ipilimumab administered intravenously at 3 mg/kg every three weeks for a total of four doses.
Nivolumab
Nivolumab administered intravenously at 240 mg every 2 weeks.
Pembrolizumab
Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
Locations (6)
Augusta University
Augusta, Georgia, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Mayo Clinic
Rochester, Minnesota, United States
New Mexico Cancer Center Alliance
Albuquerque, New Mexico, United States
Penn State Hershey Cancer Institue
Hershey, Pennsylvania, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States