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COMPLETED
NCT02073123
PHASE1/PHASE2

Study of IDO Inhibitor in Combination With Checkpoint Inhibitors for Adult Patients With Metastatic Melanoma

Sponsor: NewLink Genetics Corporation

View on ClinicalTrials.gov

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

DRUG

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

DRUG

Ipilimumab

Ipilimumab administered intravenously at 3 mg/kg every three weeks for a total of four doses.

DRUG

Nivolumab

Nivolumab administered intravenously at 240 mg every 2 weeks.

DRUG

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