NCT03301636

A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma

A Phase 2/3 (Adaptive Design) Study of the Concomitant Administration of Indoximod or Placebo Plus Pembrolizumab or Nivolumab in Adult Patients With Unresectable Stage III or Stage IV Malignant Melanoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: NewLink Genetics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab will be administered intravenously every 3 weeks starting on day 1.
DRUG	Nivolumab	Nivolumab will be administered intravenously every 2 weeks starting on day 1.
DRUG	Indoximod	Indoximod will be administered orally every 12 hours starting at Day 1

Timeline

• Start date: 2017-12-08
• Primary completion: 2019-10-21
• Completion: 2019-11-04
• First posted: 2017-10-04
• Last updated: 2022-09-27
• Results posted: 2022-09-27

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study