drugset
drugset / Trial / NCT02073123

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

NCT02073123 ↗

Phase 1/2 Completed 131 enrolled NewLink Genetics Corporation
Non-randomizedSequentialOpen-labelTreatment

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

Timeline

Start
2014-07
Primary completion
2018-01-17
Completion
2019-07-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Indoximod Small molecule 200 mg Oral
Subject Indoximod Small molecule 400 mg Oral
Subject Indoximod Small molecule 600 mg Oral
Subject Indoximod Small molecule 1200 mg Oral
Subject Ipilimumab Monoclonal antibody 3 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 240 mg Intravenous
Subject Pembrolizumab Monoclonal antibody 2 mg/kg Intravenous

Indications

metastatic melanoma