Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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

Indoximod

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.

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

NewLink Genetics Corporation

The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.

Pembrolizumab 200mg Q3 weeks and Indoximod 600mg Q12 hr

Dose Level 1

Pembrolizumab 200mg Q3 weeks and Indoximod 1200mg Q12 hr

Dose Level 2

Pembrolizumab 200mg Q3 weeks and Indoximod 1800mg Q12 hr

Dose Level 3

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Height

Weight

Lumos Pharma

Number of Participants With Regimen-limiting Toxicities (RLTs) of Indoximod in Combination With Pembrolizumab

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma	NCT03301636	Melanoma	Pembrolizumab Nivolumab Indoximod	18 Years -	Lumos Pharma
A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma	NCT03301636	Melanoma	Pembrolizumab Nivolumab Indoximod	18 Years -	Lumos Pharma

Spots Global Cancer Trial Database for melanoma, metastaic melanoma