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

Melanoma Clinical Trial

— NLG2107  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03301636
• Other study ID #: NLG2107
• Status: Terminated
• Phase: Phase 2
• Start date: December 8, 2017
• Est. completion date: November 4, 2019

Study information

• Verified date: September 2022
• Source: Lumos Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: November 4, 2019
• Est. primary completion date: October 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have histologically- or cytologically-confirmed unresectable stage III or stage IV melanoma not amenable to local therapy

• At least one radiologically measurable lesion as per RECIST 1.1

• Have documentation of V600-activating BRAF mutation status or consent to BRAF V600 mutation testing during the screening period.

• ECOG performance status 0 or 1

• Ability to ingest oral medications

Exclusion Criteria:

• Has Ocular Melanoma

• Has received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy).

• Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or IDO1 inhibitor or any other antibody or drug specifically targeting checkpoint pathways other than anti-CTLA-4 which is permitted in the adjuvant setting.

• Has received prior adjuvant therapy, monoclonal antibody or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer)

• Has received prior radiotherapy within 2 weeks of therapy.

• Is pregnant or breast-feeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.

• Patients who have active, chronic, or on active treatment for Hep B or Hep C are excluded.

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• Pembrolizumab
Pembrolizumab will be administered intravenously every 3 weeks starting on day 1.
• Nivolumab
Nivolumab will be administered intravenously every 2 weeks starting on day 1.
• Indoximod
Indoximod will be administered orally every 12 hours starting at Day 1

Locations

Country	Name	City	State
United States	University of New Mexico Comprehensive Cancer Center	Albuquerque	New Mexico
United States	University of Iowa Hospital and Clinics	Iowa City	Iowa
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	Utah Cancer Specialists	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
NewLink Genetics Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Regimen-limiting Toxicities (RLTs) of Indoximod in Combination With Pembrolizumab		28 Days