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

NCT03301636 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: NLG2107
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Melanoma, Metastaic Melanoma

Outcome Measures

Primary Outcomes (1)

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

  28 Days

Study Arms (2)

Pembrolizumab + Indoximiod

EXPERIMENTAL

Drug: Pembrolizumab; Drug: Indoximod

Nivolumab + Indoximiod

EXPERIMENTAL

Drug: Nivolumab; Drug: Indoximod

Interventions

Pembrolizumab DRUG

Pembrolizumab will be administered intravenously every 3 weeks starting on day 1.

Also known as: Keytruda

Pembrolizumab + Indoximiod

Nivolumab DRUG

Nivolumab will be administered intravenously every 2 weeks starting on day 1.

Also known as: Opdivo

Nivolumab + Indoximiod

Indoximod DRUG

Indoximod will be administered orally every 12 hours starting at Day 1

Nivolumab + Indoximiod; Pembrolizumab + Indoximiod

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NewLink Genetics Corporation: lead

Study Sites (4)

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87102, United States

Location

Utah Cancer Specialists

Salt Lake City, Utah, 84102, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

pembrolizumab; Nivolumab; 1-methyltryptophan

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Lumos Pharma
• Organization: Lumos Pharma Inc. (Formerly NewLink Genetics)

clinical.trials@lumos-pharma.com

515-598-2921

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 4, 2017
• Study Start: December 8, 2017
• Primary Completion: October 21, 2019
• Study Completion: November 4, 2019
• Last Updated: September 27, 2022
• Results First Posted: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)