A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma (NLG2107)
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ClinicalTrials.gov Identifier: NCT03301636 |
Recruitment Status :
Terminated
(Sponsor termination, not related to efficacy, safety or feasibility.)
First Posted : October 4, 2017
Last Update Posted : June 5, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Melanoma | Drug: Pembrolizumab Drug: Nivolumab Drug: Indoximod | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | December 8, 2017 |
Actual Primary Completion Date : | October 21, 2019 |
Actual Study Completion Date : | November 4, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Pembrolizumab + Indoximiod |
Drug: Pembrolizumab
Pembrolizumab will be administered intravenously every 3 weeks starting on day 1.
Other Name: Keytruda Drug: Indoximod Indoximod will be administered orally every 12 hours starting at Day 1 |
Experimental: Nivolumab + Indoximiod |
Drug: Nivolumab
Nivolumab will be administered intravenously every 2 weeks starting on day 1.
Other Name: Opdivo Drug: Indoximod Indoximod will be administered orally every 12 hours starting at Day 1 |
- Evaluation of safety and tolerability of indoximod in combination with pembrolizumab or nivolumab measured by number of subjects with regimen-limiting toxicities (RLTs) [ Time Frame: 28 Days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301636
United States, Iowa | |
University of Iowa Hospital and Clinics | |
Iowa City, Iowa, United States, 52242 | |
United States, Minnesota | |
Mayo Clinic - Rochester | |
Rochester, Minnesota, United States, 55905 | |
United States, New Mexico | |
University of New Mexico Comprehensive Cancer Center | |
Albuquerque, New Mexico, United States, 87102 | |
United States, Utah | |
Utah Cancer Specialists | |
Salt Lake City, Utah, United States, 84102 |
Responsible Party: | NewLink Genetics Corporation |
ClinicalTrials.gov Identifier: | NCT03301636 |
Other Study ID Numbers: |
NLG2107 |
First Posted: | October 4, 2017 Key Record Dates |
Last Update Posted: | June 5, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Melanoma, Metastaic Melanoma |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue |
Nevi and Melanomas Pembrolizumab Nivolumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |