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A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma (NLG2107)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03301636
Recruitment Status : Active, not recruiting
First Posted : October 4, 2017
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
NewLink Genetics Corporation

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.


Condition or disease Intervention/treatment Phase
Melanoma Drug: Pembrolizumab Drug: Nivolumab Drug: Indoximod Phase 2

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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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
NewLink Genetics Corporation

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Responsible Party: NewLink Genetics Corporation
ClinicalTrials.gov Identifier: NCT03301636     History of Changes
Other Study ID Numbers: NLG2107
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NewLink Genetics Corporation:
Melanoma, Metastaic Melanoma
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Nivolumab
Pembrolizumab
Tryptophan
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs