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Trial record 8 of 2177 for:    Melanoma

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 : Recruiting
First Posted : October 4, 2017
Last Update Posted : January 9, 2018
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.

Condition or disease Intervention/treatment Phase
Melanoma Drug: Pembrolizumab Drug: Nivolumab Drug: Indoximod Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 624 participants
Allocation: 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.

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

Active Comparator: Pembrolizumab + Placebo Drug: Pembrolizumab
Pembrolizumab will be administered intravenously every 3 weeks starting on day 1.

Drug: Placebo
Placebo 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.

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

Active Comparator: Nivolumab + Placebo Drug: Nivolumab
Nivolumab will be administered intravenously every 2 weeks starting on day 1.

Drug: Placebo
Placebo 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 ]
  2. Progression-free-survival defined from date of patient's randomization until the earliest date of disease progression or death [ Time Frame: Up to approximately 18 months ]
    Will be determined using RECIST 1.1 criteria, or death, whichever comes first.

  3. Overall survival defined from date of patient's randomization until death from any cause. [ Time Frame: Up to approximately 3 years ]

Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: Assessed every 8-10 weeks for the duration of study participation which is estimated to be 24 months ]
    The proportion of subjects who have experienced complete response or partial response based on RECIST 1.1.

  2. Safety and tolerability, as assessed by the percentage of subjects with adverse events. [ Time Frame: From start of treatment through 30 days after end of treatment, up to 25 months. ]


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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


Contacts
Contact: Eugene Kennedy, MD 515-598-2935 clinicaltrials@linkp.com

Locations
United States, Iowa
University of Iowa Hospital and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
NewLink Genetics Corporation

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: January 9, 2018
Last Verified: January 2018
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

Keywords provided by NewLink Genetics Corporation:
Melanoma, Metastaic Melanoma

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Pembrolizumab
Nivolumab
Antibodies, Monoclonal
Tryptophan
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs