Clinical Trials /

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

NCT03301636

Description:

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.

Related Conditions:
  • Melanoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma
  • 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 IDs

  • ORG STUDY ID: NLG2107
  • NCT ID: NCT03301636

Conditions

  • Melanoma

Interventions

DrugSynonymsArms
PembrolizumabPembrolizumab + Indoximiod
NivolumabNivolumab + Indoximiod
IndoximodPembrolizumab + Indoximiod
PlaceboPembrolizumab + Placebo

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Pembrolizumab + IndoximiodExperimental
  • Pembrolizumab
  • Indoximod
Pembrolizumab + PlaceboActive Comparator
  • Pembrolizumab
  • Placebo
Nivolumab + IndoximiodExperimental
  • Nivolumab
  • Indoximod
Nivolumab + PlaceboActive Comparator
  • Nivolumab
  • Placebo

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:Will be determined using RECIST 1.1 criteria, or death, whichever comes first.

Secondary Outcome Measures

Measure:Objective response rate
Time Frame:Assessed every 8-10 weeks for the duration of study participation which is estimated to be 24 months
Safety Issue:
Description:The proportion of subjects who have experienced complete response or partial response based on RECIST 1.1.
Measure: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.
Safety Issue:
Description:

Details

Phase:Phase 2/Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:NewLink Genetics Corporation

Trial Keywords

  • Melanoma, Metastaic Melanoma

Last Updated

January 5, 2018