Status:
TERMINATED
A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma
Lead Sponsor:
NewLink Genetics Corporation
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2019
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03301636
Start Date
December 8 2017
End Date
November 4 2019
Last Update
September 27 2022
Active Locations (4)
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1
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
2
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
3
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States, 87102
4
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84102