Back to resultsA Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma (NLG2107)
Primary Purpose
Melanoma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pembrolizumab
Nivolumab
Indoximod
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma focused on measuring Melanoma, Metastaic Melanoma
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.
Sites / Locations
- University of Iowa Hospital and Clinics
- Mayo Clinic - Rochester
- University of New Mexico Comprehensive Cancer Center
- Utah Cancer Specialists
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Pembrolizumab + Indoximiod
Nivolumab + Indoximiod
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Regimen-limiting Toxicities (RLTs) of Indoximod in Combination With Pembrolizumab
Secondary Outcome Measures
Full Information
NCT ID
NCT03301636
First Posted
September 29, 2017
Last Updated
September 2, 2022
Sponsor
NewLink Genetics Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03301636
Brief Title
A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma
Acronym
NLG2107
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Sponsor termination, not related to efficacy, safety or feasibility.
Study Start Date
December 8, 2017 (Actual)
Primary Completion Date
October 21, 2019 (Actual)
Study Completion Date
November 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NewLink Genetics Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Melanoma, Metastaic Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab + Indoximiod
Arm Type
Experimental
Arm Title
Nivolumab + Indoximiod
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda
Intervention Description
Pembrolizumab will be administered intravenously every 3 weeks starting on day 1.
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo
Intervention Description
Nivolumab will be administered intravenously every 2 weeks starting on day 1.
Intervention Type
Drug
Intervention Name(s)
Indoximod
Intervention Description
Indoximod will be administered orally every 12 hours starting at Day 1
Primary Outcome Measure Information:
Title
Number of Participants With Regimen-limiting Toxicities (RLTs) of Indoximod in Combination With Pembrolizumab
Time Frame
28 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of New Mexico Comprehensive Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma
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