Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03301636 · ClinicalTrials.gov registry record · Phase 2
A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma
A Phase 2 study, sponsored by NewLink Genetics Corporation.
- Terminated
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT03301636 is a Phase 2 study that was terminated before completion, run by NewLink Genetics Corporation. The registered enrollment target is 21 participants.
The verdict
NCT03301636, a Phase 2 study, was terminated before completion, sponsored by NewLink Genetics Corporation.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study 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.
Interventions
- DRUG Pembrolizumab
- DRUG Nivolumab
- DRUG Indoximod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2017-12-08 |
| Est. Completion | 2019-11-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03301636
The ClinicalTrials.gov registry entry for NCT03301636 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NewLink Genetics Corporation, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03301636 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03301636 about?
NCT03301636 is a clinical study titled "A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma". 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 metastati...
What is the current status of trial NCT03301636?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2017-12-08. Estimated completion is 2019-11-04.
What interventions are being tested in trial NCT03301636?
The interventions under investigation include: Pembrolizumab (DRUG), Nivolumab (DRUG), Indoximod (DRUG).
Who is sponsoring clinical trial NCT03301636?
This trial is sponsored by NewLink Genetics Corporation, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.