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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: Clinical Trial Phase 2 study, sponsored by NewLink Genetics Corporation.
NCT03301636 is a Phase 2 study that was terminated before completion, run by NewLink Genetics Corporation. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT03301636 stopped before completion
NCT03301636 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03301636 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03301636's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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