A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma
Public ClinicalTrials.gov record NCT03301636. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03301636
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 21 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 8, 2017 (Actual)
- Primary completion
- Oct 21, 2019 (Actual)
- Completion
- Nov 4, 2019 (Actual)
- Last update posted
- Sep 27, 2022
2017 – 2019
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52242 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | — |
| University of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico | 87102 | — |
| Utah Cancer Specialists | Salt Lake City | Utah | 84102 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03301636, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 27, 2022 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03301636 live on ClinicalTrials.gov.