Trial · NCT03301636
A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma
NCT03301636, Phase 2, Terminated, NewLink Genetics Corporation; results first posted 2022-09-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma. Trials, record NCT03301636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03301636
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma
- NCT number
- NCT03301636
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- NewLink Genetics Corporation
- Conditions
- Melanoma
- Interventions
- Pembrolizumab, Nivolumab, Indoximod
- First posted
- 2017-10-04
- Last updated
- 2022-09-27
- Results first posted
- 2022-09-27
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Regimen-limiting Toxicities (RLTs) of Indoximod in Combination With Pembrolizumab | 28 Days |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Regimen-limiting Toxicities (RLTs) of Indoximod in Combination With Pembrolizumab | 28 Days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Regimen-limiting Toxicities (RLTs) of Indoximod in Combination With Pembrolizumab | Dose Level 1 | 1 | Participants | ||
| Number of Participants With Regimen-limiting Toxicities (RLTs) of Indoximod in Combination With Pembrolizumab | Dose Level 2 | 1 | Participants | ||
| Number of Participants With Regimen-limiting Toxicities (RLTs) of Indoximod in Combination With Pembrolizumab | Dose Level 3 | 0 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Level 1 | 7 | |
| Overall Study | STARTED | Dose Level 2 | 6 | |
| Overall Study | STARTED | Dose Level 3 | 8 | |
| Overall Study | COMPLETED | Dose Level 1 | 7 | |
| Overall Study | COMPLETED | Dose Level 2 | 6 | |
| Overall Study | COMPLETED | Dose Level 3 | 8 | |
| Overall Study | NOT COMPLETED | Dose Level 1 | 0 | |
| Overall Study | NOT COMPLETED | Dose Level 2 | 0 | |
| Overall Study | NOT COMPLETED | Dose Level 3 | 0 |
Source ClinicalTrials.gov
Adverse events279
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Rash | Skin and subcutaneous tissue disorders | Dose Level 1 | 2 | 7 | 2 |
| other | Rash | Skin and subcutaneous tissue disorders | Dose Level 2 | 2 | 6 | 2 |
| other | Rash | Skin and subcutaneous tissue disorders | Dose Level 3 | 3 | 7 | 3 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Dose Level 1 | 2 | 7 | 2 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Dose Level 2 | 3 | 6 | 3 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Dose Level 3 | 1 | 7 | 1 |
| other | Rash maculo-papular | Skin and subcutaneous tissue disorders | Dose Level 1 | 0 | 7 | 0 |
| other | Rash maculo-papular | Skin and subcutaneous tissue disorders | Dose Level 2 | 0 | 6 | 0 |
| other | Rash maculo-papular | Skin and subcutaneous tissue disorders | Dose Level 3 | 2 | 7 | 2 |
| other | Vitiligo | Skin and subcutaneous tissue disorders | Dose Level 1 | 0 | 7 | 0 |
1 to 10 of 279Source ClinicalTrials.gov
See all 279 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 1 | 2 | 7 |
| Total, all-cause mortality | Dose Level 2 | 0 | 6 |
| Total, all-cause mortality | Dose Level 3 | 2 | 7 |
| Total, other adverse events | Dose Level 1 | 7 | 7 |
| Total, other adverse events | Dose Level 2 | 6 | 6 |
| Total, other adverse events | Dose Level 3 | 7 | 7 |
| Total, serious adverse events | Dose Level 1 | 0 | 7 |
| Total, serious adverse events | Dose Level 2 | 1 | 6 |
| Total, serious adverse events | Dose Level 3 | 3 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03301636
GET https://conductscience.org/api/trials/v1/NCT03301636/events?page=2