Trial · NCT02978443
A Biomarker Study in Advanced Mucosal or Acral Lentiginous Melanoma Receiving Nivolumab in Combination With Ipilimumab
NCT02978443, Phase 2, Terminated, Georgetown University; results first posted 2024-04-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Biomarker Study in Advanced Mucosal or Acral Lentiginous Melanoma Receiving Nivolumab in Combination With Ipilimumab. Trials, record NCT02978443. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02978443
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Biomarker Study in Advanced Mucosal or Acral Lentiginous Melanoma Receiving Nivolumab in Combination With Ipilimumab
- NCT number
- NCT02978443
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- Georgetown University
- Conditions
- Acral Lentiginous Melanoma, Mucosal Melanoma
- Interventions
- Nivolumab, Ipilimumab
- First posted
- 2016-12-01
- Last updated
- 2024-04-04
- Results first posted
- 2024-04-04
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) With Mucosal Melanoma (MCM) | 24 months | ORR, defined as complete response \[CR\] + partial response \[PR\] per RECIST 1.1 criteria and to compare this response rate to the response rate of patients with "good" molecular predictive features |
| Secondary | Objective Response Rate With Acral Lentiginous Melanoma (ALM) | 24 months | ORR, defined as complete response \[CR\] + partial response \[PR\] per RECIST 1.1 criteria and to compare this response rate to the response rate of patients with "good" molecular predictive features |
| Secondary | Progression-free Survival (PFS) | 33 months | Progression-free survival is defined as the time from the date of treatment initiation until the date that disease progression criteria are met or the date death without progression, or is censored at the date of last disease assessment without evidence of progression. |
| Secondary | Overall Survival (OS) | 44 months | OS is calculated from the date of treatment initiation to the date of death, or censored at date of last contact. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) With Mucosal Melanoma (MCM) | 24 months | patients with mucosal melanoma (MCM) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate With Acral Lentiginous Melanoma (ALM) | 24 months | patients with with acral lentiginous melanoma (ALM) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival (PFS) | 33 months | days | MEDIAN | |
| SECONDARY | Overall Survival (OS) | 44 months | days | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) With Mucosal Melanoma (MCM) | Nivolumab-Ipilimumab Combination Therapy | 1 | Participants | ||
| Objective Response Rate With Acral Lentiginous Melanoma (ALM) | Nivolumab-Ipilimumab Combination Therapy | 1 | Participants | ||
| Progression-free Survival (PFS) | Nivolumab-Ipilimumab Combination Therapy | 127 | Full Range 12 to 995 | days | |
| Overall Survival (OS) | Nivolumab-Ipilimumab Combination Therapy | 567 | Full Range 12 to 1312 | days |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nivolumab-Ipilimumab Combination Therapy | 14 | |
| Overall Study | COMPLETED | Nivolumab-Ipilimumab Combination Therapy | 0 | |
| Overall Study | NOT COMPLETED | Nivolumab-Ipilimumab Combination Therapy | 14 |
Source ClinicalTrials.gov
Adverse events69
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 | Anemia | Blood and lymphatic system disorders | Nivolumab-Ipilimumab Combination Therapy | 3 | 13 | 4 |
| other | Supraventricular tachycardia | Cardiac disorders | Nivolumab-Ipilimumab Combination Therapy | 1 | 13 | 1 |
| other | Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | Nivolumab-Ipilimumab Combination Therapy | 1 | 13 | 1 |
| other | Hearing impaired | Ear and labyrinth disorders | Nivolumab-Ipilimumab Combination Therapy | 1 | 13 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Nivolumab-Ipilimumab Combination Therapy | 1 | 13 | 1 |
| other | Anal hemorrhage | Gastrointestinal disorders | Nivolumab-Ipilimumab Combination Therapy | 1 | 13 | 1 |
| other | Anal pain | Gastrointestinal disorders | Nivolumab-Ipilimumab Combination Therapy | 1 | 13 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Nivolumab-Ipilimumab Combination Therapy | 3 | 13 | 5 |
| other | Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Nivolumab-Ipilimumab Combination Therapy | 1 | 13 | 1 |
| other | Nausea | Gastrointestinal disorders | Nivolumab-Ipilimumab Combination Therapy | 1 | 13 | 1 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nivolumab-Ipilimumab Combination Therapy | 9 | 13 |
| Total, other adverse events | Nivolumab-Ipilimumab Combination Therapy | 13 | 13 |
| Total, serious adverse events | Nivolumab-Ipilimumab Combination Therapy | 7 | 13 |
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/NCT02978443
GET https://conductscience.org/api/trials/v1/NCT02978443/events?page=2