Trial · NCT01585194
Nivolumab and Ipilimumab in Treating Patients With Metastatic Uveal Melanoma
NCT01585194, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2020-12-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nivolumab and Ipilimumab in Treating Patients With Metastatic Uveal Melanoma. Trials, record NCT01585194. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01585194
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nivolumab and Ipilimumab in Treating Patients With Metastatic Uveal Melanoma
- NCT number
- NCT01585194
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 67 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Metastatic Uveal Melanoma, Stage IV Uveal Melanoma AJCC v7
- Interventions
- Ipilimumab, Laboratory Biomarker Analysis, Nivolumab
- First posted
- 2012-04-25
- Last updated
- 2024-07-09
- Results first posted
- 2020-12-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate, Defined Per RECIST 1.1 | Up to 2 years of treatment plus 60 days from last study dose | RECIST 1.1 response is defined as \>=30% reduction in sum of the longest diameter of target lesions |
| Secondary | Progression-Free Survival | From date of enrollment until the date of progressive disease or date of death from any cause, whichever came first, and assessed up to 60 days after completion of study treatment, a median of 13.0 months | Time from enrollment to progressive disease or death. Progressive disease is defined per RECIST 1.1 as \>=20% increase in the sum of the longest diameter of target lesions from nadir, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Secondary | Overall Survival | From date of enrollment until the date of death from any cause, a median of 13.0 months | Measured from time of enrollment to death |
| Secondary | 1-year Overall Survival | Baseline up to 1 year | Measured as percentage of patients alive at 1 year from enrollment |
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 | Overall Response Rate, Defined Per RECIST 1.1 | Up to 2 years of treatment plus 60 days from last study dose | 5 patients not analyzed due to lack of follow-up efficacy imaging | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-Free Survival | From date of enrollment until the date of progressive disease or date of death from any cause, whichever came first, and assessed up to 60 days after completion of study treatment, a median of 13.0 months | Weeks | MEDIAN | |
| SECONDARY | Overall Survival | From date of enrollment until the date of death from any cause, a median of 13.0 months | Weeks | MEDIAN | |
| SECONDARY | 1-year Overall Survival | Baseline up to 1 year | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate, Defined Per RECIST 1.1 | Treatment (Nivolumab, Ipilimumab) | Complete Response | 1 | Participants | |
| Overall Response Rate, Defined Per RECIST 1.1 | Treatment (Nivolumab, Ipilimumab) | Partial Response | 5 | Participants | |
| Overall Response Rate, Defined Per RECIST 1.1 | Treatment (Nivolumab, Ipilimumab) | Stable Disease | 11 | Participants | |
| Overall Response Rate, Defined Per RECIST 1.1 | Treatment (Nivolumab, Ipilimumab) | Progressive Disease | 16 | Participants | |
| Overall Response Rate, Defined Per RECIST 1.1 | Treatment (Nivolumab, Ipilimumab) | Unknown | 2 | Participants | |
| Progression-Free Survival | Treatment (Nivolumab, Ipilimumab) | 5.5 | 95% Confidence Interval 3.4 to 9.5 | Weeks | |
| Overall Survival | Treatment (Nivolumab, Ipilimumab) | 19.1 | 95% Confidence Interval 9.6 to NA | Weeks | |
| 1-year Overall Survival | Treatment (Nivolumab, Ipilimumab) | 19 | Participants |
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 | Treatment (Nivolumab, Ipilimumab) | 39 | |
| Overall Study | COMPLETED | Treatment (Nivolumab, Ipilimumab) | 35 | |
| Overall Study | NOT COMPLETED | Treatment (Nivolumab, Ipilimumab) | 4 |
Source ClinicalTrials.gov
Adverse events12
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 | Diarrhea | Gastrointestinal disorders | Treatment (Nivolumab, Ipilimumab) | 21 | 35 | |
| other | Increased ALT | Hepatobiliary disorders | Treatment (Nivolumab, Ipilimumab) | 17 | 35 | |
| other | Increased AST | Hepatobiliary disorders | Treatment (Nivolumab, Ipilimumab) | 14 | 35 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Treatment (Nivolumab, Ipilimumab) | 14 | 35 | |
| other | Hypothyroidism | Endocrine disorders | Treatment (Nivolumab, Ipilimumab) | 13 | 35 | |
| other | Rash | Skin and subcutaneous tissue disorders | Treatment (Nivolumab, Ipilimumab) | 11 | 35 | |
| other | Pyrexia | General disorders | Treatment (Nivolumab, Ipilimumab) | 8 | 35 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Treatment (Nivolumab, Ipilimumab) | 5 | 35 | |
| other | Adrenal insufficiency | Endocrine disorders | Treatment (Nivolumab, Ipilimumab) | 4 | 35 | |
| other | Eye disorder | Eye disorders | Treatment (Nivolumab, Ipilimumab) | 3 | 35 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Nivolumab, Ipilimumab) | 16 | 35 |
| Total, other adverse events | Treatment (Nivolumab, Ipilimumab) | 32 | 35 |
| Total, serious adverse events | Treatment (Nivolumab, Ipilimumab) | 2 | 35 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33125309 | DERIVED |
Source PubMed
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 | NIH RePORTER |
| R21CA208609 | Unlocking Tumor Immunophenotype in Responders versus Non-Responders in Metastatic Uveal Melanoma Patients Receiving Immune Checkpoint Blockade | PATEL, SAPNA | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 2016 to 2017 | NIH RePORTER |
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/NCT01585194
GET https://conductscience.org/api/trials/v1/NCT01585194/registered