Trial · NCT01134614
Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
NCT01134614, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2015-04-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery. Trials, record NCT01134614. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01134614
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
- NCT number
- NCT01134614
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 245 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Advanced Melanoma, Metastatic Melanoma, Recurrent Melanoma, Stage III Cutaneous Melanoma AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7, Unresectable Melanoma
- Interventions
- Ipilimumab, Sargramostim
- First posted
- 2010-06-02
- Last updated
- 2026-10-01
- Results first posted
- 2015-04-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Assessed every 3 months for 2 years, then every 6 months for 3 years | Overall survival is defined as the time from randomization to death from any cause. |
| Secondary | Progression-free Survival (PFS) | Assessed every 3 months for 2 years, then every 6 months for 3 years | Progression-free survival is defined as the time from randomization to disease progression or death, whichever occurs first. Response and disease progression will be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Disease progression is defined as \>= 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) and the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions is also considered progression. |
| Secondary | Proportion of Patients With Objective Response | Assessed every 3 months for 2 years, then every 6 months for 3 years | Objective response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). Partial response (PR)= At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. To be assigned a status of partial response, changes in tumor measurements must be confirmed by a repeat assessment performed no less than four weeks after the criteria for response is met. Objective response = CR + PR. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Assessed every 3 months for 2 years, then every 6 months for 3 years | All randomized patients are included in this analysis. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Assessed every 3 months for 2 years, then every 6 months for 3 years | All randomized patients are included in this analysis. | Months | MEDIAN |
| SECONDARY | Proportion of Patients With Objective Response | Assessed every 3 months for 2 years, then every 6 months for 3 years | All randomized patients are included in this analysis. | Proportion of patients | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Arm A (Ipilimumab and Sargramostim) | 17.5 | 95% Confidence Interval 14.9 to NA | Months | |
| Overall Survival | Arm B (Ipilimumab) | 12.7 | 95% Confidence Interval 10.0 to NA | Months | |
| Progression-free Survival (PFS) | Arm A (Ipilimumab and Sargramostim) | 3.1 | 95% Confidence Interval 2.9 to 4.6 | Months | |
| Progression-free Survival (PFS) | Arm B (Ipilimumab) | 3.1 | 95% Confidence Interval 2.9 to 4.0 | Months | |
| Proportion of Patients With Objective Response | Arm A (Ipilimumab and Sargramostim) | 0.155 | 95% Confidence Interval 0.096 to 0.231 | Proportion of patients | |
| Proportion of Patients With Objective Response | Arm B (Ipilimumab) | 0.148 | 95% Confidence Interval 0.090 to 0.223 | Proportion of patients |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Ipilimumab and Sargramostim) | 123 | |
| Overall Study | STARTED | Arm B (Ipilimumab) | 122 | |
| Overall Study | Treated | Arm A (Ipilimumab and Sargramostim) | 119 | |
| Overall Study | Treated | Arm B (Ipilimumab) | 121 | |
| Overall Study | Treated and Toxicity Assessed | Arm A (Ipilimumab and Sargramostim) | 118 | |
| Overall Study | Treated and Toxicity Assessed | Arm B (Ipilimumab) | 120 | |
| Overall Study | COMPLETED | Arm A (Ipilimumab and Sargramostim) | 0 | |
| Overall Study | COMPLETED | Arm B (Ipilimumab) | 0 | |
| Overall Study | NOT COMPLETED | Arm A (Ipilimumab and Sargramostim) | 123 | |
| Overall Study | NOT COMPLETED | Arm B (Ipilimumab) | 122 |
Source ClinicalTrials.gov
Adverse events248
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 | Arm A (Ipilimumab and Sargramostim) | 22 | 118 | |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Ipilimumab) | 24 | 120 | |
| other | Chills | General disorders | Arm A (Ipilimumab and Sargramostim) | 18 | 118 | |
| other | Chills | General disorders | Arm B (Ipilimumab) | 8 | 120 | |
| other | Edema limbs | General disorders | Arm A (Ipilimumab and Sargramostim) | 10 | 118 | |
| other | Edema limbs | General disorders | Arm B (Ipilimumab) | 4 | 120 | |
| other | Fatigue | General disorders | Arm A (Ipilimumab and Sargramostim) | 70 | 118 | |
| other | Fatigue | General disorders | Arm B (Ipilimumab) | 75 | 120 | |
| other | Fever | General disorders | Arm A (Ipilimumab and Sargramostim) | 17 | 118 | |
| other | Fever | General disorders | Arm B (Ipilimumab) | 18 | 120 |
1 to 10 of 248Source ClinicalTrials.gov
See all 248 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Ipilimumab and Sargramostim) | ||
| Total, all-cause mortality | Arm B (Ipilimumab) | ||
| Total, other adverse events | Arm A (Ipilimumab and Sargramostim) | 110 | 118 |
| Total, other adverse events | Arm B (Ipilimumab) | 111 | 120 |
| Total, serious adverse events | Arm A (Ipilimumab and Sargramostim) | 56 | 118 |
| Total, serious adverse events | Arm B (Ipilimumab) | 69 | 120 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25369488 | 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 |
|---|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm A (Ipilimumab and Sargramostim) vs Arm B (Ipilimumab): serious adverse events |
Source Trial comparisons
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/NCT01134614
GET https://conductscience.org/api/trials/v1/NCT01134614/events?page=2