Trial · NCT01363206
Granulocyte Macrophage-Colony Stimulating Factor and Ipilimumab as Therapy in Melanoma
NCT01363206, Phase 2, Completed, Lynn E. Spitler, MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Granulocyte Macrophage-Colony Stimulating Factor and Ipilimumab as Therapy in Melanoma. Trials, record NCT01363206. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01363206
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Granulocyte Macrophage-Colony Stimulating Factor and Ipilimumab as Therapy in Melanoma
- NCT number
- NCT01363206
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- Lynn E. Spitler, MD
- Conditions
- Malignant Melanoma, Metastatic
- Interventions
- Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), Ipilimumab
- First posted
- 2011-06-01
- Last updated
- 2020-03-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease control rate at 24 weeks as defined by the immune-related Response Criteria (irRC) | 24 weeks | Disease control rate will be measured at 24 weeks from the start date of protocol therapy using the immune-related Response Criteria (irRC) |
| Secondary | Assessment of immune activation as determined in the Companion Protocol | Three years | Blood will be drawn for immunologic testing at each patient visit. |
| Secondary | Duration of disease control defined as the time from the date of the first treatment dose to the date of first documentation of disease progression as defined by irRC. | Four years | According to irRC criteria, increase in the size of target lesions or the appearance of new lesions within 12 weeks of the initiation of ipilimumab therapy does not necessarily represent disease progression (as they would using conventional RECIST criteria). |
| Secondary | Overall Survival (OS) | Four years | Overall Survival (OS) is defined as the time from the date of the first treatment dose to date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the patient was known to be alive. |
| Secondary | Objective Response Rate (RR) | Two years | The Objective Response Rate (RR) at any time during the 2 years of study treatment will be evaluated in this study using the immune related Response Criteria (irRC). |
| Secondary | Time to Objective response | Three years | The Time to Objective response is defined as the time from the date of the first treatment dose to the date of first documentation of disease response. |
| Secondary | Duration of objective response (CR or PR) | Four years | The duration of objective response (CR or PR) will be measured from the date the response was first documented to the date of progression or death due to progressive disease, whichever occurs first. |
| Secondary | Safety of the combination | Three years | The safety of the combination as defined by the NCI CTCAE criteria, Version 4.0. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
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/NCT01363206
GET https://conductscience.org/api/trials/v1/NCT01363206/registered