Trial · NCT01274338
Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery
NCT01274338, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2021-05-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery. Trials, record NCT01274338. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01274338
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery
- NCT number
- NCT01274338
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 1,673 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Melanoma of Unknown Primary, Recurrent Melanoma, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7
- Interventions
- Ipilimumab, Quality-of-Life Assessment, Recombinant Interferon Alfa-2b
- First posted
- 2011-01-11
- Last updated
- 2026-10-22
- Results first posted
- 2021-05-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recurrence-free Survival (RFS; Arm B [HDI] vs. Arm C [LIP]) | Assessed every 3 months for 2 years, then every 6 months for years 3-5 and then annually up to 8 years | Recurrence-free survival is defined as the time from randomization to recurrence or death, whichever occurs first. The following criteria constitute the only acceptable evidence of disease recurrence. Lung and liver: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease. Central Nervous System: A positive brain CT or MRI scan or CSF cytology. Cutaneous, Subcutaneous and Lymph Node Recurrence: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease. Bone and Other Organs: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease identified on two different radiologic studies: i.e., positive nuclear bone scan or PET scan and contrast GI series or ultrasound, X-ray or CT of abdomen for abdominal disease. |
| Primary | 5-year Overall Survival (OS) Rate (Arm B [HDI] vs. Arm C [LIP]) | Assessed every 3 months for 2 years, then every 6 months for years 3-5 | Overall survival is defined as the time from randomization to death or date last known alive. |
| Primary | Recurrence-free Survival (RFS; Arm A [HIP] vs. Arm B [HDI]) | Assessed every 3 months for 2 years, then every 6 months for years 3-5 and then annually up to 8 years | Recurrence-free survival is defined as the time from randomization to recurrence or death, whichever occurs first. The following criteria constitute the only acceptable evidence of disease recurrence. Lung and liver: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease. Central Nervous System: A positive brain CT or MRI scan or CSF cytology. Cutaneous, Subcutaneous and Lymph Node Recurrence: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease. Bone and Other Organs: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease identified on two different radiologic studies: i.e., positive nuclear bone scan or PET scan and contrast GI series or ultrasound, X-ray or CT of abdomen for abdominal disease. |
| Primary | 5-year Overall Survival (OS) Rate (Arm A [HIP] vs. Arm B [HDI]) | Assessed every 3 months for 2 years, then every 6 months for years 3-5 | Overall survival is defined as the time from randomization to death or date last known alive. |
| Secondary | Change in FACT-G (Functional Assessment of Cancer Therapy - General) Total Score From Baseline to 3 Months | Assessed at baseline and 3 months | The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that has four areas of measurements (physical well-being, social/family well-being, emotional well-being and functional well-being) with a scale of 0-4. The FACT-G total score ranges between 0 and 108. The higher the score, the better the quality of life. Change in FACT-G total score from baseline to 3 months was calculated as month 3 score - baseline score. |
| Secondary | Change in FACIT-D (Functional Assessment of Cancer Therapy - Diarrhea) Diarrhea Subscale Score From Baseline to 3 Months | Assessed at baseline and 3 months | The diarrhea subscale of The Functional Assessment of Chronic Illness Therapy - Diarrhea (FACIT-D) is an 11-item questionnaire with a scale of 0-4. The FACIT-D diarrhea subscale score ranges between 0 and 44. The higher the score, the better the quality of life. Change in FACIT-D diarrhea subscale score from baseline to 3 months was calculated as month 3 score - baseline score. |
| Secondary | Change in FACT-BRM (Functional Assessment of Cancer Therapy - Biologic Response Modifiers) Total Score From Baseline to 3 Months | Assessed at baseline and 3 months | The Functional Assessment of Cancer Therapy - Biologic Response Modifiers (FACT-BRM) is a questionnaire including FACT-G (The Functional Assessment of Cancer Therapy - General) and additional sections addressing physical and mental quality of life aspects. It is a 40-item questionnaire with a scale of 0-4. The FACT-BRM total score ranges between 0 and 160. The higher the score, the better the quality of life. Change in FACT-BRM total score from baseline to 3 months is calculated as month 3 score - baseline score. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recurrence-free Survival (RFS; Arm B [HDI] vs. Arm C [LIP]) | Assessed every 3 months for 2 years, then every 6 months for years 3-5 and then annually up to 8 years | Concurrently randomized patients on Arms B and C | years | MEDIAN |
| PRIMARY | 5-year Overall Survival (OS) Rate (Arm B [HDI] vs. Arm C [LIP]) | Assessed every 3 months for 2 years, then every 6 months for years 3-5 | Concurrently randomized patients on Arms B and C | proportion of participants | NUMBER |
| PRIMARY | Recurrence-free Survival (RFS; Arm A [HIP] vs. Arm B [HDI]) | Assessed every 3 months for 2 years, then every 6 months for years 3-5 and then annually up to 8 years | Concurrently randomized patients on Arms A and B | years | MEDIAN |
| PRIMARY | 5-year Overall Survival (OS) Rate (Arm A [HIP] vs. Arm B [HDI]) | Assessed every 3 months for 2 years, then every 6 months for years 3-5 | Concurrently randomized patients on Arms A and B | proportion of participants | NUMBER |
| SECONDARY | Change in FACT-G (Functional Assessment of Cancer Therapy - General) Total Score From Baseline to 3 Months | Assessed at baseline and 3 months | Patients with baseline and 3-month FACT-G assessments were included in this analysis. Pediatric patients did not participate in the quality of life part of the study. | score on a scale | MEAN |
| SECONDARY | Change in FACIT-D (Functional Assessment of Cancer Therapy - Diarrhea) Diarrhea Subscale Score From Baseline to 3 Months | Assessed at baseline and 3 months | Patients with baseline and 3-month FACIT-D diarrhea subscale assessments were included in this analysis. Pediatric patients did not participate in the quality of life part of the study. | score on a scale | MEAN |
| SECONDARY | Change in FACT-BRM (Functional Assessment of Cancer Therapy - Biologic Response Modifiers) Total Score From Baseline to 3 Months | Assessed at baseline and 3 months | Patients with baseline and 3-month FACT-BRM assessments were included in this analysis. Pediatric patients did not participate in the quality of life part of the study. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Recurrence-free Survival (RFS; Arm B [HDI] vs. Arm C [LIP]) | Arm B (HDI) | 2.5 | 95% Confidence Interval 1.7 to 3.3 | years | |
| Recurrence-free Survival (RFS; Arm B [HDI] vs. Arm C [LIP]) | Arm C (LIP) | 4.5 | 95% Confidence Interval 2.6 to NA | years | |
| 5-year Overall Survival (OS) Rate (Arm B [HDI] vs. Arm C [LIP]) | Arm B (HDI) | 0.67 | 95% Confidence Interval 0.62 to 0.72 | proportion of participants | |
| 5-year Overall Survival (OS) Rate (Arm B [HDI] vs. Arm C [LIP]) | Arm C (LIP) | 0.72 | 95% Confidence Interval 0.68 to 0.76 | proportion of participants | |
| Recurrence-free Survival (RFS; Arm A [HIP] vs. Arm B [HDI]) | Arm A (HIP) | 3.9 | 95% Confidence Interval 2.9 to NA | years | |
| Recurrence-free Survival (RFS; Arm A [HIP] vs. Arm B [HDI]) | Arm B (HDI) | 2.4 | 95% Confidence Interval 1.6 to 3.0 | years | |
| 5-year Overall Survival (OS) Rate (Arm A [HIP] vs. Arm B [HDI]) | Arm A (HIP) | 0.70 | 95% Confidence Interval 0.65 to 0.74 | proportion of participants | |
| 5-year Overall Survival (OS) Rate (Arm A [HIP] vs. Arm B [HDI]) | Arm B (HDI) | 0.65 | 95% Confidence Interval 0.60 to 0.70 | proportion of participants | |
| Change in FACT-G (Functional Assessment of Cancer Therapy - General) Total Score From Baseline to 3 Months | Arm A (HIP) | -4.9 | Standard Deviation 14.1 | score on a scale | |
| Change in FACT-G (Functional Assessment of Cancer Therapy - General) Total Score From Baseline to 3 Months | Arm B (HDI) | -12.9 | Standard Deviation 14.1 | score on a scale |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (HIP) | 511 | |
| Overall Study | STARTED | Arm B (HDI) | 636 | |
| Overall Study | STARTED | Arm C (LIP) | 523 | |
| Overall Study | STARTED | Arm D (HIP; Pediatric) | 1 | |
| Overall Study | STARTED | Arm E (HDI; Pediatric) | 1 | |
| Overall Study | STARTED | Arm F (LIP; Pediatric) | 1 | |
| Overall Study | Received Treatment | Arm A (HIP) | 503 | |
| Overall Study | Received Treatment | Arm B (HDI) | 520 | |
| Overall Study | Received Treatment | Arm C (LIP) | 516 | |
| Overall Study | Received Treatment | Arm D (HIP; Pediatric) | 1 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events1,332
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 (HIP) | 90 | 503 | |
| other | Anemia | Blood and lymphatic system disorders | Arm B (HDI) | 209 | 520 | |
| other | Anemia | Blood and lymphatic system disorders | Arm C (LIP) | 69 | 516 | |
| other | Anemia | Blood and lymphatic system disorders | Arm D (HIP; Pediatric) | 1 | ||
| other | Anemia | Blood and lymphatic system disorders | Arm E (HDI; Pediatric) | 1 | ||
| other | Anemia | Blood and lymphatic system disorders | Arm F (LIP; Pediatric) | 1 | ||
| other | Chills | General disorders | Arm A (HIP) | 61 | 503 | |
| other | Chills | General disorders | Arm B (HDI) | 178 | 520 | |
| other | Chills | General disorders | Arm C (LIP) | 34 | 516 | |
| other | Chills | General disorders | Arm D (HIP; Pediatric) | 1 |
1 to 10 of 1,332Source ClinicalTrials.gov
See all 1,332 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (HIP) | 153 | 511 |
| Total, all-cause mortality | Arm B (HDI) | 168 | 636 |
| Total, all-cause mortality | Arm C (LIP) | 135 | 523 |
| Total, all-cause mortality | Arm D (HIP; Pediatric) | 0 | 1 |
| Total, all-cause mortality | Arm E (HDI; Pediatric) | 0 | 1 |
| Total, all-cause mortality | Arm F (LIP; Pediatric) | 0 | 1 |
| Total, other adverse events | Arm A (HIP) | 495 | 503 |
| Total, other adverse events | Arm B (HDI) | 510 | 520 |
| Total, other adverse events | Arm C (LIP) | 488 | 516 |
| Total, other adverse events | Arm D (HIP; Pediatric) | 0 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants4
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 |
| U24CA196172 | ECOG-ACRIN Biospecimen Bank to Support NCTN | JEWELL, SCOTT D; HAMILTON, STANLEY R. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2015 to 2025 | NIH RePORTER |
| P50CA121973 | SPORE in Skin Cancer | KIRKWOOD, JOHN MUNN | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL CANCER INSTITUTE | 2008 to 2018 | 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 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/NCT01274338
GET https://conductscience.org/api/trials/v1/NCT01274338/flow?page=2