Trial · NCT00636168
Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma
NCT00636168, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2014-08-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma. Trials, record NCT00636168. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00636168
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma
- NCT number
- NCT00636168
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,211 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- High Risk Stage III Melanoma
- Interventions
- ipilimumab, Placebo
- First posted
- 2008-03-14
- Last updated
- 2019-12-17
- Results first posted
- 2014-08-19
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recurrence Free Survival (RFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population | Date of randomization to first date of recurrence or death or last available disease assessment with RFS data up to 5 years. Median follow-up was 2.7 years. | Recurrence free survival (RFS) was programmatically determined based on the disease recurrence data provided by the IRC and was defined as the time between the date of randomization and the date of first recurrence or death (whatever the cause), whichever occurred first. A participant who died without reported recurrence was considered to have recurrence on the date of death. For those participants who remained alive and recurrence-free, RFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, RFS was censored on the day of randomization. Participants with disease at baseline were considered to have an event on the day of randomization. Computerized tomography (CT) and magnetic resonance imaging (MRI) were mandatory to establish recurrence. The primary analysis was event-driven and planned when at least 512 RFS events assessed per IRC were collected. |
| Primary | Number of Participants With Recurrence or Death as Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population | Date of randomization to first date of recurrence or death or last available disease assessment with RFS data upto 5 years. Median follow-up was 2.7 years. | Recurrence was defined as appearance of one or more new melanoma lesions: local, regional or distant metastasis. Computerized tomography (CT) and magnetic resonance imaging (MRI) were mandatory to establish recurrence. A participant who died without reported recurrence was considered to have recurred on the date of death. Disease was assessed at randomization and every 12 weeks (±2 weeks) for 3 years, then every 24 weeks until documented distant progression. |
| Primary | Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population | At years 1, 2, and 3 | Yearly recurrence-free survival rates, eg. at 1 year, defined as the probability that a participant was recurrence-free at 1 year following randomization, were estimated for each treatment group using the Kaplan-Meier product-limit method, along with their corresponding log-log transformed 95% confidence intervals. RFS was defined as the time between the date of randomization and the date of first recurrence or death (whatever the cause), whichever occurred first. A participant who died without reported recurrence was considered to have recurrence on the date of death. For those who remained alive and recurrence-free, RFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, RFS was censored on the day of randomization. Participants with disease at baseline were considered to have an event on the day of randomization. CT and MRI were mandatory to establish recurrence. |
| Secondary | Distant Metastasis-Free Survival (DMFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population | From June 2008 to January 2016 (approximately 90 months) | Distant Metastasis-Free Survival (DMFS) was programmatically determined based on the first date of distant metastasis provided by the IRC and was defined as the time between the date of randomization and the date of first distant metastasis or death (whatever the cause), whichever occurred first. A participant who died without reported disease distant metastasis was considered to have distant metastasis on the date of death. For those who remained alive and metastasis-free, DMFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, DMFS was censored on the day of randomization. Participants with disease at baseline were considered to have an event on the day of randomization. Disease was assessed at baseline (randomization) and every 12 weeks (±2 weeks) for 3 years, then every 24 weeks until documented distant progression. |
| Secondary | Number of Participants With Distant Metastasis-Free Survival (DMFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population | From June 2008 to January 2016 (approximately 90 months) | DMFS was programmatically determined based on the first date of distant metastasis provided by the IRC and was defined as the time between the date of randomization and the date of first distant metastasis or death (whatever the cause), whichever occurred first. A participant who died without reported disease distant metastasis was considered to have distant metastasis on the date of death. For those who remained alive and metastasis-free, DMFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, DMFS was censored on the day of randomization. Participants with disease at baseline were considered to have an event on the day of randomization. Disease was assessed at baseline (randomization) and every 12 weeks (2 weeks) for 3 years, then every 24 weeks until documented distant progression. |
| Secondary | Distant Metastasis-Free Survival (DMFS) Rates Per IRC at 1 Year, 2 Years, 3 Years, 4 Years and 5 Years in the ITT Population | At years 1, 2, 3, 4 and 5 | Yearly distant metastasis-free survival rates, e.g. at 1 year, defined as the probability that a participant was alive at 1 year following randomization, were estimated via the Kaplan-Meier method. Distant Metastasis-Free Survival (DMFS) was programmatically determined based on the first date of distant metastasis provided by the IRC and was defined as the time between the date of randomization and the date of first distant metastasis or death (whatever the cause), whichever occurred first. A participant who died without reported disease distant metastasis was considered to have distant metastasis on the date of death. For those who remained alive and metastasis-free, DMFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment. Participants with disease at baseline were considered to have an event on the day of randomization. |
| Secondary | Overall Survival in the Intent to Treat (ITT) Population | From June 2008 to January 2016 (approximately 90 months) | OS was defined as the time from the date of randomization to the date of death. For those participants who had not died, OS was censored at the recorded last non-missing date of contact for which the participant was known to be alive. |
| Secondary | Rate of Overall Survival (OS) | From date of randomization to date of death, assessed up to 9 years | OS was defined as the time from the date of randomization to the date of death. For those participants who had not died, OS was censored at the recorded last non-missing date of contact for which the participant was known to be alive.Yearly survival rates, e.g. at 3 years, defined as the probability that a participant was alive at 3 years following randomization, were estimated via the Kaplan-Meier method |
| Secondary | Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population | Day 1 up to 70 days after last dose; up to 5 years | AEs: Medical Dictionary for Regulatory Activities (MedDRA) version 16.1. irAEs=unknown etiology consistent with an immune phenomenon, considered as causally related to drug. imARs=based on investigator's assessment of immune-mediated etiology \[excluding novel maintenance events (ie, patients with imARs occurring for the first time during maintenance)\]. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related (D-R)=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. |
| Secondary | Number of Participants With Serious Adverse Events (SAEs), Non-serious AEs (NSAEs) and Number of Deaths: Overall Study | SAEs and NSAEs: Day 1 up to 70 days after last dose(safety window). Deaths: All deaths regardless of 70 day safety window.Up to 10 years | AEs: Medical Dictionary for Regulatory Activities (MedDRA) version 16.1. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population | Date of randomization to first date of recurrence or death or last available disease assessment with RFS data up to 5 years. Median follow-up was 2.7 years. | Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization | months | MEDIAN |
| PRIMARY | Number of Participants With Recurrence or Death as Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population | Date of randomization to first date of recurrence or death or last available disease assessment with RFS data upto 5 years. Median follow-up was 2.7 years. | Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population | At years 1, 2, and 3 | Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization | Percentage of participants | NUMBER |
| SECONDARY | Distant Metastasis-Free Survival (DMFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population | From June 2008 to January 2016 (approximately 90 months) | Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization | Months | MEDIAN |
| SECONDARY | Number of Participants With Distant Metastasis-Free Survival (DMFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population | From June 2008 to January 2016 (approximately 90 months) | Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Distant Metastasis-Free Survival (DMFS) Rates Per IRC at 1 Year, 2 Years, 3 Years, 4 Years and 5 Years in the ITT Population | At years 1, 2, 3, 4 and 5 | Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival in the Intent to Treat (ITT) Population | From June 2008 to January 2016 (approximately 90 months) | Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization | Months | MEDIAN |
| SECONDARY | Rate of Overall Survival (OS) | From date of randomization to date of death, assessed up to 9 years | Intent to Treat Population: All randomized participants,analyzed in the arm to which they were allocated by randomization | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population | Day 1 up to 70 days after last dose; up to 5 years | Safety population: All randomized participants who received at least 1 dose of study therapy | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs), Non-serious AEs (NSAEs) and Number of Deaths: Overall Study | SAEs and NSAEs: Day 1 up to 70 days after last dose(safety window). Deaths: All deaths regardless of 70 day safety window.Up to 10 years | Safety population: All randomized participants who received at least 1 dose of study therapy | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group114
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) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population | Ipilimumab 10mg/kg | 26.09 | 95% Confidence Interval 19.32 to 39.26 | months | |
| Recurrence Free Survival (RFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population | Placebo | 17.05 | 95% Confidence Interval 13.40 to 21.62 | months | |
| Number of Participants With Recurrence or Death as Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population | Ipilimumab 10mg/kg | 234 | 19.32 to 39.26 | Participants | |
| Number of Participants With Recurrence or Death as Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population | Placebo | 294 | 13.40 to 21.62 | Participants | |
| Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population | Ipilimumab 10mg/kg | RFS Rate at 1 Year | 63.50 | 95% Confidence Interval 58.89 to 67.74 | Percentage of participants |
| Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population | Placebo | RFS Rate at 1 Year | 56.13 | 95% Confidence Interval 51.52 to 60.47 | Percentage of participants |
| Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population | Ipilimumab 10mg/kg | RFS Rate at 2 Years | 51.45 | 95% Confidence Interval 46.69 to 56.00 | Percentage of participants |
| Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population | Placebo | RFS Rate at 2 Years | 43.83 | 95% Confidence Interval 39.27 to 48.28 | Percentage of participants |
| Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population | Ipilimumab 10mg/kg | RFS Rate at 3 Years | 46.48 | 95% Confidence Interval 41.46 to 51.34 | Percentage of participants |
| Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population | Placebo | RFS Rate at 3 Years | 34.79 | 95% Confidence Interval 30.12 to 39.50 | Percentage of participants |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized to Study Drug | STARTED | Ipilimumab 10mg/kg | 475 | |
| Randomized to Study Drug | STARTED | Placebo | 476 | |
| Randomized to Study Drug | COMPLETED | Ipilimumab 10mg/kg | 471 | |
| Randomized to Study Drug | COMPLETED | Placebo | 474 | |
| Randomized to Study Drug | NOT COMPLETED | Ipilimumab 10mg/kg | 4 | |
| Randomized to Study Drug | NOT COMPLETED | Placebo | 2 | |
| Treated With Study Drug | STARTED | Ipilimumab 10mg/kg | 471 | |
| Treated With Study Drug | STARTED | Placebo | 474 | |
| Treated With Study Drug | COMPLETED | Ipilimumab 10mg/kg | 63 | |
| Treated With Study Drug | COMPLETED | Placebo | 143 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events550
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 | Hypophysitis | Endocrine disorders | IPILIMUMAB 10 MG/KG | 56 | 471 | |
| other | Hypophysitis | Endocrine disorders | PLACEBO | 2 | 474 | |
| other | Hypothyroidism | Endocrine disorders | IPILIMUMAB 10 MG/KG | 47 | 471 | |
| other | Hypothyroidism | Endocrine disorders | PLACEBO | 7 | 474 | |
| other | Abdominal pain | Gastrointestinal disorders | IPILIMUMAB 10 MG/KG | 64 | 471 | |
| other | Abdominal pain | Gastrointestinal disorders | PLACEBO | 44 | 474 | |
| other | Colitis | Gastrointestinal disorders | IPILIMUMAB 10 MG/KG | 43 | 471 | |
| other | Colitis | Gastrointestinal disorders | PLACEBO | 5 | 474 | |
| other | Constipation | Gastrointestinal disorders | IPILIMUMAB 10 MG/KG | 31 | 471 | |
| other | Constipation | Gastrointestinal disorders | PLACEBO | 30 | 474 |
1 to 10 of 550Source ClinicalTrials.gov
See all 550 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IPILIMUMAB 10 MG/KG | 173 | 471 |
| Total, all-cause mortality | PLACEBO | 223 | 474 |
| Total, other adverse events | IPILIMUMAB 10 MG/KG | 441 | 471 |
| Total, other adverse events | PLACEBO | 382 | 474 |
| Total, serious adverse events | IPILIMUMAB 10 MG/KG | 257 | 471 |
| Total, serious adverse events | PLACEBO | 128 | 474 |
Source ClinicalTrials.gov
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ipilimumab 10mg/kg vs Placebo: Number of Participants With Recurrence or Death as Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population | Trial comparisons |
| IPILIMUMAB 10 MG/KG vs PLACEBO: deaths from any cause | Trial comparisons |
| Ipilimumab 10mg/kg vs Placebo: Number of Participants With Distant Metastasis-Free Survival (DMFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population | Trial comparisons |
| IPILIMUMAB 10 MG/KG vs PLACEBO: serious adverse events | 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.
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