Trial · NCT01515189
Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab
NCT01515189, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2017-03-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab. Trials, record NCT01515189. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01515189
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab
- NCT number
- NCT01515189
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 831 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Melanoma
- Interventions
- Ipilimumab
- First posted
- 2012-01-24
- Last updated
- 2019-07-31
- Other registries' IDs
- eudract:2011-004029-28
- Results first posted
- 2017-03-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Approximately 48 months (assessed up to February 2016) | OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median and associated 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley. |
| Secondary | Progression Free Survival (PFS) by mWHO Criteria | From date of randomization until 540 death events occurred (approximately 48 months) | PFS was defined as the time between randomization date and the date of progression or death, whichever occurred first. A participant who died without reported prior progression was considered to have progressed on the date of death. For a participant who underwent resection post randomization, PFS was censored on last tumor assessment date prior to resection. For those who remained alive and had not progressed, PFS was censored on last evaluable tumor assessment date. Participants who had not died and had no recorded post-baseline tumor assessment were censored at the day of randomization. For participants who had Progressive Disease (PD) prior to Week 12 and a subsequent assessment of Stable Disease (SD), Partial Response (PR), or Complete Response (CR), the date of PD following response was used in the analysis of PFS; otherwise these participants were censored on the date of their last tumor assessment. Median and 2-sided 95% CIs were calculated with Brookmeyer Crowley method. |
| Secondary | Best Overall Response Rate (BORR) by mWHO Criteria | From date of randomization until 540 death events occurred (approximately 48 months) | BORR by treatment arm was defined as the total number of randomized participants in the arm whose BOR is CR or PR, divided by the total number of randomized participants in the arm. Any participant who was unevaluable for BOR, e.g. on account of missing or "not evaluable" assessments, was included in the denominator of the calculation (i.e. was considered a non-responder with respect to the BORR endpoint). 95% 2-sided exact confidence intervals were computed using the method of Clopper and Pearson. |
| Secondary | Disease Control Rate (DCR) by mWHO Criteria | From date of randomization until 540 death events occurred (approximately 48 months) | DCR by treatment arm was defined as the total number of randomized participants in the arm whose BOR is CR, PR or SD, divided by the total number of randomized participants in the arm. Any participant who was unevaluable for Disease Control (DC), (e.g. on account of missing or "not evaluable" assessments), was included in the denominator of the calculation (i.e. was considered a non-responder with respect to the DCR endpoint). 95% 2-sided exact confidence intervals were computed using the Clopper and Pearson method. |
| Secondary | Duration of Response (DOR) by mWHO Criteria | From date of randomization until 540 death events occurred (approximately 48 months) | Duration of response for participants whose BOR was CR or PR was defined as the time between the date measurement criteria were first met for overall response of PR or CR (whichever status was recorded first) and the date of disease progression or death (whichever occurred first). For participants who underwent tumor resection following response but prior to disease progression, duration of response was censored on the date of last evaluable tumor assessment prior to resection. For participants who had BOR of SD, PR or CR at Week 12, or a confirmed response of PR or CR before Week 12, the date of PD following thereafter (where available) was used in the analysis of duration of response. For those participants who remained alive and had not progressed following response, duration of response was censored on the date of last evaluable tumor assessment. Median and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer Crowley method. |
| Secondary | Duration of Stable Disease by mWHO Criteria | From date of randomization until 540 death events occurred (approximately 48 months) | Duration of stable disease was defined for participants whose BOR was SD as the time between when SD was first documented and the date of PD or death (whichever occurred first). For a participant who underwent tumor resection following Week 12 but prior to disease progression, duration of stable disease was censored on the date of the last evaluable tumor assessment prior to resection. For participants who had BOR of SD at Week 12, the date of PD following thereafter (where available) was used in the analysis of duration of stable disease. For participants with BOR of SD who had not subsequently progressed and who remained alive, duration of stable disease was censored on the date of last evaluable tumor assessment. Median and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer and Crowley method. |
| Secondary | Rate of Overall Survival | Approximately 66 months | OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Survival rates were calculated based on Kaplan-Meier estimation with log-log transformed confidence intervals. The survival rate at x year(s) is defined as the probability that a subject is alive at x year(s) following randomization. |
| Secondary | Overall Survival of Participants With Brain Metastases at Baseline | From date of randomization until 540 death events occurred (approximately 48 months) | OS for each participant with brain metastases at baseline was measured as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median OS, and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer and Crowley method. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Approximately 48 months (assessed up to February 2016) | All randomized participants | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) by mWHO Criteria | From date of randomization until 540 death events occurred (approximately 48 months) | All randomized participants. | months | MEDIAN |
| SECONDARY | Best Overall Response Rate (BORR) by mWHO Criteria | From date of randomization until 540 death events occurred (approximately 48 months) | All randomized participants | percentage of participants with BORR | NUMBER |
| SECONDARY | Disease Control Rate (DCR) by mWHO Criteria | From date of randomization until 540 death events occurred (approximately 48 months) | All randomized participants | percentage of participants with DC | NUMBER |
| SECONDARY | Duration of Response (DOR) by mWHO Criteria | From date of randomization until 540 death events occurred (approximately 48 months) | All randomized participants | months | MEDIAN |
| SECONDARY | Duration of Stable Disease by mWHO Criteria | From date of randomization until 540 death events occurred (approximately 48 months) | All randomized participants | months | MEDIAN |
| SECONDARY | Rate of Overall Survival | Approximately 66 months | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Overall Survival of Participants With Brain Metastases at Baseline | From date of randomization until 540 death events occurred (approximately 48 months) | All randomized participants with brain metastases at baseline | months | MEDIAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Ipilimumab (10 mg/kg) | 15.70 | 95% Confidence Interval 11.63 to 17.84 | months | |
| Overall Survival (OS) | Ipilimumab (3 mg/kg) | 11.53 | 95% Confidence Interval 9.86 to 13.27 | months | |
| Progression Free Survival (PFS) by mWHO Criteria | Ipilimumab (10 mg/kg) | 2.83 | 95% Confidence Interval 2.79 to 2.99 | months | |
| Progression Free Survival (PFS) by mWHO Criteria | Ipilimumab (3 mg/kg) | 2.79 | 95% Confidence Interval 2.76 to 2.83 | months | |
| Best Overall Response Rate (BORR) by mWHO Criteria | Ipilimumab (10 mg/kg) | 15.3 | 95% Confidence Interval 11.8 to 19.5 | percentage of participants with BORR | |
| Best Overall Response Rate (BORR) by mWHO Criteria | Ipilimumab (3 mg/kg) | 12.2 | 95% Confidence Interval 9.0 to 16.0 | percentage of participants with BORR | |
| Disease Control Rate (DCR) by mWHO Criteria | Ipilimumab (10 mg/kg) | 31.5 | 95% Confidence Interval 26.8 to 36.5 | percentage of participants with DC | |
| Disease Control Rate (DCR) by mWHO Criteria | Ipilimumab (3 mg/kg) | 27.9 | 95% Confidence Interval 23.3 to 32.8 | percentage of participants with DC | |
| Duration of Response (DOR) by mWHO Criteria | Ipilimumab (10 mg/kg) | 16.33 | 95% Confidence Interval 5.98 to 23.98 | months | |
| Duration of Response (DOR) by mWHO Criteria | Ipilimumab (3 mg/kg) | 15.90 | 95% Confidence Interval 10.35 to NA | months |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction | STARTED | Ipilimumab (10 mg/kg) | 365 | |
| Induction | STARTED | Ipilimumab (3 mg/kg) | 362 | |
| Induction | COMPLETED | Ipilimumab (10 mg/kg) | 128 | |
| Induction | COMPLETED | Ipilimumab (3 mg/kg) | 130 | |
| Induction | NOT COMPLETED | Ipilimumab (10 mg/kg) | 237 | |
| Induction | NOT COMPLETED | Ipilimumab (3 mg/kg) | 232 | |
| First Re-Induction Phase | STARTED | Ipilimumab (10 mg/kg) | 23 | |
| First Re-Induction Phase | STARTED | Ipilimumab (3 mg/kg) | 32 | |
| First Re-Induction Phase | COMPLETED | Ipilimumab (10 mg/kg) | 9 | |
| First Re-Induction Phase | COMPLETED | Ipilimumab (3 mg/kg) | 17 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events518
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 | Anaemia | Blood and lymphatic system disorders | 10 MG/KG IPILIMUMAB | 24 | 364 | |
| other | Anaemia | Blood and lymphatic system disorders | 3 MG/KG IPILIMUMAB | 17 | 362 | |
| other | Abdominal pain | Gastrointestinal disorders | 10 MG/KG IPILIMUMAB | 33 | 364 | |
| other | Abdominal pain | Gastrointestinal disorders | 3 MG/KG IPILIMUMAB | 34 | 362 | |
| other | Constipation | Gastrointestinal disorders | 10 MG/KG IPILIMUMAB | 38 | 364 | |
| other | Constipation | Gastrointestinal disorders | 3 MG/KG IPILIMUMAB | 40 | 362 | |
| other | Diarrhoea | Gastrointestinal disorders | 10 MG/KG IPILIMUMAB | 140 | 364 | |
| other | Diarrhoea | Gastrointestinal disorders | 3 MG/KG IPILIMUMAB | 105 | 362 | |
| other | Nausea | Gastrointestinal disorders | 10 MG/KG IPILIMUMAB | 59 | 364 | |
| other | Nausea | Gastrointestinal disorders | 3 MG/KG IPILIMUMAB | 74 | 362 |
1 to 10 of 518Source ClinicalTrials.gov
See all 518 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 10 MG/KG IPILIMUMAB | ||
| Total, all-cause mortality | 3 MG/KG IPILIMUMAB | ||
| Total, other adverse events | 10 MG/KG IPILIMUMAB | 319 | 364 |
| Total, other adverse events | 3 MG/KG IPILIMUMAB | 302 | 362 |
| Total, serious adverse events | 10 MG/KG IPILIMUMAB | 245 | 364 |
| Total, serious adverse events | 3 MG/KG IPILIMUMAB | 194 | 362 |
Source ClinicalTrials.gov
Papers3
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| 10 MG/KG IPILIMUMAB vs 3 MG/KG 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/NCT01515189
GET https://conductscience.org/api/trials/v1/NCT01515189/results?page=2