Trial · NCT00324155
Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma
NCT00324155, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2014-03-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma. Trials, record NCT00324155. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00324155
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma
- NCT number
- NCT00324155
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 681 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Melanoma
- Interventions
- Ipilimumab, Placebo, Dacarbazine
- First posted
- 2006-05-10
- Last updated
- 2014-11-03
- Results first posted
- 2014-03-10
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months | OS was defined as the time from the date of randomization until the date of death. Analysis of OS was to be done once 416 deaths had occurred (primary endpoint). However, analysis occurred at 414 deaths (February 7, 2011), due to operational timing of the study. Median number of months of OS and associated confidence interval calculated using the method of Brookmeyer and Crowley. |
| Secondary | Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years | Date of randomization to 3 years following randomization | The survival rate (percentage of participants alive) was defined as the probability that a participant is alive at 1 year (or 18 months, 2 years, or 3 years) following randomization and was estimated via the Kaplan-Meier method. |
| Secondary | Disease Control Rate (DCR) | First dose to last tumor assessment prior to subsequent therapy at data cutoff for Primary Endpoint (approximately 5 years) | DCR=number whose best overall response (BOR) was partial response (PR), complete response (CR) or stable disease (SD), divided by all randomized participants (unevaluable participants included). Independent review committee assessment. BOR=date of first dose to last tumor assessment prior to subsequent cancer therapy (including tumor resection, excluding palliative local radiotherapy). Modified World Health Organization criteria: CR=disappearance of all lesions; no evidence of progressive disease (PD); PR=50% or more decrease in the sum of products of the longest diameter and greatest perpendicular diameter of all index lesions compared with baseline; SD=neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD; PD=at least 25% increase in sum of products of all index lesions and/or appearance of any new lesions; nonindex lesions: appearance of any new lesions and/or unequivocal progression of nonindex lesions. |
| Secondary | Median Number of Months of Progression-free Survival (PFS) | Randomization to date of progression or death to approximately 5 years | PFS=time between randomization and date of progression or death, whichever occurs first. Participants who died without reported prior progression were considered to have progressed on date of death. For those alive and not progressed, PFS was censored on date of last evaluable tumor assessment (TA). Those who have not died and have no recorded postbaseline TA were censored at randomization. Those who died without any recorded postbaseline TA were considered to have progressed on date of death. Evaluation was conducted by both investigator and an independent review committee (IRC), who assessed radiologic imaging studies, photographs of skin lesions, and clinical data. Progressive disease defined using modified criteria of the World Health Organization: demonstration of at least a 25% increase in the sum of products of all index lesions or the appearance of any new lesions. For nonindex lesions: appearance of any new lesions or unequivocal progression of nonindex lesions. |
| Secondary | Progression-free Survival (PFS) Rate Truncated at Week 12 | Day 78 | PFS rate=probability patient was progression-free at Day 78, calculated as total patients receiving treatment and with an overall response of stable disease (SD), partial response (PR), or complete response (CR) at Week 12, divided by total patients. For those alive and not progressed at or before Week 12, PFS censored on date of last evaluable tumor assessment (TA) at or before Week 12. Those with an assessment of PD prior to Week 12 and subsequent assessment of SD, PR, or CR at Week 12 were called progression-free at Week 12. Those with no recorded postbaseline TA dated on or before Day 109, and who had not died on or before Day 109, were censored at randomization. PD=at least 25% increase in sum of products of all index lesions or appearance of any new lesions. Both an investigator and independent review committee (IRC) assessed radiologic imaging studies, photographs of skin lesions, and clinical data. IRC assessment was considered primary over that of the investigators. |
| Secondary | Best Overall Response Rate (BORR) | First dose to last tumor assessment at data cutoff for primary endpoint (approximately 5 years) | BORR=number with Best Overall Response (BOR) of complete response (CR) or partial response (PR), divided by total number of randomized patients. BOR=date of first dose to the last tumor assessment prior to subsequent cancer therapy (including tumor resection surgery but excluding palliative local radiotherapy for bone lesions). Independent review committee assessment. Modified criteria of the World Health Organization (mWHO): CR=disappearance of all lesions; no evidence of progressive disease; PR=50% or greater decrease in the sum of products of the longest diameter and greatest perpendicular diameter of all index lesions compared with baseline. Immune-related (ir) response criteria (irRC) assess tumor response in patients on immunotherapy: irCR=disappearance of all lesions in 2 consecutive observations at least 4 weeks apart; irPR=50% or greater decrease in total measureable tumor burden compared with peak in 2 observations at least 4 weeks apart. |
| Secondary | Duration of Response (DOR): Randomized Participants With Response of Complete Response (CR) or Partial Response (PR) | Day of CR or PR to day of PD or death up to data cutoff for primary endpoint (approximately 5 years) | DOR defined in those with Best Overall Response (BOR)=CR or PR per independent review committee (IRC) as time between date of response of confirmed CR or PR, whichever occurred first, and date of PD or death. If PR assessed before CR, DOR confirmed at earlier time-point showing PR. Modified criteria of the World Health Organization (mWHO): CR=disappearance of all lesions;no evidence of PD; PR=50% or greater decrease in the sum of products of longest and greatest perpendicular diameters (SPD) of all index lesions compared with baseline. PD=an increase of 25% or greater in SPD of index lesions compared with the smallest recorded sum, or appearance of 1 or more new lesions. Immune-related response criteria (irRC): SD=50% decrease in total measurable tumor burden compared with peak cannot be established nor 25% increase compared with nadir, in absence of unequivocal progression of nonindex lesions. Unconfirmed immune-related (ir) CR, irPR, or irPD=irSD. |
| Secondary | Time to Response: All Randomized Participants With Response to Treatment | First dose to date of BOR up to data cutoff for primary endpoint (approximately 5 years) | Time to response was defined as the time between the first dose of study therapy and the date when measurement criteria were met for Best Overall Response (BOR) of partial response (PR) or complete response (CR), whichever occurred first, per independent review committee. Note that if an overall response of PR occurred before confirmation of CR, the time to response endpoint was not determined by the time that the BOR of CR was shown but rather by the earlier time point showing PR. Modified criteria of the World Health Organization: CR=disappearance of all lesions; no evidence of progressive disease (PD); PR=50% or more decrease in the sum of products of the longest and greatest perpendicular diameters (SPD) of all index lesions compared with baseline; PD=an increase of 25% or greater in the SPD of index lesions compared with the smallest recorded sum, or the appearance of 1 or more new lesions. |
| Secondary | Duration of Stable Disease (SD): Randomized Participants With Stable Disease | Week 12 to date of disease progression or death up to data cutoff for primary endpoint (approximately 5 years) | Duration of SD was defined in those whose Best Overall Response (BOR) was SD, per independent review committee (IRC) as the time between Week 12 and date of progressive disease (PD) or death , whichever occurs first. For those who underwent tumor resection following Week 12 but prior to PD, duration of SD was censored on date of last evaluable tumor assessment (TA) prior to resection. For those with BOR of SD at Week 12, date of PD was used in analysis of duration of SD. For those with BOR=SD who have not subsequently progressed and who remain alive, duration of SD censored on date of last evaluable TA. Modified criteria of the World Health Organization (mWHO): SD=insufficient decrease to qualify for partial response or sufficient increase to qualify for PD; PD=an increase of 25% or more in sum of products of longest diameter and greatest perpendicular diameter of index lesions compared with smallest recorded sum, or appearance of 1 or more new lesions. |
| Secondary | Percentage of Participants With Brain Metastasis-Free Survival at Time of Data Cutoff | Date of randomization up to data cutoff for primary endpoint (approximately 5 years) | Brain metastasis-free survival was defined as the time from randomization to the date of progression with a new lesion located in the brain. New brain lesions prior to Week 12 constituted a progression event (unlike main progression-free survival analysis). A participant who dies without documentation of a brain lesion was considered to have progressed with brain metastasis on the date of death. Participants who are free of brain metastasis were censored on the date of their last tumor assessment. An independent review committee evaluated images of participants with clinical symptoms to determine the number of those free of brain metastasis. The brain metastasis-free status was reported as a percent of participants (n/N), where n= participants with metastasis-free brains at data cutoff for the Primary Endpoint and N= randomized participants. A 2-sided Clopper and Pearson confidence interval was performed. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years | Date of randomization to 3 years following randomization | All participants who were randomized to a treatment group | Percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | First dose to last tumor assessment prior to subsequent therapy at data cutoff for Primary Endpoint (approximately 5 years) | All participants who were randomized to a treatment group | Percentage of participants | NUMBER |
| SECONDARY | Median Number of Months of Progression-free Survival (PFS) | Randomization to date of progression or death to approximately 5 years | All participants who were randomized to a treatment group | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) Rate Truncated at Week 12 | Day 78 | All participants who were randomized to a treatment group | Percentage of participants | NUMBER |
| SECONDARY | Best Overall Response Rate (BORR) | First dose to last tumor assessment at data cutoff for primary endpoint (approximately 5 years) | All participants who were randomized to a treatment group | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR): Randomized Participants With Response of Complete Response (CR) or Partial Response (PR) | Day of CR or PR to day of PD or death up to data cutoff for primary endpoint (approximately 5 years) | All participants who were randomized to a treatment group and had a response of CR, PR, irCR, or irPR. n=number of participants who responded by mWHO criteria and irRC. | Months | MEDIAN |
| SECONDARY | Time to Response: All Randomized Participants With Response to Treatment | First dose to date of BOR up to data cutoff for primary endpoint (approximately 5 years) | All participants who were randomized to a treatment group and who had a response of CR or PR | Months | MEDIAN |
| SECONDARY | Duration of Stable Disease (SD): Randomized Participants With Stable Disease | Week 12 to date of disease progression or death up to data cutoff for primary endpoint (approximately 5 years) | All participants who were randomized to a treatment group and had SD | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Brain Metastasis-Free Survival at Time of Data Cutoff | Date of randomization up to data cutoff for primary endpoint (approximately 5 years) | All participants who were randomized to a treatment group | Percentage of participants | NUMBER |
| PRIMARY | Overall Survival (OS) | Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months | All randomized participants whose survival follow-up was current (defined as having died or last known alive date occurring on or after the data cutoff date, which was when a total of 414 deaths occurred). | Months | MEDIAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group88
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years | Ipilimumab and Dacarbazine | At 1 year | 47.3 | 95% Confidence Interval 41.0 to 53.6 | Percentage of participants |
| Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years | Placebo and Dacarbazine | At 1 year | 36.3 | 95% Confidence Interval 30.4 to 42.4 | Percentage of participants |
| Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years | Ipilimumab and Dacarbazine | At 18 months | 35.6 | 95% Confidence Interval 29.7 to 41.6 | Percentage of participants |
| Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years | Placebo and Dacarbazine | At 18 months | 26.1 | 95% Confidence Interval 20.7 to 31.6 | Percentage of participants |
| Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years | Ipilimumab and Dacarbazine | At 2 years | 28.5 | 95% Confidence Interval 22.9 to 34.2 | Percentage of participants |
| Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years | Placebo and Dacarbazine | At 2 years | 17.9 | 95% Confidence Interval 13.3 to 22.8 | Percentage of participants |
| Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years | Ipilimumab and Dacarbazine | At 3 years | 20.8 | 95% Confidence Interval 15.7 to 26.1 | Percentage of participants |
| Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years | Placebo and Dacarbazine | At 3 years | 12.2 | 95% Confidence Interval 8.2 to 16.5 | Percentage of participants |
| Disease Control Rate (DCR) | Ipilimumab and Dacarbazine | 33.2 | Percentage of participants | ||
| Disease Control Rate (DCR) | Placebo and Dacarbazine | 30.2 | Percentage of participants |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Enrolled and Randomized | STARTED | Ipilimumab and Dacarbazine | 250 | |
| Enrolled and Randomized | STARTED | Placebo and Dacarbazine | 252 | |
| Enrolled and Randomized | COMPLETED | Ipilimumab and Dacarbazine | 247 | |
| Enrolled and Randomized | COMPLETED | Placebo and Dacarbazine | 251 | |
| Enrolled and Randomized | NOT COMPLETED | Ipilimumab and Dacarbazine | 3 | |
| Enrolled and Randomized | NOT COMPLETED | Placebo and Dacarbazine | 1 | |
| Received Treatment in Induction Phase | STARTED | Ipilimumab and Dacarbazine | 247 | |
| Received Treatment in Induction Phase | STARTED | Placebo and Dacarbazine | 251 | |
| Received Treatment in Induction Phase | COMPLETED | Ipilimumab and Dacarbazine | 45 | |
| Received Treatment in Induction Phase | COMPLETED | Placebo and Dacarbazine | 54 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events468
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 | Blood alkaline phosphatase increased | Investigations | 10 mg/kg Ipilimumab + Dacarbazine | 16 | 247 | |
| other | Blood alkaline phosphatase increased | Investigations | Placebo + Dacarbazine | 9 | 251 | |
| other | Nausea | Gastrointestinal disorders | 10 mg/kg Ipilimumab + Dacarbazine | 119 | 247 | |
| other | Nausea | Gastrointestinal disorders | Placebo + Dacarbazine | 120 | 251 | |
| other | Neutropenia | Blood and lymphatic system disorders | 10 mg/kg Ipilimumab + Dacarbazine | 16 | 247 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Dacarbazine | 14 | 251 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | 10 mg/kg Ipilimumab + Dacarbazine | 73 | 247 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Placebo + Dacarbazine | 22 | 251 | |
| other | Weight decreased | Investigations | 10 mg/kg Ipilimumab + Dacarbazine | 27 | 247 | |
| other | Weight decreased | Investigations | Placebo + Dacarbazine | 13 | 251 |
1 to 10 of 468Source ClinicalTrials.gov
See all 468 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 + Dacarbazine | ||
| Total, all-cause mortality | Placebo + Dacarbazine | ||
| Total, other adverse events | 10 mg/kg Ipilimumab + Dacarbazine | 220 | 247 |
| Total, other adverse events | Placebo + Dacarbazine | 218 | 251 |
| Total, serious adverse events | 10 mg/kg Ipilimumab + Dacarbazine | 170 | 247 |
| Total, serious adverse events | Placebo + Dacarbazine | 121 | 251 |
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 + Dacarbazine vs Placebo + Dacarbazine: 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/NCT00324155
GET https://conductscience.org/api/trials/v1/NCT00324155/results?page=2