Trial · NCT00094653
MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma
NCT00094653, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2011-06-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma. Trials, record NCT00094653. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00094653
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma
- NCT number
- NCT00094653
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,783 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Melanoma, Metastases
- Interventions
- MDX-010 (anti-CTLA4) monoclonal antibody, MDX-1379 (gp100) Melanoma Peptide Vaccine
- First posted
- 2004-10-22
- Last updated
- 2011-07-11
- Results first posted
- 2011-06-23
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone | From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) | OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method. |
| Secondary | Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 Monotherapy Versus gp100 Melanoma Peptide Vaccine Alone and MDX-010 in Combination With gp100 Melanoma Peptide Vaccine Versus MDX-010 Monotherapy | From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) | OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method. |
| Secondary | 12-, 18-, and 24-Month Survival Rates | Month 12, Month 18, Month 24 | The probability that a subject is alive at 12 months, 18 months, and 24 months following randomization, estimated via the non-parametric method (Kaplan-Meier method). For calculating 95% CI, bootstrap method was used with 20000 simulated trials. |
| Secondary | Progression Free Survival (PFS) | From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) | PFS was defined as the number of days between the date of randomization and the date of the progression or the date of death. A subject who died without prior progression was considered to have progressed on the date of death. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method. |
| Secondary | Percentage of Participants With Progression Free Survival (PFS) at Week 12 and Week 24 | Week 12, Week 24 | PFS at Week 12 was defined as the probability that the subject was progression-free at 12 weeks and 24 weeks following the start of randomization. It was computed via Kaplan-Meier method, truncated at Week 12 and Week 24. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method. |
| Secondary | Time to Progression (TTP) | from time of randomization to date of PD or death due to PD (end of the study was defined as the time at which 481 deaths were observed [264 weeks]) | TTP was defined as the number of days between the date of the randomization and date of PD or death due to PD. For subjects who had not progression and remained alive, TTP was censored on the date of last assessment; those who remained alive and had no recorded post-baseline assessment, TTP was censored on the date of randomization; those who remained alive and had randomized but were not treated, TTP was censored at the date of randomization; for those who died without reported disease progression, TTP was censored on the date of death. |
| Secondary | Best Overall Response (BOR): Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressed Disease (PD) | BOR was determined between Weeks 12 and Week 24 confirmation at least 4 weeks later at Cycle 1. | Investigator's assessment, modified World Health Organization criteria. CR: disappearance of all lesions by 2 consecutive observations \>=4 weeks apart, no evidence of PD. PR: \>=50% ↓ in sum of products of longest diameter \& greatest perpendicular diameter of all target lesions compared to baseline by 2 observations \>=4 weeks apart. SD: Neither sufficient ↓ to qualify for PR nor sufficient ↑ to qualify for PD. PD: ↑ \>=25% in sum of products of longest diameter \& greatest perpendicular diameter of target lesions compared to smallest recorded sum during study, or appearance of \>= 1 new lesion. |
| Secondary | Determination of Best Overall Response Rate (BORR) | Up to week 24 | Response was based on the investigators' assessment using modified WHO criteria. BORR is defined as the number of subjects whose BOR is complete or partial response (CR or PR) divided by the total number of subjects in the group. BORR was comprised of responder and non-responder. The definition of a responder in BORR was either confirmed CR or PR, and a non-responder was defined as stable disease (SD), progressed disease (PD), unconfirmed CR (uCR), unconfirmed PR (uPR), and not evaluated. |
| Secondary | Time to Response | From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) | Time to response was defined as the number of days from the date of randomization to the date when measurement criteria are met for BOR of CR or PR, as determined by investigator. |
| Secondary | Duration of Response | from time of initial drug administration to date of PD or death due to PD (the end of the study was defined as the time at which 481 deaths were observed [264 weeks]) | Kaplan-Meier medians along with Brookmeyer and Crowley 95% confidence intervals (CI) for were computed. Duration of response was defined in subjects whose BOR was CR or PR as the number of days between the date of response (CR or PR) and the date of PD or the date of death (whichever occurs first). |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone | From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) | Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 Monotherapy Versus gp100 Melanoma Peptide Vaccine Alone and MDX-010 in Combination With gp100 Melanoma Peptide Vaccine Versus MDX-010 Monotherapy | From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) | Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. | months | MEDIAN |
| SECONDARY | 12-, 18-, and 24-Month Survival Rates | Month 12, Month 18, Month 24 | Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. | probability | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) | Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. Subjects who neither progressed nor died were censored at the date of the last tumor assessment. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Progression Free Survival (PFS) at Week 12 and Week 24 | Week 12, Week 24 | Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. | percentage of participants | MEDIAN |
| SECONDARY | Time to Progression (TTP) | from time of randomization to date of PD or death due to PD (end of the study was defined as the time at which 481 deaths were observed [264 weeks]) | Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. | months | MEDIAN |
| SECONDARY | Best Overall Response (BOR): Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressed Disease (PD) | BOR was determined between Weeks 12 and Week 24 confirmation at least 4 weeks later at Cycle 1. | Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. | participants | NUMBER |
| SECONDARY | Determination of Best Overall Response Rate (BORR) | Up to week 24 | Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. | percentage of participants | NUMBER |
| SECONDARY | Time to Response | From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) | Responder subjects in intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. | months | MEAN |
| SECONDARY | Duration of Response | from time of initial drug administration to date of PD or death due to PD (the end of the study was defined as the time at which 481 deaths were observed [264 weeks]) | Responders only in intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. Patients who did not progress or died were censored at the date of their last tumor assessment. | months | MEDIAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group395
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone | Ipilimumab Plus gp100 | 9.95 | 95% Confidence Interval 8.48 to 11.50 | months | |
| Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone | gp100 | 6.44 | 95% Confidence Interval 5.49 to 8.71 | months | |
Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 Monotherapy Versus gp100 Melanoma Peptide Vaccine Alone and MDX-010 in Combination With gp100 Melanoma Peptide Vaccine Versus MDX-010 Monotherapy | Ipilimumab Plus gp100 | 9.95 | 95% Confidence Interval 8.48 to 11.50 | months | |
Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 Monotherapy Versus gp100 Melanoma Peptide Vaccine Alone and MDX-010 in Combination With gp100 Melanoma Peptide Vaccine Versus MDX-010 Monotherapy | Ipilimumab Monotherapy | 10.12 | 95% Confidence Interval 8.02 to 13.80 | months | |
Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 Monotherapy Versus gp100 Melanoma Peptide Vaccine Alone and MDX-010 in Combination With gp100 Melanoma Peptide Vaccine Versus MDX-010 Monotherapy | gp100 | 6.44 | 95% Confidence Interval 5.49 to 8.71 | months | |
| 12-, 18-, and 24-Month Survival Rates | Ipilimumab Plus gp100 | 12-Month Survival Rate | 0.436 | 95% Confidence Interval 0.386 to 0.485 | probability |
| 12-, 18-, and 24-Month Survival Rates | Ipilimumab Monotherapy | 12-Month Survival Rate | 0.456 | 95% Confidence Interval 0.370 to 0.541 | probability |
| 12-, 18-, and 24-Month Survival Rates | gp100 | 12-Month Survival Rate | 0.253 | 95% Confidence Interval 0.181 to 0.329 | probability |
| 12-, 18-, and 24-Month Survival Rates | Ipilimumab Plus gp100 | 18-Month Survival Rate | 0.300 | 95% Confidence Interval 0.254 to 0.347 | probability |
| 12-, 18-, and 24-Month Survival Rates | Ipilimumab Monotherapy | 18-Month Survival Rate | 0.332 | 95% Confidence Interval 0.249 to 0.417 | probability |
1 to 10 of 395Source ClinicalTrials.gov
See all 395 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ipilimumab Plus gp100 | 403 | |
| Overall Study | STARTED | Ipilimumab Monotherapy | 137 | |
| Overall Study | STARTED | gp100 | 136 | |
| Overall Study | Treated | Ipilimumab Plus gp100 | 381 | |
| Overall Study | Treated | Ipilimumab Monotherapy | 131 | |
| Overall Study | Treated | gp100 | 131 | |
| Overall Study | COMPLETED | Ipilimumab Plus gp100 | 82 | |
| Overall Study | COMPLETED | Ipilimumab Monotherapy | 31 | |
| Overall Study | COMPLETED | gp100 | 10 | |
| Overall Study | NOT COMPLETED | Ipilimumab Plus gp100 | 321 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events756
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 | ABDOMINAL DISTENSION | Gastrointestinal disorders | Ipilimumab Monotherapy | 0 | 131 | |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | Ipilimumab Plus gp100 | 13 | 380 | |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | gp100 | 9 | 132 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Ipilimumab Monotherapy | 20 | 131 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Ipilimumab Plus gp100 | 64 | 380 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | gp100 | 18 | 132 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Ipilimumab Monotherapy | 7 | 131 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Ipilimumab Plus gp100 | 17 | 380 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | gp100 | 11 | 132 | |
| other | ADVERSE EVENT | General disorders | Ipilimumab Monotherapy | 4 | 131 |
1 to 10 of 756Source ClinicalTrials.gov
See all 756 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ipilimumab Monotherapy | ||
| Total, all-cause mortality | Ipilimumab Plus gp100 | ||
| Total, all-cause mortality | gp100 | ||
| Total, other adverse events | Ipilimumab Monotherapy | 124 | 131 |
| Total, other adverse events | Ipilimumab Plus gp100 | 362 | 380 |
| Total, other adverse events | gp100 | 124 | 132 |
| Total, serious adverse events | Ipilimumab Monotherapy | 55 | 131 |
| Total, serious adverse events | Ipilimumab Plus gp100 | 155 | 380 |
| Total, serious adverse events | gp100 | 52 | 132 |
Source ClinicalTrials.gov
Papers10
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/NCT00094653
GET https://conductscience.org/api/trials/v1/NCT00094653/results?page=2