Phase 3
Completed N=727
Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab
Source: ClinicalTrials.gov NCT01515189 ↗Enrolled (actual)
727
Serious AEs
60.5%
Results posted
Mar 2017
Primary outcomePrimary: Overall Survival (OS) — 15.70; 11.53 months — p=0.0400
◆ Published Evidence
Highly cited
493citations · ~55 / year
Ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with unresectable or metastatic melanoma: a randomised, double-blind, multicentre, phase 3 trial.
Summary
The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving Ipilimumab at a dose of 3 mg/kg
Linked Publications (3)
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Ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with unresectable or metastatic melanoma: a randomised, double-blind, multicentre, phase 3 trial.
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Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma.
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Linking Tumor Growth Dynamics to Survival in Ipilimumab-Treated Patients With Advanced Melanoma Using Mixture Tumor Growth Dynamic Modeling.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
15.70; 11.53 | 0.0400 sig |
| SECONDARY Progression Free Survival (PFS) by mWHO Criteria |
2.83; 2.79 | 0.1548 |
| SECONDARY Best Overall Response Rate (BORR) by mWHO Criteria |
15.3; 12.2 | — |
| SECONDARY Disease Control Rate (DCR) by mWHO Criteria |
31.5; 27.9 | — |
| SECONDARY Duration of Response (DOR) by mWHO Criteria |
16.33; 15.90 | — |
| SECONDARY Duration of Stable Disease by mWHO Criteria |
5.55; 3.19 | — |
| SECONDARY Rate of Overall Survival |
54.28; 47.62; 38.46; 30.97; 31.16; 23.15 | — |
| SECONDARY Overall Survival of Participants With Brain Metastases at Baseline |
7.00; 5.67 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria
- Unresectable Stage III or Stage IV melanoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
- Brain metastases with symptoms or requiring treatment
- History of autoimmune disease
Data sourced from ClinicalTrials.gov (NCT01515189) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.