Dose-escalation Study of Combination BMS-936558 (MDX-1106) and Ipilimumab in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma
Phase 1
Completed
NCT01024231
| Condition | Malignant Melanoma |
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| Phase | Phase 1 |
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| Sponsor | Bristol-Myers Squibb |
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| Status | Completed |
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| Enrollment | 127 participants |
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| Interventions | BMS-936558 (MDX1106-04), Ipilimumab |
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| Start date | Dec 14, 2009 |
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| Completion date | Feb 4, 2014 |
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| Results posted | Mar 22, 2021 |
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Summary
The purpose of this study is to determine the safety and tolerability of treatment with BMS-936558 (MDX-1106) in combination with Ipilimumab (BMS-734016) when given at the same time or as a sequenced regimen in subjects with unresectable Stage III or Stage IV malignant melanoma (MEL)
Number of Participants With an Adverse Event (AE)
Up to 3 years · Participants
| Cohort 1 | 14 Participants |
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| Cohort 2 | 17 Participants |
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| Cohort 2a | 16 Participants |
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| Cohort 3 | 6 Participants |
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| Any BMS and Ipi Combo | 53 Participants |
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| Cohort 6 | 17 Participants |
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Number of Participants With a Serious Adverse Event (AE)
Up to 3 years · Participants
| Cohort 1 | 10 Participants |
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| Cohort 2 | 15 Participants |
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| Cohort 2a | 10 Participants |
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| Cohort 3 | 5 Participants |
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| Any BMS and Ipi Combo | 40 Participants |
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| Cohort 6 | 9 Participants |
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Number of Participants With an Adverse Event (AE) Which Lead to Discontinuation
Up to 3 years · Participants
| Cohort 1 | 2 Participants |
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| Cohort 2 | 8 Participants |
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| Cohort 2a | 5 Participants |
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| Cohort 3 | 1 Participants |
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| Any BMS and Ipi Combo | 16 Participants |
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| Cohort 6 | 5 Participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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