BENITIONSClinical Trial Intelligence

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

ConditionMalignant Melanoma
PhasePhase 1
SponsorBristol-Myers Squibb
StatusCompleted
Enrollment127 participants
InterventionsBMS-936558 (MDX1106-04), Ipilimumab
Start dateDec 14, 2009
Completion dateFeb 4, 2014
Results postedMar 22, 2021

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 114 Participants
Cohort 217 Participants
Cohort 2a16 Participants
Cohort 36 Participants
Any BMS and Ipi Combo53 Participants
Cohort 617 Participants

Number of Participants With a Serious Adverse Event (AE)

Up to 3 years · Participants

Cohort 110 Participants
Cohort 215 Participants
Cohort 2a10 Participants
Cohort 35 Participants
Any BMS and Ipi Combo40 Participants
Cohort 69 Participants

Number of Participants With an Adverse Event (AE) Which Lead to Discontinuation

Up to 3 years · Participants

Cohort 12 Participants
Cohort 28 Participants
Cohort 2a5 Participants
Cohort 31 Participants
Any BMS and Ipi Combo16 Participants
Cohort 65 Participants

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