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nivolumab and ipilimumab

Phase 2

Malignant Pleural Mesothelioma | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jan 20, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment36
FDA Designations
BREAKTHROUGH_THERAPYPRIORITY_REVIEW
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03048474Ipilimumab and Nivolumab in the Treatment of Malignant Pleural MesotheliomaPHASE2 COMPLETED 36Sep 1, 2016Dec 1, 2019Jan 20, 20211 Netherlands
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Study Endpoints
Primary Endpoints
Disease Controle Rate (DCR) at 12 weeks
at 12 weeks

The number of patients that have CR or PR plus the number of patients with stable disease as a percentage of the total number of patients in the study.

Secondary Endpoints
Safety: the incidence of adverse events, serious adverse events, deaths and laboratory abnormalities.
Participants will be followed for the duration of the trial, an expected average of 6 weeks
Disease Controle Rate (DCR) at 6 months
at 6 months
Progression Free Survival (PFS)
Until progression, every 6 weeks up to 48 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Nivolumab and IpilimumabEXPERIMENTALNivolumab will be administered at a fixed dose of 240 mg every 2 weeks for a maximum period of 2 years. Nivolumab will be given in combination with ipilimumab on week 1, 7, 13 and 19. Ipilimumab will be administered at the dose of 1 mg/Kg.
Interventions
NameTypeDescription
nivolumab and ipilimumabDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Signed informed consent form * Age ≥ 18 years * WHO-ECOG performance status 0 or 1 * Able to comply with the study protocol, in the investigator's judgment * Patients with histologically confirmed diagnosis of the recurrence of MPM. Any pleural MPM subtype is permitted for inc...

Countries:Netherlands
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