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ACY-241

Phase 1

Malignant Melanoma | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Aug 24, 2017

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment1
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02935790Selective HDAC6 Inhibitor ACY-241 in Combination With Ipilimumab and NivolumabPHASE1 COMPLETED 1Sep 30, 2016Apr 7, 2017Aug 24, 20171 United States
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Study Endpoints
Primary Endpoints
Number of Dose Limiting Toxicities defining the MTD
12 months
Secondary Endpoints
Percentage of Patients with ORR based on RECIST 1.1 change from baseline by CT or MRI measurements
12 months
Percentage of Patients with ORR based on irRC change from baseline by CT or MRI measurements
12 months
Maximum observed concentration (Cmax) of ACY-241 administered in combination with ipilimumab and nivolumab
12 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ACY-241 combo with Ipi and NivoEXPERIMENTALACY-241 in Combination with Ipilimumab and Nivolumab
Interventions
NameTypeDescription
ACY-241DRUGtablet
nivolumabDRUGinfusion
ipilimumabDRUGinfusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patients must have signed and dated an Institutional Review Board/Independent Ethics Committee -approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures t...

Countries:United States
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