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MK-3795

Phase 2

VHL Gene Mutation | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Sep 24, 2024

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 Enrollment4
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03108066MK-3795 (PT2385) for the Treatment of Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma (MK-3795-003)PHASE2 COMPLETED 4Apr 24, 2017Sep 27, 2023Sep 24, 20241 United States
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Study Endpoints
Primary Endpoints
Overall Response Rate (ORR) in VHL Disease-Associated ccRCC Tumors
Up to approximately 76 months

ORR was defined as the percentage of participants in the analysis population who have a best confirmed response of Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR was assessed by independent review committee (ICR) for the primary analysis.

Secondary Endpoints
Progression-free Survival (PFS) in VHL Disease-Associated ccRCC Tumors
Up to approximately 76 months
Duration of Response (DOR) in VHL Disease-Associated ccRCC Tumors
Up to approximately 76 months
Time to Response (TTR) in VHL Disease-Associated ccRCC Tumors
Up to approximately 76 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MK-3795EXPERIMENTALParticipants receive 800 mg MK-3795 orally twice daily. Participants may continue to receive MK-3795 in the absence of unacceptable treatment related toxicity or unequivocal disease progression.
Interventions
NameTypeDescription
MK-3795DRUG800 mg twice daily (four 200 mg oral tablets twice daily)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Has at least 1 measurable ccRCC tumor and no solid ccRCC tumor greater than 3.0 cm, based on radiologic diagnosis (histologic diagnosis not required); may have VHL disease-associated lesions in other organ systems * Has a diagnosis of von Hippel Lindau disease, based on a germ...

Countries:United States
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