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MK-3475

Phase 1

Renal Cell Carcinoma | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Jul 28, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02133742A Dose Finding Study To Evaluate Safety, Drug Interaction, Tumor Markers Of Axitinib In Combination With MK-3475 In Adult Patients With Previously Untreated Advanced Renal Cell CancerPHASE1 COMPLETED 52Sep 16, 2014Jul 3, 2019Jul 28, 202119 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Dose-Limiting Toxicities (DLT): Dose Finding Phase
Cycle 1 Day 1 to Cycle 2 Day 21 (up to 42 days)

DLT was defined as any of the following adverse events (AEs) occurring in the first two cycles of treatment which were attributable to one or both the study drugs: 1) Grade 4 neutropenia, 2) Febrile neutropenia lasting greater than (\>) 1 hour, 3) Grade greater than or equal to (\>=) 3 neutropenia with infection, 4) Grade \>=3 thrombocytopenia with bleeding, 4) Grade 4 thrombocytopenia, 5) Any grade \>=3 non-hematologic: non-laboratory toxicities despite maximum supportive therapy or hypertension despite maximal medical therapy, 6) Grade \>=3 non-hematologic toxicities resulted in hospitalisation or medical intervention 7) Inability to complete at least 75 percent (%) of axitinib dosing or 2 infusions of pembrolizumab within the DLT observation period (up to 42 days) due to treatment related toxicity. Severity of AEs was graded according to NCI (National Cancer Institute) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Secondary Endpoints
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline up to 28 days after last dose of study drug (approximately up to 1552 days)
Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline up to 28 days after last dose of study drug (approximately up to 1552 days)
Number of Participants With Adverse Events (AEs) According to Severity of Grade 3 or Higher Severity Based on NCI CTCAE Version 4.03
Baseline up to 28 days after last dose of study drug (approximately up to 1552 days)
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Study Design & Arms
AllocationNA
MaskingNONE
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose finding phase and dose expansion phaseEXPERIMENTALTo test the maximum tolerated dose of MK-3475 at 2 mg/kg every three weeks intravenous infusion in combination with approved axitinib dose
Interventions
NameTypeDescription
AxitinibDRUGAxitinib at starting dose of 5 mg and 3 mg BID.
MK-3475DRUGMK-3475 with two dose levels: 2 mg/kg every three weeks to find the maximum tolerated dose and continue treatment in a dose expansion phase.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Histologically or cytologically confirmed advanced RCC with predominantly clear-cell subtype with primary tumor resected * At least one measureable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. * Eastern Cooperative Oncology Group perf...

Countries:United States
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