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Cabozantinib

Phase 2

Castration-resistant Prostate Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jan 23, 2026

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 Enrollment47
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05502315Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate CancerPHASE2 RECRUITING 47Feb 2, 2023Apr 12, 2027Jan 23, 20264 United States
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Study Endpoints
Primary Endpoints
Radiographic Progression Free Survival (rPFS)
6 months

The primary endpoint is the efficacy of treatment via assessment of 6 month rPFS defined by RECIST version 1.1 for soft tissue and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases. rPFS is defined as the duration of time from the first day of the start of study treatment to time of radiographic progression or death due to any cause, whichever occurs first.

Secondary Endpoints
PSA Response
3 years
Overall Response Rate (ORR)
3 years
6-month rPFS in predefined subgroups
6 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Experimental GroupEXPERIMENTAL40 mg of cabozantinib taken orally every day (days 1-28) of a 28 day cycle 480 mg of nivolumab given intravenously on the first day (day 1) of each 28 day cycle
Interventions
NameTypeDescription
CabozantinibDRUG40 mg taken orally
NivolumabDRUG480 mg by infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: Subjects must meet all of the following applicable inclusion criteria to participate in this study: * Willing and able to provide, or have a legally authorized representative provide, written informed consent and HIPAA authorization for the release of personal health informatio...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT05502315studyFirstPostDate: changed