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Sitravatinib

Phase 2

Advanced or Metastatic Solid Malignancies | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Oct 10, 2025

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
NCT04887870Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent StudyPHASE2 COMPLETED 52Jun 29, 2021Sep 25, 2025Oct 10, 202513 United States
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Study Endpoints
Primary Endpoints
Frequency of subjects experiencing treatment-related AEs.
24 Months
Secondary Endpoints
Time to clinical or radiographic progression on study.
24 Months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 2/3: Open label extension of parent studyEXPERIMENTALThe current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial.
Interventions
NameTypeDescription
SitravatinibDRUGSitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
NivolumabDRUGNivolumab is a programmed death receptor-1 (PD-1) blocking antibody
PembrolizumabDRUGPembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody
Enfortumab Vedotin-EjfvDRUGEnfortumab is a Nectin-4 directed antibody-drug conjugate (ADC) comprised of a monoclonal antibody conjugated to the small molecule microtubule disrupting agent, monomethyl auristatin E (MMAE)
IpilimumabDRUGIpilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Currently receiving sitravatinib single- agent or in combination with other therapeutic agent(s) in another Mirati- sponsored protocol * Currently tolerating the treatment regimen in the parent protocol * Experiencing clinical benefit with or without prior radiographic progres...

Countries:United States
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