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Pembrolizumab

Phase 2

Recurrent Fallopian Tube Carcinoma | Monoclonal antibody | Oncology |United Therapeutics Corporation|Last Updated: Sep 18, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment22
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04387227Pembrolizumab and Carboplatin for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal CancerPHASE2 ACTIVE NOT_RECRUITING 22Mar 18, 2021Jun 1, 2026Sep 18, 20251 United States
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Study Endpoints
Primary Endpoints
Progression-free survival
At 6 months
Rate of radiographic recurrence
At 6 months
Secondary Endpoints
Programmed cell death ligand 1 (PD-L1) expression
Up to 2 years
Changes in T cell activation
Baseline and 2 years
Overall survival
Up to 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment (carboplatin, pembrolizumab)EXPERIMENTALPatients receive carboplatin IV over 30 minutes on day -2 of cycle 1 only. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI throughout the trial. Patients also undergo blood sample collection on the trial.
Interventions
NameTypeDescription
CarboplatinDRUGGiven IV
PembrolizumabBIOLOGICALGiven IV
Computed TomographyPROCEDUREUndergo CT
Magnetic Resonance ImagingPROCEDUREUndergo MRI
Biospecimen CollectionPROCEDUREUndergo blood sample collection
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Have a diagnosis of ovarian, fallopian tube, or primary peritoneal cancer who have received systemic chemotherapy including platinum-based chemotherapy * Have a cancer antigen (CA)-125 that normalized after first-line therapy * CA-125 increased to more than twice the upper lim...

Countries:United States
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