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Oregovomab

Phase 3

Carcinoma, Ovarian Epithelial | Monoclonal antibody | Oncology |IQVIA Holdings, Inc.|Last Updated: Apr 1, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment615
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04498117Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking SurgeryPHASE3 ACTIVE NOT_RECRUITING 615 — — Aug 25, 2020Aug 26, 2028Apr 1, 2026148 United States, Argentina +12
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Study Endpoints
Primary Endpoints
Investigator Assessed Progression Free Survival
Date of randomization until date of first documented disease progression or date of death from any cause, whichever comes first, at up to approximately 6 years.

Date of randomization to radiographically-confirmed disease progression according to RECIST v1.1 as determined by the investigator or death

Secondary Endpoints
Overall Survival
Date of randomization up until date of death from any cause, up to approximately 11 years
Safety and Tolerability
Date of randomization up until date of discontinuation of treatment, date of significant physical examination changes, date of significant clinical changes, up to approximately 6 years
Change in Quality of Life
Changes from baseline assessment, until date of discontinuation, or up to approximately 6 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1- Surgery ActiveEXPERIMENTALSix (6) 21-day cycles of chemotherapy with oregovomab given at four (4) cycles (Cycle 1, Cycle 3, Cycle 5, and Cycle 5 plus 12 weeks).
Cohort 1 - Primary Surgery ControlPLACEBO_COMPARATORSix (6) 21-day cycles of chemotherapy with placebo comparator given with chemotherapy at four (4) cycles (Cycle 1, Cycle 3, Cycle 5, and Cycle 5 plus 12 weeks).
Cohort 2 - NACT + Interval Surgery ActiveEXPERIMENTALIn Cohort 2 - NACT + Interval Surgery, subjects must already have received three (3) cycles of paclitaxel and carboplatin neoadjuvant therapy. Subjects in Cohort 2 - NACT + Interval Surgery will receive three (3) cycles of chemotherapy with oregovomab given at four (4) cycles (Cycle 4, Cycle 6, Cycle 6 plus 6 weeks and Cycle 6 plus 18 weeks).
Cohort 2 - NACT + Interval Surgery ControlPLACEBO_COMPARATORIn Cohort 2 - NACT + Interval Surgery, subjects must already have received three (3) cycles of paclitaxel and carboplatin neoadjuvant therapy. Subjects in Cohort 2 - NACT + Interval Surgery will receive three (3) cycles of chemotherapy with placebo comparator given at four (4) cycles (Cycle 4, Cycle 6, Cycle 6 plus 6 weeks and Cycle 6 plus 18 weeks).
Interventions
NameTypeDescription
OregovomabBIOLOGICAL2 mg, dissolved in 2 mL of 0.9% Sodium Chloride Injection USP, then added to 50 mL of Sodium Chloride Injection USP infused over 20 ± 5 minutes
PaclitaxelDRUG175 mg/m\^2, every 3 weeks
CarboplatinDRUGAUC 6 IV Day 1 x 6 cycles (every 21 days)
PlaceboBIOLOGICAL2 mg, dissolved in 2 mL of 0.9% Sodium Chloride Injection USP, then added to 50 mL of Sodium Chloride Injection USP infused over 20 ± 5 minutes
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites148

Inclusion Criteria: 1. Adults 18 years old or older. 2. Newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO Stage III or IV disease. 3. Histologic epithelial cell types: high grade serous adenocarcinoma, high grade endometrioid adenocarcinoma, undifferenti...

Countries:United StatesArgentinaBelgiumBrazilCanadaChileCzechiaHungaryIndiaItalyMexicoSouth KoreaSpainTaiwan
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT04498117studyFirstPostDate: changed