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Rucaparib

Phase 3

Epithelial Ovarian Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jun 24, 2025

Target and mechanism

Molecular targetPARP1, PARP3, PARP2
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment1,097

FDA Designations

No designations recorded

Clinical trial landscape

Rucaparib · 1 trial · 7 indications

Phase 3 1
NCT03522246A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based ChemotherapyEpithelial Ovarian Cancer
ACTIVE NOT_RECRUITING1,097 Analytics
PHASE3ACTIVE NOT_RECRUITING
A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
Epithelial Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS)
From randomization until disease progression (up to the primary data analysis at approximately 39 months)

PFS by investigator was defined as the time from randomization to disease progression, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

Monotherapy Arm B and Arm D: Investigator Assessed PFS
From randomization until disease progression (up to the primary data analysis at approximately 39 months)

PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

Combination Therapy Arm A and Arm B: Investigator Assessed PFS
From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)

PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

Secondary Endpoints

Monotherapy Arm B and Arm D: Blinded Independent Central Review (BICR) PFS
From randomization until disease progression (up to the primary data analysis at approximately 39 months)
Monotherapy Arm B and Arm D: BICR PFS
From randomization until disease progression (up to the primary data analysis at approximately 39 months)
Combination Therapy Arm A and Arm B: BICR PFS
From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTALOral rucaparib + intravenous (IV) nivolumab
Arm BEXPERIMENTALOral rucaparib + IV placebo
Arm CEXPERIMENTALOral placebo + IV nivolumab
Arm DPLACEBO_COMPARATOROral placebo + IV placebo
Japanese Open-label Safety CohortEXPERIMENTALOral rucaparib + IV nivolumab

Interventions

NameTypeDescription
RucaparibDRUGOral rucaparib will be administered twice daily
NivolumabDRUGIV nivolumab will be administered once every 4 weeks
Placebo Oral TabletDRUGPlacebo tablets will be administered twice daily
Placebo IV InfusionDRUGIV placebo will be administered once every 4 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites238

Inclusion Criteria: * Newly diagnosed advanced (FIGO stage III-IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. * Completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy and partial omentectomy, either prior to chemotherapy (primary surgery) or fol...

Countries:United StatesAustraliaBelgiumCanadaCzechiaDenmarkFinlandGermanyGreeceIrelandIsraelItalyJapanNew ZealandPolandRomaniaRussiaSingaporeSouth KoreaSpainSwedenTaiwanTurkey (Türkiye)United Kingdom
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Frequently asked questions about Rucaparib

What is Rucaparib used for in Epithelial Ovarian Cancer?

Rucaparib is being studied as maintenance treatment in patients with newly diagnosed epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, specifically those with FIGO stage III-IV disease who have achieved a partial or complete response to front-line platinum-based chemotherapy. It is currently in Phase 3 clinical development.

What does Rucaparib target?

Rucaparib targets PARP1, PARP2, and PARP3, and it is a small molecule inhibitor of these enzymes. By inhibiting PARP proteins, it interferes with DNA repair mechanisms in cancer cells. This mechanism is being evaluated in the context of ovarian cancer maintenance therapy.

Who makes Rucaparib?

Rucaparib is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting a Phase 3 clinical trial of Rucaparib for the treatment of epithelial ovarian cancer.

What phase is Rucaparib in?

Rucaparib is currently in Phase 3 clinical development. It is being investigated as a maintenance treatment for patients with newly diagnosed advanced ovarian cancer following response to front-line platinum-based chemotherapy. The drug is not yet approved for this indication and remains investigational.

What clinical trials is Rucaparib in?

Rucaparib is being evaluated in a Phase 3 clinical trial with the identifier NCT03522246. This study is assessing Rucaparib in combination with nivolumab as maintenance treatment in ovarian cancer patients who have responded to front-line platinum-based chemotherapy. The trial is active but not recruiting participants.

Is Rucaparib the same as any other drug?

Rucaparib is also known by the ChEMBL identifier CHEMBL1173055. This identifier is used in chemical and biological databases to track the compound. No other alternative names have been established in the available information.