A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
pharmaand GmbH
Study ID
NCT03522246
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Complete Response
  • Epithelial Ovarian Cancer
  • FIGO Stage III-IV
  • Fallopian Tube Cancer
  • Newly Diagnosed
  • Partial Response
  • Primary Peritoneal

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rucaparib — DRUG
    Oral rucaparib will be administered twice daily
  • Nivolumab — DRUG
    IV nivolumab will be administered once every 4 weeks
  • Placebo Oral Tablet — DRUG
    Placebo tablets will be administered twice daily
  • Placebo IV Infusion — DRUG
    IV placebo will be administered once every 4 weeks

Study Details

This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.

Key Dates

Start date
May 14, 2018
Status verified
Jun 2025
Primary completion
May 20, 2024
Completion
Dec 30, 2030

Study Design

Enrollment
1,097 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Oral rucaparib + intravenous (IV) nivolumab
  • Experimental: Arm B
    Oral rucaparib + IV placebo
  • Experimental: Arm C
    Oral placebo + IV nivolumab
  • Placebo Comparator: Arm D
    Oral placebo + IV placebo
  • Experimental: Japanese Open-label Safety Cohort
    Oral rucaparib + IV nivolumab

Primary Outcome Measure

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

Locations (64)

FacilityCityStateZIPSite coordinators
Arizona Oncology Associates, PC - HALPhoenixArizona85016-
Arizona Oncology Associates, PC - HOPETucsonArizona85711-
The University of Arizona Cancer CenterTucsonArizona85724-
John Muir Clinical Research CenterConcordCalifornia94520-
UCLA Women's Health Clinical Research UnitLos AngelesCalifornia90095-
Kaiser Permanente Northern CaliforniaSan FranciscoCalifornia94589-
University of Colorado Cancer CenterAuroraColorado80045-
Rocky Mountain Cancer CentersLakewoodColorado80228-
Yale UniversityNew HavenConnecticut06520-
Florida Gynecologic OncologyFort MyersFlorida33905-
MD Anderson Cancer Center-BaptistJacksonvilleFlorida32207-
Baptist Health Medical Group Oncology, LLCMiamiFlorida33176-
Florida HospitalOrlandoFlorida32804-
Northside HospitalAtlantaGeorgia30342-
Augusta UniversityAugustaGeorgia30912-
Rush University Medical CenterChicagoIllinois60612-
Dr. Sudarshan K. Sharma, Ltd - Gynecologic OncologyHinsdaleIllinois60521-
Ferrell-Duncan ClinicSpringfieldIllinois62769-
Community Health NetworkIndianapolisIndiana46250-
University of Iowa HospitalsIowa CityIowa52242-
University of Kansas Cancer CenterWestwoodKansas66205-
University of KentuckyLexingtonKentucky40536-
Norton Cancer InstituteLouisvilleKentucky40241-
Ochsner Medical CenterNew OrleansLouisiana70121-
Maine Medical CenterScarboroughMaine04074-
SKCCC at Johns HopkinsBaltimoreMaryland21287-
Massachusetts General HospitalBostonMassachusetts02114-
Karmanos Cancer InstituteDetroitMichigan48201-
Metro Minnesota Community Oncology Research ConsortiumSaint Louis ParkMinnesota55416-
Washington University School of MedicineSt LouisMissouri63110-
Women's Cancer Center of NevadaLas VegasNevada89169-
MD Anderson Cancer Center at CooperCamdenNew Jersey08103-
Summit Medical GroupFlorham ParkNew Jersey07932-
Women's Cancer Care AssociatesAlbanyNew York12008-
Broome Oncology, LLCJohnson CityNew York13790-
Northwell Health Monter Cancer CenterLake SuccessNew York11042-
New York University Medical CenterNew YorkNew York10016-
University of North CarolinaChapel HillNorth Carolina27707-
Oncology Hematology Care, IncCincinnatiOhio45242-
University of CincinnatiCincinnatiOhio45221-
Cleveland ClinicClevelandOhio44106-
MD Anderson Cancer Center - Ohio HealthColumbusOhio44907-
The Ohio State UniversityColumbusOhio43210-
University of Oklahoma Health Science CenterOklahoma CityOklahoma73104-
Oklahoma Cancer Specialists and Research InstituteTulsaOklahoma74146-
Oncology Associates of Oregon, P.C.EugeneOregon97401-
LMG Gynecologic OncologyPortlandOregon97210-
Northwest Cancer Specialists, P.C.PortlandOregon97225-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
UPMC Magee-Womens HospitalPittsburghPennsylvania15213-
Abington Memorial HospitalWillow GrovePennsylvania19090-
Avera Gynecologic OncologySioux FallsSouth Dakota57105-
Texas Oncology - Austin CentralAustinTexas78731-
Texas Oncology - BedfordBedfordTexas76022-
Texas Oncology - Dallas Presbyterian HospitalDallasTexas75231-
Texas Oncology - Fort WorthFort WorthTexas76104-
Memorial HermannHoustonTexas77030-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Texas Oncology - San Antonio Medical CenterSan AntonioTexas78240-
Texas Oncology - The Woodlands, Gynecologic OncologyThe WoodlandsTexas77380-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
Virginia Oncology AssociatesNorfolkVirginia23502-
Froedtert and Medical College of WisconsinMilwaukeeWisconsin53226-

Related coverage on Hipa.ai

Find similar trials in Phoenix, AZ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Arizona Oncology Associates, PC - HAL· Phoenix, AZArizona Oncology Associates, PC - HOPE· Tucson, AZThe University of Arizona Cancer Center· Tucson, AZJohn Muir Clinical Research Center· Concord, CAUCLA Women's Health Clinical Research Unit· Los Angeles, CAKaiser Permanente Northern California· San Francisco, CA

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