Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer

Part of paid clinical trials in Orange, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04034927
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Fallopian Tube Endometrioid Tumor
  • Fallopian Tube High Grade Serous Adenocarcinoma
  • Malignant Ovarian Endometrioid Tumor
  • Ovarian High Grade Serous Adenocarcinoma
  • Platinum-Sensitive Fallopian Tube Carcinoma
  • Platinum-Sensitive Ovarian Carcinoma
  • Platinum-Sensitive Primary Peritoneal Carcinoma
  • Primary Peritoneal High Grade Serous Adenocarcinoma
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Fallopian Tube Endometrioid Adenocarcinoma
  • Recurrent Ovarian Endometrioid Adenocarcinoma
  • Recurrent Ovarian Serous Adenocarcinoma
  • Recurrent Primary Peritoneal Carcinoma
  • Recurrent Primary Peritoneal Endometrioid Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Olaparib — DRUG
    Given PO
  • Tremelimumab — BIOLOGICAL
    Given IV

Study Details

This phase II trial studies how well olaparib with or without tremelimumab works in treating patients with ovarian, fallopian tube, or peritoneal cancer that has come back (recurrent). PARPs are proteins that help repair deoxyribonucleic acid (DNA) mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Immunotherapy with monoclonal antibodies, such as tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving olaparib and tremelimumab together may work better than olaparib alone in treating patients with ovarian, fallopian tube, or peritoneal cancer.

Key Dates

Start date
Dec 4, 2019
Status verified
Feb 2026
Primary completion
Jul 31, 2021
Completion
Feb 21, 2027

Study Design

Enrollment
61 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm I (olaparib)
    Patients receive olaparib PO BID in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.
  • Experimental: Arm II (olaparib, tremelimumab)
    Patients receive olaparib as in Arm I. Patients also receive tremelimumab IV over 60 minutes on day 1. Cycles of tremelimumab repeat every 4 weeks for 4 doses and then every 12 weeks for up to 2 years total in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: PFS is monitored for progression or death due to any cause, whichever occurs first. The median follow-up time is 22 months. Since the study was stopped early, the follow-up for progression-free survival was significantly reduced. ]

Locations (20)

FacilityCityStateZIPSite coordinators
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
UCHealth University of Colorado HospitalAuroraColorado80045-
Hartford HospitalHartfordConnecticut06102-
Augusta University Medical CenterAugustaGeorgia30912-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
Washington University School of MedicineSt LouisMissouri63110-
University of New Mexico Cancer CenterAlbuquerqueNew Mexico87106-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
UHHS-Chagrin Highlands Medical CenterBeachwoodOhio44122-
Case Western Reserve UniversityClevelandOhio44106-
Cleveland Clinic FoundationClevelandOhio44195-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
Women and Infants HospitalProvidenceRhode Island02905-
UT MD Anderson Cancer CenterHoustonTexas77030-
University of Virginia Cancer CenterCharlottesvilleVirginia22908-
VCU Massey Comprehensive Cancer CenterRichmondVirginia23298-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Orange, CA

By research site
UC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAUCHealth University of Colorado Hospital· Aurora, COHartford Hospital· Hartford, CTAugusta University Medical Center· Augusta, GAUniversity of Chicago Comprehensive Cancer Center· Chicago, ILWashington University School of Medicine· St Louis, MO

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