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

Phase 2 Active, not recruiting NCT04034927

Summary

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.

Progression Free Survival (PFS)

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. · Participants

Dose-limiting Toxicity (DLT) (Safety Lead-In)

At least 4 weeks after initiating treatment, no longer than 12 weeks (three complete treatment cycles). Maximum follow-up was 12 weeks. · Participants

Open in BENITIONS View on ClinicalTrials.gov

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• Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With Granulo — Beth Israel Deaconess Medical Center
• Durvalumab and Tremelimumab in Treating Participants With Recurrent or Refractory Ovarian, — M.D. Anderson Cancer Center
• Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carbop — AstraZeneca
• Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Trea — National Cancer Institute (NCI)
• Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunother — National Cancer Institute (NCI)
• Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or — National Cancer Institute (NCI)

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