Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · September 21, 2026
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Phase 1/2 Trial.
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Registry record from ClinicalTrials.gov (NCT02484404). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 268 participants (ACTUAL). Conditions: Colorectal Neoplasms, Breast Neoplasms. Interventions: DRUG: Olaparib; DRUG: Cediranib; DRUG: Durvalumab. Primary outcome measures: Ph II Determine overall response rate of Durvalumab-O and Durvalumab-C in patients with recurrent ovarian cancer , every 4 wks for toxicity and every 8 wks for response; Ph I Determine the recommended phase II dose (RP2D) and the safety of doublet therapies of Durvalumab/olaparib (Durvalumab-O) and Durvalumab/cediranib (Durvalumab-C) in patients with advanced solid tumors , 28 days. Brief summary: Background: \- Durvalumab is a drug that may help people s immune systems respond to and kill cancer cells. Olaparib is a drug that may inhibit repairing DNA damage of cancer cells. Cediranib is a drug that may stop the blood vessel growth of cancer cells. This study has two components. In the phase 1 component of the study, researchers want to investigate how well participants tolerate the combination of these drugs in treating advanced solid tumors, and in the phase 2 part of this study, researchers want to study if the combination treatments are effective in ovarian cancer. Objectives: \- Phase 2 part of the study: To determine how effective this combination is in treating ovarian cancer. Eligibility: \- Phase 2 part of the study: Adults age 18 or older with advanced or recurrent ovarian cancer that has no standard treatment. Design: * Participants will be screened with medical history, physical exam, and blood and urine tests. They will have CT or MRI scans. For these, they will lie in a machine that takes pictures of their bodies. * Phase 2 part of the study requests the participants to have tumor samples removed. * Participants will get Durvalumab through an IV. A small plastic tube will be inserted into a vein. The drug will be given every 4 weeks until disease progression. * Participants will take olaparib or cediranib by mouth every day. * Every 28 days will be 1 cycle. For cycle 1, participants will have 2 study visits. All other cycles, they will have 1 visit. At these visits, they will repeat the screening procedures. * Patients will keep a drug and diarrhea diary. * Patients on cediranib will monitor their blood pressure and keep a blood pressure diary. * Participants who can become pregnant, or have a partner who can become pregnant, must practice an effective form of birth control. * After 12 cycles, participants will have 1-3 months of follow-up.