Active — Not RecruitingPhase 1/2

Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...

United States268 participantsStarted 2015-06-29

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* ELIGIBILITY: INCLUSION CRITERIA GENERAL: * Patients must be at least 18 years of age. * Patients must have adequately controlled blood pressure on a maximum of three antihypertensive medications. * Patients who have the following clinical conditions are considered to be at increased risk for cardiac toxicities. Patients with any cardiac history of the following conditions within 1 year prior to study enrollment are excluded from the study: * Prior events including myocardial infarction, pericardial effusion, and myocarditis. * Prior cardiac arrhythmia including atrial fibrillation and atrial flutter, or requiring concurrent use of drugs or biologics with pro-arrhythmic potential. * NYHA Class II or greater heart failure. * If cardiac function assessment is clinically indicated or performed, an LVEF less than normal per institutional guidelines, or \<55%, if threshold for normal is not otherwise specified by institutional guidelines. * QTc prolongation \>470 msec or other significant ECG abnormality noted within 14 days of treatment. * Hypertensive crisis or hypertensive encephalopathy. * Clinically significant peripheral vascular disease or vascular disease, including rapidly growing aortic aneurysm or abdominal aortic aneurysm \>5 cm or aortic dissection. * Unstable angina. * Eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea \> 1 month without immune or inflammatory colitis is a P…

What they're measuring

Ph II Determine overall response rate of Durvalumab-O and Durvalumab-C in patients with recurrent ovarian cancer

Timeframe: 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

Timeframe: 28 days

Trial details

NCT IDNCT02484404

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2027-10-30

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