Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combinat… (NCT02484404) | Clinical Trial Compass
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 range
18 Years – 99 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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