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Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents
Sponsor: National Cancer Institute (NCI)
Summary
This phase II trial studies the possible benefits of treatment with different combinations of the drugs durvalumab, olaparib and cediranib vs. the usual treatment in patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of improvement with platinum therapy (recurrent platinum resistant). Usual treatment is the type of treatment most patients with this condition receive if they are not part of a clinical study. Combination therapies studied in this trial include MEDI4736 (durvalumab) plus olaparib and cediranib, durvalumab and cediranib, or olaparib and cediranib. Monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumors cells to grow and spread. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Cediranib may stop the growth of tumor cells by blocking VEGF (an enzyme). needed for cell growth. Giving different combinations of durvalumab, olaparib and cediranib may work better in increasing the duration of time that the cancer does not progress compared to the usual treatment.
Official title: A Randomized Phase II Trial of Triplet Therapy (A PD-L1 Inhibitor Durvalumab (MEDI4736) in Combination With Olaparib and Cediranib) Compared to Olaparib and Cediranib or Durvalumab (MEDI4736) and Cediranib or Standard of Care Chemotherapy in Women With Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Primary Peritoneal or Fallopian Cancer Who Have Received Prior Bevacizumab
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2021-06-10
Completion Date
2027-06-25
Last Updated
2026-10-22
Healthy Volunteers
No
Conditions
Interventions
Biospecimen Collection
Undergo collection of blood
Cediranib Maleate
Given PO
Computed Tomography
Undergo CT
Computed Tomography with Contrast
Undergo CT with contrast
Durvalumab
Given IV
Echocardiography Test
Undergo ECHO
Magnetic Resonance Imaging
Undergo MRI
Multigated Acquisition Scan
Undergo MUGA
Olaparib
Given PO
Paclitaxel
Given IV
Pegylated Liposomal Doxorubicin Hydrochloride
Given IV
Topotecan Hydrochloride
Given IV
Locations (391)
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Anchorage Oncology Centre
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
CTCA at Western Regional Medical Center
Goodyear, Arizona, United States
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, United States
Sutter Auburn Faith Hospital
Auburn, California, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States
Eden Hospital Medical Center
Castro Valley, California, United States
John Muir Medical Center-Concord
Concord, California, United States
Sutter Davis Hospital
Davis, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Palo Alto Medical Foundation-Fremont
Fremont, California, United States
City of Hope Antelope Valley
Lancaster, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Memorial Medical Center
Modesto, California, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States
Sutter Roseville Medical Center
Roseville, California, United States
Sutter Medical Center Sacramento
Sacramento, California, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, United States
City of Hope South Pasadena
South Pasadena, California, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States
City of Hope Upland
Upland, California, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States
AdventHealth Porter
Denver, Colorado, United States
CommonSpirit Cancer Center Mercy
Durango, Colorado, United States
Mercy Medical Center
Durango, Colorado, United States
CommonSpirit Saint Anthony Hospital Cancer Center
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States
AdventHealth Littleton
Littleton, Colorado, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States
Longmont United Hospital
Longmont, Colorado, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, United States
Banner North Colorado Medical Center - Loveland Campus
Loveland, Colorado, United States
AdventHealth Parker
Parker, Colorado, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States
Danbury Hospital
Danbury, Connecticut, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Sacred Heart Hospital
Pensacola, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
CTCA at Southeastern Regional Medical Center
Newnan, Georgia, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Walter Knox Memorial Hospital
Emmett, Idaho, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, United States
OSF Saint Anthony's Health Center
Alton, Illinois, United States
Rush-Copley Medical Center
Aurora, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, United States
SIH Cancer Institute
Carterville, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Centralia Oncology Clinic
Centralia, Illinois, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
Rush MD Anderson Cancer Center
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Carle at The Riverfront
Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Illinois CancerCare-Dixon
Dixon, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States