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ACTIVE NOT RECRUITING
NCT04739800
PHASE2

Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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

Fallopian Tube Mucinous AdenocarcinomaOvarian Seromucinous CarcinomaPlatinum-Refractory Fallopian Tube CarcinomaPlatinum-Refractory Ovarian CarcinomaPlatinum-Refractory Primary Peritoneal CarcinomaRecurrent Fallopian Tube Clear Cell AdenocarcinomaRecurrent Fallopian Tube Endometrioid AdenocarcinomaRecurrent Fallopian Tube High Grade Serous AdenocarcinomaRecurrent Fallopian Tube Mucinous AdenocarcinomaRecurrent Fallopian Tube Transitional Cell CarcinomaRecurrent Fallopian Tube Undifferentiated CarcinomaRecurrent Low Grade Fallopian Tube Serous AdenocarcinomaRecurrent Ovarian Clear Cell AdenocarcinomaRecurrent Ovarian Endometrioid AdenocarcinomaRecurrent Ovarian High Grade Serous AdenocarcinomaRecurrent Ovarian Low Grade Serous AdenocarcinomaRecurrent Ovarian Mucinous AdenocarcinomaRecurrent Ovarian Seromucinous CarcinomaRecurrent Ovarian Transitional Cell CarcinomaRecurrent Ovarian Undifferentiated CarcinomaRecurrent Platinum-Resistant Fallopian Tube CarcinomaRecurrent Platinum-Resistant Ovarian CarcinomaRecurrent Platinum-Resistant Primary Peritoneal CarcinomaRecurrent Primary Peritoneal Clear Cell AdenocarcinomaRecurrent Primary Peritoneal Endometrioid AdenocarcinomaRecurrent Primary Peritoneal High Grade Serous AdenocarcinomaRecurrent Primary Peritoneal Low Grade Serous AdenocarcinomaRecurrent Primary Peritoneal Transitional Cell CarcinomaRecurrent Primary Peritoneal Undifferentiated CarcinomaRefractory Fallopian Tube Clear Cell AdenocarcinomaRefractory Fallopian Tube Endometrioid AdenocarcinomaRefractory Fallopian Tube High Grade Serous AdenocarcinomaRefractory Fallopian Tube Mucinous AdenocarcinomaRefractory Fallopian Tube Transitional Cell CarcinomaRefractory Fallopian Tube Undifferentiated CarcinomaRefractory Low Grade Fallopian Tube Serous AdenocarcinomaRefractory Ovarian Clear Cell AdenocarcinomaRefractory Ovarian Endometrioid AdenocarcinomaRefractory Ovarian High Grade Serous AdenocarcinomaRefractory Ovarian Low Grade Serous AdenocarcinomaRefractory Ovarian Mucinous AdenocarcinomaRefractory Ovarian Seromucinous CarcinomaRefractory Ovarian Transitional Cell CarcinomaRefractory Ovarian Undifferentiated CarcinomaRefractory Primary Peritoneal Clear Cell AdenocarcinomaRefractory Primary Peritoneal Endometrioid AdenocarcinomaRefractory Primary Peritoneal High Grade Serous AdenocarcinomaRefractory Primary Peritoneal Low Grade Serous AdenocarcinomaRefractory Primary Peritoneal Transitional Cell CarcinomaRefractory Primary Peritoneal Undifferentiated Carcinoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood

DRUG

Cediranib Maleate

Given PO

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Computed Tomography with Contrast

Undergo CT with contrast

BIOLOGICAL

Durvalumab

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Olaparib

Given PO

DRUG

Paclitaxel

Given IV

DRUG

Pegylated Liposomal Doxorubicin Hydrochloride

Given IV

DRUG

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

And 291 more locations on ClinicalTrials.gov