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Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations
Sponsor: National Cancer Institute (NCI)
Summary
This phase II trial studies whether adding pembrolizumab to olaparib (standard of care) works better than olaparib alone in treating patients with pancreatic cancer with germline BRCA1 or BRCA2 mutations that has spread to other places in the body (metastatic). BRCA1 and BRCA2 are human genes that produce tumor suppressor proteins. These proteins help repair damaged deoxyribonucleic acid (DNA) and, therefore, play a role in ensuring the stability of each cell's genetic material. When either of these genes is mutated, or altered, such that its protein product is not made or does not function correctly, DNA damage may not be repaired properly. As a result, cells are more likely to develop additional genetic alterations that can lead to some types of cancer, including pancreatic cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Olaparib is an inhibitor of PARP, a protein that helps repair damaged DNA. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. The addition of pembrolizumab to the usual treatment of olaparib may help to shrink tumors in patients with metastatic pancreatic cancer with BRCA1 or BRCA2 mutations.
Official title: Randomized Phase II Clinical Trial of Olaparib + Pembrolizumab vs. Olaparib Alone as Maintenance Therapy in Metastatic Pancreatic Cancer Patients With Germline BRCA1 or BRCA2 Mutations
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2021-02-22
Completion Date
2027-10-05
Last Updated
2026-10-07
Healthy Volunteers
No
Interventions
Biopsy Procedure
Undergo tumor biopsy
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT scan
Magnetic Resonance Imaging
Undergo MRI
Olaparib
Given PO
Pembrolizumab
Given IV
Locations (533)
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
Kingman Regional Medical Center
Kingman, 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
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, United States
PCR Oncology
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
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
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
City of Hope at Irvine Lennar
Irvine, 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
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, 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
Mills Health Center
San Mateo, 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
Providence Medical Foundation - Santa Rosa
Santa Rosa, California, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, United States
Providence Santa Rosa Memorial Hospital
Santa Rosa, California, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States
The Medical Center of Aurora
Aurora, Colorado, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Boulder Community Foothills Hospital
Boulder, 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
The Women's Imaging Center
Denver, Colorado, United States
AdventHealth Porter
Denver, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Western Surgical Care
Denver, Colorado, United States
CommonSpirit Cancer Center Mercy
Durango, Colorado, United States
Mercy Medical Center
Durango, Colorado, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, United States
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
The Melanoma and Skin Cancer Institute
Englewood, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, United States
Banner North Colorado Medical Center
Greeley, Colorado, United States
UCHealth Greeley Hospital
Greeley, Colorado, United States
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, United States
CommonSpirit Saint Anthony Hospital Cancer Center
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood
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
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Longmont United Hospital
Longmont, Colorado, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, United States
Medical Center of the Rockies
Loveland, 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
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, United States
Danbury Hospital
Danbury, Connecticut, United States
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, United States
Beebe South Coastal Health Campus
Millville, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States