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
Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8
About this trial
This is an interventional treatment trial for Pancreatic Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Patient must have a histologic or cytologic diagnosis of pancreatic adenocarcinoma. Patients with neuroendocrine tumors, acinar cell and adenosquamous carcinomas are excluded. All disease must be assessed and documented on the Baseline Tumor Assessment Form
- Patients must have one of the following mutations: germline mutation in BRCA 1 or 2 that was tested in a Clinical Laboratory Improvement Act (CLIA) certified lab defined as positive and/or deleterious (that is, pathogenic or likely pathogenic variant). (NOTE: Patients with tumor somatic mutations are not eligible)
- Patient must have metastatic disease and received first line platinum-based chemotherapy (i.e. fluorouracil, irinotecan, leucovorin and oxaliplatin [FOLFIRINOX], leucovorin calcium, 5-fluorouracil, and oxaliplatin [FOLFOX], gemcitabine + nab-paclitaxel + cisplatin or gemcitabine + cisplatin)
- Patients must have had a computed tomography (CT) or magnetic resonance imaging (MRI) showing stable or responding disease on first line platinum-based chemotherapy within 30 days prior to registration
- Patients with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to registration
- Patients with history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 30 days prior to registration
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment must have an undetectable HCV viral load within 30 days prior to registration
- Patients must have received at least 16 weeks of first line platinum-based chemotherapy for metastatic disease. Patients may have also received one cycle of treatment (no more than 4 weeks) with gemcitabine + nab-paclitaxel while waiting for germline test results, prior to platinum-based therapy
- Patients' last chemotherapy treatment must be within 30 days prior to registration
- Patients must have resolved or stable =< grade 1 toxicity from prior administration of another investigational drug and/or prior anti-cancer treatment, excluding neuropathy and alopecia
- Zubrod performance status of 0-1
- Patients must be >= 18 years old
- Patients must have a complete medical history and physical exam within 28 days prior to registration
- Absolute neutrophil count >= 1.5 x 10^3/uL (within 14 days of registration)
- Platelets >= 100 x 10^3/uL (within 14 days of registration)
- Total bilirubin =< 1.5 institutional upper limit of normal (ULN) (within 14 days of registration)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional ULN (within 14 days of registration)
- Albumin >= 3.0 g/dL (within 14 days of registration)
- Hemoglobin >= 9.0 g/dL (within 14 days of registration)
- Participants must have a serum creatinine =< the institutional (I)ULN OR measured OR calculated creatinine clearance >= 50 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 14 days prior to registration
- Patients must have CA19-9 obtained within 42 days prior to registration
- Patients must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of the study medication
- Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial provided it does not require concurrent therapy
- Patients must be offered the opportunity to participate in specimen banking of formalin-fixed paraffin-embedded (FFPE) tissue and whole blood. If a patient is unable to submit archival tissue, should the patient need to undergo a standard of care biopsy per National Comprehensive Cancer Network (NCCN) guidelines, patients must then be offered the opportunity to submit the fresh tumor tissue from that biopsy. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
- Patients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Canada Industrial Relations Board (CIRB) regulations
- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Exclusion Criteria:
- Patients must not have a known hypersensitivity to olaparib or any of the excipients of the product
- Patients must not be planning to receive strong or moderate CYP3A inhibitors or inducers while on olaparib treatment. Patients receiving strong or moderate CYP3A inhibitors must discontinue use at least 2 weeks prior to receiving olaparib. Patients receiving strong or moderate CYP3A inducers must discontinue use at least 5 weeks prior to receiving olaparib. Medications should be checked using a frequently updated medical reference for a list of drugs to avoid
- Patients must not have received live vaccines within 42 days prior to randomization and must not be planning to receive live virus or live bacterial vaccines while receiving study treatment and during the 30 day follow up period. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed. Coronavirus disease 2019 (COVID-19) messenger ribonucleic acid (mRNA) vaccine is allowed
- Patients must not have had prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or any other immune checkpoint inhibitors
- Patients must not have had prior therapy with PARP inhibitors
- Patients must not have had a prior diagnosis of immunodeficiency or receiving systemic steroid therapy (defined as >= 10 mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
- Participants must not be pregnant or nursing due to the possibility of harm to the fetus or nursing infant from this treatment regimen. Women of childbearing potential must have a negative urine or serum pregnancy test within 28 days prior to registration. Women/men of reproductive potential must have agreed to use an effective contraceptive method for the course of the study through 6 months after the last dose of study medication. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures, he/she is responsible for beginning contraceptive measures. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Patients must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
- Patients must not have an active infection requiring systemic therapy
- Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Sites / Locations
- Anchorage Associates in Radiation Medicine
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Fairbanks Memorial HospitalRecruiting
- Kingman Regional Medical CenterRecruiting
- Cancer Center at Saint Joseph's
- Mercy Hospital Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs
- Mission Hope Medical Oncology - Arroyo Grande
- PCR Oncology
- Sutter Auburn Faith HospitalRecruiting
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- Alta Bates Summit Medical Center-Herrick CampusRecruiting
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- Eden Hospital Medical Center
- Sutter Davis Hospital
- City of Hope Comprehensive Cancer CenterRecruiting
- Palo Alto Medical Foundation-FremontRecruiting
- City of Hope at Irvine LennarRecruiting
- Memorial Medical CenterRecruiting
- Palo Alto Medical Foundation-Camino DivisionRecruiting
- Palo Alto Medical Foundation-Gynecologic Oncology
- UC Irvine Health/Chao Family Comprehensive Cancer CenterRecruiting
- Palo Alto Medical Foundation Health CareRecruiting
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- Sutter Roseville Medical CenterRecruiting
- Sutter Medical Center SacramentoRecruiting
- California Pacific Medical Center-Pacific CampusRecruiting
- Pacific Central Coast Health Center-San Luis Obispo
- Mills Health Center
- Palo Alto Medical Foundation-Santa CruzRecruiting
- Mission Hope Medical Oncology - Santa Maria
- Providence Medical Foundation - Santa RosaRecruiting
- Sutter Pacific Medical Foundation
- Providence Santa Rosa Memorial HospitalRecruiting
- Palo Alto Medical Foundation-SunnyvaleRecruiting
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Sutter Solano Medical Center/Cancer CenterRecruiting
- Rocky Mountain Cancer Centers-AuroraRecruiting
- The Medical Center of Aurora
- UCHealth University of Colorado HospitalRecruiting
- Boulder Community Foothills Hospital
- Rocky Mountain Cancer Centers-BoulderRecruiting
- Rocky Mountain Cancer Centers - CentennialRecruiting
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- The Women's Imaging Center
- Porter Adventist HospitalRecruiting
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-MidtownRecruiting
- Rocky Mountain Cancer Centers-RoseRecruiting
- Rose Medical Center
- Western Surgical Care
- Mercy Medical Center
- Southwest Oncology PC
- Mountain Blue Cancer Care Center - Swedish
- Rocky Mountain Cancer Centers - SwedishRecruiting
- Swedish Medical Center
- The Melanoma and Skin Cancer Institute
- Poudre Valley HospitalRecruiting
- Cancer Care and Hematology-Fort CollinsRecruiting
- North Colorado Medical Center
- UCHealth Greeley HospitalRecruiting
- UCHealth Highlands Ranch HospitalRecruiting
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-LittletonRecruiting
- Littleton Adventist HospitalRecruiting
- Rocky Mountain Cancer Centers-Sky RidgeRecruiting
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- Medical Center of the RockiesRecruiting
- McKee Medical Center
- Parker Adventist HospitalRecruiting
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers-Thornton
- Danbury HospitalRecruiting
- Smilow Cancer Hospital Care Center at GreenwichRecruiting
- Yale UniversityRecruiting
- Yale-New Haven Hospital North Haven Medical CenterRecruiting
- Norwalk HospitalRecruiting
- Beebe South Coastal Health CampusRecruiting
- Helen F Graham Cancer CenterRecruiting
- Medical Oncology Hematology Consultants PARecruiting
- Beebe Health CampusRecruiting
- Sibley Memorial Hospital
- Mount Sinai Comprehensive Cancer Center at AventuraRecruiting
- Holy Cross Hospital
- Mount Sinai Medical CenterRecruiting
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Luke's Cancer Institute - Boise
- Saint Alphonsus Cancer Care Center-CaldwellRecruiting
- Kootenai Health - Coeur d'AleneRecruiting
- Walter Knox Memorial Hospital
- Saint Luke's Cancer Institute - Fruitland
- Idaho Urologic Institute-Meridian
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Saint Alphonsus Cancer Care Center-NampaRecruiting
- Kootenai Clinic Cancer Services - Post FallsRecruiting
- Kootenai Cancer ClinicRecruiting
- Saint Luke's Cancer Institute - Twin Falls
- Saint Anthony's Health
- Rush - Copley Medical CenterRecruiting
- Illinois CancerCare-BloomingtonRecruiting
- Illinois CancerCare-CantonRecruiting
- Memorial Hospital of Carbondale
- SIH Cancer Institute
- Illinois CancerCare-CarthageRecruiting
- Centralia Oncology Clinic
- Northwestern University
- Carle at The RiverfrontRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial Hospital
- Illinois CancerCare-DixonRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Illinois CancerCare-EurekaRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Western Illinois Cancer Treatment Center
- Illinois CancerCare-Kewanee ClinicRecruiting
- Northwestern Medicine Lake Forest Hospital
- Illinois CancerCare-MacombRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Good Samaritan Regional Health Center
- Cancer Care Center of O'FallonRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Illinois CancerCare-PekinRecruiting
- Illinois CancerCare-PeoriaRecruiting
- Methodist Medical Center of Illinois
- Illinois CancerCare-PeruRecruiting
- Valley Radiation Oncology
- Illinois CancerCare-PrincetonRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Carle Cancer CenterRecruiting
- The Carle Foundation Hospital
- Illinois CancerCare - WashingtonRecruiting
- Rush-Copley Healthcare CenterRecruiting
- Indiana University/Melvin and Bren Simon Cancer CenterRecruiting
- Reid HealthRecruiting
- Mary Greeley Medical CenterRecruiting
- McFarland Clinic - AmesRecruiting
- McFarland Clinic - BooneRecruiting
- Saint Anthony Regional HospitalRecruiting
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Jennie Edmundson Memorial HospitalRecruiting
- Alegent Health Mercy Hospital
- Heartland Oncology and Hematology LLPRecruiting
- Greater Regional Medical Center
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des MoinesRecruiting
- Broadlawns Medical CenterRecruiting
- Mercy Medical Center - Des MoinesRecruiting
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- McFarland Clinic - Trinity Cancer CenterRecruiting
- Trinity Regional Medical Center
- McFarland Clinic - JeffersonRecruiting
- McFarland Clinic - MarshalltownRecruiting
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Central Care Cancer Center - Garden City
- Central Care Cancer Center - Great Bend
- Flaget Memorial Hospital
- Commonwealth Cancer Center-Corbin
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- Saint Joseph London
- Jewish Hospital
- Saints Mary and Elizabeth Hospital
- UofL Health Medical Center Northeast
- Jewish Hospital Medical Center South
- Hickman Cancer Center
- Saint Joseph Mercy HospitalRecruiting
- University of Michigan Comprehensive Cancer CenterRecruiting
- Bronson Battle CreekRecruiting
- Saint Joseph Mercy BrightonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
- Saint Joseph Mercy CantonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
- Caro Cancer Center
- Saint Joseph Mercy ChelseaRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalRecruiting
- Hematology Oncology Consultants-ClarkstonRecruiting
- Newland Medical Associates-ClarkstonRecruiting
- Henry Ford Macomb Hospital-Clinton TownshipRecruiting
- Wayne State University/Karmanos Cancer InstituteRecruiting
- Henry Ford HospitalRecruiting
- Ascension Saint John HospitalRecruiting
- Great Lakes Cancer Management Specialists-Doctors ParkRecruiting
- Weisberg Cancer Treatment CenterRecruiting
- Genesee Cancer and Blood Disease Treatment CenterRecruiting
- Genesee Hematology Oncology PCRecruiting
- Genesys Hurley Cancer InstituteRecruiting
- Hurley Medical CenterRecruiting
- Helen DeVos Children's Hospital at Spectrum Health
- Spectrum Health at Butterworth CampusRecruiting
- Trinity Health Grand Rapids HospitalRecruiting
- Academic Hematology Oncology SpecialistsRecruiting
- Great Lakes Cancer Management Specialists-Van Elslander Cancer CenterRecruiting
- Michigan Breast Specialists-Grosse Pointe Woods
- Bronson Methodist HospitalRecruiting
- West Michigan Cancer CenterRecruiting
- Ascension Borgess Cancer CenterRecruiting
- Borgess Medical Center
- Sparrow HospitalRecruiting
- Hope Cancer Clinic
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- Great Lakes Cancer Management Specialists-Macomb Medical CampusRecruiting
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of Marlette
- Toledo Clinic Cancer Centers-Monroe
- Trinity Health Muskegon HospitalRecruiting
- Lakeland Hospital Niles
- Cancer and Hematology Centers of Western Michigan - Norton ShoresRecruiting
- Ascension Providence Hospitals - NoviRecruiting
- 21st Century Oncology-PontiacRecruiting
- Hope Cancer Center
- Newland Medical Associates-PontiacRecruiting
- Saint Joseph Mercy OaklandRecruiting
- Spectrum Health Reed City HospitalRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Oncology Hematology Associates of Saginaw Valley PCRecruiting
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer CenterRecruiting
- Ascension Providence Hospitals - SouthfieldRecruiting
- Bhadresh Nayak MD PC-Sterling HeightsRecruiting
- Ascension Saint Joseph HospitalRecruiting
- Munson Medical CenterRecruiting
- Advanced Breast Care Center PLLCRecruiting
- Great Lakes Cancer Management Specialists-Macomb Professional BuildingRecruiting
- Macomb Hematology Oncology PC
- Michigan Breast Specialists-WarrenRecruiting
- Saint John Macomb-Oakland HospitalRecruiting
- Saint Mary's Oncology/Hematology Associates of West BranchRecruiting
- University of Michigan Health - WestRecruiting
- Huron Gastroenterology PCRecruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Fairview Ridges Hospital
- Minnesota Oncology - Burnsville
- Cambridge Medical Center
- Mercy Hospital
- Fairview Southdale Hospital
- Unity Hospital
- Fairview Clinics and Surgery Center Maple Grove
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- Monticello Cancer Center
- New Ulm Medical Center
- Fairview Northland Medical Center
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Fairview Lakes Medical Center
- Baptist Memorial Hospital and Cancer Center-Golden TriangleRecruiting
- Baptist Cancer Center-GrenadaRecruiting
- Baptist Memorial Hospital and Cancer Center-OxfordRecruiting
- Baptist Memorial Hospital and Cancer Center-DesotoRecruiting
- Saint Louis Cancer and Breast Institute-Ballwin
- Central Care Cancer Center - Bolivar
- Saint Francis Medical CenterRecruiting
- Southeast Cancer Center
- Parkland Health Center - FarmingtonRecruiting
- Capital Region Southwest Campus
- Freeman Health System
- Mercy Hospital Joplin
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute-South City
- Mercy Hospital South
- Missouri Baptist Medical CenterRecruiting
- Mercy Hospital Saint LouisRecruiting
- Sainte Genevieve County Memorial HospitalRecruiting
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan HospitalRecruiting
- Missouri Baptist Outpatient Center-Sunset HillsRecruiting
- Mercy Hospital Washington
- Community Hospital of AnacondaRecruiting
- Billings Clinic Cancer CenterRecruiting
- Bozeman Deaconess HospitalRecruiting
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Great Falls Clinic
- Kalispell Regional Medical CenterRecruiting
- Saint Patrick Hospital - Community Hospital
- Community Medical HospitalRecruiting
- CHI Health Saint Francis
- CHI Health Good Samaritan
- Saint Elizabeth Regional Medical Center
- Nebraska Cancer Specialists/Oncology Hematology West PC - MECCRecruiting
- Nebraska Methodist HospitalRecruiting
- Oncology Associates PCRecruiting
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- Midlands Community Hospital
- Carson Tahoe Regional Medical Center
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
- Las Vegas Cancer Center-Henderson
- OptumCare Cancer Care at Seven Hills
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- GenesisCare USA - Henderson
- Las Vegas Urology - Green Valley
- Las Vegas Urology - Pebble
- Urology Specialists of Nevada - Green Valley
- Las Vegas Urology - Pecos
- Desert West Surgery
- OptumCare Cancer Care at CharlestonRecruiting
- University Medical Center of Southern Nevada
- Hope Cancer Care of Nevada
- Radiation Oncology Centers of Nevada Central
- Urology Specialists of Nevada - Central
- GenesisCare USA - Las Vegas
- Sunrise Hospital and Medical Center
- Las Vegas Prostate Cancer Center
- Las Vegas Urology - Sunset
- Urology Specialists of Nevada - Southwest
- Radiation Oncology Centers of Nevada Southeast
- Ann M Wierman MD LTD
- Comprehensive Cancer Centers of Nevada - Northwest
- GenesisCare USA - Vegas Tenaya
- Las Vegas Urology - Cathedral Rock
- Las Vegas Urology - Smoke Ranch
- OptumCare Cancer Care at MountainView
- Urology Specialists of Nevada - Northwest
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
- Comprehensive Cancer Centers of Nevada - Town Center
- Comprehensive Cancer Centers of Nevada-Summerlin
- Summerlin Hospital Medical Center
- Las Vegas Cancer Center-Medical Center
- Comprehensive Cancer Centers of Nevada
- GenesisCare USA - Fort Apache
- OptumCare Cancer Care at Fort ApacheRecruiting
- Comprehensive Cancer Centers of Nevada - Central Valley
- University Cancer Center
- Hope Cancer Care of Nevada-Pahrump
- Renown Regional Medical Center
- Saint Mary's Regional Medical Center
- Radiation Oncology Associates
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
- Roswell Park Cancer InstituteRecruiting
- Southeastern Medical Oncology Center-ClintonRecruiting
- Southeastern Medical Oncology Center-GoldsboroRecruiting
- Southeastern Medical Oncology Center-JacksonvilleRecruiting
- Vidant Oncology-KenansvilleRecruiting
- Vidant Oncology-KinstonRecruiting
- Vidant Oncology-RichlandsRecruiting
- Sanford Bismarck Medical CenterRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Indu and Raj Soin Medical Center
- Strecker Cancer Center-BelpreRecruiting
- Saint Elizabeth Boardman Hospital
- Dayton Physicians LLC-Miami Valley SouthRecruiting
- Miami Valley Hospital South
- Adena Regional Medical CenterRecruiting
- Good Samaritan Hospital - Cincinnati
- Oncology Hematology Care Inc-Kenwood
- Bethesda North Hospital
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Mount Carmel East HospitalRecruiting
- Columbus Oncology and Hematology Associates IncRecruiting
- Riverside Methodist HospitalRecruiting
- Grant Medical CenterRecruiting
- The Mark H Zangmeister CenterRecruiting
- Mount Carmel Health Center WestRecruiting
- Doctors HospitalRecruiting
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
- Miami Valley Hospital North
- Delaware Health Center-Grady Cancer CenterRecruiting
- Grady Memorial HospitalRecruiting
- Dublin Methodist Hospital
- Armes Family Cancer CenterRecruiting
- Blanchard Valley Hospital
- Orion Cancer Care
- Atrium Medical Center-Middletown Regional Hospital
- Dayton Physicians LLC-AtriumRecruiting
- Central Ohio Breast and Endocrine Surgery
- Dayton Physicians LLC-Wayne
- Wayne Hospital
- Mount Carmel Grove City Hospital
- Greater Dayton Cancer CenterRecruiting
- Kettering Medical CenterRecruiting
- Fairfield Medical CenterRecruiting
- Saint Rita's Medical Center
- OhioHealth Mansfield HospitalRecruiting
- Marietta Memorial HospitalRecruiting
- OhioHealth Marion General HospitalRecruiting
- Knox Community HospitalRecruiting
- Licking Memorial HospitalRecruiting
- Newark Radiation Oncology
- Southern Ohio Medical CenterRecruiting
- Springfield Regional Cancer CenterRecruiting
- Springfield Regional Medical Center
- Saint Vincent Mercy Medical Center
- Mercy Health - Saint Anne Hospital
- Toledo Clinic Cancer Centers-ToledoRecruiting
- Dayton Physicians LLC - Troy
- Upper Valley Medical Center
- Saint Joseph Warren Hospital
- Saint Ann's HospitalRecruiting
- Saint Elizabeth Youngstown Hospital
- Genesis Healthcare System Cancer Care CenterRecruiting
- Cancer Centers of Southwest Oklahoma ResearchRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Integris Southwest Medical Center
- Mercy Hospital Oklahoma CityRecruiting
- Saint Alphonsus Medical Center-Baker City
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Cancer Institute Clackamas ClinicRecruiting
- Bay Area Hospital
- Providence Newberg Medical CenterRecruiting
- Saint Alphonsus Medical Center-OntarioRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Saint Charles Health System-Redmond
- Lehigh Valley Hospital-Cedar CrestRecruiting
- Lehigh Valley Hospital - MuhlenbergRecruiting
- Geisinger Medical CenterRecruiting
- Pocono Medical Center
- Saint Vincent HospitalRecruiting
- Geisinger Medical Center-Cancer Center HazletonRecruiting
- Lehigh Valley Hospital-Hazleton
- Jefferson HospitalRecruiting
- Geisinger Medical Oncology-LewisburgRecruiting
- Forbes HospitalRecruiting
- University of Pennsylvania/Abramson Cancer CenterRecruiting
- Allegheny General HospitalRecruiting
- West Penn HospitalRecruiting
- Geisinger Cancer Services-PottsvilleRecruiting
- Community Medical CenterRecruiting
- Wexford Health and Wellness PavilionRecruiting
- Geisinger Wyoming Valley/Henry Cancer CenterRecruiting
- Avera Cancer Institute-AberdeenRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Avera Cancer InstituteRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- Baptist Memorial Hospital and Cancer Center-ColliervilleRecruiting
- Baptist Memorial Hospital and Cancer Center-MemphisRecruiting
- Vanderbilt University/Ingram Cancer CenterRecruiting
- Hendrick Medical CenterRecruiting
- Saint Joseph Regional Cancer Center
- Farmington Health CenterRecruiting
- University of Utah Sugarhouse Health CenterRecruiting
- Huntsman Cancer Institute/University of UtahRecruiting
- Bon Secours Memorial Regional Medical CenterRecruiting
- Bon Secours Westchester Emergency CenterRecruiting
- Bon Secours Saint Francis Medical CenterRecruiting
- Bon Secours Saint Mary's HospitalRecruiting
- Providence Regional Cancer System-Aberdeen
- Overlake Medical Center
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-BremertonRecruiting
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-Edmonds
- Saint Elizabeth Hospital
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and OncologyRecruiting
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical CenterRecruiting
- Jefferson HealthcareRecruiting
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Valley Medical Center
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard Campus
- Swedish Medical Center-Cherry Hill
- Swedish Medical Center-First Hill
- PeaceHealth United General Medical Center
- Providence Regional Cancer System-Shelton
- Franciscan Research Center-Northwest Medical Plaza
- Northwest Medical Specialties PLLC
- PeaceHealth Southwest Medical Center
- Providence Saint Mary Regional Cancer Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Providence Regional Cancer System-Yelm
- Marshfield Medical Center-EC Cancer CenterRecruiting
- Mayo Clinic Health System-Eau Claire Clinic
- Gundersen Lutheran Medical CenterRecruiting
- Mayo Clinic Health System-Franciscan Healthcare
- Marshfield Medical Center-MarshfieldRecruiting
- Marshfield Clinic-Minocqua CenterRecruiting
- ProHealth D N Greenwald CenterRecruiting
- Cancer Center of Western Wisconsin
- ProHealth Oconomowoc Memorial HospitalRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- Marshfield Medical Center-River Region at Stevens PointRecruiting
- ProHealth Waukesha Memorial HospitalRecruiting
- UW Cancer Center at ProHealth CareRecruiting
- Marshfield Medical Center - WestonRecruiting
- Cheyenne Regional Medical Center-West
- Billings Clinic-Cody
- Welch Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm A (olaparib, pembrolizumab)
Arm B (olaparib)
Patients receive olaparib PO BID on days 1-21 and pembrolizumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Beginning in cycle 19, patients receive olaparib PO BID on days 1-42 and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI, tumor biopsy and blood sample collection throughout the study.
Patients receive olaparib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI, tumor biopsy and blood sample collection throughout the study.