Testing Maintenance Therapy for Small Cell Lung Cancer in Patients With SLFN11 Positive Biomarker
Extensive Stage Lung Small Cell Carcinoma
About this trial
This is an interventional treatment trial for Extensive Stage Lung Small Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- STEP 1: SCREENING REGISTRATION: Participants must have histologically or pathologically confirmed diagnosis of extensive stage small cell lung cancer (ES-SCLC) at the time of protocol entry. Participants who have transformed to SCLC from lung non-small cell carcinoma (NSCLC) or have SCLC with mixed histology are not eligible
STEP 1: SCREENING REGISTRATION: Participants must have completed at least day 3 of cycle 1 dosing of frontline induction treatment with platinum plus etoposide plus atezolizumab prior to Step 1 Screening Registration. Cycle 1 of frontline induction treatment may or may not contain atezolizumab
- NOTE: Participants may be screened while receiving consolidation thoracic radiation or during prophylactic cranial irradiation (PCI) at the time of Step 1 Screening Registration. Participants may or may not receive consolidation thoracic radiation and/or PCI per the discretion of their treating investigator
- STEP 1: SCREENING REGISTRATION: Participants must not have received any immunotherapy for SCLC prior to starting the frontline induction treatment for ES-SCLC
- STEP 1: SCREENING REGISTRATION: Participants must not have received any investigational agent for the treatment of ES-SCLC
- STEP 1: SCREENING REGISTRATION: Participants must be >= 18 years of age at the time of Step 1 Screening Registration
STEP 1: SCREENING REGISTRATION: Participants must have adequate tumor tissue available from a core biopsy or fine needle aspiration (FNA) defined as:
- At least two (3-5 microns) (three slides preferred) unstained slides, or;
- One (3-5 microns) (two slides preferred) unstained slide plus one H&E stained slide
- Participants must agree to have this tissue submitted to M.D. Anderson Cancer Center (MDACC) for SLFN11 immunohistochemistry (IHC) testing. Note: A histologic review will be performed at MDACC to confirm adequate cellularity for the testing. If inadequate cellularity, additional unstained slides from the same participant may be submitted if it doesn't exceed the window of starting maintenance therapy
- STEP 1: SCREENING REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
- STEP 1: SCREENING REGISTRATION: As a part of the Oncology Participant 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
- STEP 1: SCREENING REGISTRATION: Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)
- STEP 2: RANDOMIZATION: Site must have received notification from the SWOG Statistics and Data Management Center (SDMC) that the participant's tumor sample is SLFN11 positive
- STEP 2: RANDOMIZATION: Participants must have their disease assessed either by computed tomography (CT) of chest/abdomen/pelvis (with contrast, unless contraindicated) within 28 days prior to Step 2 Registration for measurable disease or by positron emission tomography (PET)PET/CT of chest/abdomen/pelvis (with contrast, unless contraindicated) within 42 days prior to Step 2 Registration for non-measurable disease. Participants may have a complete response to induction therapy. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1). Study participants will not be considered eligible if a non-diagnostic PET/CT of chest/abdomen/pelvis is used to assess measurable disease prior to Step 2 Registration
- STEP 2: RANDOMIZATION: Patients must have a CT or magnetic resonance imaging (MRI) scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to Step 2 randomization. Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to Step 2 randomization, AND (2) participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to Step 2 randomization
- STEP 2: RANDOMIZATION: Participants must not have had disease progression based on post induction imaging in the opinion of treating investigator
- STEP 2: RANDOMIZATION: Participants must be registered to Step 2 Randomization prior to the start of maintenance atezolizumab
- STEP 2: RANDOMIZATION: Participants must have received no fewer than 2 cycles and no more than 4 cycles of induction treatment with platinum/etoposide/atezolizumab
- STEP 2: RANDOMIZATION: Participant must not have received radiation treatment (RT) or prophylactic cranial irradiation (PCI) within 14 days prior to Step 2 Randomization
- STEP 2: RANDOMIZATION: Participants must not be taking strong P-glycoprotein (P-gp) inhibitors (e.g., dronedarone, quinidine, ranolazine), P-gp inducers (e.g., rifampin), or breast cancer resistance protein (BCRP) inhibitors (e.g., elacridar) within 7 days prior to randomization. Participants must not plan to receive the therapies listed above while on protocol treatment)
STEP 2: RANDOMIZATION: Participants must not have experienced the following during induction treatment:
- Any grade 3 or worse immune-related adverse event (irAE) in the opinion of the treating investigator. Exception: asymptomatic nonbullous/nonexfoliative rash
- Any unresolved grade 2 irAE
- Any toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy. Exception to the above: Toxicities of any grade that require replacement therapy and have stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed
- STEP 2: RANDOMIZATION: History and physical exam must be obtained within 28 days prior to Step 2 randomization
- STEP 2: RANDOMIZATION: Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function and be considered class 2B or better on the New York Heart Association Functional Classification
- STEP 2: RANDOMIZATION: Participants must have Zubrod performance status 0-2 documented within 28 days prior to Step 2 Randomization.
- STEP 2: RANDOMIZATION: Leukocytes >= 3 x 10^3/mL (within 28 days prior to Step 2 Randomization)
- STEP 2: RANDOMIZATION: Absolute neutrophil count >= 1.5 x 10^3/mL (within 28 days prior to Step 2 Randomization)
- STEP 2: RANDOMIZATION: Platelets >= 100 x 10^3/mL (within 28 days prior to Step 2 Randomization)
- STEP 2: RANDOMIZATION: Total bilirubin =< institutional upper limit of normal (ULN) (within 28 days prior to Step 2 Randomization)
- STEP 2: RANDOMIZATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional ULN (within 28 days prior to Step 2 Randomization)
- STEP 2: RANDOMIZATION: Creatinine =< institutional ULN OR estimated creatinine clearance > 30 mL/min (within 28 days prior to Step 2 Randomization)
- STEP 2: RANDOMIZATION: Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within in 6 months prior to Step 2 Randomization
- STEP 2: RANDOMIZATION: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment must have an undetectable HCV viral load within in 6 months prior to Step 2 Randomization
- STEP 2: RANDOMIZATION: Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy and must have undetectable viral load at their most recent viral load test and within 6 months prior to Step 2 Randomization
- STEP 2: RANDOMIZATION: Participants must be able to swallow capsule whole
- STEP 2: RANDOMIZATION: Participants with known diabetes must not have uncontrolled diabetes. (Uncontrolled diabetes is defined as glycosylated hemoglobin [HgA1C] > 7%)
- STEP 2: RANDOMIZATION: Participants must not have any known clinically significant liver disease, including cirrhosis, fatty liver, or inherited liver disease
- STEP 2: RANDOMIZATION: Participants must not have end stage renal or other serious medical illness that may limit survival or the ability to participate in this study
- STEP 2: RANDOMIZATION: Participants must not have a history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- STEP 2: RANDOMIZATION: Participants must not have known active tuberculosis (TB)
- STEP 2: RANDOMIZATION: Participants must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation
- STEP 2: RANDOMIZATION: Participants must not have history of allergic reaction attributed to compounds of similar chemical or biological composition to atezolizumab and/or talazoparib
- STEP 2: RANDOMIZATION: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
- STEP 2: RANDOMIZATION: Participants must not be on corticosteroids at doses greater than prednisone 10 mg daily or equivalent within 7 days prior to Step 2 Randomization
- STEP 2: RANDOMIZATION: Participants must not receive any live attenuated vaccines within 28 days prior to Step 2 Randomization or at any time during the study and until 5 months after the last dose of protocol treatment
- STEP 2: RANDOMIZATION: Participants must not have severe infections in the form of severe sepsis or septic shock including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia within 14 days prior to Step 2 Randomization
- STEP 2: RANDOMIZATION: Participants must not be pregnant due to the potential teratogenic side effects of the protocol treatment. Women of reproductive potential and men must have agreed to use an effective contraception method for the duration of protocol treatment, and for 7 months after the last dose of protocol treatment. A woman is considered to be of "reproductive potential" if she has had a 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 outlined in the protocol, he/she is responsible for beginning contraceptive measures. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding must be discontinued prior to Step 2 Randomization
- STEP 2: RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System
- STEP 2: RANDOMIZATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
- STEP 2: RANDOMIZATION: As a part of the 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
- STEP 2: RANDOMIZATION: Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)
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
- Kingman Regional Medical Center
- Cancer Center at Saint Joseph's
- Mercy Hospital Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- University of Arkansas for Medical Sciences
- Mission Hope Medical Oncology - Arroyo Grande
- PCR Oncology
- Tower Cancer Research Foundation
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- 21st Century Oncology - El Segundo
- Loma Linda University Medical Center
- Cedars Sinai Medical Center
- Fremont - Rideout Cancer Center
- Providence Queen of The Valley
- University of California Davis Comprehensive Cancer Center
- Pacific Central Coast Health Center-San Luis Obispo
- Mission Hope Medical Oncology - Santa Maria
- Providence Medical Foundation - Santa Rosa
- Providence Santa Rosa Memorial Hospital
- Cedars-Sinai Cancer - Tarzana
- Torrance Memorial Physician Network - Cancer Care
- Torrance Memorial Medical Center
- Gene Upshaw Memorial Tahoe Forest Cancer Center
- UCHealth University of Colorado Hospital
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- UCHealth Memorial Hospital Central
- Memorial Hospital North
- Saint Francis Cancer Center
- Porter Adventist Hospital
- Mercy Medical Center
- Southwest Oncology PC
- Poudre Valley Hospital
- Cancer Care and Hematology-Fort Collins
- Grand Valley Oncology
- UCHealth Greeley Hospital
- Saint Anthony Hospital
- Littleton Adventist Hospital
- UCHealth Lone Tree Health Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- Medical Center of the Rockies
- Parker Adventist Hospital
- Saint Mary Corwin Medical Center
- Beebe South Coastal Health Campus
- Beebe Medical Center
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- TidalHealth Nanticoke / Allen Cancer Center
- Christiana Care Health System-Wilmington Hospital
- GenesisCare USA - Aventura FP
- GenesisCare USA - Aventura
- Mount Sinai Comprehensive Cancer Center at Aventura
- GenesisCare USA - Boca Raton FP02
- GenesisCare USA - Boca Ration FP06
- Holy Cross Hospital
- GenesisCare USA - Key West
- GenesisCare USA - Lakewood Ranch
- Mount Sinai Medical Center
- GenesisCare USA - Palm Beach Gardens
- GenesisCare USA - Plantation
- Good Samaritan Medical Center
- Augusta University Medical Center
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Cancer Institute - Boise
- Saint Alphonsus Cancer Care Center-Caldwell
- Kootenai Health - Coeur d'Alene
- 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-Nampa
- Kootenai Clinic Cancer Services - Post Falls
- Kootenai Cancer Clinic
- Saint Luke's Cancer Institute - Twin Falls
- Saint Anthony's Health
- Rush - Copley Medical Center
- Illinois CancerCare-Bloomington
- Loyola Center for Health at Burr Ridge
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- SIH Cancer Institute
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Northwestern University
- Jesse Brown Veterans Affairs Medical Center
- University of Illinois
- University of Chicago Comprehensive Cancer Center
- Carle at The Riverfront
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Illinois CancerCare-Dixon
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Ingalls Memorial Hospital
- Loyola Medicine Homer Glen
- Illinois CancerCare-Kewanee Clinic
- Northwestern Medicine Lake Forest Hospital
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Loyola University Medical Center
- Marjorie Weinberg Cancer Center at Loyola-Gottlieb
- Good Samaritan Regional Health Center
- UC Comprehensive Cancer Center at Silver Cross
- Cancer Care Center of O'Fallon
- University of Chicago Medicine-Orland Park
- Illinois CancerCare-Ottawa Clinic
- Illinois CancerCare-Pekin
- Illinois CancerCare-Peoria
- Methodist Medical Center of Illinois
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Southwest Illinois Health Services LLP
- Carle Cancer Center
- The Carle Foundation Hospital
- Illinois CancerCare - Washington
- Rush-Copley Healthcare Center
- Reid Health
- Mary Greeley Medical Center
- McFarland Clinic - Ames
- McFarland Clinic - Boone
- Saint Anthony Regional Hospital
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Jennie Edmundson Memorial Hospital
- Alegent Health Mercy Hospital
- Heartland Oncology and Hematology LLP
- Greater Regional Medical Center
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Broadlawns Medical Center
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- McFarland Clinic - Trinity Cancer Center
- Trinity Regional Medical Center
- McFarland Clinic - Jefferson
- McFarland Clinic - Marshalltown
- 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
- LSU Health Baton Rouge-North Clinic
- Our Lady of The Lake
- Louisiana Hematology Oncology Associates LLC
- Mary Bird Perkins Cancer Center
- Our Lady of the Lake Physicians Group - Medical Oncology
- Northshore Oncology Associates-Covington
- Terrebonne General Medical Center
- Ochsner LSU Health Monroe Medical Center
- LSU Health Sciences Center at Shreveport
- Greater Baltimore Medical Center
- Beverly Hospital
- Lahey Hospital and Medical Center
- Addison Gilbert Hospital
- Lahey Medical Center-Peabody
- Winchester Hospital
- Saint Joseph Mercy Hospital
- Bronson Battle Creek
- Saint Joseph Mercy Brighton
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
- Henry Ford Cancer Institute-Downriver
- Saint Joseph Mercy Canton
- Trinity Health IHA Medical Group Hematology Oncology - Canton
- Caro Cancer Center
- Saint Joseph Mercy Chelsea
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
- Hematology Oncology Consultants-Clarkston
- Michigan Healthcare Professionals Clarkston
- Newland Medical Associates-Clarkston
- Henry Ford Hematology Oncology - Hayes
- Henry Ford Macomb Hospital-Clinton Township
- Henry Ford Medical Center-Fairlane
- Henry Ford Hospital
- Ascension Saint John Hospital
- Great Lakes Cancer Management Specialists-Doctors Park
- Michigan Healthcare Professionals Farmington
- Genesee Cancer and Blood Disease Treatment Center
- Genesee Hematology Oncology PC
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Helen DeVos Children's Hospital at Spectrum Health
- Spectrum Health at Butterworth Campus
- Trinity Health Grand Rapids Hospital
- Academic Hematology Oncology Specialists
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
- Michigan Breast Specialists-Grosse Pointe Woods
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Ascension Borgess Cancer Center
- Borgess Medical Center
- Sparrow Hospital
- Hope Cancer Clinic
- Trinity Health Saint Mary Mercy Livonia Hospital
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
- Michigan Breast Specialists-Macomb Township
- Michigan Healthcare Professionals Macomb
- Michigan Healthcare Professionals Madison Heights
- Saint Mary's Oncology/Hematology Associates of Marlette
- Trinity Health Muskegon Hospital
- Lakeland Hospital Niles
- Cancer and Hematology Centers of Western Michigan - Norton Shores
- Ascension Providence Hospitals - Novi
- Henry Ford Medical Center-Columbus
- 21st Century Oncology-Pontiac
- Hope Cancer Center
- Newland Medical Associates-Pontiac
- Saint Joseph Mercy Oakland
- Spectrum Health Reed City Hospital
- Ascension Saint Mary's Hospital
- Oncology Hematology Associates of Saginaw Valley PC
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Henry Ford Macomb Health Center - Shelby Township
- Ascension Providence Hospitals - Southfield
- Bhadresh Nayak MD PC-Sterling Heights
- Ascension Saint Joseph Hospital
- Munson Medical Center
- GenesisCare USA - Troy
- Advanced Breast Care Center PLLC
- Great Lakes Cancer Management Specialists-Macomb Professional Building
- Macomb Hematology Oncology PC
- Michigan Breast Specialists-Warren
- Saint John Macomb-Oakland Hospital
- Henry Ford West Bloomfield Hospital
- Saint Mary's Oncology/Hematology Associates of West Branch
- Henry Ford Wyandotte Hospital
- University of Michigan Health - West
- Huron Gastroenterology PC
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
- Sanford Joe Lueken Cancer Center
- 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
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Sanford Thief River Falls Medical Center
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Sanford Cancer Center Worthington
- Fairview Lakes Medical Center
- Baptist Memorial Hospital and Cancer Center-Golden Triangle
- Baptist Cancer Center-Grenada
- Jackson Oncology Associates PLLC
- University of Mississippi Medical Center
- Baptist Memorial Hospital and Cancer Center-Union County
- Baptist Memorial Hospital and Cancer Center-Oxford
- Baptist Memorial Hospital and Cancer Center-Desoto
- Saint Louis Cancer and Breast Institute-Ballwin
- Central Care Cancer Center - Bolivar
- Cox Cancer Center Branson
- Saint Francis Medical Center
- Southeast Cancer Center
- Parkland Health Center - Farmington
- 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 Center
- Mercy Hospital Saint Louis
- Sainte Genevieve County Memorial Hospital
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Mercy Hospital Washington
- Community Hospital of Anaconda
- Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Kalispell Regional Medical Center
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- Nebraska Medicine-Bellevue
- CHI Health Saint Francis
- CHI Health Good Samaritan
- Saint Elizabeth Regional Medical Center
- Nebraska Methodist Hospital
- Oncology Associates PC
- Nebraska Medicine-Village Pointe
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- University of Nebraska 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 Charleston
- 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
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- Sunrise Hospital and Medical Center
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- 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
- HealthCare Partners Medical Group Oncology/Hematology-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 Apache
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- 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
- Inspira Medical Center Mullica Hill
- Inspira Medical Center Vineland
- University of New Mexico Cancer Center
- Mount Sinai Chelsea
- Mount Sinai Hospital
- Stony Brook University Medical Center
- Atrium Health Stanly/LCI-Albemarle
- Carolinas Medical Center/Levine Cancer Institute
- Atrium Health Pineville/LCI-Pineville
- Wake Forest University at Clemmons
- Southeastern Medical Oncology Center-Clinton
- Atrium Health Cabarrus/LCI-Concord
- Levine Cancer Institute-Gaston
- Southeastern Medical Oncology Center-Goldsboro
- Southeastern Medical Oncology Center-Jacksonville
- Atrium Health Lincoln/LCI-Lincolnton
- Atrium Health Union/LCI-Union
- FirstHealth of the Carolinas-Moore Regional Hospital
- Wake Forest University Health Sciences
- Sanford Bismarck Medical Center
- Sanford South University Medical Center
- Southpointe-Sanford Medical Center Fargo
- Sanford Medical Center Fargo
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- Indu and Raj Soin Medical Center
- Saint Elizabeth Boardman Hospital
- Cleveland Clinic Mercy Hospital
- Mercy Hematology and Oncology Associates Inc
- Dayton Physicians LLC-Miami Valley South
- Miami Valley Hospital South
- Good Samaritan Hospital - Cincinnati
- Oncology Hematology Care Inc-Kenwood
- Bethesda North Hospital
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital North
- Miami Valley Hospital North
- Armes Family Cancer Center
- Blanchard Valley Hospital
- Orion Cancer Care
- Atrium Medical Center-Middletown Regional Hospital
- Dayton Physicians LLC-Atrium
- Dayton Physicians LLC-Wayne
- Wayne Hospital
- Greater Dayton Cancer Center
- First Dayton Cancer Care
- Kettering Medical Center
- Springfield Regional Cancer Center
- Springfield Regional Medical Center
- Trinity's Tony Teramana Cancer Center
- Dayton Physicians LLC - Troy
- Upper Valley Medical Center
- Saint Joseph Warren Hospital
- Saint Elizabeth Youngstown Hospital
- Cancer Centers of Southwest Oklahoma Research
- University of Oklahoma Health Sciences Center
- Integris Southwest Medical Center
- Mercy Hospital Oklahoma City
- Integris Cancer Institute of Oklahoma
- Saint Alphonsus Medical Center-Baker City
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Cancer Institute Clackamas Clinic
- Bay Area Hospital
- Providence Newberg Medical Center
- Saint Alphonsus Medical Center-Ontario
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Saint Charles Health System-Redmond
- Lehigh Valley Hospital-Cedar Crest
- UPMC Altoona
- UPMC-Heritage Valley Health System Beaver
- Lehigh Valley Hospital - Muhlenberg
- UPMC Camp Hill
- Carlisle Regional Cancer Center
- Christiana Care Health System-Concord Health Center
- Chambersburg Hospital
- WellSpan Medical Oncology and Hematology
- Pocono Medical Center
- Ephrata Cancer Center
- Ephrata Community Hospital
- UPMC Hillman Cancer Center Erie
- UPMC Cancer Center at UPMC Horizon
- Adams Cancer Center
- UPMC Cancer Centers - Arnold Palmer Pavilion
- Oncology Hematology Associates
- Cherry Tree Cancer Center
- UPMC Pinnacle Harrisburg
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
- Lehigh Valley Hospital-Hazleton
- UPMC-Johnstown/John P. Murtha Regional Cancer Center
- Sechler Family Cancer Center
- UPMC Cancer Center at UPMC McKeesport
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
- UPMC Hillman Cancer Center - Part of Frick Hospital
- Arnold Palmer Cancer Center Medical Oncology Norwin
- Oncology Hematology Association
- UPMC-Saint Margaret
- UPMC-Mercy Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- UPMC-Passavant Hospital
- UPMC-Saint Clair Hospital Cancer Center
- UPMC Cancer Center at UPMC Northwest
- UPMC Cancer Center-Uniontown
- UPMC Cancer Center-Washington
- UPMC West Mifflin-Cancer Center Jefferson
- UPMC Susquehanna
- Divine Providence Hospital
- Cancer Care Associates of York
- WellSpan Health-York Cancer Center
- WellSpan Health-York Hospital
- UPMC Memorial
- Carolina Regional Cancer Center
- Levine Cancer Institute-Rock Hill
- Sanford Cancer Center Oncology Clinic
- Sanford USD Medical Center - Sioux Falls
- Bristol Regional Medical Center
- Baptist Memorial Hospital and Cancer Center-Collierville
- Ballad Health Cancer Care - Kingsport
- Wellmont Holston Valley Hospital and Medical Center
- Baptist Memorial Hospital and Cancer Center-Memphis
- Saint Joseph Regional Cancer Center
- M D Anderson Cancer Center
- Wellmont Medical Associates-Bristol
- Sovah Health Martinsville
- Southwest VA Regional Cancer Center
- Providence Regional Cancer System-Aberdeen
- Overlake Medical Center
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- 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 Oncology
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical Center
- 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
- Langlade Hospital and Cancer Center
- HSHS Sacred Heart Hospital
- Marshfield Medical Center-EC Cancer Center
- Bellin Memorial Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Gundersen Lutheran Medical Center
- Marshfield Medical Center-Marshfield
- Aspirus Medford Hospital
- Marshfield Clinic-Minocqua Center
- Cancer Center of Western Wisconsin
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Marshfield Medical Center-Rice Lake
- Marshfield Medical Center-River Region at Stevens Point
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
- Aspirus Regional Cancer Center
- Marshfield Medical Center - Weston
- Aspirus Cancer Care - Wisconsin Rapids
- Billings Clinic-Cody
- Welch Cancer Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (atezolizumab)
Arm II (atezolizumab, talazoparib)
Patients receive atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may undergo MRI during screening. Patients undergo tumor biopsy while on study. Patients undergo CT scan and blood sample collection throughout the study.
Patients receive atezolizumab IV over 30-60 minutes on day 1 and talazoparib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may undergo MRI during screening. Patients undergo tumor biopsy while on study. Patients undergo CT scan and blood sample collection throughout the study.