Anus Cancer

EA2176



EA2176: Phase 3 Clinical Trial of Carboplatin and Paclitaxel +/- Nivolumab in Metastatic Anal Cancer Patients

STATUS: Active


This phase 3 trial compares the addition of nivolumab to chemotherapy (carboplatin and paclitaxel) versus usual treatment (chemotherapy alone) for the treatment of anal cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab together with carboplatin and paclitaxel may help doctors find out if the treatment is better or the same as the usual approach.
  • Patient must have inoperable, recurrent, or metastatic disease not amenable to curative therapy

  • Patient must have histological or cytological confirmation of anal squamous cell carcinoma (includes basaloid and cloacogenic lesions) from the primary tumor or a newly diagnosed recurrent/metastatic lesion

  • Patient must be >= 18 years of age

  • Patient must have Eastern Cooperative Oncology Group (ECOG) performance status =< 0-1

  • Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and based on radiologic assessment performed < 4 weeks prior to randomization

  • Patient receiving palliative (limited-field) radiation therapy is allowed, as long as the lesion treated for palliation is not a target lesion and is > 7 days from completion from palliative radiation

  • Patients with brain metastasis are eligible if patient is asymptomatic and if treatment ended > 3 months prior to randomization. Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression within 4 weeks prior to randomization

  • Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study with a minimum sensitivity of 25 IU/L or equivalent units of Bacille Calmette-Guerin (BCG), within 14 days prior to randomization to rule out pregnancy. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

  • Women of childbearing potential and sexually active males must not expect to conceive or father children by using accepted and effective method(s) of contraception or to abstain from sexual intercourse for at least one week prior to the start of treatment, and continue for 5 months after the last dose of protocol treatment for women of childbearing potential and 7 months after the last dose of protocol treatment for males who are sexually active with women of childbearing potential (WOCBP)

  • Absolute neutrophil count >= 1,500/mcL (obtained < 14 days prior to randomization)

  • Platelets >= 100,000/mcL (obtained < 14 days prior to randomization)

  • Hemoglobin (Hb) >= 9 g/dL for males and >= 9 g/dL for females (obtained < 14 days prior to randomization)

  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (obtained < 14 days prior to randomization)

  • Aspartate transaminase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) /alanine transferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 5 x institutional ULN (obtained < 14 days prior to randomization)

  • Creatinine =< 1.5 x institutional ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula) (obtained < 14 days prior to randomization)

  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy (ART) with CD4 count >= 200 or have a CD4 count < 200 but an undetectable viral load are eligible * All HIV+ patients should be under the care of an infectious diseases specialist. If a relationship with an infectious diseases specialist is not established, an infectious disease specialist should be consulted. Records of all viral counts and peripheral T-cell counts should be documented in order to follow these values over the course of treatment * All patients must be willing to undergo testing for HIV testing if not tested within the past 12 months

  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable or on suppressive therapy (if indicated)

  • 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, they are eligible if they have an undetectable HCV viral load

  • Patients with known history or current symptoms of cardiac disease, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Patients with a history of congestive heart failure (CHF) or who are at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs must be willing to undergo evaluation of cardiac function including electrocardiogram (EKG) and echocardiogram (ECHO) as clinically indicated

  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible

  • Patient must not have had previous use of systemic chemotherapy or other investigational drugs for the treatment of inoperable recurrent or metastatic anal cancer (previous use of radiotherapy or chemoradiotherapy in this setting is not an exclusion criterion if: 1) non-irradiated target tumor lesions are present at randomization for the purpose of tumor response assessment or 2) in the absence of non-irradiated target tumor lesions, progression of the irradiated tumor lesions according to the RECIST criteria version 1.1 is documented)

  • Patient must not have current or recent (within 30 days prior to randomization) treatment with another investigational drug or participation in another investigational study

  • Patient must not have had prior immunotherapy

  • Patient must not have a history of known hypersensitivity reaction to any platinum or taxane-based chemotherapy or monoclonal antibody

  • Patient must not have active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater). These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or anti-phospholipid syndrome. Patients with any of these are ineligible because of the risk of recurrence or exacerbation of autoimmune disease

  • Patient must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if < 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted

  • Patient must not have had major surgery performed =< 28 days prior to randomization

  • Patient must not have a history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan

  • Patient must not have a serious active infection requiring IV antibiotics at time of randomization

  • Patient must not have other primary malignancy within the last 3 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer, or any other cancer from which the patient has been disease-free for at least 3 years

  • Patient must not have known peripheral neuropathy > grade 1 at the time of randomization (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible)

  • Patients must agree to not receive live vaccines while on this study

United States
AK
Anchorage
Alaska Breast Care and Surgery LLC
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Alaska Oncology and Hematology LLC
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Alaska Women's Cancer Care
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Associates in Radiation Medicine
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Oncology Centre
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Anchorage Radiation Therapy Center
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Katmai Oncology Group
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Providence Alaska Medical Center
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

AR
Ft. Smith
Mercy Hospital Fort Smith
Contact: Site Public Contact

Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

AZ
Kingman
Kingman Regional Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

Phoenix
Cancer Center at Saint Joseph's
Contact: Site Public Contact
Email: Research-cancerinstitute@dignityhealth.org

CA
Anaheim
Kaiser Permanente-Anaheim
Contact: Site Public Contact
Email: clinical.trials@kp.org

Antioch
Kaiser Permanente-Deer Valley Medical Center
Contact: Site Public Contact
Email: Kpoct@kp.org

Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

PCR Oncology
Contact: Site Public Contact
Email: research@sncrf.org

Baldwin Park
Kaiser Permanente-Baldwin Park
Contact: Site Public Contact
Email: clinical.trials@kp.org

Bellflower
Kaiser Permanente-Bellflower
Contact: Site Public Contact
Email: clinical.trials@kp.org

Burbank
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Contact: Site Public Contact
Email: Najee.Boucher@providence.org

Dublin
Kaiser Permanente Dublin
Contact: Site Public Contact

Fontana
Kaiser Permanente-Fontana
Contact: Site Public Contact
Email: clinical.trials@kp.org

Fremont
Kaiser Permanente-Fremont
Contact: Site Public Contact
Email: Kpoct@kp.org

Fresno
Fresno Cancer Center
Contact: Site Public Contact
Email: Kpoct@kp.org

Kaiser Permanente-Fresno
Contact: Site Public Contact
Email: Kpoct@kp.org

Harbor City
Kaiser Permanente - Harbor City
Contact: Site Public Contact
Email: clinical.trials@kp.org

Irvine
Kaiser Permanente-Irvine
Contact: Site Public Contact
Email: clinical.trials@kp.org

Los Angeles
Cedars Sinai Medical Center
Contact: Site Public Contact

Kaiser Permanente Los Angeles Medical Center
Contact: Site Public Contact
Email: clinical.trials@kp.org

Kaiser Permanente West Los Angeles
Contact: Site Public Contact
Email: clinical.trials@kp.org

Keck Medicine of USC Koreatown
Contact: Site Public Contact

Los Angeles General Medical Center
Contact: Site Public Contact
Email: uscnorrisinfo@med.usc.edu

USC / Norris Comprehensive Cancer Center
Contact: Site Public Contact

Modesto
Kaiser Permanente-Modesto
Contact: Site Public Contact
Email: Kpoct@kp.org

Newport Beach
USC Norris Oncology/Hematology-Newport Beach
Contact: Site Public Contact

Oakland
Kaiser Permanente Oakland-Broadway
Contact: Site Public Contact
Email: Kpoct@kp.org

Kaiser Permanente-Oakland
Contact: Site Public Contact
Email: Kpoct@kp.org

Ontario
Kaiser Permanente-Ontario
Contact: Site Public Contact
Email: clinical.trials@kp.org

Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Contact: Site Public Contact
Email: ucstudy@uci.edu

Panorama City
Kaiser Permanente - Panorama City
Contact: Site Public Contact
Email: clinical.trials@kp.org

Rancho Cordova
Kaiser Permanente-Rancho Cordova Cancer Center
Contact: Site Public Contact
Email: Kpoct@kp.org

Redwood City
Kaiser Permanente-Redwood City
Contact: Site Public Contact
Email: Kpoct@kp.org

Richmond
Kaiser Permanente-Richmond
Contact: Site Public Contact
Email: Kpoct@kp.org

Riverside
Kaiser Permanente-Riverside
Contact: Site Public Contact
Email: clinical.trials@kp.org

Rohnert Park
Rohnert Park Cancer Center
Contact: Site Public Contact
Email: Kpoct@kp.org

Roseville
Kaiser Permanente-Roseville
Contact: Site Public Contact
Email: Kpoct@kp.org

The Permanente Medical Group-Roseville Radiation Oncology
Contact: Site Public Contact
Email: Kpoct@kp.org

Sacramento
Kaiser Permanente Downtown Commons
Contact: Site Public Contact
Email: kpoct@kp.org

Kaiser Permanente-South Sacramento
Contact: Site Public Contact
Email: Kpoct@kp.org

South Sacramento Cancer Center
Contact: Site Public Contact
Email: Kpoct@kp.org

San Diego
Kaiser Permanente-San Diego Mission
Contact: Site Public Contact
Email: clinical.trials@kp.org

Kaiser Permanente-San Diego Zion
Contact: Site Public Contact
Email: clinical.trials@kp.org

San Francisco
Kaiser Permanente-San Francisco
Contact: Site Public Contact
Email: Kpoct@kp.org

San Jose
Kaiser Permanente-Santa Teresa-San Jose
Contact: Site Public Contact
Email: Kpoct@kp.org

San Leandro
Kaiser Permanente San Leandro
Contact: Site Public Contact
Email: Kpoct@kp.org

San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

San Marcos
Kaiser Permanente-San Marcos
Contact: Site Public Contact
Email: clinical.trials@kp.org

San Rafael
Kaiser San Rafael-Gallinas
Contact: Site Public Contact
Email: Kpoct@kp.org

Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Contact: Site Public Contact
Email: Kpoct@kp.org

Santa Maria
Mission Hope Medical Oncology - Santa Maria
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Santa Rosa
Kaiser Permanente-Santa Rosa
Contact: Site Public Contact
Email: Kpoct@kp.org

South San Francisco
Kaiser Permanente Cancer Treatment Center
Contact: Site Public Contact
Email: Kpoct@kp.org

Kaiser Permanente-South San Francisco
Contact: Site Public Contact
Email: Kpoct@kp.org

Stockton
Kaiser Permanente-Stockton
Contact: Site Public Contact
Email: Kpoct@kp.org

Torrance
Torrance Memorial Medical Center
Contact: Site Public Contact

Torrance Memorial Physician Network - Cancer Care
Contact: Site Public Contact
Email: courtney.steeneken@tmphysicians.com

Vacaville
Kaiser Permanente Medical Center-Vacaville
Contact: Site Public Contact
Email: Kpoct@kp.org

Vallejo
Kaiser Permanente-Vallejo
Contact: Site Public Contact
Email: Kpoct@kp.org

Walnut Creek
Kaiser Permanente-Walnut Creek
Contact: Site Public Contact
Email: Kpoct@kp.org

Woodland Hills
Kaiser Permanente-Woodland Hills
Contact: Site Public Contact
Email: clinical.trials@kp.org

CO
Colorado Springs
Penrose-Saint Francis Healthcare
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Penrose
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Denver
Porter Adventist Hospital
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Durango
Mercy Medical Center
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Southwest Oncology PC
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Lakewood
Saint Anthony Hospital
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Littleton
Littleton Adventist Hospital
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Longmont
Longmont United Hospital
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Longmont
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Parker
Parker Adventist Hospital
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Pueblo
Saint Mary Corwin Medical Center
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

DE
Frankford
Beebe South Coastal Health Campus
Contact: Site Public Contact
Email: research@beebehealthcare.org

Lewes
Beebe Medical Center
Contact: Site Public Contact
Email: research@beebehealthcare.org

Newark
Christiana Care Health System-Christiana Hospital
Contact: Site Public Contact
Email: lbarone@christianacare.org

Delaware Clinical and Laboratory Physicians PA
Contact: Site Public Contact
Email: mhayden@christianacare.org

Helen F Graham Cancer Center
Contact: Site Public Contact
Email: lbarone@christianacare.org

Medical Oncology Hematology Consultants PA
Contact: Site Public Contact
Email: lbarone@christianacare.org

Rehoboth Beach
Beebe Health Campus
Contact: Site Public Contact
Email: research@beebehealthcare.org

Seaford
TidalHealth Nanticoke / Allen Cancer Center
Contact: Site Public Contact
Email: anna-maria.howard@peninsula.org

Wilmington
Christiana Care Health System-Wilmington Hospital
Contact: Site Public Contact
Email: lbarone@christianacare.org

FL
Altamonte Springs
AdventHealth Altamonte
Contact: Site Public Contact

Celebration
AdventHealth Celebration
Contact: Site Public Contact

Fort Lauderdale
Holy Cross Hospital
Contact: Site Public Contact

Kissimmee
AdventHealth Kissimmee
Contact: Site Public Contact

Orlando
AdventHealth East Orlando
Contact: Site Public Contact

AdventHealth Medical Group Urology at Orlando
Contact: Site Public Contact

AdventHealth Orlando
Contact: Site Public Contact
Email: FH.Cancer.Research@flhosp.org

Pensacola
Sacred Heart Hospital
Contact: Site Public Contact
Email: eebrou@ascension.org

Winter Park
AdventHealth Winter Park
Contact: Site Public Contact

GA
Thomasville
Lewis Hall Singletary Oncology Center
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

HI
Honolulu
Kaiser Permanente Moanalua Medical Center
Contact: Site Public Contact
Email: shelley.a.clark@kp.org

IA
Ames
Mary Greeley Medical Center
Contact: Site Public Contact

McFarland Clinic - Ames
Contact: Site Public Contact
Email: ksoder@mcfarlandclinic.com

Ankeny
Mission Cancer and Blood - Ankeny
Contact: Site Public Contact

Boone
McFarland Clinic - Boone
Contact: Site Public Contact

Carroll
Saint Anthony Regional Hospital
Contact: Site Public Contact
Email: sbenson@iora.org

Clive
Medical Oncology and Hematology Associates-West Des Moines
Contact: Site Public Contact

Mercy Cancer Center-West Lakes
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Council Bluffs
Alegent Health Mercy Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Creston
Greater Regional Medical Center
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Des Moines
Broadlawns Medical Center
Contact: Site Public Contact

Iowa Lutheran Hospital
Contact: Site Public Contact

Iowa Methodist Medical Center
Contact: Site Public Contact

Medical Oncology and Hematology Associates-Des Moines
Contact: Site Public Contact

Mercy Medical Center - Des Moines
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Mission Cancer and Blood - Laurel
Contact: Site Public Contact

Fort Dodge
McFarland Clinic - Trinity Cancer Center
Contact: Site Public Contact

Trinity Regional Medical Center
Contact: Site Public Contact

Jefferson
McFarland Clinic - Jefferson
Contact: Site Public Contact

Marshalltown
McFarland Clinic - Marshalltown
Contact: Site Public Contact

West Des Moines
Mercy Medical Center-West Lakes
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Methodist West Hospital
Contact: Site Public Contact

ID
Boise
Saint Alphonsus Cancer Care Center-Boise
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Boise
Contact: Site Public Contact
Email: eslinget@slhs.org

Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Coeur D'Alene
Kootenai Health - Coeur d'Alene
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Emmett
Walter Knox Memorial Hospital
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Fruitland
Saint Luke's Cancer Institute - Fruitland
Contact: Site Public Contact
Email: eslinget@slhs.org

Meridian
Idaho Urologic Institute-Meridian
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Meridian
Contact: Site Public Contact
Email: eslinget@slhs.org

Nampa
Saint Alphonsus Cancer Care Center-Nampa
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Nampa
Contact: Site Public Contact
Email: eslinget@slhs.org

Post Falls
Kootenai Clinic Cancer Services - Post Falls
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Sandpoint
Kootenai Cancer Clinic
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Contact: Site Public Contact
Email: eslinget@slhs.org

IL
Alton
Saint Anthony's Health
Contact: Site Public Contact

Aurora
Rush - Copley Medical Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

Bloomington
Illinois CancerCare-Bloomington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Canton
Illinois CancerCare-Canton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Carbondale
Memorial Hospital of Carbondale
Contact: Site Public Contact
Email: clinical.research@sih.net

Carterville
SIH Cancer Institute
Contact: Site Public Contact
Email: clinical.research@sih.net

Carthage
Illinois CancerCare-Carthage
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Centralia
Centralia Oncology Clinic
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Chicago
Northwestern University
Contact: Site Public Contact
Email: cancer@northwestern.edu

Rush University Medical Center
Contact: Site Public Contact
Email: clinical_trials@rush.edu

University of Illinois
Contact: Site Public Contact

Danville
Carle at The Riverfront
Contact: Site Public Contact
Email: Research@Carle.com

Decatur
Cancer Care Specialists of Illinois - Decatur
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Dixon
Illinois CancerCare-Dixon
Contact: Site Public Contact

Effingham
Carle Physician Group-Effingham
Contact: Site Public Contact
Email: Research@carle.com

Crossroads Cancer Center
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Eureka
Illinois CancerCare-Eureka
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Galesburg
Illinois CancerCare-Galesburg
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
Contact: Site Public Contact

Harvey
Ingalls Memorial Hospital
Contact: Site Public Contact
Email: clinicaltrials@ingalls.org

Kewanee
Illinois CancerCare-Kewanee Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Macomb
Illinois CancerCare-Macomb
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Mattoon
Carle Physician Group-Mattoon/Charleston
Contact: Site Public Contact
Email: Research@carle.com

Mount Vernon
Good Samaritan Regional Health Center
Contact: Site Public Contact

O'Fallon
Cancer Care Center of O'Fallon
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Ottawa
Illinois CancerCare-Ottawa Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Pekin
Illinois CancerCare-Pekin
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peoria
Illinois CancerCare-Peoria
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peru
Illinois CancerCare-Peru
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Valley Radiation Oncology
Contact: Site Public Contact

Princeton
Illinois CancerCare-Princeton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Springfield
Memorial Medical Center
Contact: Site Public Contact
Email: pallante.beth@mhsil.com

Southern Illinois University School of Medicine
Contact: Site Public Contact

Springfield Clinic
Contact: Site Public Contact

Swansea
Southwest Illinois Health Services LLP
Contact: Site Public Contact
Email: lynns@thecancercenter.com

Urbana
Carle Cancer Center
Contact: Site Public Contact
Email: Research@carle.com

The Carle Foundation Hospital
Contact: Site Public Contact
Email: Research@carle.com

Washington
Illinois CancerCare - Washington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Yorkville
Rush-Copley Healthcare Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

IN
Richmond
Reid Health
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

KS
Garden City
Central Care Cancer Center - Garden City
Contact: Site Public Contact
Email: aroland@kccop.org

Great Bend
Central Care Cancer Center - Great Bend
Contact: Site Public Contact
Email: aroland@kccop.org

KY
Bardstown
Flaget Memorial Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Corbin
Commonwealth Cancer Center-Corbin
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Lexington
Saint Joseph Hospital East
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Radiation Oncology Resource Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

London
Saint Joseph London
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Louisville
Jewish Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Saints Mary and Elizabeth Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

UofL Health Medical Center Northeast
Contact: Site Public Contact
Email: ctoinfo@louisville.edu

Shepherdsville
Jewish Hospital Medical Center South
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

LA
Baton Rouge
LSU Health Baton Rouge-North Clinic
Contact: Site Public Contact
Email: research@ololrmc.com

Our Lady of the Lake Physicians Group - Medical Oncology
Contact: Site Public Contact
Email: research@ololrmc.com

New Orleans
Louisiana State University Health Science Center
Contact: Site Public Contact
Email: emede1@lsuhsc.edu

University Medical Center New Orleans
Contact: Site Public Contact
Email: emede1@lsuhsc.edu

MA
Worcester
UMass Memorial Medical Center - University Campus
Contact: Site Public Contact
Email: cancer.research@umassmed.edu

MI
Ann Arbor
Saint Joseph Mercy Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

University of Michigan Comprehensive Cancer Center
Contact: Site Public Contact

Battle Creek
Bronson Battle Creek
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Brighton
Saint Joseph Mercy Brighton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Brighton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Canton
Saint Joseph Mercy Canton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Canton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Caro
Caro Cancer Center
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Chelsea
Saint Joseph Mercy Chelsea
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Clarkston
Hematology Oncology Consultants-Clarkston
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Newland Medical Associates-Clarkston
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Detroit
Ascension Saint John Hospital
Contact: Site Public Contact
Email: karen.forman@ascension.org

Wayne State University/Karmanos Cancer Institute
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

East China
Great Lakes Cancer Management Specialists-Doctors Park
Contact: Site Public Contact
Email: karen.forman@ascension.org

Farmington Hills
Weisberg Cancer Treatment Center
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Flint
Genesee Cancer and Blood Disease Treatment Center
Contact: Site Public Contact
Email: wstrong@ghci.org

Genesee Hematology Oncology PC
Contact: Site Public Contact
Email: wstrong@ghci.org

Genesys Hurley Cancer Institute
Contact: Site Public Contact
Email: wstrong@ghci.org

Hurley Medical Center
Contact: Site Public Contact
Email: wstrong@ghci.org

Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Spectrum Health at Butterworth Campus
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Trinity Health Grand Rapids Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Grosse Pointe Woods
Academic Hematology Oncology Specialists
Contact: Site Public Contact
Email: karen.forman@ascension.org

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Grosse Pointe Woods
Contact: Site Public Contact
Email: karen.forman@ascension.org

Kalamazoo
Ascension Borgess Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Borgess Medical Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Lansing
Karmanos Cancer Institute at McLaren Greater Lansing
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Sparrow Hospital
Contact: Site Public Contact

Livonia
Hope Cancer Clinic
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Trinity Health Saint Mary Mercy Livonia Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Macomb Township
Contact: Site Public Contact
Email: karen.forman@ascension.org

Marlette
Saint Mary's Oncology/Hematology Associates of Marlette
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Muskegon
Trinity Health Muskegon Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Niles
Corewell Health Lakeland Hospitals - Niles Hospital
Contact: Site Public Contact

Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Contact: Site Public Contact
Email: connie.szczepanek@crcwm.org

Novi
Ascension Providence Hospitals - Novi
Contact: Site Public Contact
Email: karen.fife@ascension.org

Pontiac
21st Century Oncology-Pontiac
Contact: Site Public Contact
Email: Emily.Crofts@trinity-health.org

Hope Cancer Center
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Newland Medical Associates-Pontiac
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Saint Joseph Mercy Oakland
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Reed City
Corewell Health Reed City Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Rochester Hills
Great Lakes Cancer Management Specialists-Rochester Hills
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saginaw
Ascension Saint Mary's Hospital
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Oncology Hematology Associates of Saginaw Valley PC
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Saint Joseph
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Lakeland Medical Center Saint Joseph
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Southfield
Ascension Providence Hospitals - Southfield
Contact: Site Public Contact
Email: karen.fife@ascension.org

Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
Contact: Site Public Contact
Email: karen.forman@ascension.org

Tawas City
Ascension Saint Joseph Hospital
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Traverse City
Munson Medical Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Warren
Advanced Breast Care Center PLLC
Contact: Site Public Contact
Email: karen.forman@ascension.org

Great Lakes Cancer Management Specialists-Macomb Professional Building
Contact: Site Public Contact
Email: karen.forman@ascension.org

Macomb Hematology Oncology PC
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Warren
Contact: Site Public Contact
Email: karen.forman@ascension.org

Saint John Macomb-Oakland Hospital
Contact: Site Public Contact
Email: karen.forman@ascension.org

West Branch
Saint Mary's Oncology/Hematology Associates of West Branch
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Wyoming
University of Michigan Health - West
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Ypsilanti
Huron Gastroenterology PC
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

MN
Bemidji
Sanford Joe Lueken Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Burnsville
Fairview Ridges Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minnesota Oncology - Burnsville
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Cambridge
Cambridge Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Coon Rapids
Mercy Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Edina
Fairview Southdale Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Fridley
Unity Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maplewood
Minnesota Oncology Hematology PA-Maplewood
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint John's Hospital - Healtheast
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minneapolis
Abbott-Northwestern Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Health Partners Inc
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Hennepin County Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Monticello
Monticello Cancer Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

New Ulm
New Ulm Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Princeton
Fairview Northland Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Robbinsdale
North Memorial Medical Health Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint Paul
Regions Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

United Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Shakopee
Saint Francis Regional Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Stillwater
Lakeview Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Thief River Falls
Sanford Thief River Falls Medical Center
Contact: Site Public Contact

Waconia
Ridgeview Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Willmar
Rice Memorial Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Woodbury
Minnesota Oncology Hematology PA-Woodbury
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Worthington
Sanford Cancer Center Worthington
Contact: Site Public Contact

Wyoming
Fairview Lakes Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Contact: Site Public Contact

Bolivar
Central Care Cancer Center - Bolivar
Contact: Site Public Contact
Email: aroland@kccop.org

Cape Girardeau
Saint Francis Medical Center
Contact: Site Public Contact
Email: sfmc@sfmc.net

Southeast Cancer Center
Contact: Site Public Contact

Chesterfield
Saint Luke's Hospital
Contact: Site Public Contact

Creve Coeur
Siteman Cancer Center at West County Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Farmington
Parkland Health Center - Farmington
Contact: Site Public Contact

Jefferson City
Capital Region Southwest Campus
Contact: Site Public Contact
Email: amy.franken@health.missouri.edu

Joplin
Freeman Health System
Contact: Site Public Contact
Email: LJCrockett@freemanhealth.com

Mercy Hospital Joplin
Contact: Site Public Contact
Email: esmeralda.carrillo@mercy.net

Rolla
Delbert Day Cancer Institute at PCRMC
Contact: Site Public Contact
Email: research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
Contact: Site Public Contact

Saint Joseph
Heartland Regional Medical Center
Contact: Site Public Contact
Email: linda.schumacher@mymlc.com

Saint Louis
Mercy Hospital Saint Louis
Contact: Site Public Contact

Mercy Hospital South
Contact: Site Public Contact
Email: Danielle.Werle@mercy.net

Missouri Baptist Medical Center
Contact: Site Public Contact

Saint Louis Cancer and Breast Institute-South City
Contact: Site Public Contact

Siteman Cancer Center at Christian Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Siteman Cancer Center-South County
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Washington University School of Medicine
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Contact: Site Public Contact

Springfield
CoxHealth South Hospital
Contact: Site Public Contact

Mercy Hospital Springfield
Contact: Site Public Contact

Sullivan
Missouri Baptist Sullivan Hospital
Contact: Site Public Contact

Sunset Hills
BJC Outpatient Center at Sunset Hills
Contact: Site Public Contact

Washington
Mercy Hospital Washington
Contact: Site Public Contact

MT
Anaconda
Community Hospital of Anaconda
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Billings
Billings Clinic Cancer Center
Contact: Site Public Contact
Email: research@billingsclinic.org

Bozeman
Bozeman Deaconess Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls
Benefis Healthcare- Sletten Cancer Institute
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls Clinic
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Kalispell
Kalispell Regional Medical Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Missoula
Community Medical Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Saint Patrick Hospital - Community Hospital
Contact: Site Public Contact
Email: amy.hanneman@providence.org

NC
Albemarle
Atrium Health Stanly/LCI-Albemarle
Contact: Site Public Contact

Charlotte
Atrium Health Pineville/LCI-Pineville
Contact: Site Public Contact

Atrium Health University City/LCI-University
Contact: Site Public Contact

Carolinas Medical Center/Levine Cancer Institute
Contact: Site Public Contact

Levine Cancer Institute-Ballantyne
Contact: Site Public Contact

Levine Cancer Institute-SouthPark
Contact: Site Public Contact

Clinton
Southeastern Medical Oncology Center-Clinton
Contact: Site Public Contact
Email: jfields@cancersmoc.com

Concord
Atrium Health Cabarrus/LCI-Concord
Contact: Site Public Contact

Gastonia
Levine Cancer Institute-Gaston
Contact: Site Public Contact

Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Contact: Site Public Contact
Email: jfields@cancersmoc.com

Jacksonville
Southeastern Medical Oncology Center-Jacksonville
Contact: Site Public Contact
Email: jfields@cancersmoc.com

Lincolnton
Atrium Health Lincoln/LCI-Lincolnton
Contact: Site Public Contact

Monroe
Atrium Health Union/LCI-Union
Contact: Site Public Contact

Pinehurst
FirstHealth of the Carolinas-Moore Regional Hospital
Contact: Site Public Contact
Email: jcwilliams@firsthealth.org

ND
Bismarck
Sanford Bismarck Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Fargo
Sanford Broadway Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Medical Center Fargo
Contact: Site Public Contact

Sanford Roger Maris Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford South University Medical Center
Contact: Site Public Contact

Southpointe-Sanford Medical Center Fargo
Contact: Site Public Contact

NE
Bellevue
Nebraska Medicine-Bellevue
Contact: Site Public Contact
Email: unmcrsa@unmc.edu

Grand Island
CHI Health Saint Francis
Contact: Site Public Contact

Kearney
CHI Health Good Samaritan
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Lincoln
Saint Elizabeth Regional Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Omaha
Alegent Health Bergan Mercy Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Immanuel Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Lakeside Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Creighton University Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Nebraska Medicine-Village Pointe
Contact: Site Public Contact

University of Nebraska Medical Center
Contact: Site Public Contact
Email: unmcrsa@unmc.edu

Papillion
Midlands Community Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

NH
Concord
New Hampshire Oncology Hematology PA-Concord
Contact: Site Public Contact

Manchester
Solinsky Center for Cancer Care
Contact: Site Public Contact

NJ
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Contact: Site Public Contact

Middletown
Memorial Sloan Kettering Monmouth
Contact: Site Public Contact

Montvale
Memorial Sloan Kettering Bergen
Contact: Site Public Contact

NV
Carson City
Carson Tahoe Regional Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

Henderson
Cancer and Blood Specialists-Henderson
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Henderson
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Horizon Ridge
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Southeast Henderson
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Henderson
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Cancer Center-Henderson
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Green Valley
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Pebble
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Seven Hills
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Green Valley
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Contact: Site Public Contact
Email: research@sncrf.org

Ann M Wierman MD LTD
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Central Valley
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Northwest
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Town Center
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Summerlin
Contact: Site Public Contact
Email: research@sncrf.org

Desert West Surgery
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Fort Apache
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Las Vegas
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Vegas Tenaya
Contact: Site Public Contact
Email: research@sncrf.org

Hope Cancer Care of Nevada
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Cancer Center-Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Prostate Cancer Center
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Cathedral Rock
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Pecos
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Smoke Ranch
Contact: Site Public Contact
Email: research@smcrf.org

Las Vegas Urology - Sunset
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Charleston
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Fort Apache
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at MountainView
Contact: Site Public Contact
Email: research@sncrf.org

Radiation Oncology Centers of Nevada Central
Contact: Site Public Contact
Email: research@sncrf.org

Radiation Oncology Centers of Nevada Southeast
Contact: Site Public Contact
Email: research@sncrf.org

Summerlin Hospital Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

Sunrise Hospital and Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

University Cancer Center
Contact: Site Public Contact
Email: research@sncrf.org

University Medical Center of Southern Nevada
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Central
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Northwest
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Southwest
Contact: Site Public Contact
Email: research@sncrf.org

Pahrump
Hope Cancer Care of Nevada-Pahrump
Contact: Site Public Contact
Email: research@sncrf.org

Reno
Radiation Oncology Associates
Contact: Site Public Contact
Email: research@sncrf.org

Renown Regional Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

Saint Mary's Regional Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

NY
Buffalo
Roswell Park Cancer Institute
Contact: Site Public Contact
Email: askroswell@roswellpark.org

Commack
Memorial Sloan Kettering Commack
Contact: Site Public Contact

New York
Memorial Sloan Kettering Cancer Center
Contact: Site Public Contact

Uniondale
Memorial Sloan Kettering Nassau
Contact: Site Public Contact

West Harrison
Memorial Sloan Kettering Westchester
Contact: Site Public Contact

OH
Beavercreek
Indu and Raj Soin Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Belpre
Strecker Cancer Center-Belpre
Contact: Site Public Contact
Email: sheree@columbusccop.org

Boardman
Saint Elizabeth Boardman Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Centerville
Dayton Physicians LLC-Miami Valley South
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital South
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Chillicothe
Adena Regional Medical Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Cincinnati
Bethesda North Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Good Samaritan Hospital - Cincinnati
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Oncology Hematology Care Inc-Kenwood
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

TriHealth Cancer Institute-Anderson
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Westside
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

University of Cincinnati Cancer Center-UC Medical Center
Contact: Site Public Contact
Email: cancer@uchealth.com

Cleveland
MetroHealth Medical Center
Contact: Site Public Contact
Email: ababal@metrohealth.org

Columbus
Columbus Oncology and Hematology Associates Inc
Contact: Site Public Contact
Email: sheree@columbusccop.org

Doctors Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Grant Medical Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Mount Carmel East Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Mount Carmel Health Center West
Contact: Site Public Contact
Email: sheree@columbusccop.org

Ohio State University Comprehensive Cancer Center
Contact: Site Public Contact
Email: Jamesline@osumc.edu

Riverside Methodist Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

The Mark H Zangmeister Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Dayton
Dayton Blood and Cancer Center
Contact: Site Public Contact

Dayton Physician LLC-Miami Valley Hospital North
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital North
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Delaware
Delaware Health Center-Grady Cancer Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Grady Memorial Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Dublin
Dublin Methodist Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Findlay
Armes Family Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Blanchard Valley Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Orion Cancer Care
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Franklin
Atrium Medical Center-Middletown Regional Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Dayton Physicians LLC-Atrium
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Gahanna
Central Ohio Breast and Endocrine Surgery
Contact: Site Public Contact
Email: sheree@columbusccop.org

Greenville
Dayton Physicians LLC-Wayne
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Cancer Care and Infusion
Contact: Site Public Contact

Wayne Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Grove City
Mount Carmel Grove City Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Kettering
Greater Dayton Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Kettering Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Lancaster
Fairfield Medical Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Lima
Saint Rita's Medical Center
Contact: Site Public Contact

Mansfield
OhioHealth Mansfield Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Marietta
Marietta Memorial Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Marion
OhioHealth Marion General Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Marysville
Memorial Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Mount Vernon
Knox Community Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Newark
Licking Memorial Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Newark Radiation Oncology
Contact: Site Public Contact
Email: sheree@columbusccop.org

Perrysburg
Mercy Health Perrysburg Cancer Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Portsmouth
Southern Ohio Medical Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Springfield
Springfield Regional Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Springfield Regional Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Toledo
Mercy Health - Saint Anne Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Saint Vincent Mercy Medical Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Troy
Dayton Physicians LLC - Troy
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Upper Valley Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Warren
Saint Joseph Warren Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

West Chester
University of Cincinnati Cancer Center-West Chester
Contact: Site Public Contact
Email: cancer@uchealth.com

Westerville
Saint Ann's Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Youngstown
Saint Elizabeth Youngstown Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Zanesville
Genesis Healthcare System Cancer Care Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

OK
Oklahoma City
Mercy Hospital Oklahoma City
Contact: Site Public Contact

University of Oklahoma Health Sciences Center
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu

OR
Baker City
Saint Alphonsus Medical Center-Baker City
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Bend
Saint Charles Health System
Contact: Site Public Contact
Email: nosall@stcharleshealthcare.org

Clackamas
Clackamas Radiation Oncology Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Cancer Institute Clackamas Clinic
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Coos Bay
Bay Area Hospital
Contact: Site Public Contact
Email: cherie.cox@bayareahospital.org

Newberg
Providence Newberg Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Ontario
Saint Alphonsus Medical Center-Ontario
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Oregon City
Providence Willamette Falls Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Portland
Oregon Health and Science University
Contact: Site Public Contact
Email: trials@ohsu.edu

Providence Portland Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Redmond
Saint Charles Health System-Redmond
Contact: Site Public Contact

PA
Allentown
Lehigh Valley Hospital-Cedar Crest
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Bethlehem
Lehigh Valley Hospital - Muhlenberg
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Chadds Ford
Christiana Care Health System-Concord Health Center
Contact: Site Public Contact
Email: lbarone@christianacare.org

Danville
Geisinger Medical Center
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

East Stroudsburg
Pocono Medical Center
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Hazleton
Geisinger Medical Center-Cancer Center Hazleton
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Lehigh Valley Hospital-Hazleton
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Lewisburg
Geisinger Medical Oncology-Lewisburg
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Philadelphia
Pennsylvania Hospital
Contact: Site Public Contact

Pottsville
Geisinger Cancer Services-Pottsville
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Scranton
Community Medical Center
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Wilkes-Barre
Geisinger Wyoming Valley/Henry Cancer Center
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

SC
Greenville
Saint Francis Cancer Center
Contact: Site Public Contact
Email: melissa_beckman@bshsi.org

Saint Francis Hospital
Contact: Site Public Contact
Email: melissa_beckman@bshsi.org

Rock Hill
Levine Cancer Institute-Rock Hill
Contact: Site Public Contact

SD
Sioux Falls
Sanford Cancer Center Oncology Clinic
Contact: Site Public Contact
Email: OncologyClinicTrialsSF@sanfordhealth.org

Sanford USD Medical Center - Sioux Falls
Contact: Site Public Contact
Email: OncologyClinicalTrialsSF@SanfordHealth.org

TN
Knoxville
Thompson Cancer Survival Center
Contact: Site Public Contact

Thompson Cancer Survival Center - West
Contact: Site Public Contact

Lenoir City
Thompson Oncology Group-Lenoir City
Contact: Site Public Contact

Nashville
Vanderbilt University/Ingram Cancer Center
Contact: Site Public Contact

Oak Ridge
Thompson Oncology Group-Oak Ridge
Contact: Site Public Contact

TX
Bryan
Saint Joseph Regional Cancer Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Conroe
MD Anderson in The Woodlands
Contact: Site Public Contact
Email: askmdanderson@mdanderson.org

Dallas
Parkland Memorial Hospital
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

UT Southwestern/Simmons Cancer Center-Dallas
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

Houston
M D Anderson Cancer Center
Contact: Site Public Contact
Email: askmdanderson@mdanderson.org

MD Anderson West Houston
Contact: Site Public Contact
Email: askmdanderson@mdanderson.org

League City
MD Anderson League City
Contact: Site Public Contact
Email: askmdanderson@mdanderson.org

Sugar Land
MD Anderson in Sugar Land
Contact: Site Public Contact
Email: askmdanderson@mdanderson.org

VA
Chesapeake
Cancer Specialists of Tidewater Limited
Contact: Site Public Contact
Email: casey.morris@rivhs.com

Fredericksburg
Hematology Oncology Associates of Fredericksburg Inc
Contact: Site Public Contact
Email: cvaughn@hoafredericksburg.com

Gloucester
Peninsula Cancer Institute-Gloucester
Contact: Site Public Contact
Email: casey.morris@rivhs.com

Newport News
Peninsula Cancer Institute-Newport News
Contact: Site Public Contact
Email: casey.morris@rivhs.com

Richmond
Virginia Cancer Institute
Contact: Site Public Contact
Email: smoore@vacancer.com

Virginia Commonwealth University/Massey Cancer Center
Contact: Site Public Contact
Email: CTOclinops@vcu.edu

Suffolk
Cancer Specialists of Tidewater-Suffolk
Contact: Site Public Contact
Email: casey.morris@rivhs.com

Virginia Beach
Peninsula Cancer Institute-Cancer Specialists of Tidewater
Contact: Site Public Contact
Email: casey.morris@rivhs.com

Williamsburg
Peninsula Cancer Institute-Williamsburg
Contact: Site Public Contact
Email: casey.morris@rivhs.com

WI
Appleton
ThedaCare Regional Cancer Center
Contact: Site Public Contact
Email: ResearchDept@thedacare.org

Eau Claire
Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

La Crosse
Gundersen Lutheran Medical Center
Contact: Site Public Contact
Email: cancerctr@gundersenhealth.org

Marshfield
Marshfield Medical Center-Marshfield
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Milwaukee
Medical College of Wisconsin
Contact: Site Public Contact

Minocqua
Marshfield Clinic-Minocqua Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Mukwonago
ProHealth D N Greenwald Center
Contact: Site Public Contact
Email: research.institute@phci.org

New Richmond
Cancer Center of Western Wisconsin
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Contact: Site Public Contact

Rice Lake
Marshfield Medical Center-Rice Lake
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Waukesha
ProHealth Waukesha Memorial Hospital
Contact: Site Public Contact

UW Cancer Center at ProHealth Care
Contact: Site Public Contact
Email: Chanda.miller@phci.org

Weston
Marshfield Medical Center - Weston
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

WV
Bridgeport
United Hospital Center
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu

Martinsburg
WVUH-Berkely Medical Center
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu

Morgantown
West Virginia University Healthcare
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu

Parkersburg
Camden Clark Medical Center
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu

WY
Cody
Billings Clinic-Cody
Contact: Site Public Contact
Email: research@billingsclinic.org

Sheridan
Welch Cancer Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

PRIMARY OBJECTIVE:
I. To demonstrate that anti-PD-1 therapy in combination with carboplatin/weekly paclitaxel results in improved progression-free survival (PFS) versus systemic chemotherapy alone.

SECONDARY OBJECTIVES:
I. To demonstrate that anti-PD-1 therapy in combination with carboplatin/weekly paclitaxel results in improved overall survival (OS) versus systemic chemotherapy alone.
II. To demonstrate that anti-PD-1 therapy in combination with carboplatin/weekly paclitaxel results in improved objective response using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 versus systemic chemotherapy alone.
III. To evaluate toxicity profiles of the two regimens.

OUTLINE: Patients are randomized to 1 of 2 arms. Randomization will be 2:1 favoring the experimental regimen, Arm B.

ARM A: Patients receive paclitaxel intravenously (IV) on days 1, 8, and 15 of each cycle, and carboplatin IV on day 1 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive nivolumab IV over 30 minutes on days 1 and 15 of cycle 1 and then on day 1 only of subsequent cycles, paclitaxel IV on days 1, 8, and 15 of each cycle, and carboplatin on day 1 of each cycle. Treatment repeats every 28 days for up to 6 cycles for carboplatin and paclitaxel, and up to 2 years for nivolumab in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 month, then every 3 months for 2 years.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.


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