Combination Chemotherapy, Bevacizumab, and / or Atezolizumab in Treating Patients with Deficient DNA Mismatch Repair Metastatic Colorectal Cancer

Status: Active

Description

This randomized phase III trial studies how well combination chemotherapy, bevacizumab, and / or atezolizumab work in treating patients with deficient deoxyribonucleic acid (DNA) mismatch repair colorectal cancer that has spread to other places in the body. Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin calcium, 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. Immunotherapy with monoclonal antibodies, such as bevacizumab and atezolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy, bevacizumab, and atezolizumab may work better in treating patients with colorectal cancer.

Eligibility Criteria

Inclusion Criteria

  • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Diagnosis of metastatic adenocarcinoma of colon or rectum without previous chemotherapy or any other systemic therapy for metastatic colorectal cancer
  • Tumor determined to be mismatch-repair deficient (dMMR) by Clinical Laboratory Improvement Act (CLIA)-certified immunohistochemical (IHC) assay with a panel of all four IHC markers, including MLH1, MSH2, PMS2, and MSH6; Note: microsatellite instability high (MSI-H) diagnosed by microsatellite instability (MSI) testing (either Bethesda markers or Pentaplex panel) or by next-generation sequencing (NGS) is not eligible unless dMMR is confirmed by CLIA-certified immunohistochemical (IHC) assay with a panel of all four IHC markers including MLH1, MSH2, PMS2 and MSH6
  • An adequate amount of archived tumor tissue, either from primary colorectal cancer site or metastatic lesions, for central confirmation of dMMR status: * Either whole or part of the formalin-fixed paraffin-embedded (FFPE) block containing tumor tissue; or * At least 9 unstained slides containing tumor sections
  • Documentation by positron emission tomography(PET)/computed tomography (CT) scan, CT scan, or magnetic resonance imaging (MRI) that the patient has untreated measurable metastatic disease per RECIST 1.1
  • No immediate need for surgical intervention for the primary tumor or palliative diversion/bypass
  • Absolute neutrophil count (ANC) must be >= 1500/mm^3 (obtained within 28 days prior randomization)
  • Platelet count must be >= 100,000/mm^3 (obtained within 28 days prior randomization)
  • Hemoglobin must be >= 8 g/dL (obtained within 28 days prior randomization)
  • Total bilirubin must be =< 1.5 x ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation > 1.5 x ULN to 3 x ULN due to Gilbert’s disease or similar syndrome involving slow conjugation of bilirubin (obtained within 28 days prior randomization); and
  • Alkaline phosphatase must be =< 2.5 x ULN for the lab with the following exception: patients with documented liver metastases or bone involvement - alkaline phosphatase must be =< 5 x ULN (obtained within 28 days prior randomization); and
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be =< 3 x ULN for the lab with the following exception: for patients with documented liver metastases, AST and ALT must be =< 5 x ULN (obtained within 28 days prior randomization)
  • Serum creatinine =< 1.5 x ULN for the lab or measured or calculated creatinine clearance >= 30 mL/min (obtained within 28 days prior randomization)
  • A urine sample tested for proteinuria by the dipstick method must indicate 0 -1+ protein; if dipstick reading is >= 2+, a 24-hour urine specimen must demonstrate < 1.0 g of protein per 24 hours
  • International normalized ratio of prothrombin time (INR) and prothrombin time (PT) must be =< 1.5 x ULN for the lab within 28 days before randomization; patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history
  • Pregnancy test done within 14 days prior randomization must be negative (for women of childbearing potential only); pregnancy testing should be performed according to institutional standards; administration of atezolizumab and/or mFOLFOX6/bevacizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, and 6 months after the last dose of mFOLFOX6; men with female partners of child-bearing potential must agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after the last dose of bevacizumab and 6 months after the last dose of mFOLFOX6

Exclusion Criteria

  • Patients with central nervous system (CNS) metastases are excluded, with the following exceptions: * Patients with asymptomatic untreated CNS metastases may be enrolled, provided all eligibility criteria are met, as well as the following: ** Evaluable or measurable disease outside the CNS ** No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm) ** No history of intracranial hemorrhage or spinal cord hemorrhage ** No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted. ** No neurosurgical resection or brain biopsy within 28 days prior to randomization * Patients with asymptomatic treated CNS metastases may be enrolled, provided all eligibility criteria are met, as well as the following: ** Radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study ** No stereotactic radiation or whole-brain radiation within 28 days prior to randomization ** Screening CNS radiographic study >= 28 days from completion of radiotherapy and >= 14 days from discontinuation of corticosteroids
  • Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies, fluoropyrimidines, folic acid derivatives or oxaliplatin
  • Uncontrolled high blood pressure defined as systolic blood pressure (BP) > 150 mmHg or diastolic BP 90 mmHg with or without anti-hypertensive medication; patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria
  • Any of the following cardiac conditions: * Documented New York Heart Association (NYHA) class III or IV congestive heart failure * Myocardial infarction within 6 months prior to randomization * Unstable angina within 6 months prior to randomization * Symptomatic arrhythmia
  • Serious or non-healing wound, skin ulcer, or bone fracture
  • History of transient ischemic attack (TIA), cerebrovascular accident (CVA), gastrointestinal (GI) perforation or arterial thrombotic event within 6 months prior to randomization or symptomatic peripheral ischemia
  • Other malignancies are excluded unless the patient has completed therapy for the malignancy >= 12 months prior to randomization and is considered disease-free; patients with the following cancers are eligible if diagnosed and treated within the past 12 months: in situ carcinomas or basal cell and squamous cell carcinoma of the skin
  • Known DPD (dihydro pyrimidine dehydrogenase) deficiency
  • Symptomatic peripheral sensory neuropathy >= grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0) in patients with no prior oxaliplatin therapy
  • Prior treatment with oxaliplatin chemotherapy within 6 months prior to randomization
  • Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents; patients who have received prior treatment with anti-CTLA-4 may be enrolled provided the following requirements are met: * Minimum of 12 weeks from the first dose of anti-CTLA-4 and > 6 weeks from the last dose to randomization * No history of severe immune-related adverse effects (CTCAE Grade 3 and 4) from anti-CTLA-4
  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (other than alopecia) due to agents administered more than 4 weeks earlier are excluded; however, the following therapies are allowed: * Hormone-replacement therapy or oral contraception * Herbal therapy > 7 days prior to randomization (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to randomization) * Palliative radiotherapy for bone metastases > 14 days prior to randomization
  • Treatment with systemic immunostimulatory medications (including, but not limited to interferon [IFN]-alpha or interleukin [IL]-2 within 42 days prior to randomization
  • Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 14 days prior to randomization; however, * Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea; or chronic daily treatment with corticosteroids with a dose of =< 10 mg/day methylprednisolone equivalent) may be enrolled * The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
  • Patients taking bisphosphonate therapy for symptomatic hypercalcemia; use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed
  • Patients requiring treatment with a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor (e.g., denosumab) who cannot discontinue it before treatment with atezolizumab
  • Treatment with any other investigational agent within 4 weeks prior to randomization
  • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease; however, * Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible * Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
  • History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis; however, * Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible * Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible * Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: ** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations ** Rash must cover less than 10% of body surface area (BSA) ** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%) ** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
  • 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
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Patients with known active tuberculosis (TB) are excluded
  • Severe infections within 28 days prior to randomization, including but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Signs or symptoms of infection within 14 days prior to randomization
  • Received oral or intravenous (IV) antibiotics within 14 days prior to randomization; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study
  • Administration of a live, attenuated vaccine within 28 days prior to randomization or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab; Note: influenza vaccination should be given during influenza season only (approximately October to March); patients must not receive live, attenuated influenza vaccine within 28 days prior to randomization or at any time during the study
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study because atezolizumab is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding should be discontinued if the mother is treated with atezolizumab; these potential risks may also apply to other agents used in this study; (Note: pregnancy testing should be performed within 14 days prior to randomization according to institutional standards for women of childbearing potential)
  • Patients positive for human immunodeficiency virus (HIV) are NOT excluded from this study, but HIV-positive patients must have: * A stable regimen of highly active anti-retroviral therapy (HAART); and * No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections; and * A CD4 count above 250 cells/uL and an undetectable HIV viral load on standard PCR-based tests
  • Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation

Locations & Contacts

Arkansas

Jonesboro
Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Status: Active
Contact: Site Public Contact
Phone: 870-936-7067
Email: Dawn.Smith@BMHCC.org

California

Anaheim
Kaiser Permanente-Anaheim
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Baldwin Park
Kaiser Permanente-Baldwin Park
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Bellflower
Kaiser Permanente-Bellflower
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Berkeley
Alta Bates Summit Medical Center-Herrick Campus
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Fontana
Kaiser Permanente-Fontana
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Harbor City
Kaiser Permanente - Harbor City
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Irvine
Kaiser Permanente-Irvine
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Los Angeles
Kaiser Permanente Los Angeles Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Kaiser Permanente-Cadillac
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Marysville
Fremont - Rideout Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 530-749-4400
Orange
Saint Joseph Hospital - Orange
Status: Active
Contact: Site Public Contact
Phone: 714-734-6220
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-827-8839
Email: ucstudy@uci.edu
Panorama City
Kaiser Permanente - Panorama City
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Riverside
Kaiser Permanente-Riverside
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 916-734-3089
San Diego
Kaiser Permanente-San Diego Mission
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Kaiser Permanente-San Diego Zion
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
San Marcos
Kaiser Permanente-San Marcos
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Woodland Hills
Kaiser Permanente-Woodland Hills
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org

Colorado

Aurora
Rocky Mountain Cancer Centers-Aurora
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
University of Colorado Hospital
Status: Active
Contact: Site Public Contact
Phone: 720-848-0650
Boulder
Boulder Community Hospital
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: jbloomfield@co-cancerresearch.org
Rocky Mountain Cancer Centers-Boulder
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Colorado Springs
Memorial Hospital North
Status: Active
Contact: Site Public Contact
Phone: 719-364-6700
Penrose-Saint Francis Healthcare
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
UCHealth Memorial Hospital Central
Status: Active
Contact: Site Public Contact
Phone: 719-365-2406
Denver
Denver Health Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
National Jewish Health-Main Campus
Status: Active
Contact: Site Public Contact
Phone: 877-225-5654
Email: glicht@co-cancerresearch.org
Rocky Mountain Cancer Centers-Midtown
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Rocky Mountain Cancer Centers-Rose
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
SCL Health Saint Joseph Hospital
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Englewood
Mountain Blue Cancer Care Center - Swedish
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: WSCR@westernstatesncorp.org
Swedish Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Fort Collins
Poudre Valley Hospital
Status: Active
Contact: Site Public Contact
Phone: 970-297-6150
Golden
National Jewish Health-Western Hematology Oncology
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 303-777-2663
Email: glicht@co-cancerresearch.org
Greeley
North Colorado Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Littleton
Rocky Mountain Cancer Centers-Littleton
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Loveland
McKee Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Thornton
National Jewish Health-Northern Hematology Oncology
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: glicht@co-cancerresearch.org
Wheat Ridge
SCL Health Lutheran Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org

Connecticut

Danbury
Danbury Hospital
Status: Active
Contact: Site Public Contact
Phone: 203-739-8074
Hartford
Hartford Hospital
Status: Active
Contact: Site Public Contact
Phone: 860-545-5363
Meriden
Midstate Medical Center
Status: Active
Contact: Site Public Contact
Phone: 866-662-5678
New Britain
The Hospital of Central Connecticut
Status: Active
Contact: Site Public Contact
Phone: 860-224-5660
Norwich
William Backus Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org

Delaware

Newark
Helen F Graham Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Medical Oncology Hematology Consultants PA
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org

District of Columbia

Washington
Kaiser Permanente-Capitol Hill Medical Center
Status: Active
Contact: Site Public Contact
Phone: 301-548-5743

Florida

Fort Lauderdale
Broward Health Medical Center
Status: Active
Contact: Site Public Contact
Phone: 954-355-5346
Fort Myers
Regional Cancer Center-Lee Memorial Health System
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Gainesville
University of Florida Health Science Center - Gainesville
Status: Active
Contact: Site Public Contact
Phone: 352-273-8010
Email: cancer-center@ufl.edu
Jacksonville
Baptist MD Anderson Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 904-202-7468

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Luke's Mountain States Tumor Institute
Status: Active
Contact: Site Public Contact
Phone: 208-381-2774
Email: eslinget@slhs.org
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Coeur D'Alene
Kootenai Medical Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Fruitland
Saint Luke's Mountain States Tumor Institute - Fruitland
Status: Active
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org
Meridian
Saint Luke's Mountain States Tumor Institute - Meridian
Status: Active
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org
Nampa
Saint Alphonsus Medical Center-Nampa
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Luke's Mountain States Tumor Institute - Nampa
Status: Active
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org
Post Falls
Kootenai Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Sandpoint
Kootenai Cancer Clinic
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Twin Falls
Saint Luke's Mountain States Tumor Institute-Twin Falls
Status: Active
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org

Illinois

Bloomington
Illinois CancerCare-Bloomington
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Canton
Illinois CancerCare-Canton
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Carthage
Illinois CancerCare-Carthage
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Centralia
Centralia Oncology Clinic
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Chicago
Rush University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 312-942-5498
Email: clinical_trials@rush.edu
University of Illinois
Status: Active
Contact: Site Public Contact
Phone: 312-355-3046
Danville
Carle on Vermilion
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Dixon
Illinois CancerCare-Dixon
Status: Active
Contact: Site Public Contact
Phone: 815-285-7800
Effingham
Carle Physician Group-Effingham
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Crossroads Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Eureka
Illinois CancerCare-Eureka
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Evanston
NorthShore University HealthSystem-Evanston Hospital
Status: Active
Contact: Site Public Contact
Phone: 847-570-2109
Galesburg
Illinois CancerCare-Galesburg
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Glenview
NorthShore University HealthSystem-Glenbrook Hospital
Status: Active
Contact: Site Public Contact
Phone: 847-570-2109
Highland Park
NorthShore University HealthSystem-Highland Park Hospital
Status: Active
Contact: Site Public Contact
Phone: 847-570-2109
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Macomb
Illinois CancerCare-Macomb
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Maywood
Loyola University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 708-226-4357
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Pekin
Illinois CancerCare-Pekin
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peoria
Illinois CancerCare-Peoria
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peru
Illinois CancerCare-Peru
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Princeton
Illinois CancerCare-Princeton
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Springfield
Southern Illinois University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: Active
Contact: Site Public Contact
Phone: 800-444-7541
Urbana
Carle Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com

Indiana

Indianapolis
Community Cancer Center East
Status: Active
Contact: Site Public Contact
Phone: 317-497-2823
Email: lcheri@ecommunity.com
Community Cancer Center North
Status: Active
Contact: Site Public Contact
Phone: 317-497-2823
Email: lcheri@ecommunity.com
Community Cancer Center South
Status: Active
Contact: Site Public Contact
Phone: 317-497-2823
Email: lcheri@ecommunity.com
Franciscan Health Indianapolis
Status: Active
Contact: Site Public Contact
Phone: 317-528-7060
Kokomo
Community Howard Regional Health
Status: Active
Contact: Site Public Contact
Phone: 765-453-8571
Email: oncology@communityhoward.org
Mooresville
Franciscan Health Mooresville
Status: Active
Contact: Site Public Contact
Phone: 317-834-3603
Terre Haute
Union Hospital
Status: Active
Contact: Site Public Contact
Phone: 812-238-7394

Iowa

Ames
Mary Greeley Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
McFarland Clinic PC - Ames
Status: Active
Contact: Site Public Contact
Phone: 515-239-4734
Email: ksoder@mcfarlandclinic.com
Bettendorf
University of Iowa Healthcare Cancer Services Quad Cities
Status: Active
Contact: Site Public Contact
Phone: 563-355-7733
Email: kedaprile@rccqc.com
Boone
McFarland Clinic PC-Boone
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Mercy Cancer Center-West Lakes
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Des Moines
Broadlawns Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-282-2200
Medical Oncology and Hematology Associates-Des Moines
Status: Active
Contact: Site Public Contact
Phone: 515-282-2921
Medical Oncology and Hematology Associates-Laurel
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Mercy Medical Center - Des Moines
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
Trinity Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-574-8302
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-237-1225
Jefferson
McFarland Clinic PC-Jefferson
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
Marshalltown
McFarland Clinic PC-Marshalltown
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
West Des Moines
Mercy Medical Center-West Lakes
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org

Kansas

Hays
Hays Medical Center
Status: Active
Contact: Site Public Contact
Phone: 785-623-5774
Lawrence
Lawrence Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Olathe
Olathe Medical Center
Status: Active
Contact: Site Public Contact
Phone: 913-791-3500
Email: Jeni.wakefield@olathehealth.org
Salina
Salina Regional Health Center
Status: Active
Contact: Site Public Contact
Phone: 785-452-7038
Email: kkavoura@srhc.com
Topeka
Saint Francis Hospital and Medical Center - Topeka
Status: Active
Contact: Site Public Contact
Phone: 785-295-8000
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Wichita
Cancer Center of Kansas - Wichita
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Cancer Center of Kansas-Wichita Medical Arts Tower
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org

Kentucky

Bardstown
Flaget Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Lexington
Saint Joseph Hospital East
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
University of Kentucky / Markey Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 859-257-3379
Louisville
Norton Audubon Hospital and Medical Campus
Status: Active
Contact: Site Public Contact
Phone: 502-629-3465
Norton Brownsboro Hospital and Medical Campus
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Norton Hospital Pavilion and Medical Campus
Status: Active
Contact: Site Public Contact
Phone: 502-629-2500

Louisiana

Kenner
Ochsner Medical Center Kenner
Status: Active
Contact: Site Public Contact
Phone: 504-464-8314
Email: cris.molina@ochsner.org
New Orleans
Ochsner Medical Center Jefferson
Status: Active
Contact: Site Public Contact
Phone: 504-703-8712
Email: Gregory.Johnstone@ochsner.org

Maine

Augusta
Harold Alfond Center for Cancer Care
Status: Active
Contact: Site Public Contact
Phone: 207-626-4855
Bangor
Eastern Maine Medical Center
Status: Active
Contact: Site Public Contact
Phone: 207-973-4274
Biddeford
MaineHealth / SMHC Cancer Care and Blood Disorders-Biddeford
Status: Active
Contact: Site Public Contact
Email: LLemire@mmc.org
Brewer
Lafayette Family Cancer Center-EMMC
Status: Active
Contact: Site Public Contact
Phone: 800-987-3005
Sanford
MaineHealth / SMHC Cancer Care and Blood Disorders-Sanford
Status: Active
Contact: Site Public Contact
Email: LLemire@mmc.org
South Portland
Maine Medical Partners - South Portland
Status: Active
Contact: Site Public Contact
Phone: 207-396-8670
Email: ClinicalResearch@mmc.org

Maryland

Baltimore
Kaiser Permanente-Woodlawn Medical Center
Status: Active
Contact: Site Public Contact
Phone: 301-816-7218
Easton
University of Maryland Shore Medical Center at Easton
Status: Active
Contact: Site Public Contact
Phone: 410-822-1000
Email: Christina.weisenborn@umm.edu
Gaithersburg
Kaiser Permanente-Gaithersburg Medical Center
Status: Active
Contact: Site Public Contact
Phone: 301-816-7218
Largo
Kaiser Permanente - Largo Medical Center
Status: Active
Contact: Site Public Contact
Phone: 301-816-7446

Massachusetts

Lowell
Lowell General Hospital
Status: Active
Contact: Site Public Contact
Phone: 978-788-7084
Email: ghincks@lowellgeneral.org

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Bay City
McLaren Cancer Institute-Bay City
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Bloomfield
McLaren Cancer Institute-Bloomfield
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Brighton
IHA Hematology Oncology Consultants-Brighton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Brighton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Brownstown
Henry Ford Cancer Institute-Downriver
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Canton
IHA Hematology Oncology Consultants-Canton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Canton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Chelsea
IHA Hematology Oncology Consultants-Chelsea
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Chelsea
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Clarkston
Hematology Oncology Consultants-Clarkston
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
McLaren Cancer Institute-Clarkston
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Newland Medical Associates-Clarkston
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Dearborn
Henry Ford Medical Center-Fairlane
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Detroit
Henry Ford Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Wayne State University / Karmanos Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Farmington Hills
Weisberg Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Flint
McLaren Cancer Institute-Flint
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Singh and Arora Hematology Oncology PC
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Grand Rapids
Spectrum Health at Butterworth Campus
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Jackson
Allegiance Health
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Kalamazoo
West Michigan Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Lansing
McLaren-Greater Lansing
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Sparrow Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Lapeer
McLaren Cancer Institute-Lapeer Region
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Livonia
Hope Cancer Clinic
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Mary Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Mount Clemens
McLaren Cancer Institute-Macomb
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Novi
Henry Ford Medical Center-Columbus
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Petoskey
McLaren Cancer Institute-Northern Michigan
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Pontiac
Newland Medical Associates-Pontiac
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Oakland
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Port Huron
McLaren-Port Huron
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Saginaw
Ascension Saint Mary's Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Oncology Hematology Associates of Saginaw Valley PC
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Tawas City
Ascension Saint Joseph Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Traverse City
Munson Medical Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
West Branch
Saint Mary's Oncology / Hematology Associates of West Branch
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Ypsilanti
IHA Hematology Oncology Consultants-Ann Arbor
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 218-333-5000
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Deer River
Essentia Health - Deer River Clinic
Status: Active
Contact: Site Public Contact
Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org
Duluth
Essentia Health Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org
Hibbing
Essentia Health Hibbing Clinic
Status: Active
Contact: Site Public Contact
Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org
Minneapolis
Health Partners Inc
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint Paul
Regions Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Virginia
Essentia Health Virginia Clinic
Status: Active
Contact: Site Public Contact
Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org

Mississippi

Grenada
Baptist Cancer Center-Grenada
Status: Active
Contact: Site Public Contact
Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org
New Albany
Baptist Memorial Hospital and Cancer Center-Union County
Status: Active
Contact: Site Public Contact
Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org
Oxford
Baptist Memorial Hospital and Cancer Center-Oxford
Status: Active
Contact: Site Public Contact
Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org
Southhaven
Baptist Memorial Hospital and Cancer Center-Desoto
Status: Active
Contact: Site Public Contact
Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org

Missouri

Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: Active
Contact: Site Public Contact
Phone: 314-251-7058
Cape Girardeau
Saint Francis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Joplin
Freeman Health System
Status: Active
Contact: Site Public Contact
Phone: 417-347-4030
Email: LJCrockett@freemanhealth.com
Mercy Hospital Joplin
Status: Active
Contact: Site Public Contact
Phone: 417-556-3074
Email: esmeralda.carrillo@mercy.net
Kansas City
Truman Medical Center
Status: Active
Contact: Site Public Contact
Phone: 816-404-4375
Saint Louis
Mercy Hospital Saint Louis
Status: Active
Contact: Site Public Contact
Phone: 314-251-7066
Saint Louis Cancer and Breast Institute-South City
Status: Active
Contact: Site Public Contact
Phone: 314-353-1870

Montana

Anaconda
Community Hospital of Anaconda
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Billings
Billings Clinic Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Bozeman
Bozeman Deaconess Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Great Falls Clinic
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Helena
Saint Peter's Community Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Kalispell
Kalispell Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Missoula
Community Medical Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Nebraska

Omaha
Nebraska Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 402-354-5144

Nevada

Henderson
OptumCare Cancer Care at Seven Hills
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Las Vegas
OptumCare Cancer Care at Fort Apache
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
OptumCare Cancer Care at MountainView
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
OptumCare Cancer Care at Oakey
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Reno
Renown Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu
Manchester
Norris Cotton Cancer Center-Manchester
Status: Active
Contact: Site Public Contact
Phone: 603-629-1828
Nashua
Norris Cotton Cancer Center-Nashua
Status: Active
Contact: Site Public Contact
Phone: 603-577-4282
Email: Laura.A.Menken@hitchcock.org

New Jersey

Hamilton
The Cancer Institute of New Jersey Hamilton
Status: Active
Contact: Site Public Contact
Phone: 609-631-6946
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Contact: Site Public Contact
Phone: 732-235-8675
Paramus
The Valley Hospital-Luckow Pavilion
Status: Active
Contact: Site Public Contact
Phone: 201-634-5792
Ridgewood
Valley Hospital
Status: Active
Contact: Site Public Contact
Phone: 201-634-5792
Email: cparish@valleyhealth.com
Somerville
Robert Wood Johnson University Hospital Somerset
Status: Active
Contact: Site Public Contact
Phone: 908-685-2481

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 505-925-0366
Email: LByatt@nmcca.org
Las Cruces
Memorial Medical Center - Las Cruces
Status: Active
Contact: Site Public Contact
Phone: 575-556-6545
Email: Kim.Hoffman@lpnt.net

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 800-767-9355
Email: askroswell@roswellpark.org
Elmira
Arnot Ogden Medical Center / Falck Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 607-271-7000
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Contact: Site Public Contact
Phone: 212-263-4434
Email: prmc.coordinator@nyumc.org
White Plains
Dickstein Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 914-849-7582
Email: mcortese@wphospital.org

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu
Hendersonville
Margaret R Pardee Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 828-696-4716
Email: karen.morris@unchealth.unc.edu
Kenansville
Vidant Oncology-Kenansville
Status: Active
Contact: Site Public Contact
Phone: 252-559-2201
Email: Carla.Zimmerman@vidanthealth.com
Kinston
Vidant Oncology-Kinston
Status: Active
Contact: Site Public Contact
Phone: 252-559-2201
Email: Carla.Zimmerman@vidanthealth.com
Pinehurst
FirstHealth of the Carolinas-Moore Regional Hospital
Status: Active
Contact: Site Public Contact
Phone: 910-715-3500
Email: jcwilliams@firsthealth.org
Richlands
Vidant Oncology-Richlands
Status: Active
Contact: Site Public Contact
Phone: 252-559-2201
Email: Carla.Zimmerman@vidanthealth.com
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Fargo
Sanford Broadway Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Sanford Roger Maris Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 701-234-6161
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Grand Forks
Altru Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 701-780-6520

Ohio

Akron
Cleveland Clinic Akron General
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Belpre
Strecker Cancer Center-Belpre
Status: Active
Contact: Site Public Contact
Phone: 800-523-3977
Email: sheree@columbusccop.org
Centerville
Dayton Physicians LLC-Miami Valley South
Status: Active
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Miami Valley Hospital South
Status: Active
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Chillicothe
Adena Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 877-779-7585
Email: sheree@columbusccop.org
Cincinnati
University of Cincinnati / Barrett Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 513-558-4553
Email: uchealthnews@uc.edu
Cleveland
Cleveland Clinic Cancer Center / Fairview Hospital
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Columbus
Columbus Oncology and Hematology Associates Inc
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Doctors Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-566-3275
Email: sheree@columbusccop.org
Grant Medical Center
Status: Active
Contact: Site Public Contact
Phone: 614-566-4475
Email: sheree@columbusccop.org
Mount Carmel East Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Mount Carmel Health Center West
Status: Active
Contact: Site Public Contact
Phone: 614-234-5433
Email: sheree@columbusccop.org
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu
Riverside Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-566-4475
Email: sheree@columbusccop.org
The Mark H Zangmeister Center
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Dayton
Miami Valley Hospital
Status: Active
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Delaware
Delaware Health Center-Grady Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 740-615-0227
Email: sheree@columbusccop.org
Grady Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 740-615-2403
Email: sheree@columbusccop.org
Kettering
Greater Dayton Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Lancaster
Fairfield Medical Center
Status: Active
Contact: Site Public Contact
Phone: 740-687-8863
Email: sheree@columbusccop.org
Mansfield
Cleveland Clinic Cancer Center Mansfield
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
OhioHealth Mansfield Hospital
Status: Active
Contact: Site Public Contact
Phone: 419-526-8018
Email: sheree@columbusccop.org
Marietta
Marietta Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-523-3977
Email: sheree@columbusccop.org
Marion
OhioHealth Marion General Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Mayfield Heights
Hillcrest Hospital Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Mount Vernon
Knox Community Hospital
Status: Active
Contact: Site Public Contact
Phone: 740-393-9000
Email: sheree@columbusccop.org
Newark
Licking Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 740-348-4000
Email: sheree@columbusccop.org
Portsmouth
Southern Ohio Medical Center
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Sandusky
North Coast Cancer Care
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Sylvania
ProMedica Flower Hospital
Status: Active
Contact: Site Public Contact
Phone: 419-824-1842
Warrensville Heights
South Pointe Hospital
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
West Chester
University Pointe
Status: Active
Contact: Site Public Contact
Email: clinicaltrials@ucphysicians.com
Westerville
Saint Ann's Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-234-5433
Email: sheree@columbusccop.org
Zanesville
Genesis Healthcare System Cancer Care Center
Status: Active
Contact: Site Public Contact
Phone: 740-454-5232
Email: sheree@columbusccop.org

Oklahoma

Lawton
Cancer Centers of Southwest Oklahoma Research
Status: Active
Contact: Site Public Contact
Phone: 877-231-4440
Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu
Tulsa
Oklahoma Cancer Specialists and Research Institute-Tulsa
Status: Active
Contact: Site Public Contact
Phone: 918-505-3200

Oregon

Clackamas
Providence Oncology and Hematology Care Southeast
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Newberg
Providence Newberg Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Portland
Providence Portland Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Bethlehem
Lehigh Valley Hospital - Muhlenberg
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Luke's University Hospital-Bethlehem Campus
Status: Active
Contact: Site Public Contact
Phone: 484-503-4151
Erie
Saint Vincent Hospital
Status: Active
Contact: Site Public Contact
Phone: 814-452-5000
Harrisburg
UPMC Pinnacle Cancer Center / Community Osteopathic Campus
Status: Active
Contact: Site Public Contact
Phone: 717-724-6765
Email: klitchfield@PINNACLEHEALTH.org
Jefferson Hills
Jefferson Hospital
Status: Active
Contact: Site Public Contact
Phone: 412-359-3043
Email: ddefazio@wpahs.org
Monroeville
Forbes Hospital
Status: Active
Contact: Site Public Contact
Phone: 412-858-7746
Natrona Heights
Allegheny Valley Hospital
Status: Active
Contact: Site Public Contact
Phone: 724-226-7380
Pittsburgh
Allegheny General Hospital
Status: Active
Contact: Site Public Contact
Phone: 877-284-2000
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Contact: Site Public Contact
Phone: 412-647-8073
West Penn Hospital
Status: Active
Contact: Site Public Contact
Phone: 412-578-5000
West Reading
Reading Hospital
Status: Active
Contact: Site Public Contact
Phone: 610-988-9323
Wexford
Wexford Health and Wellness Pavilion
Status: Active
Contact: Site Public Contact
Phone: 412-359-3043
Email: ddefazio@wpahs.org

South Carolina

Beaufort
Beaufort Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 843-522-7819
Email: kwade@bmhsc.org
Easley
Prisma Health Cancer Institute - Easley
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Greenville
Prisma Health Cancer Institute - Butternut
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Prisma Health Cancer Institute - Eastside
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Prisma Health Cancer Institute - Faris
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Greer
Prisma Health Cancer Institute - Greer
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Seneca
Prisma Health Cancer Institute - Seneca
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Spartanburg
Prisma Health Cancer Institute - Spartanburg
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Spartanburg Medical Center
Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
Email: kmertz-rivera@gibbscc.org

South Dakota

Sioux Falls
Avera Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 888-634-7268
Email: oncregulatory@avera.org
Sanford Cancer Center Oncology Clinic
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicTrialsSF@sanfordhealth.org
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicalTrialsSF@SanfordHealth.org

Tennessee

Bristol
Wellmont Bristol Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 423-578-8538
Email: justin.reynolds@wellmont.org
Collierville
Baptist Memorial Hospital and Cancer Center-Collierville
Status: Active
Contact: Site Public Contact
Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org
Cookeville
Cookeville Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 931-783-2714
Johnson City
Wellmont Medical Associates Oncology and Hematology-Johnson City
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 423-578-8538
Email: justin.reynolds@wellmont.org
Kingsport
Regional Cancer Center at Indian Path Community Hospital
Status: Active
Contact: Site Public Contact
Phone: 423-578-8538
Email: Justin.reynolds@balladhealth.org
Wellmont Holston Valley Hospital and Medical Center
Status: Active
Contact: Site Public Contact
Phone: 423-578-8538
Email: justin.reynolds@wellmont.org
Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
Status: Active
Contact: Site Public Contact
Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org

Texas

Beaumont
Baptist Hospitals of Southeast Texas Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 409-212-5956
Dallas
Parkland Memorial Hospital
Status: Approved
Contact: Site Public Contact
Phone: 214-590-5582
Email: canceranswerline@UTSouthwestern.edu
UT Southwestern / Simmons Cancer Center-Dallas
Status: Approved
Contact: Site Public Contact
Phone: 214-648-7097
Email: canceranswerline@UTSouthwestern.edu
Houston
M D Anderson Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-632-6789
Email: askmdanderson@mdanderson.org
The Methodist Hospital System
Status: Active
Contact: Site Public Contact
Phone: 713-790-2700
Port Arthur
Baptist Regional Cancer Network-Cancer Center of Southeast Texas
Status: Active
Contact: Site Public Contact
Phone: 409-729-8088

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu

Vermont

Saint Johnsbury
Norris Cotton Cancer Center-North
Status: Active
Contact: Site Public Contact
Phone: 802-473-4100

Virginia

Bristol
Wellmont Medical Associates-Bristol
Status: Active
Contact: Site Public Contact
Phone: 423-578-8538
Email: justin.reynolds@wellmont.org
Burke
Kaiser Permanente-Burke Medical Center
Status: Active
Contact: Site Public Contact
Email: Diane.Fisher@nsmtp.kp.org
Fishersville
Augusta Health Center for Cancer and Blood Disorders
Status: Active
Contact: Site Public Contact
Phone: 540-332-5960
Lynchburg
Centra Lynchburg Hematology-Oncology Clinic Inc
Status: Active
Contact: Site Public Contact
Phone: 434-200-5925
Email: Kevin.Patel@centrahealth.com
Norton
Southwest VA Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 423-578-8538
Email: justin.reynolds@wellmont.org
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 804-628-1914
Email: klcampbell@vcu.edu
South Hill
VCU Community Memorial Health Center
Status: Active
Contact: Site Public Contact
Phone: 434-774-2442
Email: sherman.baker@vcuhealth.org

Washington

Issaquah
Swedish Cancer Institute-Issaquah
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Seattle
Swedish Medical Center-First Hill
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org

West Virginia

Charleston
West Virginia University Charleston Division
Status: Active
Contact: Site Public Contact
Phone: 304-388-9944
Morgantown
West Virginia University Healthcare
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 304-293-7374
Email: cancertrialsinfo@hsc.wvu.edu
Parkersburg
Camden Clark Medical Center
Status: Active
Contact: Site Public Contact
Phone: 304-293-7374
Email: cancertrialsinfo@hsc.wvu.edu

Wisconsin

Antigo
Langlade Hospital and Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 715-623-9869
Email: Juli.Alford@aspirus.org
Appleton
Ascension Saint Elizabeth Hospital
Status: Active
Contact: Site Public Contact
Phone: 920-831-8900
Email: Dale.grimmer@ascension.org
Ashland
Duluth Clinic Ashland
Status: Active
Contact: Site Public Contact
Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org
Brookfield
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Status: Active
Contact: Site Public Contact
Phone: 414-635-6420
Email: AWRI.Inquiry@Ascension.org
Franklin
Ascension Saint Francis - Reiman Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 414-635-6420
Email: AWRI.Inquiry@Ascension.org
Green Bay
Bellin Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 920-435-8326
Janesville
Mercy Health System
Status: Active
Contact: Site Public Contact
Phone: 800-928-1103
Johnson Creek
UW Cancer Center Johnson Creek
Status: Active
Contact: Site Public Contact
Phone: 920-699-3500
Email: lynda.persico@uwmf.wisc.edu
La Crosse
Gundersen Lutheran Medical Center
Status: Active
Contact: Site Public Contact
Phone: 608-775-2385
Email: cancerctr@gundersenhealth.org
Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Site Public Contact
Phone: 800-622-8922
Mukwonago
ProHealth D N Greenwald Center
Status: Active
Contact: Site Public Contact
Email: research.institute@phci.org
Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 262-928-7878
Oshkosh
Ascension Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 920-831-8900
Email: Dale.grimmer@ascension.org
Racine
Ascension All Saints Hospital
Status: Active
Contact: Site Public Contact
Phone: 414-635-6420
Email: AWRI.Inquiry@Ascension.org
Waukesha
ProHealth Waukesha Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 262-928-7632
UW Cancer Center at ProHealth Care
Status: Active
Contact: Site Public Contact
Phone: 262-928-5539
Email: Chanda.miller@phci.org
Wausau
Aspirus Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-405-6866
Wauwatosa
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Status: Active
Contact: Site Public Contact
Phone: 414-635-6420
Email: AWRI.Inquiry@Ascension.org
Wisconsin Rapids
Aspirus UW Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 715-422-7718

Wyoming

Cheyenne
Cheyenne Regional Medical Center-West
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Cody
Billings Clinic-Cody
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the efficacy, based on progression-free survival (PFS), of fluorouracil, oxaliplatin, and leucovorin calcium (mFOLFOX6)/bevacizumab plus atezolizumab (combination) and atezolizumab (single agent) as compared to mFOLFOX6/bevacizumab (control).

SECONDARY OBJECTIVES:

I. To compare the overall survival.

II. To compare the objective response rates (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

III. To determine the safety profiles of the combination of mFOLFOX6/bevacizumab/atezolizumab and atezolizumab monotherapy in patients with mismatch-repair deficient (dMMR) metastatic colorectal cancer (mCRC).

IV. To compare the surgical conversion rate.

V. To determine the duration of response and stable disease.

VI. To determine the progression-free survival (PFS) by retrospective central independent scan review.

EXPLORATORY OBJECTIVES:

I. To compare the health-related quality of life and patient-reported symptoms.

TRANSLATIONAL OBJECTIVES:

I. To bank tissue and blood samples for other future correlative studies from patients enrolled on the study.

II. To compare disease control rate (complete response [CR] + partial response [PR] + stable disease [SD]) at 12 months.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1, oxaliplatin IV over 2 hours on day 1 of cycles 1-10, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1 and 2. Treatment with oxaliplatin repeats every 2 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity. Cycles of bevacizumab, leucovorin calcium, and fluorouracil repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 2 weeks for up to 48 cycles in the absence of disease progression or unacceptable toxicity.

ARM III: Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 2 weeks for up to 48 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive bevacizumab IV over 30-90 minutes on day 1, oxaliplatin IV over 2 hours on day 1 cycles 1-10, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on day 1. Treatment with oxaliplatin repeats every 2 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity. Cycles of bevacizumab, leucovorin calcium, and fluorouracil repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 8 weeks for 18 months, and then every 12 weeks for up to 5 years.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
NRG Oncology

Principal Investigator
James Jinhak Lee

Trial IDs

Primary ID NRG-GI004
Secondary IDs NCI-2016-01961, NRG-GI004/S1610
Clinicaltrials.gov ID NCT02997228