Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study
Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v7
About this trial
This is an interventional treatment trial for Metastatic Colorectal Adenocarcinoma
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; alternatively, MSI-H diagnosed by polymerase chain reaction (PCR)-based assessment of microsatellite alterations (either Bethesda markers or Pentaplex panel) or by next-generation sequencing (NGS) are eligible
- Documentation by positron emission tomography(PET)/computed tomography (CT) scan, CT scan, or magnetic resonance imaging (MRI) that the patient has 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 (24 hour urine collection) or calculated creatinine clearance >= 30 mL/min (obtained within 28 days prior randomization)
A urine sample tested for proteinuria by either the dipstick method, urinalysis (UA), or a urine protein creatinine (UPC) ratio:
- The dipstick method must indicate 0-1+ protein; if dipstick reading is >= 2+, a 24-hour urine must be done and it must demonstrate < 1.0 g of protein per 24 hours
- A urine protein creatinine (UPC) ratio must be < 1.0; if the UPC ratio is >= 1.0 a 24-hour urine must be done and it must demonstrate < 1.0 g of protein per 24 hours
- Urinalysis must indicate < 30 mg/dl. If urinalysis >= 30 mg/dl, a 24-hour urine must be done and it 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, regardless of PT/INR results
- 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 or mFOLFOX6/bevacizumab/atezolizumab 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 and men must agree to use adequate contraception methods that result in a failure rate of < 1% per year during the treatment period (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; a woman is considered to be of childbearing potential if she is not postmenopausal, has not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus); examples of contraceptive methods with a failure rate of < 1% per year include: bilateral tubal ligation; male partner sterilization; intrauterine devices; the reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception; men must refrain from donating sperm during this same period
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:
- No radiographic demonstration 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, symptomatic peripheral ischemia, or other medical condition in the opinion of the treating oncologist that makes the risk of cardiovascular or bleeding complications with bevacizumab use unacceptably high
- 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)
- 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 if polymerase chain reaction (PCR) for HBV RNA is negative per local guidelines
- Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA) per local guidelines
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: pre
Sites / Locations
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- Kaiser Permanente-AnaheimRecruiting
- Kaiser Permanente-Baldwin ParkRecruiting
- Kaiser Permanente-BellflowerRecruiting
- Alta Bates Summit Medical Center-Herrick CampusRecruiting
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- Fremont - Rideout Cancer CenterRecruiting
- Memorial Medical CenterRecruiting
- Kaiser Permanente-OntarioRecruiting
- Saint Joseph Hospital - OrangeRecruiting
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Kaiser Permanente - Panorama CityRecruiting
- Kaiser Permanente-RiversideRecruiting
- University of California Davis Comprehensive Cancer Center
- Salinas Valley MemorialRecruiting
- Kaiser Permanente-San Diego MissionRecruiting
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- John Muir Medical Center-Walnut Creek
- Presbyterian Intercommunity Hospital
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- Rocky Mountain Cancer Centers-AuroraRecruiting
- UCHealth University of Colorado HospitalRecruiting
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-BoulderRecruiting
- Penrose-Saint Francis HealthcareRecruiting
- UCHealth Memorial Hospital CentralRecruiting
- Memorial Hospital NorthRecruiting
- Denver Health Medical Center
- National Jewish Health-Main Campus
- Porter Adventist HospitalRecruiting
- Rocky Mountain Cancer Centers-MidtownRecruiting
- SCL Health Saint Joseph Hospital
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- Mountain Blue Cancer Care Center - Swedish
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- Cancer Care and Hematology-Fort CollinsRecruiting
- National Jewish Health-Western Hematology Oncology
- North Colorado Medical Center
- UCHealth Greeley HospitalRecruiting
- Rocky Mountain Cancer Centers-Littleton
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- Medical Center of the RockiesRecruiting
- McKee Medical Center
- National Jewish Health-Northern Hematology Oncology
- SCL Health Lutheran Medical Center
- Danbury Hospital
- Hartford Hospital
- Midstate Medical Center
- The Hospital of Central Connecticut
- William Backus Hospital
- Beebe South Coastal Health Campus
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Beebe Health Campus
- Kaiser Permanente-Capitol Hill Medical CenterRecruiting
- Broward Health Medical Center
- Regional Cancer Center-Lee Memorial Health System
- University of Florida Health Science Center - Gainesville
- Baptist MD Anderson Cancer CenterRecruiting
- AdventHealth Orlando
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- University Cancer and Blood Center LLCRecruiting
- Augusta Oncology Associates PC-D'AntignacRecruiting
- Augusta Oncology Associates PC-WheelerRecruiting
- Augusta University Medical CenterRecruiting
- CTCA at Southeastern Regional Medical Center
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Luke's Cancer Institute - BoiseRecruiting
- Saint Alphonsus Cancer Care Center-CaldwellRecruiting
- Kootenai Health - Coeur d'AleneRecruiting
- Saint Luke's Cancer Institute - FruitlandRecruiting
- Saint Luke's Cancer Institute - MeridianRecruiting
- Saint Luke's Cancer Institute - NampaRecruiting
- Saint Alphonsus Cancer Care Center-NampaRecruiting
- Kootenai Clinic Cancer Services - Post FallsRecruiting
- Kootenai Cancer ClinicRecruiting
- Saint Luke's Cancer Institute - Twin FallsRecruiting
- Illinois CancerCare-Bloomington
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- Rush University Medical CenterRecruiting
- University of IllinoisRecruiting
- Carle at The RiverfrontRecruiting
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- Illinois CancerCare-Dixon
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- Crossroads Cancer CenterRecruiting
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- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Loyola University Medical CenterRecruiting
- Good Samaritan Regional Health CenterRecruiting
- Cancer Care Center of O'FallonRecruiting
- Illinois CancerCare-Ottawa Clinic
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- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Carle Cancer CenterRecruiting
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- McFarland Clinic - AmesRecruiting
- University of Iowa Healthcare Cancer Services Quad Cities
- McFarland Clinic - Boone
- Mercy HospitalRecruiting
- Oncology Associates at Mercy Medical CenterRecruiting
- Medical Oncology and Hematology Associates-West Des MoinesRecruiting
- Mercy Cancer Center-West LakesRecruiting
- Medical Oncology and Hematology Associates-Des Moines
- Broadlawns Medical Center
- Mercy Medical Center - Des MoinesRecruiting
- Mission Cancer and Blood - LaurelRecruiting
- McFarland Clinic - Trinity Cancer Center
- Trinity Regional Medical Center
- University of Iowa/Holden Comprehensive Cancer Center
- McFarland Clinic - Jefferson
- McFarland Clinic - Marshalltown
- Mercy Medical Center-West LakesRecruiting
- HaysMed University of Kansas Health SystemRecruiting
- Lawrence Memorial HospitalRecruiting
- Olathe Health Cancer CenterRecruiting
- Salina Regional Health CenterRecruiting
- University of Kansas Health System Saint Francis CampusRecruiting
- University of Kansas Hospital-Westwood Cancer CenterRecruiting
- Cancer Center of Kansas-Wichita Medical Arts TowerRecruiting
- Cancer Center of Kansas - WichitaRecruiting
- Flaget Memorial Hospital
- Baptist Health LexingtonRecruiting
- Saint Joseph Hospital EastRecruiting
- University of Kentucky/Markey Cancer CenterRecruiting
- Norton Hospital Pavilion and Medical Campus
- Norton Audubon Hospital and Medical Campus
- Norton Brownsboro Hospital and Medical Campus
- Ochsner Medical Center Kenner
- Ochsner Medical Center Jefferson
- Harold Alfond Center for Cancer CareRecruiting
- Eastern Maine Medical CenterRecruiting
- Waldo County General HospitalRecruiting
- MaineHealth/SMHC Cancer Care and Blood Disorders-BiddefordRecruiting
- Lafayette Family Cancer Center-EMMCRecruiting
- Penobscot Bay Medical CenterRecruiting
- MaineHealth/SMHC Cancer Care and Blood Disorders-SanfordRecruiting
- Maine Medical Partners - South PortlandRecruiting
- Kaiser Permanente-Woodlawn Medical CenterRecruiting
- University of Maryland Shore Medical Center at EastonRecruiting
- Kaiser Permanente-Gaithersburg Medical CenterRecruiting
- Kaiser Permanente - Largo Medical CenterRecruiting
- Kaiser Permanente Lutherville - Timonium Medical CenterRecruiting
- Dana-Farber Cancer Institute
- Lowell General Hospital
- Saint Joseph Mercy HospitalRecruiting
- McLaren Cancer Institute-Bay City
- McLaren Cancer Institute-Bloomfield
- Saint Joseph Mercy BrightonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
- Henry Ford Cancer Institute-DownriverRecruiting
- Saint Joseph Mercy CantonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
- Saint Joseph Mercy ChelseaRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalRecruiting
- Hematology Oncology Consultants-ClarkstonRecruiting
- McLaren Cancer Institute-ClarkstonRecruiting
- Newland Medical Associates-ClarkstonRecruiting
- Henry Ford Macomb Hospital-Clinton TownshipRecruiting
- Henry Ford Medical Center-FairlaneRecruiting
- Wayne State University/Karmanos Cancer InstituteRecruiting
- Henry Ford HospitalRecruiting
- Weisberg Cancer Treatment Center
- McLaren Cancer Institute-Flint
- Singh and Arora Hematology Oncology PCRecruiting
- Spectrum Health at Butterworth CampusRecruiting
- Allegiance HealthRecruiting
- West Michigan Cancer CenterRecruiting
- Karmanos Cancer Institute at McLaren Greater LansingRecruiting
- Sparrow HospitalRecruiting
- McLaren Cancer Institute-Lapeer RegionRecruiting
- Hope Cancer Clinic
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- McLaren Cancer Institute-MacombRecruiting
- McLaren Cancer Institute-Central Michigan
- Henry Ford Medical Center-ColumbusRecruiting
- McLaren Cancer Institute-Northern MichiganRecruiting
- Newland Medical Associates-PontiacRecruiting
- Saint Joseph Mercy OaklandRecruiting
- McLaren-Port HuronRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Oncology Hematology Associates of Saginaw Valley PCRecruiting
- Ascension Saint Joseph HospitalRecruiting
- Munson Medical CenterRecruiting
- Henry Ford West Bloomfield HospitalRecruiting
- Saint Mary's Oncology/Hematology Associates of West BranchRecruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Minnesota Oncology - BurnsvilleRecruiting
- Essentia Health - Deer River ClinicRecruiting
- Essentia Health Cancer CenterRecruiting
- Essentia Health Hibbing ClinicRecruiting
- Minnesota Oncology Hematology PA-MaplewoodRecruiting
- Hennepin County Medical CenterRecruiting
- Health Partners Inc
- Regions HospitalRecruiting
- Essentia Health SandstoneRecruiting
- Essentia Health Virginia ClinicRecruiting
- Baptist Cancer Center-Grenada
- Baptist Memorial Hospital and Cancer Center-Union County
- Baptist Memorial Hospital and Cancer Center-Oxford
- Baptist Memorial Hospital and Cancer Center-DesotoRecruiting
- Saint Louis Cancer and Breast Institute-BallwinRecruiting
- Saint Francis Medical CenterRecruiting
- MU Health - University Hospital/Ellis Fischel Cancer Center
- Freeman Health System
- Mercy Hospital JoplinRecruiting
- Truman Medical CentersRecruiting
- Saint Louis Cancer and Breast Institute-South CityRecruiting
- Mercy Hospital Saint LouisRecruiting
- Community Hospital of AnacondaRecruiting
- Billings Clinic Cancer CenterRecruiting
- Bozeman Deaconess HospitalRecruiting
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Great Falls Clinic
- Saint Peter's Community Hospital
- Kalispell Regional Medical CenterRecruiting
- Community Medical HospitalRecruiting
- Nebraska Methodist HospitalRecruiting
- OptumCare Cancer Care at Seven HillsRecruiting
- OptumCare Cancer Care at CharlestonRecruiting
- OptumCare Cancer Care at MountainViewRecruiting
- OptumCare Cancer Care at Fort ApacheRecruiting
- Renown Regional Medical CenterRecruiting
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
- Norris Cotton Cancer Center-ManchesterRecruiting
- Dartmouth Cancer Center - NashuaRecruiting
- The Cancer Institute of New Jersey Hamilton
- Morristown Medical Center
- Rutgers Cancer Institute of New JerseyRecruiting
- The Valley Hospital-Luckow PavilionRecruiting
- Valley HospitalRecruiting
- Robert Wood Johnson University Hospital Somerset
- Overlook Hospital
- University of New Mexico Cancer CenterRecruiting
- Presbyterian Kaseman HospitalRecruiting
- Memorial Medical Center - Las CrucesRecruiting
- Presbyterian Rust Medical Center/Jorgensen Cancer CenterRecruiting
- Roswell Park Cancer Institute
- Arnot Ogden Medical Center/Falck Cancer Center
- Northwell Health/Center for Advanced Medicine
- Laura and Isaac Perlmutter Cancer Center at NYU LangoneRecruiting
- University of RochesterRecruiting
- Dickstein Cancer Treatment Center
- UNC Lineberger Comprehensive Cancer CenterRecruiting
- Southeastern Medical Oncology Center-ClintonRecruiting
- Southeastern Medical Oncology Center-GoldsboroRecruiting
- Margaret R Pardee Memorial HospitalRecruiting
- Southeastern Medical Oncology Center-JacksonvilleRecruiting
- Vidant Oncology-KenansvilleRecruiting
- Vidant Oncology-KinstonRecruiting
- FirstHealth of the Carolinas-Moore Regional HospitalRecruiting
- Vidant Oncology-Richlands
- Wake Forest University Health SciencesRecruiting
- Sanford Bismarck Medical CenterRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Altru Cancer Center
- Cleveland Clinic Akron General
- Strecker Cancer Center-BelpreRecruiting
- Dayton Physicians LLC-Miami Valley SouthRecruiting
- Miami Valley Hospital South
- Adena Regional Medical CenterRecruiting
- University of Cincinnati Cancer Center-UC Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Ohio State University Comprehensive Cancer CenterRecruiting
- Mount Carmel East HospitalRecruiting
- Columbus Oncology and Hematology Associates IncRecruiting
- Riverside Methodist HospitalRecruiting
- Grant Medical CenterRecruiting
- The Mark H Zangmeister CenterRecruiting
- Mount Carmel Health Center WestRecruiting
- Doctors HospitalRecruiting
- Miami Valley Hospital
- Delaware Health Center-Grady Cancer CenterRecruiting
- Grady Memorial HospitalRecruiting
- Greater Dayton Cancer CenterRecruiting
- Fairfield Medical CenterRecruiting
- OhioHealth Mansfield HospitalRecruiting
- Cleveland Clinic Cancer Center Mansfield
- Marietta Memorial HospitalRecruiting
- OhioHealth Marion General HospitalRecruiting
- Hillcrest Hospital Cancer Center
- Knox Community HospitalRecruiting
- Licking Memorial HospitalRecruiting
- Southern Ohio Medical CenterRecruiting
- North Coast Cancer Care
- ProMedica Flower HospitalRecruiting
- South Pointe Hospital
- University of Cincinnati Cancer Center-West Chester
- Saint Ann's HospitalRecruiting
- Genesis Healthcare System Cancer Care CenterRecruiting
- Cancer Centers of Southwest Oklahoma ResearchRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Cancer Treatment Centers of America
- Oklahoma Cancer Specialists and Research Institute-TulsaRecruiting
- Saint Charles Health SystemRecruiting
- Clackamas Radiation Oncology CenterRecruiting
- Providence Cancer Institute Clackamas Clinic
- Providence Newberg Medical CenterRecruiting
- Saint Alphonsus Medical Center-OntarioRecruiting
- Providence Willamette Falls Medical CenterRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Lehigh Valley Hospital-Cedar CrestRecruiting
- Saint Luke's Cancer Center - Allentown
- Saint Luke's University Hospital-Bethlehem Campus
- Lehigh Valley Hospital - MuhlenbergRecruiting
- Saint Luke's Hospital-Anderson Campus
- Saint Vincent HospitalRecruiting
- UPMC Pinnacle Cancer Center/Community Osteopathic CampusRecruiting
- Jefferson HospitalRecruiting
- Forbes Hospital
- Allegheny Valley Hospital
- Allegheny General Hospital
- West Penn Hospital
- University of Pittsburgh Cancer Institute (UPCI)Recruiting
- Saint Luke's Hospital-Quakertown Campus
- Reading HospitalRecruiting
- Wexford Health and Wellness Pavilion
- Asplundh Cancer Pavilion
- AnMed Health Cancer CenterRecruiting
- Beaufort Memorial Hospital
- Prisma Health Cancer Institute - SpartanburgRecruiting
- Prisma Health Cancer Institute - EasleyRecruiting
- Saint Francis Hospital
- Prisma Health Cancer Institute - ButternutRecruiting
- Prisma Health Cancer Institute - FarisRecruiting
- Saint Francis Cancer Center
- Prisma Health Cancer Institute - EastsideRecruiting
- Prisma Health Cancer Institute - GreerRecruiting
- Prisma Health Cancer Institute - SenecaRecruiting
- Spartanburg Medical Center
- Avera Cancer Institute-Aberdeen
- Sanford Cancer Center Oncology ClinicRecruiting
- Avera Cancer Institute
- Sanford USD Medical Center - Sioux FallsRecruiting
- Bristol Regional Medical CenterRecruiting
- Baptist Memorial Hospital and Cancer Center-Collierville
- Cookeville Regional Medical CenterRecruiting
- Wellmont Medical Associates Oncology and Hematology-Johnson City
- Ballad Health Cancer Care - KingsportRecruiting
- Wellmont Holston Valley Hospital and Medical CenterRecruiting
- Baptist Memorial Hospital and Cancer Center-MemphisRecruiting
- The Don and Sybil Harrington Cancer CenterRecruiting
- Baptist Hospitals of Southeast Texas Cancer Center
- Parkland Memorial HospitalRecruiting
- UT Southwestern/Simmons Cancer Center-DallasRecruiting
- STCC at DHR Health Institute for Research and DevelopmentRecruiting
- Houston Methodist Hospital
- M D Anderson Cancer CenterRecruiting
- Baptist Regional Cancer Network-Cancer Center of Southeast Texas
- Scott and White Memorial Hospital
- Huntsman Cancer Institute/University of UtahRecruiting
- Norris Cotton Cancer Center-NorthRecruiting
- Wellmont Medical Associates-BristolRecruiting
- Kaiser Permanente-Burke Medical CenterRecruiting
- Augusta Health Center for Cancer and Blood DisordersRecruiting
- Centra Lynchburg Hematology-Oncology Clinic IncRecruiting
- Kaiser Permanente Tysons Corner Medical CenterRecruiting
- Southwest VA Regional Cancer CenterRecruiting
- VCU Massey Cancer Center at Stony PointRecruiting
- Virginia Commonwealth University/Massey Cancer CenterRecruiting
- VCU Community Memorial Health CenterRecruiting
- Swedish Cancer Institute-EdmondsRecruiting
- Swedish Cancer Institute-IssaquahRecruiting
- Jefferson HealthcareRecruiting
- Swedish Medical Center-First HillRecruiting
- MultiCare Deaconess Cancer and Blood Specialty Center - DowntownRecruiting
- MultiCare Deaconess Cancer and Blood Specialty Center - NorthRecruiting
- West Virginia University Charleston DivisionRecruiting
- West Virginia University Healthcare
- Camden Clark Medical Center
- Langlade Hospital and Cancer CenterRecruiting
- ThedaCare Regional Cancer CenterRecruiting
- Ascension Saint Elizabeth HospitalRecruiting
- Duluth Clinic AshlandRecruiting
- Ascension Southeast Wisconsin Hospital - Elmbrook CampusRecruiting
- Marshfield Medical Center-EC Cancer CenterRecruiting
- Ascension Saint Francis - Reiman Cancer CenterRecruiting
- Bellin Memorial HospitalRecruiting
- Mercyhealth Hospital and Cancer Center - JanesvilleRecruiting
- UW Cancer Center Johnson CreekRecruiting
- Gundersen Lutheran Medical CenterRecruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Aspirus Medford HospitalRecruiting
- Marshfield Clinic-Minocqua CenterRecruiting
- ProHealth D N Greenwald CenterRecruiting
- Cancer Center of Western WisconsinRecruiting
- ProHealth Oconomowoc Memorial HospitalRecruiting
- Ascension Mercy HospitalRecruiting
- Ascension All Saints HospitalRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- Marshfield Medical Center-River Region at Stevens PointRecruiting
- ProHealth Waukesha Memorial HospitalRecruiting
- UW Cancer Center at ProHealth CareRecruiting
- Aspirus Regional Cancer CenterRecruiting
- Ascension Medical Group Southeast Wisconsin - Mayfair RoadRecruiting
- Marshfield Medical Center - WestonRecruiting
- Aspirus Cancer Care - Wisconsin RapidsRecruiting
- Cheyenne Regional Medical Center-West
- Billings Clinic-Cody
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Arm I (bevacizumab, mFOLFOX6)
Arm II (atezolizumab)
Arm III (atezolizumab, bevacizumab, mFOLFOX6)
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. Treatment of bevacizumab, leucovorin calcium, and fluorouracil repeat every 2 weeks for up to 48 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT with or without PET or MRI throughout the trial. Patients may also undergo collection of optional blood samples throughout the trial. (CLOSED TO ACCRUAL)
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 undergo CT with or without PET or MRI throughout the trial. Patients may also undergo collection of optional blood samples throughout the trial.
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. Treatment of bevacizumab, leucovorin calcium, and fluorouracil repeat every 2 weeks for up to 48 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT with or without PET or MRI throughout the trial. Patients may also undergo collection of optional blood samples throughout the trial.