mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma, Advanced Gastroesophageal Junction Adenocarcinoma
About this trial
This is an interventional treatment trial for Advanced Esophageal Adenocarcinoma
Eligibility Criteria
Inclusion Criteria: Histologic documentation: HER2 negative adenocarcinoma as defined by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (Bartley et al., Journal of Clinical Oncology [JCO] 2017) with known PD-L1 CPS (Any CPS is allowed, but should be known prior to registration) Stage: unresectable or metastatic Tumor site: esophagus, gastroesophageal junction, or stomach Measurable disease or non-measurable but evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 No prior treatment for unresectable or metastatic disease Prior neoadjuvant or adjuvant cytotoxic chemotherapy or adjuvant immunotherapy is allowed as long as it was completed at least 1 year prior to registration Age >= 18 years Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 Absolute neutrophil count (ANC) >= 1,500/mm^3 Platelet count >= 100,000/mm^3 Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance >= 30 mL/min Total bilirubin =< 1.5 x ULN Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (in patients with liver metastasis: =< 5 x ULN if clearly attributable to liver metastases) Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial Patients positive for human immunodeficiency virus (HIV) are eligible only if they meet all of the following: On effective anti-retroviral therapy Undetectable HIV viral load by standard clinical assay =< 6 months of registration Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better Patients who will receive nivolumab in addition to chemotherapy must not have any contraindications to immune checkpoint inhibitors Patients must not have active autoimmune disease that has required systemic treatment within 6 months prior to registration. Patients are permitted to receive immunotherapy if they have vitiligo, type I diabetes, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event) Patients must not have a condition requiring systemic treatment with either corticosteroids (>10mg/day prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids and adrenal replacement doses (=< 10mg/day prednisone equivalent) are permitted Patients must not have a history of noninfectious pneumonitis requiring steroids Patients with prior immune mediated adverse events related to immunotherapy that resulted in permanent treatment discontinuation with these agents are ineligible This study includes the use of the mandatory patient completed measure, PRO-CTCAE. For this study the PRO-CTCAE is available in English, Spanish, Korean, Chinese (Simplified), and Russian, hence patients must be able to speak, understand and read in these languages. Ad-hoc translation of patient-reported measures is not permitted Exclusion Criteria: Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects * Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =< 7 days prior to registration is required No known Gilbert's syndrome or known homozygosity for UGAT1A1*28 polymorphism No baseline grade >= 2 peripheral neuropathy, neurosensory toxicity, or neuromotor toxicity per CTCAE version (v) 5.0 regardless of causality No medical condition such as uncontrolled infection or uncontrolled diabetes mellitus which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient No untreated, symptomatic brain metastasis. Patients with treated brain metastases are eligible if the following criteria are met: 1) follow-up brain imaging done at least in 4 weeks after central nervous system (CNS)-directed therapy shows no evidence of progression and 2) the patient no longer requires steroids, or is on a stable steroid dose for more than four weeks No allogeneic tissue/organ transplant
Sites / Locations
- University of Alabama at Birmingham Cancer CenterRecruiting
- Anchorage Associates in Radiation MedicineRecruiting
- Anchorage Radiation Therapy CenterRecruiting
- Alaska Breast Care and Surgery LLCRecruiting
- Alaska Oncology and Hematology LLCRecruiting
- Alaska Women's Cancer CareRecruiting
- Anchorage Oncology CentreRecruiting
- Katmai Oncology GroupRecruiting
- Providence Alaska Medical CenterRecruiting
- Fairbanks Memorial HospitalRecruiting
- Kingman Regional Medical CenterRecruiting
- Cancer Center at Saint Joseph'sRecruiting
- Mercy Hospital Fort SmithRecruiting
- Kaiser Permanente-Deer Valley Medical CenterRecruiting
- Mission Hope Medical Oncology - Arroyo GrandeRecruiting
- PCR OncologyRecruiting
- Providence Saint Joseph Medical Center/Disney Family Cancer CenterRecruiting
- Mercy Cancer Center �� CarmichaelRecruiting
- Mercy San Juan Medical CenterRecruiting
- Kaiser Permanente DublinRecruiting
- Mercy Cancer Center - Elk GroveRecruiting
- Kaiser Permanente-FremontRecruiting
- Fresno Cancer CenterRecruiting
- Kaiser Permanente-FresnoRecruiting
- Kaiser Permanente-ModestoRecruiting
- Providence Queen of The ValleyRecruiting
- Kaiser Permanente Oakland-BroadwayRecruiting
- Kaiser Permanente-OaklandRecruiting
- Kaiser Permanente-Rancho Cordova Cancer CenterRecruiting
- Kaiser Permanente- Marshall Medical OfficesRecruiting
- Kaiser Permanente-RichmondRecruiting
- Mercy Cancer Center - RocklinRecruiting
- Rohnert Park Cancer CenterRecruiting
- Kaiser Permanente-RosevilleRecruiting
- The Permanente Medical Group-Roseville Radiation OncologyRecruiting
- Kaiser Permanente Downtown CommonsRecruiting
- Mercy Cancer Center - SacramentoRecruiting
- Kaiser Permanente-South SacramentoRecruiting
- South Sacramento Cancer CenterRecruiting
- Kaiser Permanente-San FranciscoRecruiting
- Kaiser Permanente-Santa Teresa-San JoseRecruiting
- Kaiser Permanente San LeandroRecruiting
- Pacific Central Coast Health Center-San Luis ObispoRecruiting
- Kaiser San Rafael-GallinasRecruiting
- Kaiser Permanente Medical Center - Santa ClaraRecruiting
- Mission Hope Medical Oncology - Santa MariaRecruiting
- Kaiser Permanente-Santa RosaRecruiting
- Providence Medical Foundation - Santa RosaRecruiting
- Providence Santa Rosa Memorial HospitalRecruiting
- Kaiser Permanente Cancer Treatment CenterRecruiting
- Kaiser Permanente-South San FranciscoRecruiting
- Kaiser Permanente-StocktonRecruiting
- Kaiser Permanente Medical Center-VacavilleRecruiting
- Kaiser Permanente-VallejoRecruiting
- Kaiser Permanente-Walnut CreekRecruiting
- Woodland Memorial HospitalRecruiting
- Rocky Mountain Cancer Centers-AuroraRecruiting
- Boulder Community Foothills HospitalRecruiting
- Rocky Mountain Cancer Centers-BoulderRecruiting
- Rocky Mountain Cancer Centers - CentennialRecruiting
- Penrose-Saint Francis HealthcareRecruiting
- Rocky Mountain Cancer Centers-PenroseRecruiting
- UCHealth Memorial Hospital CentralRecruiting
- Memorial Hospital NorthRecruiting
- Saint Francis Cancer CenterRecruiting
- National Jewish Health-Main CampusRecruiting
- The Women's Imaging CenterRecruiting
- Porter Adventist HospitalRecruiting
- Colorado Blood Cancer InstituteRecruiting
- Presbyterian - Saint Lukes Medical Center - Health OneRecruiting
- Rocky Mountain Cancer Centers-MidtownRecruiting
- SCL Health Saint Joseph HospitalRecruiting
- Rocky Mountain Cancer Centers-RoseRecruiting
- Rose Medical Center
- Mercy Medical CenterRecruiting
- Southwest Oncology PCRecruiting
- Mountain Blue Cancer Care Center - SwedishRecruiting
- Rocky Mountain Cancer Centers - SwedishRecruiting
- Swedish Medical CenterRecruiting
- The Melanoma and Skin Cancer InstituteRecruiting
- Poudre Valley HospitalRecruiting
- Cancer Care and Hematology-Fort CollinsRecruiting
- National Jewish Health-Western Hematology OncologyRecruiting
- SCL Health Cancer Centers of Colorado - Lutheran Medical CenterRecruiting
- UCHealth Greeley HospitalRecruiting
- Rocky Mountain Cancer Centers-LakewoodRecruiting
- Saint Anthony HospitalRecruiting
- Rocky Mountain Cancer Centers-LittletonRecruiting
- Littleton Adventist HospitalRecruiting
- Rocky Mountain Cancer Centers-Sky RidgeRecruiting
- Longmont United HospitalRecruiting
- Medical Center of the RockiesRecruiting
- Parker Adventist HospitalRecruiting
- Saint Mary Corwin Medical CenterRecruiting
- National Jewish Health-Northern Hematology OncologyRecruiting
- Rocky Mountain Cancer Centers-ThorntonRecruiting
- SCL Health Lutheran Medical CenterRecruiting
- Beebe South Coastal Health CampusRecruiting
- Beebe Medical CenterRecruiting
- Delaware Clinical and Laboratory Physicians PARecruiting
- Helen F Graham Cancer CenterRecruiting
- Medical Oncology Hematology Consultants PARecruiting
- Christiana Care Health System-Christiana HospitalRecruiting
- Beebe Health CampusRecruiting
- Christiana Care Health System-Wilmington HospitalRecruiting
- Regional Cancer Center-Lee Memorial Health SystemRecruiting
- University of Florida Health Science Center - GainesvilleRecruiting
- Kaiser Permanente Moanalua Medical CenterRecruiting
- Saint Luke's Cancer Institute - BoiseRecruiting
- Saint Luke's Cancer Institute - FruitlandRecruiting
- Saint Luke's Cancer Institute - MeridianRecruiting
- Saint Luke's Cancer Institute - NampaRecruiting
- Saint Luke's Cancer Institute - Twin FallsRecruiting
- Saint Anthony's HealthRecruiting
- Rush - Copley Medical CenterRecruiting
- Advocate Good Shepherd HospitalRecruiting
- Illinois CancerCare-BloomingtonRecruiting
- Illinois CancerCare-CantonRecruiting
- Memorial Hospital of CarbondaleRecruiting
- SIH Cancer InstituteRecruiting
- Illinois CancerCare-CarthageRecruiting
- Centralia Oncology ClinicRecruiting
- Saint Mary's HospitalRecruiting
- John H Stroger Jr Hospital of Cook CountyRecruiting
- University of Chicago Comprehensive Cancer CenterRecruiting
- Advocate Illinois Masonic Medical CenterRecruiting
- AMG Crystal Lake - OncologyRecruiting
- Carle at The RiverfrontRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Illinois CancerCare-DixonRecruiting
- Advocate Good Samaritan HospitalRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Advocate Sherman HospitalRecruiting
- Illinois CancerCare-EurekaRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Western Illinois Cancer Treatment CenterRecruiting
- Ingalls Memorial HospitalRecruiting
- Advocate South Suburban HospitalRecruiting
- Illinois CancerCare-Kewanee ClinicRecruiting
- AMG Libertyville - OncologyRecruiting
- Condell Memorial HospitalRecruiting
- Illinois CancerCare-MacombRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Trinity Medical CenterRecruiting
- Good Samaritan Regional Health CenterRecruiting
- UC Comprehensive Cancer Center at Silver CrossRecruiting
- Carle Cancer Institute NormalRecruiting
- Cancer Care Center of O'FallonRecruiting
- Advocate Christ Medical CenterRecruiting
- University of Chicago Medicine-Orland ParkRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Advocate Lutheran General HospitalRecruiting
- Illinois CancerCare-PekinRecruiting
- Illinois CancerCare-PeoriaRecruiting
- Methodist Medical Center of IllinoisRecruiting
- Illinois CancerCare-PeruRecruiting
- Valley Radiation OncologyRecruiting
- Illinois CancerCare-PrincetonRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Carle Cancer CenterRecruiting
- Illinois CancerCare - WashingtonRecruiting
- Rush-Copley Healthcare CenterRecruiting
- Northwest Cancer Center - Main CampusRecruiting
- Northwest Oncology LLCRecruiting
- Northwest Cancer Center - HobartRecruiting
- Saint Mary Medical CenterRecruiting
- Saint Catherine HospitalRecruiting
- The Community HospitalRecruiting
- Women's Diagnostic Center - MunsterRecruiting
- Reid HealthRecruiting
- Northwest Cancer Center - ValparaisoRecruiting
- Mary Greeley Medical CenterRecruiting
- McFarland Clinic - AmesRecruiting
- McFarland Clinic - BooneRecruiting
- Mercy HospitalRecruiting
- Oncology Associates at Mercy Medical CenterRecruiting
- Jennie Edmundson Memorial HospitalRecruiting
- Alegent Health Mercy HospitalRecruiting
- Heartland Oncology and Hematology LLPRecruiting
- Iowa Methodist Medical CenterRecruiting
- Medical Oncology and Hematology Associates-Des MoinesRecruiting
- McFarland Clinic - Trinity Cancer CenterRecruiting
- McFarland Clinic - JeffersonRecruiting
- McFarland Clinic - MarshalltownRecruiting
- Central Care Cancer Center - Garden CityRecruiting
- Central Care Cancer Center - Great BendRecruiting
- HaysMed University of Kansas Health SystemRecruiting
- Lawrence Memorial HospitalRecruiting
- Olathe Health Cancer CenterRecruiting
- Freeman Physician Group of PittsburgRecruiting
- Salina Regional Health CenterRecruiting
- University of Kansas Health System Saint Francis CampusRecruiting
- Flaget Memorial HospitalRecruiting
- Commonwealth Cancer Center-CorbinRecruiting
- Saint Joseph HospitalRecruiting
- Saint Joseph Radiation Oncology Resource CenterRecruiting
- Saint Joseph Hospital EastRecruiting
- University of Kentucky/Markey Cancer CenterRecruiting
- Saint Joseph LondonRecruiting
- Saint Joseph Mount SterlingRecruiting
- Mercy Health - Paducah Medical Oncology and HematologyRecruiting
- Christiana Care - Union HospitalRecruiting
- Boston Medical CenterRecruiting
- Dana-Farber Cancer InstituteRecruiting
- Steward Saint Elizabeth's Medical CenterRecruiting
- Dana-Farber Cancer Institute at FoxboroughRecruiting
- Dana Farber-Merrimack ValleyRecruiting
- Dana-Farber/Brigham and Women's Cancer Center at Milford RegionalRecruiting
- Dana-Farber/Brigham and Women's Cancer Center at South ShoreRecruiting
- Hickman Cancer CenterRecruiting
- Saint Joseph Mercy HospitalRecruiting
- McLaren Cancer Institute-Bay CityRecruiting
- Saint Joseph Mercy BrightonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
- Saint Joseph Mercy CantonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
- Caro Cancer CenterRecruiting
- 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
- Wayne State University/Karmanos Cancer InstituteRecruiting
- Ascension Saint John HospitalRecruiting
- Great Lakes Cancer Management Specialists-Doctors ParkRecruiting
- Weisberg Cancer Treatment CenterRecruiting
- Genesee Cancer and Blood Disease Treatment CenterRecruiting
- Genesee Hematology Oncology PCRecruiting
- Genesys Hurley Cancer InstituteRecruiting
- Hurley Medical CenterRecruiting
- McLaren Cancer Institute-FlintRecruiting
- Academic Hematology Oncology SpecialistsRecruiting
- Great Lakes Cancer Management Specialists-Van Elslander Cancer CenterRecruiting
- Michigan Breast Specialists-Grosse Pointe Woods
- Karmanos Cancer Institute at McLaren Greater LansingRecruiting
- Sparrow HospitalRecruiting
- McLaren Cancer Institute-Lapeer RegionRecruiting
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- Great Lakes Cancer Management Specialists-Macomb Medical CampusRecruiting
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of MarletteRecruiting
- Toledo Clinic Cancer Centers-MonroeRecruiting
- McLaren Cancer Institute-MacombRecruiting
- McLaren Cancer Institute-Northern MichiganRecruiting
- 21st Century Oncology-PontiacRecruiting
- Hope Cancer CenterRecruiting
- Newland Medical Associates-PontiacRecruiting
- Saint Joseph Mercy OaklandRecruiting
- McLaren-Port HuronRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Oncology Hematology Associates of Saginaw Valley PCRecruiting
- Bhadresh Nayak MD PC-Sterling HeightsRecruiting
- Ascension Saint Joseph HospitalRecruiting
- Advanced Breast Care Center PLLCRecruiting
- Great Lakes Cancer Management Specialists-Macomb Professional BuildingRecruiting
- Macomb Hematology Oncology PCRecruiting
- Michigan Breast Specialists-WarrenRecruiting
- Saint John Macomb-Oakland HospitalRecruiting
- Saint Mary's Oncology/Hematology Associates of West BranchRecruiting
- Huron Gastroenterology PCRecruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Riverwood Healthcare CenterRecruiting
- Essentia Health - Baxter ClinicRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Essentia Health Saint Joseph's Medical CenterRecruiting
- Fairview Ridges Hospital
- Minnesota Oncology - BurnsvilleRecruiting
- Cambridge Medical CenterRecruiting
- Mercy HospitalRecruiting
- Essentia Health - Deer River ClinicRecruiting
- Essentia Health Saint Mary's - Detroit Lakes ClinicRecruiting
- Essentia Health Cancer CenterRecruiting
- Essentia Health Saint Mary's Medical CenterRecruiting
- Miller-Dwan HospitalRecruiting
- Fairview Southdale HospitalRecruiting
- Essentia Health - Ely ClinicRecruiting
- Essentia Health - FosstonRecruiting
- Unity HospitalRecruiting
- Essentia Health Hibbing ClinicRecruiting
- Essentia Health - International Falls ClinicRecruiting
- Fairview Clinics and Surgery Center Maple GroveRecruiting
- Minnesota Oncology Hematology PA-MaplewoodRecruiting
- Saint John's Hospital - HealtheastRecruiting
- Abbott-Northwestern HospitalRecruiting
- Hennepin County Medical CenterRecruiting
- Health Partners IncRecruiting
- Monticello Cancer CenterRecruiting
- Essentia Health - Moose Lake ClinicRecruiting
- New Ulm Medical CenterRecruiting
- Essentia Health - Park RapidsRecruiting
- Fairview Northland Medical CenterRecruiting
- North Memorial Medical Health CenterRecruiting
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions HospitalRecruiting
- United HospitalRecruiting
- Essentia Health SandstoneRecruiting
- Saint Francis Regional Medical CenterRecruiting
- Lakeview HospitalRecruiting
- Sanford Thief River Falls Medical CenterRecruiting
- Essentia Health Virginia ClinicRecruiting
- Ridgeview Medical CenterRecruiting
- Rice Memorial HospitalRecruiting
- Minnesota Oncology Hematology PA-WoodburyRecruiting
- Sanford Cancer Center WorthingtonRecruiting
- Fairview Lakes Medical CenterRecruiting
- Saint Louis Cancer and Breast Institute-BallwinRecruiting
- Central Care Cancer Center - BolivarRecruiting
- Cox Cancer Center BransonRecruiting
- Saint Francis Medical CenterRecruiting
- Southeast Cancer CenterRecruiting
- Parkland Health Center - FarmingtonRecruiting
- Capital Region Southwest CampusRecruiting
- Freeman Health SystemRecruiting
- Mercy Hospital JoplinRecruiting
- Truman Medical CentersRecruiting
- Delbert Day Cancer Institute at PCRMCRecruiting
- Mercy Clinic-Rolla-Cancer and HematologyRecruiting
- Heartland Regional Medical CenterRecruiting
- Saint Louis Cancer and Breast Institute-South CityRecruiting
- Mercy Hospital SouthRecruiting
- Missouri Baptist Medical CenterRecruiting
- Mercy Hospital Saint LouisRecruiting
- Sainte Genevieve County Memorial HospitalRecruiting
- Mercy Hospital SpringfieldRecruiting
- CoxHealth South HospitalRecruiting
- Missouri Baptist Sullivan HospitalRecruiting
- Missouri Baptist Outpatient Center-Sunset HillsRecruiting
- Mercy Hospital WashingtonRecruiting
- Saint Patrick Hospital - Community HospitalRecruiting
- Nebraska Medicine-BellevueRecruiting
- CHI Health Good SamaritanRecruiting
- Saint Elizabeth Regional Medical CenterRecruiting
- Nebraska Cancer Specialists/Oncology Hematology West PC - MECCRecruiting
- Nebraska Methodist HospitalRecruiting
- Oncology Associates PCRecruiting
- Nebraska Medicine-Village PointeRecruiting
- Alegent Health Immanuel Medical CenterRecruiting
- Alegent Health Bergan Mercy Medical CenterRecruiting
- Alegent Health Lakeside HospitalRecruiting
- Creighton University Medical CenterRecruiting
- University of Nebraska Medical CenterRecruiting
- Midlands Community HospitalRecruiting
- Carson Tahoe Regional Medical CenterRecruiting
- Cancer and Blood Specialists-HendersonRecruiting
- Comprehensive Cancer Centers of Nevada - HendersonRecruiting
- Comprehensive Cancer Centers of Nevada-Horizon RidgeRecruiting
- Las Vegas Cancer Center-Henderson
- OptumCare Cancer Care at Seven HillsRecruiting
- Comprehensive Cancer Centers of Nevada-Southeast HendersonRecruiting
- GenesisCare USA - HendersonRecruiting
- Las Vegas Urology - Green ValleyRecruiting
- Las Vegas Urology - PebbleRecruiting
- Urology Specialists of Nevada - Green ValleyRecruiting
- Las Vegas Urology - PecosRecruiting
- OptumCare Cancer Care at CharlestonRecruiting
- University Medical Center of Southern NevadaRecruiting
- Hope Cancer Care of NevadaRecruiting
- Radiation Oncology Centers of Nevada CentralRecruiting
- Urology Specialists of Nevada - CentralRecruiting
- GenesisCare USA - Las VegasRecruiting
- Sunrise Hospital and Medical CenterRecruiting
- Las Vegas Prostate Cancer CenterRecruiting
- Las Vegas Urology - SunsetRecruiting
- Urology Specialists of Nevada - SouthwestRecruiting
- Radiation Oncology Centers of Nevada SoutheastRecruiting
- Ann M Wierman MD LTDRecruiting
- Comprehensive Cancer Centers of Nevada - NorthwestRecruiting
- GenesisCare USA - Vegas TenayaRecruiting
- Las Vegas Urology - Cathedral RockRecruiting
- Las Vegas Urology - Smoke RanchRecruiting
- OptumCare Cancer Care at MountainViewRecruiting
- Urology Specialists of Nevada - NorthwestRecruiting
- Alliance for Childhood Diseases/Cure 4 the Kids FoundationRecruiting
- Comprehensive Cancer Centers of Nevada - Town CenterRecruiting
- Comprehensive Cancer Centers of Nevada-SummerlinRecruiting
- Summerlin Hospital Medical CenterRecruiting
- Las Vegas Cancer Center-Medical Center
- Comprehensive Cancer Centers of NevadaRecruiting
- GenesisCare USA - Fort ApacheRecruiting
- OptumCare Cancer Care at Fort ApacheRecruiting
- Comprehensive Cancer Centers of Nevada - Central ValleyRecruiting
- University Cancer CenterRecruiting
- Hope Cancer Care of Nevada-PahrumpRecruiting
- Renown Regional Medical CenterRecruiting
- Saint Mary's Regional Medical CenterRecruiting
- Radiation Oncology AssociatesRecruiting
- The Dana-Farber Cancer Institute at LondonderryRecruiting
- University of New Mexico Cancer CenterRecruiting
- Queens Medical Associates PCRecruiting
- Northwell Health Cancer Institute at HuntingtonRecruiting
- Northwell Health/Center for Advanced MedicineRecruiting
- Northern Westchester HospitalRecruiting
- Lenox Hill HospitalRecruiting
- Manhattan Eye Ear and Throat HospitalRecruiting
- NYP/Weill Cornell Medical CenterRecruiting
- Phelps Memorial Hospital CenterRecruiting
- Wake Forest University at ClemmonsRecruiting
- Southeastern Medical Oncology Center-ClintonRecruiting
- Southeastern Medical Oncology Center-GoldsboroRecruiting
- Southeastern Medical Oncology Center-JacksonvilleRecruiting
- Wake Forest Baptist Health - Wilkes Medical CenterRecruiting
- Wake Forest University Health SciencesRecruiting
- Sanford Bismarck Medical CenterRecruiting
- Essentia Health Cancer Center-South University ClinicRecruiting
- Sanford South University Medical CenterRecruiting
- Southpointe-Sanford Medical Center FargoRecruiting
- Sanford Medical Center FargoRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Essentia Health - Jamestown ClinicRecruiting
- Indu and Raj Soin Medical CenterRecruiting
- Strecker Cancer Center-BelpreRecruiting
- Saint Elizabeth Boardman HospitalRecruiting
- Cleveland Clinic Mercy HospitalRecruiting
- Dayton Physicians LLC-Miami Valley SouthRecruiting
- Miami Valley Hospital SouthRecruiting
- Adena Regional Medical CenterRecruiting
- Good Samaritan Hospital - CincinnatiRecruiting
- Oncology Hematology Care Inc-KenwoodRecruiting
- Bethesda North HospitalRecruiting
- TriHealth Cancer Institute-WestsideRecruiting
- TriHealth Cancer Institute-AndersonRecruiting
- 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
- Dayton Blood and Cancer CenterRecruiting
- Miami Valley HospitalRecruiting
- Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
- Miami Valley Hospital NorthRecruiting
- Delaware Health Center-Grady Cancer CenterRecruiting
- Grady Memorial HospitalRecruiting
- Columbus Oncology and Hematology AssociatesRecruiting
- Dublin Methodist HospitalRecruiting
- Armes Family Cancer CenterRecruiting
- Blanchard Valley HospitalRecruiting
- Orion Cancer CareRecruiting
- Atrium Medical Center-Middletown Regional HospitalRecruiting
- Dayton Physicians LLC-AtriumRecruiting
- Central Ohio Breast and Endocrine SurgeryRecruiting
- Dayton Physicians LLC-WayneRecruiting
- Miami Valley Cancer Care and InfusionRecruiting
- Wayne HospitalRecruiting
- Mount Carmel Grove City HospitalRecruiting
- Zangmeister Center Grove CityRecruiting
- Greater Dayton Cancer CenterRecruiting
- Kettering Medical CenterRecruiting
- Fairfield Medical CenterRecruiting
- Saint Rita's Medical CenterRecruiting
- OhioHealth Mansfield HospitalRecruiting
- Marietta Memorial HospitalRecruiting
- OhioHealth Marion General HospitalRecruiting
- Toledo Clinic Cancer Centers-MaumeeRecruiting
- Knox Community HospitalRecruiting
- Mount Carmel New Albany Surgical HospitalRecruiting
- Licking Memorial HospitalRecruiting
- Newark Radiation OncologyRecruiting
- Mercy Health Perrysburg Cancer CenterRecruiting
- Southern Ohio Medical CenterRecruiting
- Springfield Regional Cancer CenterRecruiting
- Springfield Regional Medical CenterRecruiting
- Saint Vincent Mercy Medical CenterRecruiting
- Mercy Health - Saint Anne HospitalRecruiting
- Toledo Clinic Cancer Centers-ToledoRecruiting
- Dayton Physicians LLC - TroyRecruiting
- Upper Valley Medical CenterRecruiting
- Saint Joseph Warren HospitalRecruiting
- Saint Ann's HospitalRecruiting
- Saint Elizabeth Youngstown HospitalRecruiting
- Genesis Healthcare System Cancer Care CenterRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Mercy Hospital Oklahoma CityRecruiting
- Saint Charles Health SystemRecruiting
- Clackamas Radiation Oncology CenterRecruiting
- Providence Cancer Institute Clackamas ClinicRecruiting
- Bay Area HospitalRecruiting
- Providence Newberg Medical CenterRecruiting
- Providence Willamette Falls Medical CenterRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Saint Charles Health System-RedmondRecruiting
- Lehigh Valley Hospital-Cedar CrestRecruiting
- Lehigh Valley Hospital - MuhlenbergRecruiting
- Christiana Care Health System-Concord Health CenterRecruiting
- Pocono Medical CenterRecruiting
- Lehigh Valley Hospital-HazletonRecruiting
- Medical University of South CarolinaRecruiting
- Avera Cancer Institute-AberdeenRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Avera Cancer InstituteRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- Farmington Health CenterRecruiting
- University of Utah Sugarhouse Health CenterRecruiting
- Huntsman Cancer Institute/University of UtahRecruiting
- Inova Schar Cancer InstituteRecruiting
- Inova Fairfax HospitalRecruiting
- Providence Regional Cancer System-AberdeenRecruiting
- Overlake Medical Center
- PeaceHealth Saint Joseph Medical CenterRecruiting
- Harrison Medical CenterRecruiting
- Providence Regional Cancer System-CentraliaRecruiting
- Swedish Cancer Institute-EdmondsRecruiting
- Providence Regional Cancer PartnershipRecruiting
- Swedish Cancer Institute-IssaquahRecruiting
- Kadlec Clinic Hematology and OncologyRecruiting
- Providence Regional Cancer System-LaceyRecruiting
- PeaceHealth Saint John Medical CenterRecruiting
- Jefferson HealthcareRecruiting
- Valley Medical CenterRecruiting
- Swedish Medical Center-Ballard CampusRecruiting
- Swedish Medical Center-Cherry HillRecruiting
- Swedish Medical Center-First HillRecruiting
- PeaceHealth United General Medical CenterRecruiting
- Providence Regional Cancer System-SheltonRecruiting
- PeaceHealth Southwest Medical CenterRecruiting
- Providence Saint Mary Regional Cancer CenterRecruiting
- North Star Lodge Cancer Center at Yakima Valley Memorial HospitalRecruiting
- Providence Regional Cancer System-YelmRecruiting
- West Virginia University Charleston DivisionRecruiting
- Langlade Hospital and Cancer CenterRecruiting
- Duluth Clinic AshlandRecruiting
- Northwest Wisconsin Cancer CenterRecruiting
- Aurora Cancer Care-Southern Lakes VLCCRecruiting
- Aurora Health Care Germantown Health CenterRecruiting
- Aurora Cancer Care-GraftonRecruiting
- Aurora BayCare Medical CenterRecruiting
- Essentia Health-Hayward ClinicRecruiting
- Aurora Cancer Care-Kenosha SouthRecruiting
- Aurora Bay Area Medical Group-MarinetteRecruiting
- Aspirus Medford HospitalRecruiting
- Aurora Cancer Care-MilwaukeeRecruiting
- Aurora Saint Luke's Medical CenterRecruiting
- Aurora Sinai Medical CenterRecruiting
- ProHealth D N Greenwald CenterRecruiting
- Cancer Center of Western WisconsinRecruiting
- ProHealth Oconomowoc Memorial HospitalRecruiting
- Vince Lombardi Cancer Clinic - OshkoshRecruiting
- Aurora Cancer Care-RacineRecruiting
- Vince Lombardi Cancer Clinic-SheboyganRecruiting
- Essentia Health-Spooner ClinicRecruiting
- Ascension Saint Michael's HospitalRecruiting
- Aurora Medical Center in SummitRecruiting
- Essentia Health Saint Mary's Hospital - SuperiorRecruiting
- Vince Lombardi Cancer Clinic-Two RiversRecruiting
- ProHealth Waukesha Memorial HospitalRecruiting
- UW Cancer Center at ProHealth CareRecruiting
- Aspirus Regional Cancer CenterRecruiting
- Aurora Cancer Care-Milwaukee WestRecruiting
- Aurora West Allis Medical CenterRecruiting
- Aspirus Cancer Care - Wisconsin RapidsRecruiting
- Cheyenne Regional Medical Center-WestRecruiting
- Cancer Center-Metro Medical Center BayamonRecruiting
- Doctors Cancer CenterRecruiting
- San Juan Community Oncology GroupRecruiting
- Centro Comprensivo de Cancer de UPRRecruiting
- PROncologyRecruiting
- San Juan City HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I (mFOLFIRINOX, nivolumab)
Arm II (mFOLFOX, nivolumab)
Patients receive fluorouracil IV, leucovorin calcium IV, oxaliplatin IV, and irinotecan IV on study and nivolumab IV as clinically indicated. Patients undergo MRI and a CT scan throughout the trial. Patients may also undergo blood sample collection on study.
Patients receive fluorouracil IV, leucovorin calcium IV, and oxaliplatin IV on study and nivolumab IV as clinically indicated. Patients undergo MRI and a CT scan throughout the trial. Patients may also undergo blood sample collection on study.