mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
NCT05677490
This study is recruiting at 584 US sites in 45 states, according to its ClinicalTrials.gov record last updated .
Summary
This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) with or without nivolumab to the effect of modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) with or without nivolumab for the treatment of patients with advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, or gastric adenocarcinoma.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Advanced Esophageal Adenocarcinoma
- Advanced Gastric Adenocarcinoma
- Advanced Gastroesophageal Junction Adenocarcinoma
- Clinical Stage III Esophageal Adenocarcinoma AJCC v8
- Clinical Stage III Gastric Cancer AJCC v8
- Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
- Clinical Stage IV Gastric Cancer AJCC v8
- Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
- Metastatic Esophageal Adenocarcinoma
- Metastatic Gastric Adenocarcinoma
- Metastatic Gastroesophageal Junction Adenocarcinoma
- Unresectable Esophageal Adenocarcinoma
- Unresectable Gastric Adenocarcinoma
- Unresectable Gastroesophageal Junction Adenocarcinoma
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Alliance for Clinical Trials in Oncology
- Last updated on ClinicalTrials.gov
- October 2, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Alaska · 1
- Fairbanks Memorial Hospital · Fairbanks, AK
Arizona · 1
- Kingman Regional Medical Center · Kingman, AZ
Arkansas · 2
- Mercy Hospital Fort Smith · Fort Smith, AR
- CARTI Cancer Center · Little Rock, AR
California · 64
- Kaiser Permanente-Deer Valley Medical Center · Antioch, CA
- PCR Oncology · Arroyo Grande, CA
- Sutter Auburn Faith Hospital · Auburn, CA
- Sutter Cancer Centers Radiation Oncology Services-Auburn · Auburn, CA
- Alta Bates Summit Medical Center-Herrick Campus · Berkeley, CA
- Mills-Peninsula Medical Center · Burlingame, CA
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park · Cameron Park, CA
- Eden Hospital Medical Center · Castro Valley, CA
- UC Irvine Health Cancer Center-Newport · Costa Mesa, CA
- Sutter Davis Hospital · Davis, CA
- Kaiser Permanente Dublin · Dublin, CA
- Kaiser Permanente-Fremont · Fremont, CA
- Palo Alto Medical Foundation-Fremont · Fremont, CA
- Fresno Cancer Center · Fresno, CA
- Kaiser Permanente Fresno Orchard Plaza · Fresno, CA
- Kaiser Permanente-Fresno · Fresno, CA
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, CA
- Keck Medicine of USC Koreatown · Los Angeles, CA
- Los Angeles General Medical Center · Los Angeles, CA
- USC / Norris Comprehensive Cancer Center · Los Angeles, CA
- Kaiser Permanente- Modesto MOB II · Modesto, CA
- Kaiser Permanente-Modesto · Modesto, CA
- Memorial Medical Center · Modesto, CA
- Palo Alto Medical Foundation-Camino Division · Mountain View, CA
- Palo Alto Medical Foundation-Gynecologic Oncology · Mountain View, CA
- USC Norris Oncology/Hematology-Newport Beach · Newport Beach, CA
- Sutter Cancer Research Consortium · Novato, CA
- Kaiser Permanente Oakland-Broadway · Oakland, CA
- Kaiser Permanente-Oakland · Oakland, CA
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, CA
- Palo Alto Medical Foundation Health Care · Palo Alto, CA
- Kaiser Permanente-Rancho Cordova Cancer Center · Rancho Cordova, CA
- Eisenhower Medical Center · Rancho Mirage, CA
- Kaiser Permanente- Marshall Medical Offices · Redwood City, CA
- Kaiser Permanente-Richmond · Richmond, CA
- Rohnert Park Cancer Center · Rohnert Park, CA
- Kaiser Permanente-Roseville · Roseville, CA
- Sutter Cancer Centers Radiation Oncology Services-Roseville · Roseville, CA
- Sutter Roseville Medical Center · Roseville, CA
- The Permanente Medical Group-Roseville Radiation Oncology · Roseville, CA
- Kaiser Permanente Downtown Commons · Sacramento, CA
- Kaiser Permanente-South Sacramento · Sacramento, CA
- South Sacramento Cancer Center · Sacramento, CA
- Sutter Medical Center Sacramento · Sacramento, CA
- California Pacific Medical Center-Pacific Campus · San Francisco, CA
- Kaiser Permanente-San Francisco · San Francisco, CA
- Kaiser Permanente-Santa Teresa-San Jose · San Jose, CA
- Kaiser Permanente San Leandro · San Leandro, CA
- Mills Health Center · San Mateo, CA
- Kaiser San Rafael-Gallinas · San Rafael, CA
- Ridley-Tree Cancer Center · Santa Barbara, CA
- Kaiser Permanente Medical Center - Santa Clara · Santa Clara, CA
- Palo Alto Medical Foundation-Santa Cruz · Santa Cruz, CA
- Santa Cruz Radiation Oncology Medical Group · Santa Cruz, CA
- Kaiser Permanente-Santa Rosa · Santa Rosa, CA
- Sutter Pacific Medical Foundation · Santa Rosa, CA
- Kaiser Permanente Cancer Treatment Center · South San Francisco, CA
- Kaiser Permanente-South San Francisco · South San Francisco, CA
- Kaiser Permanente-Stockton · Stockton, CA
- Palo Alto Medical Foundation-Sunnyvale · Sunnyvale, CA
- Kaiser Permanente Medical Center-Vacaville · Vacaville, CA
- Kaiser Permanente-Vallejo · Vallejo, CA
- Sutter Solano Medical Center/Cancer Center · Vallejo, CA
- Kaiser Permanente-Walnut Creek · Walnut Creek, CA
Colorado · 14
- Intermountain Health Platte Valley Hospital · Brighton, CO
- Cancer Center of Colorado at Sloan's Lake · Denver, CO
- National Jewish Health-Main Campus · Denver, CO
- Saint Joseph Hospital - Cancer Centers of Colorado · Denver, CO
- Cancer Care and Hematology-Fort Collins · Fort Collins, CO
- Poudre Valley Hospital · Fort Collins, CO
- Lutheran Hospital - Cancer Centers of Colorado · Golden, CO
- National Jewish Health-Western Hematology Oncology · Golden, CO
- Saint Mary's Hospital and Regional Medical Center · Grand Junction, CO
- UCHealth Greeley Hospital · Greeley, CO
- Good Samaritan Hospital - Cancer Centers of Colorado · Lafayette, CO
- Medical Center of the Rockies · Loveland, CO
- National Jewish Health-Northern Hematology Oncology · Thornton, CO
- Intermountain Health Lutheran Hospital · Wheat Ridge, CO
Connecticut · 5
- Hartford HealthCare - Avon · Avon, CT
- Hartford Hospital · Hartford, CT
- Hartford HealthCare - Manchester · Manchester, CT
- Midstate Medical Center · Meriden, CT
- The Hospital of Central Connecticut · New Britain, CT
Delaware · 7
- Beebe Medical Center · Lewes, DE
- Beebe South Coastal Health Campus · Millville, DE
- Christiana Care Health System-Christiana Hospital · Newark, DE
- Helen F Graham Cancer Center · Newark, DE
- Medical Oncology Hematology Consultants PA · Newark, DE
- Beebe Health Campus · Rehoboth Beach, DE
- Christiana Care Health System-Wilmington Hospital · Wilmington, DE
District of Columbia · 3
- MedStar Georgetown University Hospital · Washington D.C., DC
- MedStar Washington Hospital Center · Washington D.C., DC
- Sibley Memorial Hospital · Washington D.C., DC
Florida · 9
- Mount Sinai Comprehensive Cancer Center at Aventura · Aventura, FL
- Schulze Family Foundation Cancer Clinic - Bonita Health Center · Bonita Springs, FL
- Holy Cross Hospital · Fort Lauderdale, FL
- Regional Cancer Center-Lee Memorial Health System · Fort Myers, FL
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital · Hollywood, FL
- Jupiter Medical Center · Jupiter, FL
- The Watson Clinic · Lakeland, FL
- Mount Sinai Medical Center · Miami Beach, FL
- Memorial Hospital West · Pembroke Pines, FL
Georgia · 1
- Tift Regional Medical Center · Tifton, GA
Hawaii · 11
- Hawaii Cancer Care - Westridge · ‘Aiea, HI
- Pali Momi Medical Center · ‘Aiea, HI
- Queen's Cancer Center - Pearlridge · ‘Aiea, HI
- The Queen's Medical Center - West Oahu · ‘Ewa Beach, HI
- Hawaii Cancer Care Inc - Waterfront Plaza · Honolulu, HI
- Kaiser Permanente Moanalua Medical Center · Honolulu, HI
- Queen's Cancer Cenrer - POB I · Honolulu, HI
- Queen's Cancer Center - Kuakini · Honolulu, HI
- Queen's Medical Center · Honolulu, HI
- Straub Clinic and Hospital · Honolulu, HI
- Straub Medical Center - Kahului Clinic · Kahului, HI
Idaho · 7
- Saint Alphonsus Cancer Care Center-Boise · Boise, ID
- Saint Alphonsus Cancer Care Center-Caldwell · Caldwell, ID
- Kootenai Health - Coeur d'Alene · Coeur d'Alene, ID
- Idaho Urologic Institute-Meridian · Meridian, ID
- Saint Alphonsus Cancer Care Center-Nampa · Nampa, ID
- Kootenai Clinic Cancer Services - Post Falls · Post Falls, ID
- Kootenai Clinic Cancer Services - Sandpoint · Sandpoint, ID
Illinois · 25
- OSF Saint Anthony's Health Center · Alton, IL
- Advocate Outpatient Center - Aurora · Aurora, IL
- Rush-Copley Medical Center · Aurora, IL
- Advocate Good Shepherd Hospital · Barrington, IL
- Illinois CancerCare-Bloomington · Bloomington, IL
- Illinois CancerCare-Canton · Canton, IL
- Memorial Hospital of Carbondale · Carbondale, IL
- SIH Cancer Institute · Carterville, IL
- Illinois CancerCare-Carthage · Carthage, IL
- Centralia Oncology Clinic · Centralia, IL
- Advocate Illinois Masonic Medical Center · Chicago, IL
- John H Stroger Jr Hospital of Cook County · Chicago, IL
- Mount Sinai Hospital Medical Center · Chicago, IL
- University of Chicago Comprehensive Cancer Center · Chicago, IL
- University of Illinois · Chicago, IL
- AMG Crystal Lake - Oncology · Crystal Lake, IL
- Carle at The Riverfront · Danville, IL
- Cancer Care Specialists of Illinois - Decatur · Decatur, IL
- Decatur Memorial Hospital · Decatur, IL
- Illinois CancerCare-Dixon · Dixon, IL
- Advocate Good Samaritan Hospital · Downers Grove, IL
- Carle Physician Group-Effingham · Effingham, IL
- Crossroads Cancer Center · Effingham, IL
- Advocate Sherman Hospital · Elgin, IL
- Illinois CancerCare-Eureka · Eureka, IL
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.