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SUSPENDED
NCT03604991
PHASE2/PHASE3

Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase II/III trial studies the usefulness of treatment with nivolumab and ipilimumab in addition to standard of care chemotherapy and radiation therapy in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery. Immunotherapy with antibodies, such as nivolumab and ipilimumab, may remove the brake on the body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy and radiation therapy may reduce the tumor size and the amount of normal tissue that needs to be removed during surgery. A combined treatment with nivolumab and ipilimumab, chemotherapy, and radiation therapy might be more effective in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery.

Official title: A Phase II/III Study of Peri-Operative Nivolumab and Ipilimumab in Patients With Locoregional Esophageal and Gastroesophageal Junction Adenocarcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

278

Start Date

2019-05-03

Completion Date

2027-03-31

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood sample

DRUG

Carboplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT scan

BIOLOGICAL

Ipilimumab

Given IV

BIOLOGICAL

Nivolumab

Given IV

DRUG

Paclitaxel

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET scan

RADIATION

Radiation Therapy

Undergo radiation therapy

Locations (488)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, United States

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Anchorage Oncology Centre

Anchorage, Alaska, United States

Katmai Oncology Group

Anchorage, Alaska, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

CHI Saint Vincent Cancer Center Hot Springs

Hot Springs, Arkansas, United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

PCR Oncology

Arroyo Grande, California, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Community Cancer Institute

Clovis, California, United States

University Oncology Associates

Clovis, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

VA Palo Alto Health Care System

Palo Alto, California, United States

Mercy Cancer Center - Sacramento

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Saint Helena Hospital

St. Helena, California, United States

Presbyterian Intercommunity Hospital

Whittier, California, United States

Woodland Memorial Hospital

Woodland, California, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Saint Francis Cancer Center

Colorado Springs, Colorado, United States

AdventHealth Porter

Denver, Colorado, United States

CommonSpirit Saint Anthony Hospital Cancer Center

Lakewood, Colorado, United States

AdventHealth Littleton

Littleton, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

AdventHealth Parker

Parker, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Beebe Medical Center

Lewes, Delaware, United States

Beebe South Coastal Health Campus

Millville, Delaware, United States

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

TidalHealth Nanticoke / Allen Cancer Center

Seaford, Delaware, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

AdventHealth Altamonte

Altamonte Springs, Florida, United States

Mount Sinai Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Regional Cancer Center-Lee Memorial Health System

Fort Myers, Florida, United States

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

AdventHealth Kissimmee

Kissimmee, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

AdventHealth East Orlando

Orlando, Florida, United States

Emory Proton Therapy Center

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, United States

Island Urology

Honolulu, Hawaii, United States

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, United States

Queen's Medical Center

Honolulu, Hawaii, United States

Straub Clinic and Hospital

Honolulu, Hawaii, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Hawaii Cancer Care Inc-Liliha

Honolulu, Hawaii, United States

Kuakini Medical Center

Honolulu, Hawaii, United States

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Wilcox Memorial Hospital and Kauai Medical Clinic

Lihue, Hawaii, United States

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, United States

Pali Momi Medical Center

‘Aiea, Hawaii, United States

Queen's Cancer Center - Pearlridge

‘Aiea, Hawaii, United States

The Cancer Center of Hawaii-Pali Momi

‘Aiea, Hawaii, United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Memorial Hospital of Carbondale

Carbondale, Illinois, United States

SIH Cancer Institute

Carterville, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Centralia Oncology Clinic

Centralia, Illinois, United States

Northwestern University

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Edward Hines Jr VA Hospital

Hines, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

SSM Health Good Samaritan

Mount Vernon, Illinois, United States

And 388 more locations on ClinicalTrials.gov