Testar Nivolumab och Ipilimumab med kortvarig strålning vid lokalt avancerad rektalcancer
21 oktober 2026 uppdaterad av: National Cancer Institute (NCI)
En fas II-studie av Neoadjuvant Nivolumab Plus Ipilimumab och kortkursstrålning vid MSI-H/dMMR lokalt avancerad rektal adenokarcinom
This phase II trial investigates the effect of nivolumab and ipilimumab when given together with short-course radiation therapy in treating patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab, ipilimumab, and radiation therapy may kill more cancer cells.
Studieöversikt
Status
Aktiv, inte rekryterande
Betingelser
Detaljerad beskrivning
PRIMARY OBJECTIVE:
I. To demonstrate that neoadjuvant nivolumab and ipilimumab in combination with short-course radiation will improve the pathologic complete response rate (pCR) in microsatellite instability-high (MSI-H)/mismatch repair deficiency (dMMR) locally advanced rectal adenocarcinoma at total mesorectal excision (TME).
SECONDARY OBJECTIVES:
I. To demonstrate that neoadjuvant nivolumab and ipilimumab in combination with short-course radiation will improve the rate of sphincter preservation in low-lying tumors.
II. To demonstrate that neoadjuvant nivolumab and ipilimumab in combination with short-course radiation will improve 5-year disease-free survival (DFS).
III. To demonstrate that neoadjuvant nivolumab and ipilimumab in combination with short-course radiation will improve overall survival (OS).
IV. To demonstrate that neoadjuvant nivolumab and ipilimumab in combination with short-course radiation will have acceptable safety/toxicity.
OUTLINE:
Patients receive nivolumab intravenously (IV) over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 28 days for 2 cycles. Starting at least 2 weeks but no longer than 6 weeks after completion of cycle 2 of nivolumab and ipilimumab, patients undergo short-course radiation therapy of 5 fractions daily for 1 week. Patients then continue to receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. 8-12 weeks after completion of 4th cycle of nivolumab and ipilimumab, patients undergo TME. Patients also undergo magnetic resonance imaging (MRI) and computed tomography (CT) prior to TME and during follow up, and undergo sigmoidoscopy prior to TME.
After completion of study treatment, patients are followed up for 5 years.
Studietyp
Interventionell
Inskrivning (Beräknad)
31
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Mobile, Alabama, Förenta staterna, 36607
- Mobile Infirmary Medical Center
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Alaska
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Anchorage, Alaska, Förenta staterna, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, Förenta staterna, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, Förenta staterna, 99508
- Alaska Oncology and Hematology LLC
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Anchorage, Alaska, Förenta staterna, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, Förenta staterna, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, Förenta staterna, 99508
- Katmai Oncology Group
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Anchorage, Alaska, Förenta staterna, 99508
- Providence Alaska Medical Center
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Arizona
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Phoenix, Arizona, Förenta staterna, 85004
- Cancer Center at Saint Joseph's
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Arkansas
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Fort Smith, Arkansas, Förenta staterna, 72903
- Mercy Hospital Fort Smith
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Hot Springs, Arkansas, Förenta staterna, 71913
- CHI Saint Vincent Cancer Center Hot Springs
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California
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Arroyo Grande, California, Förenta staterna, 93420
- PCR Oncology
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Burbank, California, Förenta staterna, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Los Angeles, California, Förenta staterna, 90033
- USC / Norris Comprehensive Cancer Center
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Orange, California, Förenta staterna, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
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San Luis Obispo, California, Förenta staterna, 93401
- Pacific Central Coast Health Center-San Luis Obispo
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Santa Maria, California, Förenta staterna, 93444
- Mission Hope Medical Oncology - Santa Maria
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Colorado
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Colorado Springs, Colorado, Förenta staterna, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Förenta staterna, 80907
- Rocky Mountain Cancer Centers-Penrose
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Denver, Colorado, Förenta staterna, 80210
- AdventHealth Porter
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Lakewood, Colorado, Förenta staterna, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
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Littleton, Colorado, Förenta staterna, 80122
- AdventHealth Littleton
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Longmont, Colorado, Förenta staterna, 80501
- Longmont United Hospital
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Parker, Colorado, Förenta staterna, 80138
- AdventHealth Parker
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Pueblo, Colorado, Förenta staterna, 81004
- Saint Mary Corwin Medical Center
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Delaware
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Millville, Delaware, Förenta staterna, 19967
- Beebe South Coastal Health Campus
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Newark, Delaware, Förenta staterna, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Förenta staterna, 19713
- Medical Oncology Hematology Consultants PA
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Rehoboth Beach, Delaware, Förenta staterna, 19971
- Beebe Health Campus
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Florida
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Altamonte Springs, Florida, Förenta staterna, 32701
- AdventHealth Altamonte
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Orlando, Florida, Förenta staterna, 32803
- AdventHealth Orlando
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Idaho
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Boise, Idaho, Förenta staterna, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Förenta staterna, 83712
- Saint Luke's Cancer Institute - Boise
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Caldwell, Idaho, Förenta staterna, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Förenta staterna, 83814
- Kootenai Health - Coeur d'Alene
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Fruitland, Idaho, Förenta staterna, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Förenta staterna, 83642
- Idaho Urologic Institute-Meridian
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Meridian, Idaho, Förenta staterna, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Förenta staterna, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, Förenta staterna, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, Förenta staterna, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Twin Falls, Idaho, Förenta staterna, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Bloomington, Illinois, Förenta staterna, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, Förenta staterna, 61520
- Illinois CancerCare-Canton
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Carbondale, Illinois, Förenta staterna, 62902
- Memorial Hospital of Carbondale
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Carterville, Illinois, Förenta staterna, 62918
- SIH Cancer Institute
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Carthage, Illinois, Förenta staterna, 62321
- Illinois CancerCare-Carthage
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Centralia, Illinois, Förenta staterna, 62801
- Centralia Oncology Clinic
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Chicago, Illinois, Förenta staterna, 60612
- University of Illinois
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Danville, Illinois, Förenta staterna, 61832
- Carle at The Riverfront
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Decatur, Illinois, Förenta staterna, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Förenta staterna, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, Förenta staterna, 61021
- Illinois CancerCare-Dixon
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Effingham, Illinois, Förenta staterna, 62401
- Crossroads Cancer Center
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Effingham, Illinois, Förenta staterna, 62401
- Carle Physician Group-Effingham
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Eureka, Illinois, Förenta staterna, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, Förenta staterna, 61401
- Western Illinois Cancer Treatment Center
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Galesburg, Illinois, Förenta staterna, 61401
- Illinois CancerCare-Galesburg
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Kewanee, Illinois, Förenta staterna, 61443
- Illinois CancerCare-Kewanee Clinic
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Macomb, Illinois, Förenta staterna, 61455
- Illinois CancerCare-Macomb
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Mattoon, Illinois, Förenta staterna, 61938
- Carle Physician Group-Mattoon/Charleston
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Mount Vernon, Illinois, Förenta staterna, 62864
- SSM Health Good Samaritan
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O'Fallon, Illinois, Förenta staterna, 62269
- Cancer Care Center of O'Fallon
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Ottawa, Illinois, Förenta staterna, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, Förenta staterna, 61554
- Illinois CancerCare-Pekin
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Pekin, Illinois, Förenta staterna, 61554
- OSF Saint Francis Radiation Oncology at Pekin
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Peoria, Illinois, Förenta staterna, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Förenta staterna, 61637
- OSF Saint Francis Medical Center
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Peoria, Illinois, Förenta staterna, 61615
- Illinois CancerCare-Peoria
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Peoria, Illinois, Förenta staterna, 61615
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
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Peru, Illinois, Förenta staterna, 61354
- Illinois CancerCare-Peru
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Peru, Illinois, Förenta staterna, 61354
- Valley Radiation Oncology
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Princeton, Illinois, Förenta staterna, 61356
- Illinois CancerCare-Princeton
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Springfield, Illinois, Förenta staterna, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Förenta staterna, 62702
- Springfield Clinic
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Springfield, Illinois, Förenta staterna, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, Förenta staterna, 61801
- Carle Cancer Center
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Washington, Illinois, Förenta staterna, 61571
- Illinois CancerCare - Washington
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Iowa
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Ames, Iowa, Förenta staterna, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Förenta staterna, 50010
- McFarland Clinic - Ames
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Carroll, Iowa, Förenta staterna, 51401
- Saint Anthony Regional Hospital
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Clive, Iowa, Förenta staterna, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Förenta staterna, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Creston, Iowa, Förenta staterna, 50801
- Greater Regional Medical Center
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Des Moines, Iowa, Förenta staterna, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Förenta staterna, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Förenta staterna, 50314
- Broadlawns Medical Center
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Des Moines, Iowa, Förenta staterna, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, Förenta staterna, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, Förenta staterna, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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West Des Moines, Iowa, Förenta staterna, 50266-7700
- Methodist West Hospital
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West Des Moines, Iowa, Förenta staterna, 50266
- Mercy Medical Center-West Lakes
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Kansas
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Garden City, Kansas, Förenta staterna, 67846
- Central Care Cancer Center - Garden City
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Great Bend, Kansas, Förenta staterna, 67530
- Central Care Cancer Center - Great Bend
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40504
- Saint Joseph Radiation Oncology Resource Center
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Lexington, Kentucky, Förenta staterna, 40509
- CommonSpirit Saint Joseph Medical Center - East Lexington
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Louisville, Kentucky, Förenta staterna, 40202
- Jewish Hospital
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Louisville, Kentucky, Förenta staterna, 40245
- UofL Health Medical Center Northeast
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Massachusetts
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Springfield, Massachusetts, Förenta staterna, 01199
- Baystate Medical Center
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Worcester, Massachusetts, Förenta staterna, 01655
- UMass Memorial Medical Center - University Campus
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Minnesota
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Burnsville, Minnesota, Förenta staterna, 55337
- Fairview Ridges Hospital
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Burnsville, Minnesota, Förenta staterna, 55337
- Minnesota Oncology - Burnsville
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Coon Rapids, Minnesota, Förenta staterna, 55433
- Mercy Hospital
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Edina, Minnesota, Förenta staterna, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Förenta staterna, 55432
- Unity Hospital
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Maple Grove, Minnesota, Förenta staterna, 55369
- Fairview Clinics and Surgery Center Maple Grove
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Maplewood, Minnesota, Förenta staterna, 55109
- Saint John's Hospital - Healtheast
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Maplewood, Minnesota, Förenta staterna, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, Förenta staterna, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, Förenta staterna, 55407
- Abbott-Northwestern Hospital
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Monticello, Minnesota, Förenta staterna, 55362
- Monticello Cancer Center
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Robbinsdale, Minnesota, Förenta staterna, 55422
- North Memorial Medical Health Center
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic in Rochester
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Saint Louis Park, Minnesota, Förenta staterna, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Förenta staterna, 55101
- Regions Hospital
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Saint Paul, Minnesota, Förenta staterna, 55102
- United Hospital
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Shakopee, Minnesota, Förenta staterna, 55379
- Saint Francis Regional Medical Center
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Waconia, Minnesota, Förenta staterna, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, Förenta staterna, 56201
- Rice Memorial Hospital
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Woodbury, Minnesota, Förenta staterna, 55125
- Minnesota Oncology Hematology PA-Woodbury
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Missouri
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Ballwin, Missouri, Förenta staterna, 63011
- Mercy Oncology and Hematology - Clayton-Clarkson
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Bolivar, Missouri, Förenta staterna, 65613
- Central Care Cancer Center - Bolivar
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Cape Girardeau, Missouri, Förenta staterna, 63703
- Saint Francis Medical Center
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Cape Girardeau, Missouri, Förenta staterna, 63703
- Mercy Cancer Center - Cape Girardeau
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Farmington, Missouri, Förenta staterna, 63640
- Parkland Health Center - Farmington
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Jefferson City, Missouri, Förenta staterna, 65109
- MU Health Care Goldschmidt Cancer Center
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Joplin, Missouri, Förenta staterna, 64804
- Freeman Health System
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Joplin, Missouri, Förenta staterna, 64804
- Mercy Hospital Joplin
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Rolla, Missouri, Förenta staterna, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
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Rolla, Missouri, Förenta staterna, 65401
- Phelps Health Delbert Day Cancer Institute
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Saint Joseph, Missouri, Förenta staterna, 64506
- Heartland Regional Medical Center
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Sainte Genevieve, Missouri, Förenta staterna, 63670
- Sainte Genevieve County Memorial Hospital
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Springfield, Missouri, Förenta staterna, 65807
- CoxHealth South Hospital
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Springfield, Missouri, Förenta staterna, 65804
- Mercy Hospital Springfield
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St Louis, Missouri, Förenta staterna, 63131
- Missouri Baptist Medical Center
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St Louis, Missouri, Förenta staterna, 63141
- Mercy Hospital Saint Louis
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St Louis, Missouri, Förenta staterna, 63128
- Mercy Hospital South
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Sullivan, Missouri, Förenta staterna, 63080
- Missouri Baptist Sullivan Hospital
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Montana
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Billings, Montana, Förenta staterna, 59101
- Billings Clinic Cancer Center
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Bozeman, Montana, Förenta staterna, 59715
- Bozeman Health Deaconess Hospital
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Great Falls, Montana, Förenta staterna, 59405
- Great Falls Clinic
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Great Falls, Montana, Förenta staterna, 59405
- Benefis Sletten Cancer Institute
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Kalispell, Montana, Förenta staterna, 59901
- Logan Health Medical Center
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Missoula, Montana, Förenta staterna, 59802
- Saint Patrick Hospital - Community Hospital
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Missoula, Montana, Förenta staterna, 59804
- Community Medical Center
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Nebraska
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Grand Island, Nebraska, Förenta staterna, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
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Kearney, Nebraska, Förenta staterna, 68847
- CHI Health Good Samaritan
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Omaha, Nebraska, Förenta staterna, 68124
- Alegent Health Bergan Mercy Medical Center
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Omaha, Nebraska, Förenta staterna, 68122
- Alegent Health Immanuel Medical Center
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Omaha, Nebraska, Förenta staterna, 68130
- Alegent Health Lakeside Hospital
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Nevada
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Henderson, Nevada, Förenta staterna, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
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Henderson, Nevada, Förenta staterna, 89074
- Oncology Las Vegas - Henderson
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Las Vegas, Nevada, Förenta staterna, 89102
- OptumCare Cancer Care at Charleston
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Las Vegas, Nevada, Förenta staterna, 89106
- Radiation Oncology Centers of Nevada Central
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Las Vegas, Nevada, Förenta staterna, 89119
- Radiation Oncology Centers of Nevada Southeast
-
Las Vegas, Nevada, Förenta staterna, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
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Las Vegas, Nevada, Förenta staterna, 89128
- OptumCare Cancer Care at MountainView
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Las Vegas, Nevada, Förenta staterna, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
-
Las Vegas, Nevada, Förenta staterna, 89144
- Comprehensive Cancer Centers of Nevada - Town Center
-
Las Vegas, Nevada, Förenta staterna, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, Förenta staterna, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Förenta staterna, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
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Las Vegas, Nevada, Förenta staterna, 89183
- OptumCare Cancer Care at Fort Apache
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Reno, Nevada, Förenta staterna, 89502
- Renown Regional Medical Center
-
Reno, Nevada, Förenta staterna, 89503
- Saint Mary's Regional Medical Center
-
Reno, Nevada, Förenta staterna, 89509
- Radiation Oncology Associates
-
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New Hampshire
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Concord, New Hampshire, Förenta staterna, 03301
- New Hampshire Oncology Hematology PA-Concord
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Lebanon, New Hampshire, Förenta staterna, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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Manchester, New Hampshire, Förenta staterna, 03103
- Solinsky Center for Cancer Care
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New York
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Lake Success, New York, Förenta staterna, 11042
- Northwell Health/Center for Advanced Medicine
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Middletown, New York, Förenta staterna, 10940
- Garnet Health Medical Center
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Mount Kisco, New York, Förenta staterna, 10549
- Northern Westchester Hospital
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New York, New York, Förenta staterna, 10075
- Lenox Hill Hospital
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New York, New York, Förenta staterna, 10065
- Manhattan Eye Ear and Throat Hospital
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45220
- Good Samaritan Hospital - Cincinnati
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Cincinnati, Ohio, Förenta staterna, 45242
- Bethesda North Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73104
- University of Oklahoma Health Sciences Center
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Oklahoma City, Oklahoma, Förenta staterna, 73120
- Mercy Hospital Oklahoma City
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Oregon
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Bend, Oregon, Förenta staterna, 97701
- Saint Charles Health System
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Clackamas, Oregon, Förenta staterna, 97015
- Clackamas Radiation Oncology Center
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Clackamas, Oregon, Förenta staterna, 97015
- Providence Cancer Institute Clackamas Clinic
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Coos Bay, Oregon, Förenta staterna, 97420
- Bay Area Hospital
-
Newberg, Oregon, Förenta staterna, 97132
- Providence Newberg Medical Center
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Portland, Oregon, Förenta staterna, 97213
- Providence Portland Medical Center
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Portland, Oregon, Förenta staterna, 97225
- Providence Saint Vincent Medical Center
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Pennsylvania
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Chadds Ford, Pennsylvania, Förenta staterna, 19317
- Christiana Care Health System-Concord Health Center
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South Dakota
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Rapid City, South Dakota, Förenta staterna, 57701
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Förenta staterna, 57105
- Avera Cancer Institute
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37232
- Vanderbilt University/Ingram Cancer Center
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Nashville, Tennessee, Förenta staterna, 37204
- Vanderbilt Breast Center at One Hundred Oaks
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Texas
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Bryan, Texas, Förenta staterna, 77802
- Saint Joseph Regional Cancer Center
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Vermont
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Saint Johnsbury, Vermont, Förenta staterna, 05819
- Dartmouth Cancer Center - North
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Washington
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Aberdeen, Washington, Förenta staterna, 98520
- Providence Regional Cancer System-Aberdeen
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Bellevue, Washington, Förenta staterna, 98004
- Overlake Medical Center
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Bellingham, Washington, Förenta staterna, 98225
- PeaceHealth Saint Joseph Medical Center
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Burien, Washington, Förenta staterna, 98166
- Saint Anne Hospital
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Centralia, Washington, Förenta staterna, 98531
- Providence Regional Cancer System-Centralia
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Edmonds, Washington, Förenta staterna, 98026
- Swedish Cancer Institute-Edmonds
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Everett, Washington, Förenta staterna, 98201
- Providence Regional Cancer Partnership
-
Issaquah, Washington, Förenta staterna, 98029
- Swedish Cancer Institute-Issaquah
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Lacey, Washington, Förenta staterna, 98503
- Providence Regional Cancer System-Lacey
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Longview, Washington, Förenta staterna, 98632
- PeaceHealth Saint John Medical Center
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Renton, Washington, Förenta staterna, 98055
- Valley Medical Center
-
Seattle, Washington, Förenta staterna, 98107
- Swedish Medical Center-Ballard Campus
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Seattle, Washington, Förenta staterna, 98122
- Swedish Medical Center-First Hill
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Sedro-Woolley, Washington, Förenta staterna, 98284
- PeaceHealth United General Medical Center
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Silverdale, Washington, Förenta staterna, 98383
- Saint Joseph Medical Center Hematology and Oncology - Silverdale
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Vancouver, Washington, Förenta staterna, 98664
- PeaceHealth Southwest Medical Center
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Walla Walla, Washington, Förenta staterna, 99362
- Providence Saint Mary Regional Cancer Center
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Yakima, Washington, Förenta staterna, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
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Wisconsin
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Appleton, Wisconsin, Förenta staterna, 54911
- ThedaCare Regional Cancer Center
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New Richmond, Wisconsin, Förenta staterna, 54017
- Cancer Center of Western Wisconsin
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Wyoming
-
Sheridan, Wyoming, Förenta staterna, 82801
- Welch Cancer Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Patient must be >= 18 years of age
- Patient must have histologically confirmed adenocarcinoma of the rectum with the inferior margin within 15 cm from the anal verge based on colonoscopy and/or flexible sigmoidoscopy
- Patient must have T3-4Nx or TxN+ disease (stage II or III) based on magnetic resonance imaging of the pelvis and computed tomography of the chest and abdomen. These baseline scans must be done within 28 days prior to registration
- Patient must have MSI-H (microsatellite instability-high) or dMMR (deficient mismatch repair) tumors based on immunohistochemistry or PCR (polymerase chain reaction)
- Patient must have Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
- Patient must not have previously received chemotherapy or immunotherapy for rectal cancer
- Patient must not have previously received radiotherapy to the pelvis
- Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
- Patient must not have had major surgery performed within 28 days prior to registration
- Patient must not have a history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan
- Patient must not have a serious active infection requiring IV antibiotics at time of registration
- Patient must agree to not receive live vaccines while on this study
- Patient must not have active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater). These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or anti-phospholipid syndrome. Patients with any of these are ineligible for this study because of the risk of recurrence or exacerbation of disease
- Patient must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if < 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted
- Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A repeat pregnancy test must be done within 72 hours prior to first dose of treatment if the baseline test was done outside the 72 hour window. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Patients of childbearing potential and sexually active patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for at least one month (female patients) or one week (male patients) prior to the start of study drug and continue for 5 months after the last dose of study drug (for female patients). Investigators must counsel patients on the importance of pregnancy prevention and the implications of an unexpected pregnancy
- Leukocytes >= 3,000/mcL (must be obtained =< 14 days prior to protocol registration)
- Absolute neutrophil count (ANC) >= 1,500/mcL (must be obtained =< 14 days prior to protocol registration)
- Platelets >= 100,000/mcL (must be obtained =< 14 days prior to protocol registration)
- Total bilirubin =< institutional upper limit of normal (ULN) (must be obtained =< 14 days prior to protocol registration)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x institutional ULN (must be obtained =< 14 days prior to protocol registration)
- Creatinine =< 1.5 x institutional ULN (must be obtained =< 14 days prior to protocol registration)
- Patients should have urine dipstick with proteinuria < 1. If urine dipstick > 2, proteinuria must be less than 1 g in 24 hours urine collection
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- 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 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
- Patient must not have had live vaccines within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Patients are permitted to receive inactivated vaccines and any non-live vaccines including those for the seasonal influenza and COVID-19 (Note: intranasal influenza vaccines, such as Flu-Mist [registered trademark] are live attenuated vaccines and are not allowed). If possible, it is recommended to separate study drug administration from vaccine administration by about a week (primarily, in order to minimize an overlap of adverse events)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Treatment (nivolumab, ipilimumab, radiation therapy, TME)
Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 28 days for 2 cycles. Starting at least 2 weeks but no longer than 6 weeks after completion of cycle 2 of nivolumab and ipilimumab, patients undergo short-course radiation therapy of 5 fractions daily for 1 week. Patients then continue to receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. 8-12 weeks after completion of 4th cycle of nivolumab and ipilimumab, patients undergo TME. Patients also undergo MRI and CT prior to TME and during follow up, and undergo sigmoidoscopy prior to TME. |
Given IV
Andra namn:
Undergo CT
Andra namn:
Undergo MRI
Andra namn:
Given IV
Andra namn:
Undergo sigmoidoscopy
Andra namn:
Undergo short-course radiation therapy
Andra namn:
Undergo TME
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Patologiskt komplett svar
Tidsram: Vid tidpunkten för total mesorektal excision
|
Vid tidpunkten för total mesorektal excision
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Rate of sphincter preservation in low-lying tumors
Tidsram: Up to 5 years
|
95% confidence interval will be estimated. |
Up to 5 years
|
|
Disease free survival
Tidsram: Up to 5 years
|
Kaplan-Meier method will be used. |
Up to 5 years
|
|
Overall survival
Tidsram: Up to 5 years
|
Kaplan-Meier method will be used. |
Up to 5 years
|
|
Incidence of adverse events
Tidsram: Up to 5 years
|
Will be assessed by Common Terminology Criteria for Adverse Events 5.0. Toxicities will be tabulated by grade and treatment relation. |
Up to 5 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Kristen K Ciombor, ECOG-ACRIN Cancer Research Group
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
8 februari 2022
Primärt slutförande (Beräknad)
30 juni 2027
Avslutad studie (Beräknad)
30 juni 2027
Studieregistreringsdatum
Först inskickad
11 februari 2021
Först inskickad som uppfyllde QC-kriterierna
11 februari 2021
Första postat (Faktisk)
12 februari 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 oktober 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 oktober 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Tarmsjukdomar
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Matsmältningssystemets sjukdomar
- Gastrointestinala sjukdomar
- Kolorektala neoplasmer
- Intestinala neoplasmer
- Rektala sjukdomar
- Rektal neoplasmer
- Aminosyror, peptider och proteiner
- Proteiner
- Undersökningstekniker
- Terapeutik
- Diagnostiska tekniker och procedurer
- Diagnos
- Kirurgiska ingrepp, operativ
- Minimalt invasiva kirurgiska ingrepp
- Biologiska faktorer
- Fysiska fenomen
- Antikroppar, monoklonal, humaniserad
- Antikroppar, monoklonal
- Antikroppar
- Immunglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Diagnostiska tekniker, kirurgiska
- Endoskopi, gastrointestinal
- Endoskopi, matsmältningssystem
- Diagnostiska tekniker, matsmältningssystem
- Endoskopi
- Matsmältningssystemets kirurgiska procedurer
- Kemitekniker, analytiska
- Spektrumanalys
- Receptorer, cellytan
- Membranproteiner
- Antigen
- Kolonoskopi
- Antigen, yta
- Biomarkörer
- Receptorer, immunologiska
- Antigen, differentiering, T-lymfocyt
- Antigener, differentiering
- Immunkontrollproteiner
- Costimulatory och hämmande T-cellreceptorer
- Nivolumab
- Ipilimumab
- Strålbehandling
- Strålning
- Magnetresonansspektroskopi
- Sigmoidoskopi
- CTLA-4-antigen
Andra studie-ID-nummer
- NCI-2021-00912
- U10CA180820 (U.S.S. NIH-anslag/kontrakt)
- NCI-2021-00912 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- EA2201 (Annan identifierare: CTEP)
- EA2201 (Annan identifierare: ECOG-ACRIN Cancer Research Group)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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