Test af Nivolumab og Ipilimumab med kortvarig stråling ved lokalt avanceret rektalcancer
21. oktober 2026 opdateret af: National Cancer Institute (NCI)
Et fase II-studie af neoadjuverende Nivolumab Plus Ipilimumab og kortkursusstråling i MSI-H/dMMR lokalt avanceret rektalt adenocarcinom
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.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
31
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Mobile, Alabama, Forenede Stater, 36607
- Mobile Infirmary Medical Center
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Alaska
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Anchorage, Alaska, Forenede Stater, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, Forenede Stater, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, Forenede Stater, 99508
- Alaska Oncology and Hematology LLC
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Anchorage, Alaska, Forenede Stater, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, Forenede Stater, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, Forenede Stater, 99508
- Katmai Oncology Group
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Anchorage, Alaska, Forenede Stater, 99508
- Providence Alaska Medical Center
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Arizona
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Phoenix, Arizona, Forenede Stater, 85004
- Cancer Center at Saint Joseph's
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Arkansas
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Fort Smith, Arkansas, Forenede Stater, 72903
- Mercy Hospital Fort Smith
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Hot Springs, Arkansas, Forenede Stater, 71913
- CHI Saint Vincent Cancer Center Hot Springs
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California
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Arroyo Grande, California, Forenede Stater, 93420
- PCR Oncology
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Burbank, California, Forenede Stater, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Los Angeles, California, Forenede Stater, 90033
- USC / Norris Comprehensive Cancer Center
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Orange, California, Forenede Stater, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
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San Luis Obispo, California, Forenede Stater, 93401
- Pacific Central Coast Health Center-San Luis Obispo
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Santa Maria, California, Forenede Stater, 93444
- Mission Hope Medical Oncology - Santa Maria
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Forenede Stater, 80907
- Rocky Mountain Cancer Centers-Penrose
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Denver, Colorado, Forenede Stater, 80210
- AdventHealth Porter
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Lakewood, Colorado, Forenede Stater, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
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Littleton, Colorado, Forenede Stater, 80122
- AdventHealth Littleton
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Longmont, Colorado, Forenede Stater, 80501
- Longmont United Hospital
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Parker, Colorado, Forenede Stater, 80138
- AdventHealth Parker
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Pueblo, Colorado, Forenede Stater, 81004
- Saint Mary Corwin Medical Center
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Delaware
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Millville, Delaware, Forenede Stater, 19967
- Beebe South Coastal Health Campus
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Newark, Delaware, Forenede Stater, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Forenede Stater, 19713
- Medical Oncology Hematology Consultants PA
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Rehoboth Beach, Delaware, Forenede Stater, 19971
- Beebe Health Campus
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Florida
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Altamonte Springs, Florida, Forenede Stater, 32701
- AdventHealth Altamonte
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Orlando, Florida, Forenede Stater, 32803
- AdventHealth Orlando
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Idaho
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Boise, Idaho, Forenede Stater, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Forenede Stater, 83712
- Saint Luke's Cancer Institute - Boise
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Caldwell, Idaho, Forenede Stater, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Forenede Stater, 83814
- Kootenai Health - Coeur d'Alene
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Fruitland, Idaho, Forenede Stater, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Forenede Stater, 83642
- Idaho Urologic Institute-Meridian
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Meridian, Idaho, Forenede Stater, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Forenede Stater, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, Forenede Stater, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, Forenede Stater, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Twin Falls, Idaho, Forenede Stater, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Bloomington, Illinois, Forenede Stater, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, Forenede Stater, 61520
- Illinois CancerCare-Canton
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Carbondale, Illinois, Forenede Stater, 62902
- Memorial Hospital of Carbondale
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Carterville, Illinois, Forenede Stater, 62918
- SIH Cancer Institute
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Carthage, Illinois, Forenede Stater, 62321
- Illinois CancerCare-Carthage
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Centralia, Illinois, Forenede Stater, 62801
- Centralia Oncology Clinic
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Chicago, Illinois, Forenede Stater, 60612
- University of Illinois
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Danville, Illinois, Forenede Stater, 61832
- Carle at The Riverfront
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Decatur, Illinois, Forenede Stater, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Forenede Stater, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, Forenede Stater, 61021
- Illinois CancerCare-Dixon
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Effingham, Illinois, Forenede Stater, 62401
- Crossroads Cancer Center
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Effingham, Illinois, Forenede Stater, 62401
- Carle Physician Group-Effingham
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Eureka, Illinois, Forenede Stater, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, Forenede Stater, 61401
- Western Illinois Cancer Treatment Center
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Galesburg, Illinois, Forenede Stater, 61401
- Illinois CancerCare-Galesburg
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Kewanee, Illinois, Forenede Stater, 61443
- Illinois CancerCare-Kewanee Clinic
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Macomb, Illinois, Forenede Stater, 61455
- Illinois CancerCare-Macomb
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Mattoon, Illinois, Forenede Stater, 61938
- Carle Physician Group-Mattoon/Charleston
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Mount Vernon, Illinois, Forenede Stater, 62864
- SSM Health Good Samaritan
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O'Fallon, Illinois, Forenede Stater, 62269
- Cancer Care Center of O'Fallon
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Ottawa, Illinois, Forenede Stater, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, Forenede Stater, 61554
- Illinois CancerCare-Pekin
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Pekin, Illinois, Forenede Stater, 61554
- OSF Saint Francis Radiation Oncology at Pekin
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Peoria, Illinois, Forenede Stater, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Forenede Stater, 61637
- OSF Saint Francis Medical Center
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Peoria, Illinois, Forenede Stater, 61615
- Illinois CancerCare-Peoria
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Peoria, Illinois, Forenede Stater, 61615
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
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Peru, Illinois, Forenede Stater, 61354
- Illinois CancerCare-Peru
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Peru, Illinois, Forenede Stater, 61354
- Valley Radiation Oncology
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Princeton, Illinois, Forenede Stater, 61356
- Illinois CancerCare-Princeton
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Springfield, Illinois, Forenede Stater, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Forenede Stater, 62702
- Springfield Clinic
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Springfield, Illinois, Forenede Stater, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, Forenede Stater, 61801
- Carle Cancer Center
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Washington, Illinois, Forenede Stater, 61571
- Illinois CancerCare - Washington
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Iowa
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Ames, Iowa, Forenede Stater, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Forenede Stater, 50010
- McFarland Clinic - Ames
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Carroll, Iowa, Forenede Stater, 51401
- Saint Anthony Regional Hospital
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Clive, Iowa, Forenede Stater, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Forenede Stater, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Creston, Iowa, Forenede Stater, 50801
- Greater Regional Medical Center
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Des Moines, Iowa, Forenede Stater, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Forenede Stater, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Forenede Stater, 50314
- Broadlawns Medical Center
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Des Moines, Iowa, Forenede Stater, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, Forenede Stater, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, Forenede Stater, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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West Des Moines, Iowa, Forenede Stater, 50266-7700
- Methodist West Hospital
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West Des Moines, Iowa, Forenede Stater, 50266
- Mercy Medical Center-West Lakes
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Kansas
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Garden City, Kansas, Forenede Stater, 67846
- Central Care Cancer Center - Garden City
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Great Bend, Kansas, Forenede Stater, 67530
- Central Care Cancer Center - Great Bend
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40504
- Saint Joseph Radiation Oncology Resource Center
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Lexington, Kentucky, Forenede Stater, 40509
- CommonSpirit Saint Joseph Medical Center - East Lexington
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Louisville, Kentucky, Forenede Stater, 40202
- Jewish Hospital
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Louisville, Kentucky, Forenede Stater, 40245
- UofL Health Medical Center Northeast
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Massachusetts
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Springfield, Massachusetts, Forenede Stater, 01199
- Baystate Medical Center
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Worcester, Massachusetts, Forenede Stater, 01655
- UMass Memorial Medical Center - University Campus
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Minnesota
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Burnsville, Minnesota, Forenede Stater, 55337
- Fairview Ridges Hospital
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Burnsville, Minnesota, Forenede Stater, 55337
- Minnesota Oncology - Burnsville
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Coon Rapids, Minnesota, Forenede Stater, 55433
- Mercy Hospital
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Edina, Minnesota, Forenede Stater, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Forenede Stater, 55432
- Unity Hospital
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Maple Grove, Minnesota, Forenede Stater, 55369
- Fairview Clinics and Surgery Center Maple Grove
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Maplewood, Minnesota, Forenede Stater, 55109
- Saint John's Hospital - Healtheast
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Maplewood, Minnesota, Forenede Stater, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, Forenede Stater, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, Forenede Stater, 55407
- Abbott-Northwestern Hospital
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Monticello, Minnesota, Forenede Stater, 55362
- Monticello Cancer Center
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Robbinsdale, Minnesota, Forenede Stater, 55422
- North Memorial Medical Health Center
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic in Rochester
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Forenede Stater, 55101
- Regions Hospital
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Saint Paul, Minnesota, Forenede Stater, 55102
- United Hospital
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Shakopee, Minnesota, Forenede Stater, 55379
- Saint Francis Regional Medical Center
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Waconia, Minnesota, Forenede Stater, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, Forenede Stater, 56201
- Rice Memorial Hospital
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Woodbury, Minnesota, Forenede Stater, 55125
- Minnesota Oncology Hematology PA-Woodbury
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Missouri
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Ballwin, Missouri, Forenede Stater, 63011
- Mercy Oncology and Hematology - Clayton-Clarkson
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Bolivar, Missouri, Forenede Stater, 65613
- Central Care Cancer Center - Bolivar
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Cape Girardeau, Missouri, Forenede Stater, 63703
- Saint Francis Medical Center
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Cape Girardeau, Missouri, Forenede Stater, 63703
- Mercy Cancer Center - Cape Girardeau
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Farmington, Missouri, Forenede Stater, 63640
- Parkland Health Center - Farmington
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Jefferson City, Missouri, Forenede Stater, 65109
- MU Health Care Goldschmidt Cancer Center
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Joplin, Missouri, Forenede Stater, 64804
- Freeman Health System
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Joplin, Missouri, Forenede Stater, 64804
- Mercy Hospital Joplin
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Rolla, Missouri, Forenede Stater, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
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Rolla, Missouri, Forenede Stater, 65401
- Phelps Health Delbert Day Cancer Institute
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Saint Joseph, Missouri, Forenede Stater, 64506
- Heartland Regional Medical Center
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Sainte Genevieve, Missouri, Forenede Stater, 63670
- Sainte Genevieve County Memorial Hospital
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Springfield, Missouri, Forenede Stater, 65807
- CoxHealth South Hospital
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Springfield, Missouri, Forenede Stater, 65804
- Mercy Hospital Springfield
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St Louis, Missouri, Forenede Stater, 63131
- Missouri Baptist Medical Center
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St Louis, Missouri, Forenede Stater, 63141
- Mercy Hospital Saint Louis
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St Louis, Missouri, Forenede Stater, 63128
- Mercy Hospital South
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Sullivan, Missouri, Forenede Stater, 63080
- Missouri Baptist Sullivan Hospital
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Montana
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Billings, Montana, Forenede Stater, 59101
- Billings Clinic Cancer Center
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Bozeman, Montana, Forenede Stater, 59715
- Bozeman Health Deaconess Hospital
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Great Falls, Montana, Forenede Stater, 59405
- Great Falls Clinic
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Great Falls, Montana, Forenede Stater, 59405
- Benefis Sletten Cancer Institute
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Kalispell, Montana, Forenede Stater, 59901
- Logan Health Medical Center
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Missoula, Montana, Forenede Stater, 59802
- Saint Patrick Hospital - Community Hospital
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Missoula, Montana, Forenede Stater, 59804
- Community Medical Center
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Nebraska
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Grand Island, Nebraska, Forenede Stater, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
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Kearney, Nebraska, Forenede Stater, 68847
- CHI Health Good Samaritan
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Omaha, Nebraska, Forenede Stater, 68124
- Alegent Health Bergan Mercy Medical Center
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Omaha, Nebraska, Forenede Stater, 68122
- Alegent Health Immanuel Medical Center
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Omaha, Nebraska, Forenede Stater, 68130
- Alegent Health Lakeside Hospital
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Nevada
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Henderson, Nevada, Forenede Stater, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
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Henderson, Nevada, Forenede Stater, 89074
- Oncology Las Vegas - Henderson
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Las Vegas, Nevada, Forenede Stater, 89102
- OptumCare Cancer Care at Charleston
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Las Vegas, Nevada, Forenede Stater, 89106
- Radiation Oncology Centers of Nevada Central
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Las Vegas, Nevada, Forenede Stater, 89119
- Radiation Oncology Centers of Nevada Southeast
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Las Vegas, Nevada, Forenede Stater, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
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Las Vegas, Nevada, Forenede Stater, 89128
- OptumCare Cancer Care at MountainView
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Las Vegas, Nevada, Forenede Stater, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las Vegas, Nevada, Forenede Stater, 89144
- Comprehensive Cancer Centers of Nevada - Town Center
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Las Vegas, Nevada, Forenede Stater, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
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Las Vegas, Nevada, Forenede Stater, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Forenede Stater, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
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Las Vegas, Nevada, Forenede Stater, 89183
- OptumCare Cancer Care at Fort Apache
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Reno, Nevada, Forenede Stater, 89502
- Renown Regional Medical Center
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Reno, Nevada, Forenede Stater, 89503
- Saint Mary's Regional Medical Center
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Reno, Nevada, Forenede Stater, 89509
- Radiation Oncology Associates
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New Hampshire
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Concord, New Hampshire, Forenede Stater, 03301
- New Hampshire Oncology Hematology PA-Concord
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Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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Manchester, New Hampshire, Forenede Stater, 03103
- Solinsky Center for Cancer Care
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New York
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Lake Success, New York, Forenede Stater, 11042
- Northwell Health/Center for Advanced Medicine
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Middletown, New York, Forenede Stater, 10940
- Garnet Health Medical Center
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Mount Kisco, New York, Forenede Stater, 10549
- Northern Westchester Hospital
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New York, New York, Forenede Stater, 10075
- Lenox Hill Hospital
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New York, New York, Forenede Stater, 10065
- Manhattan Eye Ear and Throat Hospital
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45220
- Good Samaritan Hospital - Cincinnati
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Cincinnati, Ohio, Forenede Stater, 45242
- Bethesda North Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- University of Oklahoma Health Sciences Center
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Oklahoma City, Oklahoma, Forenede Stater, 73120
- Mercy Hospital Oklahoma City
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Oregon
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Bend, Oregon, Forenede Stater, 97701
- Saint Charles Health System
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Clackamas, Oregon, Forenede Stater, 97015
- Clackamas Radiation Oncology Center
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Clackamas, Oregon, Forenede Stater, 97015
- Providence Cancer Institute Clackamas Clinic
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Coos Bay, Oregon, Forenede Stater, 97420
- Bay Area Hospital
-
Newberg, Oregon, Forenede Stater, 97132
- Providence Newberg Medical Center
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Portland, Oregon, Forenede Stater, 97213
- Providence Portland Medical Center
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Portland, Oregon, Forenede Stater, 97225
- Providence Saint Vincent Medical Center
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Pennsylvania
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Chadds Ford, Pennsylvania, Forenede Stater, 19317
- Christiana Care Health System-Concord Health Center
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South Dakota
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Rapid City, South Dakota, Forenede Stater, 57701
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Forenede Stater, 57105
- Avera Cancer Institute
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University/Ingram Cancer Center
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Nashville, Tennessee, Forenede Stater, 37204
- Vanderbilt Breast Center at One Hundred Oaks
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Texas
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Bryan, Texas, Forenede Stater, 77802
- Saint Joseph Regional Cancer Center
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Vermont
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Saint Johnsbury, Vermont, Forenede Stater, 05819
- Dartmouth Cancer Center - North
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Washington
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Aberdeen, Washington, Forenede Stater, 98520
- Providence Regional Cancer System-Aberdeen
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Bellevue, Washington, Forenede Stater, 98004
- Overlake Medical Center
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Bellingham, Washington, Forenede Stater, 98225
- PeaceHealth Saint Joseph Medical Center
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Burien, Washington, Forenede Stater, 98166
- Saint Anne Hospital
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Centralia, Washington, Forenede Stater, 98531
- Providence Regional Cancer System-Centralia
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Edmonds, Washington, Forenede Stater, 98026
- Swedish Cancer Institute-Edmonds
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Everett, Washington, Forenede Stater, 98201
- Providence Regional Cancer Partnership
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Issaquah, Washington, Forenede Stater, 98029
- Swedish Cancer Institute-Issaquah
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Lacey, Washington, Forenede Stater, 98503
- Providence Regional Cancer System-Lacey
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Longview, Washington, Forenede Stater, 98632
- PeaceHealth Saint John Medical Center
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Renton, Washington, Forenede Stater, 98055
- Valley Medical Center
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Seattle, Washington, Forenede Stater, 98107
- Swedish Medical Center-Ballard Campus
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Seattle, Washington, Forenede Stater, 98122
- Swedish Medical Center-First Hill
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Sedro-Woolley, Washington, Forenede Stater, 98284
- PeaceHealth United General Medical Center
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Silverdale, Washington, Forenede Stater, 98383
- Saint Joseph Medical Center Hematology and Oncology - Silverdale
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Vancouver, Washington, Forenede Stater, 98664
- PeaceHealth Southwest Medical Center
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Walla Walla, Washington, Forenede Stater, 99362
- Providence Saint Mary Regional Cancer Center
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Yakima, Washington, Forenede Stater, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
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Wisconsin
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Appleton, Wisconsin, Forenede Stater, 54911
- ThedaCare Regional Cancer Center
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New Richmond, Wisconsin, Forenede Stater, 54017
- Cancer Center of Western Wisconsin
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Wyoming
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Sheridan, Wyoming, Forenede Stater, 82801
- Welch Cancer Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
Andre navne:
Undergo CT
Andre navne:
Undergo MRI
Andre navne:
Given IV
Andre navne:
Undergo sigmoidoscopy
Andre navne:
Undergo short-course radiation therapy
Andre navne:
Undergo TME
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Patologisk fuldstændig respons
Tidsramme: På tidspunktet for total mesorektal excision
|
På tidspunktet for total mesorektal excision
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of sphincter preservation in low-lying tumors
Tidsramme: Up to 5 years
|
95% confidence interval will be estimated. |
Up to 5 years
|
|
Disease free survival
Tidsramme: Up to 5 years
|
Kaplan-Meier method will be used. |
Up to 5 years
|
|
Overall survival
Tidsramme: Up to 5 years
|
Kaplan-Meier method will be used. |
Up to 5 years
|
|
Incidence of adverse events
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Kristen K Ciombor, ECOG-ACRIN Cancer Research Group
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
8. februar 2022
Primær færdiggørelse (Anslået)
30. juni 2027
Studieafslutning (Anslået)
30. juni 2027
Datoer for studieregistrering
Først indsendt
11. februar 2021
Først indsendt, der opfyldte QC-kriterier
11. februar 2021
Først opslået (Faktiske)
12. februar 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. oktober 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Tarmsygdomme
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Kolorektale neoplasmer
- Intestinale neoplasmer
- Endetarmssygdomme
- Rektale neoplasmer
- Aminosyrer, peptider og proteiner
- Proteiner
- Undersøgelsesteknikker
- Terapeutik
- Diagnostiske teknikker og procedurer
- Diagnose
- Kirurgiske procedurer, operative
- Minimalt invasive kirurgiske procedurer
- Biologiske faktorer
- Fysiske fænomener
- Antistoffer, monoklonal, humaniseret
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Diagnostiske teknikker, kirurgisk
- Endoskopi, gastrointestinal
- Endoskopi, fordøjelsessystem
- Diagnostiske teknikker, fordøjelsessystem
- Endoskopi
- Kirurgiske procedurer for fordøjelsessystem
- Kemiteknikker, analytisk
- Spektrumanalyse
- Receptorer, celleoverflade
- Membranproteiner
- Antigener
- Kolonoskopi
- Antigener, overflade
- Biomarkører
- Receptorer, immunologisk
- Antigener, differentiering, T-lymfocyt
- Antigener, differentiering
- Immune kontrolpunktsproteiner
- Costimulerende og inhiberende T-celle-receptorer
- Nivolumab
- Ipilimumab
- Strålebehandling
- Stråling
- Magnetisk resonansspektroskopi
- Sigmoidoskopi
- CTLA-4-antigen
Andre undersøgelses-id-numre
- NCI-2021-00912
- U10CA180820 (U.S. NIH-bevilling/kontrakt)
- NCI-2021-00912 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- EA2201 (Anden identifikator: CTEP)
- EA2201 (Anden identifikator: ECOG-ACRIN Cancer Research Group)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .