Testowanie niwolumabu i ipilimumabu za pomocą promieniowania o krótkim przebiegu w miejscowo zaawansowanym raku odbytnicy
21 października 2026 zaktualizowane przez: National Cancer Institute (NCI)
Badanie fazy II neoadiuwantowego leczenia niwolumabem plus ipilimumabem i krótkoprzebiegowej radioterapii w miejscowo zaawansowanym gruczolakoraku odbytnicy z MSI-H/dMMR
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.
Przegląd badań
Status
Aktywny, nie rekrutujący
Warunki
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
31
Faza
- Faza 2
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Alabama
-
Mobile, Alabama, Stany Zjednoczone, 36607
- Mobile Infirmary Medical Center
-
-
Alaska
-
Anchorage, Alaska, Stany Zjednoczone, 98508
- Anchorage Associates in Radiation Medicine
-
Anchorage, Alaska, Stany Zjednoczone, 99508
- Alaska Breast Care and Surgery LLC
-
Anchorage, Alaska, Stany Zjednoczone, 99508
- Alaska Oncology and Hematology LLC
-
Anchorage, Alaska, Stany Zjednoczone, 99508
- Alaska Women's Cancer Care
-
Anchorage, Alaska, Stany Zjednoczone, 99508
- Anchorage Oncology Centre
-
Anchorage, Alaska, Stany Zjednoczone, 99508
- Katmai Oncology Group
-
Anchorage, Alaska, Stany Zjednoczone, 99508
- Providence Alaska Medical Center
-
-
Arizona
-
Phoenix, Arizona, Stany Zjednoczone, 85004
- Cancer Center at Saint Joseph's
-
-
Arkansas
-
Fort Smith, Arkansas, Stany Zjednoczone, 72903
- Mercy Hospital Fort Smith
-
Hot Springs, Arkansas, Stany Zjednoczone, 71913
- CHI Saint Vincent Cancer Center Hot Springs
-
-
California
-
Arroyo Grande, California, Stany Zjednoczone, 93420
- PCR Oncology
-
Burbank, California, Stany Zjednoczone, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
-
Los Angeles, California, Stany Zjednoczone, 90033
- USC / Norris Comprehensive Cancer Center
-
Orange, California, Stany Zjednoczone, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
-
San Luis Obispo, California, Stany Zjednoczone, 93401
- Pacific Central Coast Health Center-San Luis Obispo
-
Santa Maria, California, Stany Zjednoczone, 93444
- Mission Hope Medical Oncology - Santa Maria
-
-
Colorado
-
Colorado Springs, Colorado, Stany Zjednoczone, 80907
- Penrose-Saint Francis Healthcare
-
Colorado Springs, Colorado, Stany Zjednoczone, 80907
- Rocky Mountain Cancer Centers-Penrose
-
Denver, Colorado, Stany Zjednoczone, 80210
- AdventHealth Porter
-
Lakewood, Colorado, Stany Zjednoczone, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
-
Littleton, Colorado, Stany Zjednoczone, 80122
- AdventHealth Littleton
-
Longmont, Colorado, Stany Zjednoczone, 80501
- Longmont United Hospital
-
Parker, Colorado, Stany Zjednoczone, 80138
- AdventHealth Parker
-
Pueblo, Colorado, Stany Zjednoczone, 81004
- Saint Mary Corwin Medical Center
-
-
Delaware
-
Millville, Delaware, Stany Zjednoczone, 19967
- Beebe South Coastal Health Campus
-
Newark, Delaware, Stany Zjednoczone, 19713
- Helen F Graham Cancer Center
-
Newark, Delaware, Stany Zjednoczone, 19713
- Medical Oncology Hematology Consultants PA
-
Rehoboth Beach, Delaware, Stany Zjednoczone, 19971
- Beebe Health Campus
-
-
Florida
-
Altamonte Springs, Florida, Stany Zjednoczone, 32701
- AdventHealth Altamonte
-
Orlando, Florida, Stany Zjednoczone, 32803
- AdventHealth Orlando
-
-
Idaho
-
Boise, Idaho, Stany Zjednoczone, 83706
- Saint Alphonsus Cancer Care Center-Boise
-
Boise, Idaho, Stany Zjednoczone, 83712
- Saint Luke's Cancer Institute - Boise
-
Caldwell, Idaho, Stany Zjednoczone, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
-
Coeur d'Alene, Idaho, Stany Zjednoczone, 83814
- Kootenai Health - Coeur d'Alene
-
Fruitland, Idaho, Stany Zjednoczone, 83619
- Saint Luke's Cancer Institute - Fruitland
-
Meridian, Idaho, Stany Zjednoczone, 83642
- Idaho Urologic Institute-Meridian
-
Meridian, Idaho, Stany Zjednoczone, 83642
- Saint Luke's Cancer Institute - Meridian
-
Nampa, Idaho, Stany Zjednoczone, 83687
- Saint Alphonsus Cancer Care Center-Nampa
-
Nampa, Idaho, Stany Zjednoczone, 83687
- Saint Luke's Cancer Institute - Nampa
-
Post Falls, Idaho, Stany Zjednoczone, 83854
- Kootenai Clinic Cancer Services - Post Falls
-
Twin Falls, Idaho, Stany Zjednoczone, 83301
- Saint Luke's Cancer Institute - Twin Falls
-
-
Illinois
-
Bloomington, Illinois, Stany Zjednoczone, 61704
- Illinois CancerCare-Bloomington
-
Canton, Illinois, Stany Zjednoczone, 61520
- Illinois CancerCare-Canton
-
Carbondale, Illinois, Stany Zjednoczone, 62902
- Memorial Hospital of Carbondale
-
Carterville, Illinois, Stany Zjednoczone, 62918
- SIH Cancer Institute
-
Carthage, Illinois, Stany Zjednoczone, 62321
- Illinois CancerCare-Carthage
-
Centralia, Illinois, Stany Zjednoczone, 62801
- Centralia Oncology Clinic
-
Chicago, Illinois, Stany Zjednoczone, 60612
- University of Illinois
-
Danville, Illinois, Stany Zjednoczone, 61832
- Carle at The Riverfront
-
Decatur, Illinois, Stany Zjednoczone, 62526
- Decatur Memorial Hospital
-
Decatur, Illinois, Stany Zjednoczone, 62526
- Cancer Care Specialists of Illinois - Decatur
-
Dixon, Illinois, Stany Zjednoczone, 61021
- Illinois CancerCare-Dixon
-
Effingham, Illinois, Stany Zjednoczone, 62401
- Crossroads Cancer Center
-
Effingham, Illinois, Stany Zjednoczone, 62401
- Carle Physician Group-Effingham
-
Eureka, Illinois, Stany Zjednoczone, 61530
- Illinois CancerCare-Eureka
-
Galesburg, Illinois, Stany Zjednoczone, 61401
- Western Illinois Cancer Treatment Center
-
Galesburg, Illinois, Stany Zjednoczone, 61401
- Illinois CancerCare-Galesburg
-
Kewanee, Illinois, Stany Zjednoczone, 61443
- Illinois CancerCare-Kewanee Clinic
-
Macomb, Illinois, Stany Zjednoczone, 61455
- Illinois CancerCare-Macomb
-
Mattoon, Illinois, Stany Zjednoczone, 61938
- Carle Physician Group-Mattoon/Charleston
-
Mount Vernon, Illinois, Stany Zjednoczone, 62864
- SSM Health Good Samaritan
-
O'Fallon, Illinois, Stany Zjednoczone, 62269
- Cancer Care Center of O'Fallon
-
Ottawa, Illinois, Stany Zjednoczone, 61350
- Illinois CancerCare-Ottawa Clinic
-
Pekin, Illinois, Stany Zjednoczone, 61554
- Illinois CancerCare-Pekin
-
Pekin, Illinois, Stany Zjednoczone, 61554
- OSF Saint Francis Radiation Oncology at Pekin
-
Peoria, Illinois, Stany Zjednoczone, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Stany Zjednoczone, 61637
- OSF Saint Francis Medical Center
-
Peoria, Illinois, Stany Zjednoczone, 61615
- Illinois CancerCare-Peoria
-
Peoria, Illinois, Stany Zjednoczone, 61615
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
-
Peru, Illinois, Stany Zjednoczone, 61354
- Illinois CancerCare-Peru
-
Peru, Illinois, Stany Zjednoczone, 61354
- Valley Radiation Oncology
-
Princeton, Illinois, Stany Zjednoczone, 61356
- Illinois CancerCare-Princeton
-
Springfield, Illinois, Stany Zjednoczone, 62702
- Southern Illinois University School of Medicine
-
Springfield, Illinois, Stany Zjednoczone, 62702
- Springfield Clinic
-
Springfield, Illinois, Stany Zjednoczone, 62781
- Springfield Memorial Hospital
-
Urbana, Illinois, Stany Zjednoczone, 61801
- Carle Cancer Center
-
Washington, Illinois, Stany Zjednoczone, 61571
- Illinois CancerCare - Washington
-
-
Iowa
-
Ames, Iowa, Stany Zjednoczone, 50010
- Mary Greeley Medical Center
-
Ames, Iowa, Stany Zjednoczone, 50010
- McFarland Clinic - Ames
-
Carroll, Iowa, Stany Zjednoczone, 51401
- Saint Anthony Regional Hospital
-
Clive, Iowa, Stany Zjednoczone, 50325
- Mercy Cancer Center-West Lakes
-
Clive, Iowa, Stany Zjednoczone, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
-
Creston, Iowa, Stany Zjednoczone, 50801
- Greater Regional Medical Center
-
Des Moines, Iowa, Stany Zjednoczone, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, Stany Zjednoczone, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Stany Zjednoczone, 50314
- Broadlawns Medical Center
-
Des Moines, Iowa, Stany Zjednoczone, 50316
- Iowa Lutheran Hospital
-
Des Moines, Iowa, Stany Zjednoczone, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
-
Des Moines, Iowa, Stany Zjednoczone, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
-
West Des Moines, Iowa, Stany Zjednoczone, 50266-7700
- Methodist West Hospital
-
West Des Moines, Iowa, Stany Zjednoczone, 50266
- Mercy Medical Center-West Lakes
-
-
Kansas
-
Garden City, Kansas, Stany Zjednoczone, 67846
- Central Care Cancer Center - Garden City
-
Great Bend, Kansas, Stany Zjednoczone, 67530
- Central Care Cancer Center - Great Bend
-
-
Kentucky
-
Lexington, Kentucky, Stany Zjednoczone, 40504
- Saint Joseph Radiation Oncology Resource Center
-
Lexington, Kentucky, Stany Zjednoczone, 40509
- CommonSpirit Saint Joseph Medical Center - East Lexington
-
Louisville, Kentucky, Stany Zjednoczone, 40202
- Jewish Hospital
-
Louisville, Kentucky, Stany Zjednoczone, 40245
- UofL Health Medical Center Northeast
-
-
Massachusetts
-
Springfield, Massachusetts, Stany Zjednoczone, 01199
- Baystate Medical Center
-
Worcester, Massachusetts, Stany Zjednoczone, 01655
- UMass Memorial Medical Center - University Campus
-
-
Minnesota
-
Burnsville, Minnesota, Stany Zjednoczone, 55337
- Fairview Ridges Hospital
-
Burnsville, Minnesota, Stany Zjednoczone, 55337
- Minnesota Oncology - Burnsville
-
Coon Rapids, Minnesota, Stany Zjednoczone, 55433
- Mercy Hospital
-
Edina, Minnesota, Stany Zjednoczone, 55435
- Fairview Southdale Hospital
-
Fridley, Minnesota, Stany Zjednoczone, 55432
- Unity Hospital
-
Maple Grove, Minnesota, Stany Zjednoczone, 55369
- Fairview Clinics and Surgery Center Maple Grove
-
Maplewood, Minnesota, Stany Zjednoczone, 55109
- Saint John's Hospital - Healtheast
-
Maplewood, Minnesota, Stany Zjednoczone, 55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis, Minnesota, Stany Zjednoczone, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, Stany Zjednoczone, 55407
- Abbott-Northwestern Hospital
-
Monticello, Minnesota, Stany Zjednoczone, 55362
- Monticello Cancer Center
-
Robbinsdale, Minnesota, Stany Zjednoczone, 55422
- North Memorial Medical Health Center
-
Rochester, Minnesota, Stany Zjednoczone, 55905
- Mayo Clinic in Rochester
-
Saint Louis Park, Minnesota, Stany Zjednoczone, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Paul, Minnesota, Stany Zjednoczone, 55101
- Regions Hospital
-
Saint Paul, Minnesota, Stany Zjednoczone, 55102
- United Hospital
-
Shakopee, Minnesota, Stany Zjednoczone, 55379
- Saint Francis Regional Medical Center
-
Waconia, Minnesota, Stany Zjednoczone, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, Stany Zjednoczone, 56201
- Rice Memorial Hospital
-
Woodbury, Minnesota, Stany Zjednoczone, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
-
Missouri
-
Ballwin, Missouri, Stany Zjednoczone, 63011
- Mercy Oncology and Hematology - Clayton-Clarkson
-
Bolivar, Missouri, Stany Zjednoczone, 65613
- Central Care Cancer Center - Bolivar
-
Cape Girardeau, Missouri, Stany Zjednoczone, 63703
- Saint Francis Medical Center
-
Cape Girardeau, Missouri, Stany Zjednoczone, 63703
- Mercy Cancer Center - Cape Girardeau
-
Farmington, Missouri, Stany Zjednoczone, 63640
- Parkland Health Center - Farmington
-
Jefferson City, Missouri, Stany Zjednoczone, 65109
- MU Health Care Goldschmidt Cancer Center
-
Joplin, Missouri, Stany Zjednoczone, 64804
- Freeman Health System
-
Joplin, Missouri, Stany Zjednoczone, 64804
- Mercy Hospital Joplin
-
Rolla, Missouri, Stany Zjednoczone, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
-
Rolla, Missouri, Stany Zjednoczone, 65401
- Phelps Health Delbert Day Cancer Institute
-
Saint Joseph, Missouri, Stany Zjednoczone, 64506
- Heartland Regional Medical Center
-
Sainte Genevieve, Missouri, Stany Zjednoczone, 63670
- Sainte Genevieve County Memorial Hospital
-
Springfield, Missouri, Stany Zjednoczone, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, Stany Zjednoczone, 65804
- Mercy Hospital Springfield
-
St Louis, Missouri, Stany Zjednoczone, 63131
- Missouri Baptist Medical Center
-
St Louis, Missouri, Stany Zjednoczone, 63141
- Mercy Hospital Saint Louis
-
St Louis, Missouri, Stany Zjednoczone, 63128
- Mercy Hospital South
-
Sullivan, Missouri, Stany Zjednoczone, 63080
- Missouri Baptist Sullivan Hospital
-
-
Montana
-
Billings, Montana, Stany Zjednoczone, 59101
- Billings Clinic Cancer Center
-
Bozeman, Montana, Stany Zjednoczone, 59715
- Bozeman Health Deaconess Hospital
-
Great Falls, Montana, Stany Zjednoczone, 59405
- Great Falls Clinic
-
Great Falls, Montana, Stany Zjednoczone, 59405
- Benefis Sletten Cancer Institute
-
Kalispell, Montana, Stany Zjednoczone, 59901
- Logan Health Medical Center
-
Missoula, Montana, Stany Zjednoczone, 59802
- Saint Patrick Hospital - Community Hospital
-
Missoula, Montana, Stany Zjednoczone, 59804
- Community Medical Center
-
-
Nebraska
-
Grand Island, Nebraska, Stany Zjednoczone, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
-
Kearney, Nebraska, Stany Zjednoczone, 68847
- CHI Health Good Samaritan
-
Omaha, Nebraska, Stany Zjednoczone, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, Stany Zjednoczone, 68122
- Alegent Health Immanuel Medical Center
-
Omaha, Nebraska, Stany Zjednoczone, 68130
- Alegent Health Lakeside Hospital
-
-
Nevada
-
Henderson, Nevada, Stany Zjednoczone, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
Henderson, Nevada, Stany Zjednoczone, 89074
- Oncology Las Vegas - Henderson
-
Las Vegas, Nevada, Stany Zjednoczone, 89102
- OptumCare Cancer Care at Charleston
-
Las Vegas, Nevada, Stany Zjednoczone, 89106
- Radiation Oncology Centers of Nevada Central
-
Las Vegas, Nevada, Stany Zjednoczone, 89119
- Radiation Oncology Centers of Nevada Southeast
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- OptumCare Cancer Care at MountainView
-
Las Vegas, Nevada, Stany Zjednoczone, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
-
Las Vegas, Nevada, Stany Zjednoczone, 89144
- Comprehensive Cancer Centers of Nevada - Town Center
-
Las Vegas, Nevada, Stany Zjednoczone, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, Stany Zjednoczone, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Stany Zjednoczone, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
-
Las Vegas, Nevada, Stany Zjednoczone, 89183
- OptumCare Cancer Care at Fort Apache
-
Reno, Nevada, Stany Zjednoczone, 89502
- Renown Regional Medical Center
-
Reno, Nevada, Stany Zjednoczone, 89503
- Saint Mary's Regional Medical Center
-
Reno, Nevada, Stany Zjednoczone, 89509
- Radiation Oncology Associates
-
-
New Hampshire
-
Concord, New Hampshire, Stany Zjednoczone, 03301
- New Hampshire Oncology Hematology PA-Concord
-
Lebanon, New Hampshire, Stany Zjednoczone, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
Manchester, New Hampshire, Stany Zjednoczone, 03103
- Solinsky Center for Cancer Care
-
-
New York
-
Lake Success, New York, Stany Zjednoczone, 11042
- Northwell Health/Center for Advanced Medicine
-
Middletown, New York, Stany Zjednoczone, 10940
- Garnet Health Medical Center
-
Mount Kisco, New York, Stany Zjednoczone, 10549
- Northern Westchester Hospital
-
New York, New York, Stany Zjednoczone, 10075
- Lenox Hill Hospital
-
New York, New York, Stany Zjednoczone, 10065
- Manhattan Eye Ear and Throat Hospital
-
-
Ohio
-
Cincinnati, Ohio, Stany Zjednoczone, 45220
- Good Samaritan Hospital - Cincinnati
-
Cincinnati, Ohio, Stany Zjednoczone, 45242
- Bethesda North Hospital
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Stany Zjednoczone, 73104
- University of Oklahoma Health Sciences Center
-
Oklahoma City, Oklahoma, Stany Zjednoczone, 73120
- Mercy Hospital Oklahoma City
-
-
Oregon
-
Bend, Oregon, Stany Zjednoczone, 97701
- Saint Charles Health System
-
Clackamas, Oregon, Stany Zjednoczone, 97015
- Clackamas Radiation Oncology Center
-
Clackamas, Oregon, Stany Zjednoczone, 97015
- Providence Cancer Institute Clackamas Clinic
-
Coos Bay, Oregon, Stany Zjednoczone, 97420
- Bay Area Hospital
-
Newberg, Oregon, Stany Zjednoczone, 97132
- Providence Newberg Medical Center
-
Portland, Oregon, Stany Zjednoczone, 97213
- Providence Portland Medical Center
-
Portland, Oregon, Stany Zjednoczone, 97225
- Providence Saint Vincent Medical Center
-
-
Pennsylvania
-
Chadds Ford, Pennsylvania, Stany Zjednoczone, 19317
- Christiana Care Health System-Concord Health Center
-
-
South Dakota
-
Rapid City, South Dakota, Stany Zjednoczone, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Stany Zjednoczone, 57105
- Avera Cancer Institute
-
-
Tennessee
-
Nashville, Tennessee, Stany Zjednoczone, 37232
- Vanderbilt University/Ingram Cancer Center
-
Nashville, Tennessee, Stany Zjednoczone, 37204
- Vanderbilt Breast Center at One Hundred Oaks
-
-
Texas
-
Bryan, Texas, Stany Zjednoczone, 77802
- Saint Joseph Regional Cancer Center
-
-
Vermont
-
Saint Johnsbury, Vermont, Stany Zjednoczone, 05819
- Dartmouth Cancer Center - North
-
-
Washington
-
Aberdeen, Washington, Stany Zjednoczone, 98520
- Providence Regional Cancer System-Aberdeen
-
Bellevue, Washington, Stany Zjednoczone, 98004
- Overlake Medical Center
-
Bellingham, Washington, Stany Zjednoczone, 98225
- PeaceHealth Saint Joseph Medical Center
-
Burien, Washington, Stany Zjednoczone, 98166
- Saint Anne Hospital
-
Centralia, Washington, Stany Zjednoczone, 98531
- Providence Regional Cancer System-Centralia
-
Edmonds, Washington, Stany Zjednoczone, 98026
- Swedish Cancer Institute-Edmonds
-
Everett, Washington, Stany Zjednoczone, 98201
- Providence Regional Cancer Partnership
-
Issaquah, Washington, Stany Zjednoczone, 98029
- Swedish Cancer Institute-Issaquah
-
Lacey, Washington, Stany Zjednoczone, 98503
- Providence Regional Cancer System-Lacey
-
Longview, Washington, Stany Zjednoczone, 98632
- PeaceHealth Saint John Medical Center
-
Renton, Washington, Stany Zjednoczone, 98055
- Valley Medical Center
-
Seattle, Washington, Stany Zjednoczone, 98107
- Swedish Medical Center-Ballard Campus
-
Seattle, Washington, Stany Zjednoczone, 98122
- Swedish Medical Center-First Hill
-
Sedro-Woolley, Washington, Stany Zjednoczone, 98284
- PeaceHealth United General Medical Center
-
Silverdale, Washington, Stany Zjednoczone, 98383
- Saint Joseph Medical Center Hematology and Oncology - Silverdale
-
Vancouver, Washington, Stany Zjednoczone, 98664
- PeaceHealth Southwest Medical Center
-
Walla Walla, Washington, Stany Zjednoczone, 99362
- Providence Saint Mary Regional Cancer Center
-
Yakima, Washington, Stany Zjednoczone, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
-
-
Wisconsin
-
Appleton, Wisconsin, Stany Zjednoczone, 54911
- ThedaCare Regional Cancer Center
-
New Richmond, Wisconsin, Stany Zjednoczone, 54017
- Cancer Center of Western Wisconsin
-
-
Wyoming
-
Sheridan, Wyoming, Stany Zjednoczone, 82801
- Welch Cancer Center
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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)
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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
Inne nazwy:
Undergo CT
Inne nazwy:
Undergo MRI
Inne nazwy:
Given IV
Inne nazwy:
Undergo sigmoidoscopy
Inne nazwy:
Undergo short-course radiation therapy
Inne nazwy:
Undergo TME
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
Patologiczna pełna odpowiedź
Ramy czasowe: W momencie całkowitego wycięcia mezorektum
|
W momencie całkowitego wycięcia mezorektum
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Rate of sphincter preservation in low-lying tumors
Ramy czasowe: Up to 5 years
|
95% confidence interval will be estimated. |
Up to 5 years
|
|
Disease free survival
Ramy czasowe: Up to 5 years
|
Kaplan-Meier method will be used. |
Up to 5 years
|
|
Overall survival
Ramy czasowe: Up to 5 years
|
Kaplan-Meier method will be used. |
Up to 5 years
|
|
Incidence of adverse events
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Kristen K Ciombor, ECOG-ACRIN Cancer Research Group
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
8 lutego 2022
Zakończenie podstawowe (Szacowany)
30 czerwca 2027
Ukończenie studiów (Szacowany)
30 czerwca 2027
Daty rejestracji na studia
Pierwszy przesłany
11 lutego 2021
Pierwszy przesłany, który spełnia kryteria kontroli jakości
11 lutego 2021
Pierwszy wysłany (Rzeczywisty)
12 lutego 2021
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
22 października 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
21 października 2026
Ostatnia weryfikacja
1 września 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Nowotwory według lokalizacji
- Nowotwory
- Choroby jelit
- Nowotwory przewodu pokarmowego
- Nowotwory Układu Pokarmowego
- Choroby Układu Pokarmowego
- Choroby przewodu pokarmowego
- Nowotwory jelita grubego
- Nowotwory jelit
- Choroby odbytu
- Nowotwory odbytnicy
- Aminokwasy, peptydy i białka
- Białka
- Techniki śledcze
- Lecznictwo
- Techniki i procedury diagnostyczne
- Diagnoza
- Procedury chirurgiczne, operacyjny
- Minimalnie inwazyjne procedury chirurgiczne
- Czynniki biologiczne
- Zjawiska fizyczne
- Przeciwciała, monoklonalne, humanizowane
- Przeciwciała, monoklonalne
- Przeciwciała
- Immunoglobuliny
- Immunoproteiny
- Białka krwi
- Globuliny w surowicy
- Globuliny
- Techniki diagnostyczne, chirurgiczne
- Endoskopia, przewód pokarmowy
- Endoskopia, układ trawienny
- Techniki diagnostyczne, układ trawienny
- Endoskopia
- Procedury chirurgiczne układu trawiennego
- Techniki chemii, analityczne
- Analiza widma
- Receptory, powierzchnia komórkowa
- Białka błony
- Antygeny
- Kolonoskopia
- Antygeny, powierzchnia
- Biomarkery
- Receptory, immunologiczne
- Antygeny, różnicowanie, limfocyt t
- Antygeny, różnicowanie
- Białka immunologiczne
- Kostymulujące i hamujące receptory komórek T
- Niwolumab
- Ipilimumab
- Radioterapia
- Promieniowanie
- Spektroskopia rezonansu magnetycznego
- Sigmoidoskopia
- Antygen CTLA-4
Inne numery identyfikacyjne badania
- NCI-2021-00912
- U10CA180820 (Grant/umowa NIH USA)
- NCI-2021-00912 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))
- EA2201 (Inny identyfikator: CTEP)
- EA2201 (Inny identyfikator: ECOG-ACRIN Cancer Research Group)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Tak
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .