Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Högdos rekombinant interferon Alfa-2B, Ipilimumab eller Pembrolizumab vid behandling av patienter med steg III-IV högriskmelanom som har tagits bort genom kirurgi

30 september 2026 uppdaterad av: National Cancer Institute (NCI)

En randomiserad fas III-studie som jämför läkare/patients val av antingen hög dos interferon eller Ipilimumab med MK-3475 (Pembrolizumab) hos patienter med högriskresekerat melanom

This randomized phase III trial studies how well pembrolizumab works compared with the current standard of care, physician/patient choice of either high-dose recombinant interferon alfa-2B or ipilimumab, in treating patients with stage III-IV melanoma that has been removed by surgery but is likely to come back or spread. High-dose recombinant interferon alfa-2B may help shrink or slow the growth of melanoma. Immunotherapy with monoclonal antibodies, such as ipilimumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether pembrolizumab is more effective than the current standard of care in treating patients with melanoma.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

PRIMARY OBJECTIVES:

I. To compare overall survival (OS) of patients with resected stage III and IV melanoma treated with physician/patient choice of either high dose interferon recombinant interferon alfa-2b (alfa-2b) or ipilimumab versus MK-3475 (pembrolizumab).

II. Among patients who are PD-L1 positive, to compare OS of patients with resected stage III and IV melanoma treated with physician/patient choice of either high dose interferon alfa-2b or ipilimumab versus MK-3475 (pembrolizumab).

III. To compare relapse-free survival (RFS) of patients with resected stage III and IV melanoma treated with physician/patient choice of either high dose interferon alfa-2b or ipilimumab to MK-3475 (pembrolizumab).

SECONDARY OBJECTIVES:

I. To estimate OS and RFS for patients who are PD-L1 negative or PD-L1 indeterminate in this population.

II. To compare OS and RFS of patients between the two arms within PD-L1 positive and negative subgroups and to look at the interaction between PD-L1 (positive versus negative) and treatment arm.

III. To assess the safety and tolerability of the regimens.

ADDITIONAL OBJECTIVES:

I. To bank tissue and whole blood in anticipation of future correlative studies in this patient population.

II. To evaluate PD-L1 expression through immunohistochemistry assay. III. To evaluate the effect of treatment-related side effects that may have an impact on the health-related domains of quality of life (QOL) using the Functional Assessment of Cancer Therapy (FACT)-Biological Response Modifiers (BRM), European Quality of Life Five Dimension Three Level Scale (EQ-5D-3L), and Functional Assessment of Chronic Illness Therapy Diarrhea (FACIT-D) between patients treated with physician/patient choice of either high-dose interferon alfa-2b or ipilimumab and MK-3475 (pembrolizumab).

IV. Pharmacokinetic (PK) and anti-drug antibody (ADA) testing will be performed on all patients receiving MK-3475 (pembrolizumab).

TRANSLATIONAL OBJECTIVES RELATED TO T-CELL RECEPTOR BETA CHAIN SEQUENCING:

I. To evaluate the association between TCR beta variable gene (TRBV) haplotype and grade 3-4 immune-related adverse events (irAEs) among stage III melanoma patients treated with adjuvant ipilimumab or pembrolizumab.

II. To describe the TRBV haplotype distribution among this cohort of patients studied.

TRANSLATIONAL MEDICINAL OBJECTIVE RELATED TO ASSOCIATION OF CIRCULATING TUMOR DNA (ctDNA) WITH RELAPSE-FREE SURVIVAL IN HIGH-RISK, RESECTED MELANOMA PATIENTS.

I. To evaluate associations between pretreatment ctDNA (present versus absent) and relapse within 2 years of randomization in a case-control analysis across treatment arms.

II. To evaluate associations between pretreatment ctDNA (present versus absent) and relapse within 2 years of randomization in a case-control analysis across treatment arms.

III. To evaluate associations between pretreatment ctDNA and relapse within 2 years of randomization in a case-control analysis within each treatment arm (after treatment arm data are unblinded to investigators).

IV. To evaluate associations between "early-on treatment" ctDNA levels and relapse within 2 years of randomization.

V. To describe ctDNA levels at end of therapy and time of relapse.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I:

INDUCTION THERAPY: Patients receive high-dose recombinant interferon alfa-2B intravenously (IV) over 20 minutes on days 1-5. Treatment repeats weekly for 4 weeks in the absence of disease progression or unacceptable toxicity. Or patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 3 weeks for a total of 4 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive high-dose recombinant interferon alfa-2B subcutaneously (SC) on days 1, 3, and 5. Treatment repeats every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity. Or patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for 3 years in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo computed tomography (CT) scan, positron emission tomography (PET) scan, magnetic resonance imaging (MRI) and blood sample collection throughout the study.

After completion of study treatment, patients are followed up at 30 days, 6 and 12 weeks, every 3 months for 2 years, every 6 months for 3 years, and then every 12 months for 5 years.

Studietyp

Interventionell

Inskrivning (Faktisk)

1301

Fas

Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Förenta staterna
- Alabama
  - Birmingham, Alabama, Förenta staterna, 35233
    - University of Alabama at Birmingham Cancer Center
- Arizona
  - Phoenix, Arizona, Förenta staterna, 85004
    - Cancer Center at Saint Joseph's
  - Scottsdale, Arizona, Förenta staterna, 85258
    - Virginia G Piper Cancer Care-Del Camino
  - Tucson, Arizona, Förenta staterna, 85719
    - Banner University Medical Center - Tucson
  - Tucson, Arizona, Förenta staterna, 85719
    - University of Arizona Cancer Center-North Campus
- Arkansas
  - Little Rock, Arkansas, Förenta staterna, 72205
    - University of Arkansas for Medical Sciences
  - Rogers, Arkansas, Förenta staterna, 72758
    - Highlands Oncology Group - Rogers
- California
  - Anaheim, California, Förenta staterna, 92806
    - Kaiser Permanente-Anaheim
  - Auburn, California, Förenta staterna, 95602
    - Sutter Auburn Faith Hospital
  - Baldwin Park, California, Förenta staterna, 91706
    - Kaiser Permanente-Baldwin Park
  - Bellflower, California, Förenta staterna, 90706
    - Kaiser Permanente-Bellflower
  - Costa Mesa, California, Förenta staterna, 92627
    - UC Irvine Health Cancer Center-Newport
  - Duarte, California, Förenta staterna, 91010
    - City of Hope Comprehensive Cancer Center
  - Fontana, California, Förenta staterna, 92335
    - Kaiser Permanente-Fontana
  - Fremont, California, Förenta staterna, 94538
    - Kaiser Permanente-Fremont
  - Fremont, California, Förenta staterna, 94538
    - Palo Alto Medical Foundation-Fremont
  - Fresno, California, Förenta staterna, 93720
    - Kaiser Permanente-Fresno
  - Harbor City, California, Förenta staterna, 90710
    - Kaiser Permanente South Bay
  - Irvine, California, Förenta staterna, 92618
    - Kaiser Permanente-Irvine
  - La Jolla, California, Förenta staterna, 92093
    - UC San Diego Moores Cancer Center
  - Los Angeles, California, Förenta staterna, 90033
    - USC / Norris Comprehensive Cancer Center
  - Los Angeles, California, Förenta staterna, 90048
    - Cedars-Sinai Medical Center
  - Los Angeles, California, Förenta staterna, 90095
    - UCLA / Jonsson Comprehensive Cancer Center
  - Los Angeles, California, Förenta staterna, 90027
    - Kaiser Permanente Los Angeles Medical Center
  - Los Angeles, California, Förenta staterna, 90034
    - Kaiser Permanente West Los Angeles
  - Los Angeles, California, Förenta staterna, 90033
    - Los Angeles General Medical Center
  - Marysville, California, Förenta staterna, 95901
    - Fremont - Rideout Cancer Center
  - Modesto, California, Förenta staterna, 95355
    - Memorial Medical Center
  - Modesto, California, Förenta staterna, 95356
    - Kaiser Permanente-Modesto
  - Mountain View, California, Förenta staterna, 94040
    - Palo Alto Medical Foundation-Camino Division
  - Newport Beach, California, Förenta staterna, 92663
    - USC Norris Oncology/Hematology-Newport Beach
  - Novato, California, Förenta staterna, 94945
    - Sutter Cancer Research Consortium
  - Oakland, California, Förenta staterna, 94611
    - Kaiser Permanente-Oakland
  - Orange, California, Förenta staterna, 92868
    - UC Irvine Health/Chao Family Comprehensive Cancer Center
  - Orange, California, Förenta staterna, 92868
    - Saint Joseph Hospital - Orange
  - Palo Alto, California, Förenta staterna, 94304
    - Stanford Cancer Institute Palo Alto
  - Palo Alto, California, Förenta staterna, 94301
    - Palo Alto Medical Foundation Health Care
  - Panorama City, California, Förenta staterna, 91402
    - Kaiser Permanente - Panorama City
  - Redwood City, California, Förenta staterna, 94063
    - Kaiser Permanente-Redwood City
  - Richmond, California, Förenta staterna, 94801
    - Kaiser Permanente-Richmond
  - Riverside, California, Förenta staterna, 92505
    - Kaiser Permanente-Riverside
  - Roseville, California, Förenta staterna, 95661
    - Kaiser Permanente-Roseville
  - Roseville, California, Förenta staterna, 95661
    - Sutter Roseville Medical Center
  - Sacramento, California, Förenta staterna, 95816
    - Sutter Medical Center Sacramento
  - Sacramento, California, Förenta staterna, 95817
    - University of California Davis Comprehensive Cancer Center
  - Sacramento, California, Förenta staterna, 95823
    - Kaiser Permanente-South Sacramento
  - Sacramento, California, Förenta staterna, 95825
    - Kaiser Permanente Sacramento Medical Center
  - San Diego, California, Förenta staterna, 92120
    - Kaiser Permanente-San Diego Zion
  - San Diego, California, Förenta staterna, 92108
    - Kaiser Permanente-Rio San Diego
  - San Francisco, California, Förenta staterna, 94115
    - Kaiser Permanente-San Francisco
  - San Francisco, California, Förenta staterna, 94115
    - California Pacific Medical Center-Pacific Campus
  - San Jose, California, Förenta staterna, 95119
    - Kaiser Permanente-Santa Teresa-San Jose
  - San Leandro, California, Förenta staterna, 94577
    - Kaiser Permanente San Leandro
  - San Marcos, California, Förenta staterna, 92078
    - Kaiser Permanente-San Marcos
  - San Rafael, California, Förenta staterna, 94903
    - Kaiser Permanente-San Rafael
  - Santa Clara, California, Förenta staterna, 95051
    - Kaiser Permanente Medical Center - Santa Clara
  - Santa Cruz, California, Förenta staterna, 95065
    - Palo Alto Medical Foundation-Santa Cruz
  - Santa Rosa, California, Förenta staterna, 95403
    - Kaiser Permanente-Santa Rosa
  - Santa Rosa, California, Förenta staterna, 95403
    - Sutter Pacific Medical Foundation
  - South San Francisco, California, Förenta staterna, 94080
    - Kaiser Permanente-South San Francisco
  - Stockton, California, Förenta staterna, 95210
    - Kaiser Permanente-Stockton
  - Sunnyvale, California, Förenta staterna, 94086
    - Palo Alto Medical Foundation-Sunnyvale
  - Truckee, California, Förenta staterna, 96161
    - Gene Upshaw Memorial Tahoe Forest Cancer Center
  - Vacaville, California, Förenta staterna, 95688
    - Kaiser Permanente Medical Center-Vacaville
  - Vallejo, California, Förenta staterna, 94589
    - Kaiser Permanente-Vallejo
  - Walnut Creek, California, Förenta staterna, 94596
    - Kaiser Permanente-Walnut Creek
  - Woodland Hills, California, Förenta staterna, 91367
    - Kaiser Permanente-Woodland Hills
- Colorado
  - Aurora, Colorado, Förenta staterna, 80045
    - UCHealth University of Colorado Hospital
  - Colorado Springs, Colorado, Förenta staterna, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, Förenta staterna, 80909
    - UCHealth Memorial Hospital Central
  - Denver, Colorado, Förenta staterna, 80205
    - Kaiser Permanente-Franklin
  - Denver, Colorado, Förenta staterna, 80218
    - Saint Joseph Hospital - Cancer Centers of Colorado
  - Denver, Colorado, Förenta staterna, 80210
    - AdventHealth Porter
  - Fort Collins, Colorado, Förenta staterna, 80524
    - Poudre Valley Hospital
  - Greeley, Colorado, Förenta staterna, 80631
    - Banner North Colorado Medical Center
  - Lafayette, Colorado, Förenta staterna, 80026
    - Kaiser Permanente-Rock Creek
  - Littleton, Colorado, Förenta staterna, 80122
    - AdventHealth Littleton
  - Lone Tree, Colorado, Förenta staterna, 80124
    - Kaiser Permanente-Lone Tree
  - Parker, Colorado, Förenta staterna, 80138
    - AdventHealth Parker
- Connecticut
  - Fairfield, Connecticut, Förenta staterna, 06824
    - Smilow Cancer Hospital Care Center-Fairfield
  - Hartford, Connecticut, Förenta staterna, 06105
    - Smilow Cancer Hospital Care Center at Saint Francis
  - New Haven, Connecticut, Förenta staterna, 06520
    - Yale University
  - Stamford, Connecticut, Förenta staterna, 06904
    - Stamford Hospital/Bennett Cancer Center
  - Trumbull, Connecticut, Förenta staterna, 06611
    - Smilow Cancer Hospital Care Center-Trumbull
- Delaware
  - Newark, Delaware, Förenta staterna, 19713
    - Helen F Graham Cancer Center
  - Newark, Delaware, Förenta staterna, 19713
    - Medical Oncology Hematology Consultants PA
  - Newark, Delaware, Förenta staterna, 19718
    - Christiana Care Health System-Christiana Hospital
  - Rehoboth Beach, Delaware, Förenta staterna, 19971
    - Beebe Health Campus
- District of Columbia
  - Washington D.C., District of Columbia, Förenta staterna, 20010
    - MedStar Washington Hospital Center
  - Washington D.C., District of Columbia, Förenta staterna, 20007
    - MedStar Georgetown University Hospital
- Florida
  - Lakeland, Florida, Förenta staterna, 33805
    - Lakeland Regional Health Hollis Cancer Center
  - Miami, Florida, Förenta staterna, 33136
    - University of Miami Miller School of Medicine-Sylvester Cancer Center
  - Miami Beach, Florida, Förenta staterna, 33140
    - Mount Sinai Medical Center
  - Orlando, Florida, Förenta staterna, 32806
    - Orlando Health Cancer Institute
  - Tampa, Florida, Förenta staterna, 33612
    - Moffitt Cancer Center
  - Weston, Florida, Förenta staterna, 33331
    - Cleveland Clinic-Weston
- Georgia
  - Atlanta, Georgia, Förenta staterna, 30322
    - Emory University Hospital/Winship Cancer Institute
  - Atlanta, Georgia, Förenta staterna, 30342
    - Northside Hospital
  - Cumming, Georgia, Förenta staterna, 30041
    - Northside Hospital-Forsyth
  - Savannah, Georgia, Förenta staterna, 31405
    - Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  - Savannah, Georgia, Förenta staterna, 31404
    - Memorial Health University Medical Center
  - Valdosta, Georgia, Förenta staterna, 31602
    - South Georgia Medical Center/Pearlman Cancer Center
- Hawaii
  - Honolulu, Hawaii, Förenta staterna, 96813
    - Queen's Medical Center
  - Honolulu, Hawaii, Förenta staterna, 96813
    - Hawaii Cancer Care Inc - Waterfront Plaza
  - Honolulu, Hawaii, Förenta staterna, 96813
    - Queen's Cancer Cenrer - POB I
  - Honolulu, Hawaii, Förenta staterna, 96813
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, Förenta staterna, 96813
    - University of Hawaii Cancer Center
  - Honolulu, Hawaii, Förenta staterna, 96817
    - Hawaii Cancer Care Inc-Liliha
  - Honolulu, Hawaii, Förenta staterna, 96817
    - Queen's Cancer Center - Kuakini
  - Honolulu, Hawaii, Förenta staterna, 96813
    - Island Urology
  - Honolulu, Hawaii, Förenta staterna, 96859
    - Tripler Army Medical Center
- Idaho
  - Boise, Idaho, Förenta staterna, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Boise, Idaho, Förenta staterna, 83712
    - Saint Luke's Cancer Institute - Boise
  - Coeur d'Alene, Idaho, Förenta staterna, 83814
    - Kootenai Health - Coeur d'Alene
  - Fruitland, Idaho, Förenta staterna, 83619
    - Saint Luke's Cancer Institute - Fruitland
  - Meridian, Idaho, Förenta staterna, 83642
    - Saint Luke's Cancer Institute - Meridian
  - Nampa, Idaho, Förenta staterna, 83687
    - Saint Luke's Cancer Institute - Nampa
  - Post Falls, Idaho, Förenta staterna, 83854
    - Kootenai Clinic Cancer Services - Post Falls
  - Sandpoint, Idaho, Förenta staterna, 83864
    - Kootenai Clinic Cancer Services - Sandpoint
  - Twin Falls, Idaho, Förenta staterna, 83301
    - Saint Luke's Cancer Institute - Twin Falls
- Illinois
  - Aurora, Illinois, Förenta staterna, 60504
    - Rush-Copley Medical Center
  - Bloomington, Illinois, Förenta staterna, 61704
    - Illinois CancerCare-Bloomington
  - Canton, Illinois, Förenta staterna, 61520
    - Illinois CancerCare-Canton
  - Centralia, Illinois, Förenta staterna, 62801
    - Centralia Oncology Clinic
  - Chicago, Illinois, Förenta staterna, 60611
    - Northwestern University
  - Chicago, Illinois, Förenta staterna, 60637
    - University of Chicago Comprehensive Cancer Center
  - Chicago, Illinois, Förenta staterna, 60612
    - Rush MD Anderson Cancer Center
  - Danville, Illinois, Förenta staterna, 61832
    - Carle at The Riverfront
  - Decatur, Illinois, Förenta staterna, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, Förenta staterna, 62526
    - Cancer Care Specialists of Illinois - Decatur
  - Effingham, Illinois, Förenta staterna, 62401
    - Crossroads Cancer Center
  - Effingham, Illinois, Förenta staterna, 62401
    - Carle Physician Group-Effingham
  - Elmhurst, Illinois, Förenta staterna, 60126
    - Elmhurst Memorial Hospital
  - Eureka, Illinois, Förenta staterna, 61530
    - Illinois CancerCare-Eureka
  - Evanston, Illinois, Förenta staterna, 60201
    - NorthShore University HealthSystem-Evanston Hospital
  - Galesburg, Illinois, Förenta staterna, 61401
    - Illinois CancerCare-Galesburg
  - Geneva, Illinois, Förenta staterna, 60134
    - Northwestern Medicine Cancer Center Delnor
  - Glenview, Illinois, Förenta staterna, 60026
    - NorthShore University HealthSystem-Glenbrook Hospital
  - Highland Park, Illinois, Förenta staterna, 60035
    - NorthShore University HealthSystem-Highland Park Hospital
  - Kewanee, Illinois, Förenta staterna, 61443
    - Illinois CancerCare-Kewanee Clinic
  - Macomb, Illinois, Förenta staterna, 61455
    - Illinois CancerCare-Macomb
  - Mattoon, Illinois, Förenta staterna, 61938
    - Carle Physician Group-Mattoon/Charleston
  - Maywood, Illinois, Förenta staterna, 60153
    - Loyola University Medical Center
  - Naperville, Illinois, Förenta staterna, 60540
    - Edward Hospital/Cancer Center
  - New Lenox, Illinois, Förenta staterna, 60451
    - UC Comprehensive Cancer Center at Silver Cross
  - O'Fallon, Illinois, Förenta staterna, 62269
    - Cancer Care Center of O'Fallon
  - Orland Park, Illinois, Förenta staterna, 60462
    - University of Chicago Medicine-Orland Park
  - Ottawa, Illinois, Förenta staterna, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Pekin, Illinois, Förenta staterna, 61554
    - Illinois CancerCare-Pekin
  - Peoria, Illinois, Förenta staterna, 61615
    - Illinois CancerCare-Peoria
  - Peru, Illinois, Förenta staterna, 61354
    - Illinois CancerCare-Peru
  - Plainfield, Illinois, Förenta staterna, 60585
    - Edward Hospital/Cancer Center?Plainfield
  - Princeton, Illinois, Förenta staterna, 61356
    - Illinois CancerCare-Princeton
  - Rockford, Illinois, Förenta staterna, 61114
    - UW Health Carbone Cancer Center Rockford
  - Springfield, Illinois, Förenta staterna, 62702
    - Southern Illinois University School of Medicine
  - Springfield, Illinois, Förenta staterna, 62702
    - Springfield Clinic
  - Springfield, Illinois, Förenta staterna, 62702
    - Central Illinois Hematology Oncology Center
  - Springfield, Illinois, Förenta staterna, 62781
    - Springfield Memorial Hospital
  - Urbana, Illinois, Förenta staterna, 61801
    - Carle Cancer Center
  - Urbana, Illinois, Förenta staterna, 61801
    - The Carle Foundation Hospital
  - Warrenville, Illinois, Förenta staterna, 60555
    - Northwestern Medicine Cancer Center Warrenville
  - Yorkville, Illinois, Förenta staterna, 60560
    - Rush-Copley Healthcare Center
- Indiana
  - Indianapolis, Indiana, Förenta staterna, 46237
    - Franciscan Health Indianapolis
  - Indianapolis, Indiana, Förenta staterna, 46202
    - Indiana University/Melvin and Bren Simon Cancer Center
  - Indianapolis, Indiana, Förenta staterna, 46219
    - Community Cancer Center East
  - Indianapolis, Indiana, Förenta staterna, 46227
    - Community Cancer Center South
  - Indianapolis, Indiana, Förenta staterna, 46256
    - Community Cancer Center North
  - Mooresville, Indiana, Förenta staterna, 46158
    - Franciscan Health Mooresville
  - Richmond, Indiana, Förenta staterna, 47374
    - Reid Health
- Iowa
  - Ames, Iowa, Förenta staterna, 50010
    - Mary Greeley Medical Center
  - Ames, Iowa, Förenta staterna, 50010
    - McFarland Clinic - Ames
  - Boone, Iowa, Förenta staterna, 50036
    - McFarland Clinic - Boone
  - Cedar Rapids, Iowa, Förenta staterna, 52402
    - Physicians' Clinic of Iowa PC
  - Clive, Iowa, Förenta staterna, 50325
    - Mercy Cancer Center-West Lakes
  - Clive, Iowa, Förenta staterna, 50325
    - UI Health Care Mission Cancer and Blood - West Des Moines Clinic
  - Des Moines, Iowa, Förenta staterna, 50309
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, Förenta staterna, 50314
    - Mercy Medical Center - Des Moines
  - Des Moines, Iowa, Förenta staterna, 50309
    - UI Health Care Mission Cancer and Blood - Des Moines Clinic
  - Des Moines, Iowa, Förenta staterna, 50314
    - UI Health Care Mission Cancer and Blood - Laurel Clinic
  - Fort Dodge, Iowa, Förenta staterna, 50501
    - McFarland Clinic - Trinity Cancer Center
  - Iowa City, Iowa, Förenta staterna, 52242
    - University of Iowa/Holden Comprehensive Cancer Center
  - Jefferson, Iowa, Förenta staterna, 50129
    - McFarland Clinic - Jefferson
  - Marshalltown, Iowa, Förenta staterna, 50158
    - McFarland Clinic - Marshalltown
  - West Des Moines, Iowa, Förenta staterna, 50266
    - Mercy Medical Center-West Lakes
- Kansas
  - Chanute, Kansas, Förenta staterna, 66720
    - Cancer Center of Kansas - Chanute
  - Dodge City, Kansas, Förenta staterna, 67801
    - Cancer Center of Kansas - Dodge City
  - El Dorado, Kansas, Förenta staterna, 67042
    - Cancer Center of Kansas - El Dorado
  - Garden City, Kansas, Förenta staterna, 67846
    - Saint Catherine Hospital
  - Great Bend, Kansas, Förenta staterna, 67530
    - Central Care Cancer Center - Great Bend
  - Great Bend, Kansas, Förenta staterna, 67530
    - Saint Rose Ambulatory and Surgery Center
  - Hays, Kansas, Förenta staterna, 67601
    - HaysMed
  - Kansas City, Kansas, Förenta staterna, 66160
    - University of Kansas Cancer Center
  - Kansas City, Kansas, Förenta staterna, 66112
    - University of Kansas Cancer Center-West
  - Lawrence, Kansas, Förenta staterna, 66044
    - Lawrence Memorial Hospital
  - Lenexa, Kansas, Förenta staterna, 66219
    - Kansas Institute of Medicine Cancer and Blood Center
  - Lenexa, Kansas, Förenta staterna, 66219
    - Minimally Invasive Surgery Hospital
  - Liberal, Kansas, Förenta staterna, 67905
    - Cancer Center of Kansas-Liberal
  - McPherson, Kansas, Förenta staterna, 67460
    - Cancer Center of Kansas - McPherson
  - Newton, Kansas, Förenta staterna, 67114
    - Cancer Center of Kansas - Newton
  - Olathe, Kansas, Förenta staterna, 66061
    - The University of Kansas Cancer Center - Olathe
  - Overland Park, Kansas, Förenta staterna, 66210
    - University of Kansas Cancer Center-Overland Park
  - Overland Park, Kansas, Förenta staterna, 66209
    - Menorah Medical Center
  - Overland Park, Kansas, Förenta staterna, 66213
    - Saint Luke's South Hospital
  - Parsons, Kansas, Förenta staterna, 67357
    - Cancer Center of Kansas - Parsons
  - Pittsburg, Kansas, Förenta staterna, 66762
    - Mercy Hospital Pittsburg
  - Salina, Kansas, Förenta staterna, 67401
    - Salina Regional Health Center
  - Salina, Kansas, Förenta staterna, 67401
    - Cancer Center of Kansas - Salina
  - Topeka, Kansas, Förenta staterna, 66606
    - University of Kansas Health System Saint Francis Campus
  - Wellington, Kansas, Förenta staterna, 67152
    - Cancer Center of Kansas - Wellington
  - Wichita, Kansas, Förenta staterna, 67214
    - Ascension Via Christi Hospitals Wichita
  - Wichita, Kansas, Förenta staterna, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, Förenta staterna, 67214
    - Cancer Center of Kansas - Wichita
  - Winfield, Kansas, Förenta staterna, 67156
    - Cancer Center of Kansas - Winfield
- Kentucky
  - Bardstown, Kentucky, Förenta staterna, 40004
    - CommonSpirit Saint Joseph Hospital - Bardstown
  - Lexington, Kentucky, Förenta staterna, 40504
    - Saint Joseph Radiation Oncology Resource Center
  - Lexington, Kentucky, Förenta staterna, 40509
    - CommonSpirit Saint Joseph Medical Center - East Lexington
  - Louisville, Kentucky, Förenta staterna, 40245
    - UofL Health Medical Center Northeast
  - Louisville, Kentucky, Förenta staterna, 40215
    - Saints Mary and Elizabeth Hospital
  - Owensboro, Kentucky, Förenta staterna, 42303
    - Owensboro Health Mitchell Memorial Cancer Center
- Louisiana
  - Baton Rouge, Louisiana, Förenta staterna, 70805
    - LSU Health Baton Rouge-North Clinic
  - Baton Rouge, Louisiana, Förenta staterna, 70809
    - Louisiana Hematology Oncology Associates LLC
  - Baton Rouge, Louisiana, Förenta staterna, 70809
    - Mary Bird Perkins Cancer Center
  - Baton Rouge, Louisiana, Förenta staterna, 70808
    - Our Lady of the Lake Physician Group
  - Covington, Louisiana, Förenta staterna, 70433
    - Northshore Oncology Associates-Covington
  - Monroe, Louisiana, Förenta staterna, 71202
    - Ochsner LSU Health Monroe Medical Center
  - Shreveport, Louisiana, Förenta staterna, 71103
    - LSU Health Sciences Center at Shreveport
- Maine
  - Augusta, Maine, Förenta staterna, 04330
    - Harold Alfond Center for Cancer Care
  - Bangor, Maine, Förenta staterna, 04401
    - Eastern Maine Medical Center
  - Brewer, Maine, Förenta staterna, 04412
    - Lafayette Family Cancer Center-EMMC
  - Westbrook, Maine, Förenta staterna, 04092
    - New England Cancer Specialists
- Maryland
  - Baltimore, Maryland, Förenta staterna, 21237
    - MedStar Franklin Square Medical Center/Weinberg Cancer Institute
  - Baltimore, Maryland, Förenta staterna, 21202
    - Mercy Medical Center
  - Frederick, Maryland, Förenta staterna, 21701
    - Frederick Memorial Hospital
- Massachusetts
  - Beverly, Massachusetts, Förenta staterna, 01915
    - Beverly Hospital
  - Boston, Massachusetts, Förenta staterna, 02215
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, Förenta staterna, 02215
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, Förenta staterna, 02118
    - Boston Medical Center
  - Boston, Massachusetts, Förenta staterna, 02114
    - Massachusetts General Hospital Cancer Center
  - Burlington, Massachusetts, Förenta staterna, 01805
    - Lahey Clinic
  - Gloucester, Massachusetts, Förenta staterna, 01930
    - Addison Gilbert Hospital
  - Springfield, Massachusetts, Förenta staterna, 01199
    - Baystate Medical Center
- Michigan
  - Ann Arbor, Michigan, Förenta staterna, 48109
    - University of Michigan Rogel Cancer Center
  - Detroit, Michigan, Förenta staterna, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, Förenta staterna, 48201
    - Wayne State University/Karmanos Cancer Institute
  - Detroit, Michigan, Förenta staterna, 48236
    - Henry Ford Health Saint John Hospital
  - East China Township, Michigan, Förenta staterna, 48054
    - Henry Ford River District Hospital
  - Escanaba, Michigan, Förenta staterna, 49829
    - OSF Saint Francis Hospital and Medical Group
  - Flint, Michigan, Förenta staterna, 48503
    - Hurley Medical Center
  - Flint, Michigan, Förenta staterna, 48503
    - Genesys Hurley Cancer Institute
  - Grand Rapids, Michigan, Förenta staterna, 49503
    - Trinity Health Grand Rapids Hospital
  - Grand Rapids, Michigan, Förenta staterna, 49503
    - Corewell Health Grand Rapids Hospitals - Butterworth Hospital
  - Grosse Pointe Woods, Michigan, Förenta staterna, 48236
    - Henry Ford Saint John Hospital - Academic
  - Grosse Pointe Woods, Michigan, Förenta staterna, 48236
    - Henry Ford Saint John Hospital - Breast
  - Grosse Pointe Woods, Michigan, Förenta staterna, 48236
    - Henry Ford Saint John Hospital - Van Elslander
  - Jackson, Michigan, Förenta staterna, 49201
    - Allegiance Health
  - Kalamazoo, Michigan, Förenta staterna, 49007
    - West Michigan Cancer Center
  - Lansing, Michigan, Förenta staterna, 48912
    - University of Michigan Health - Sparrow Lansing
  - Macomb, Michigan, Förenta staterna, 48044
    - Henry Ford Warren Hospital - Breast Macomb
  - Macomb, Michigan, Förenta staterna, 48044
    - Henry Ford Saint John Hospital - Macomb Medical
  - Muskegon, Michigan, Förenta staterna, 49444
    - Trinity Health Muskegon Hospital
  - Reed City, Michigan, Förenta staterna, 49677
    - Corewell Health Reed City Hospital
  - Rochester Hills, Michigan, Förenta staterna, 48309
    - Henry Ford Rochester Hospital
  - Saginaw, Michigan, Förenta staterna, 48601
    - MyMichigan Medical Center Saginaw
  - Traverse City, Michigan, Förenta staterna, 49684
    - Munson Medical Center
  - Warren, Michigan, Förenta staterna, 48093
    - Henry Ford Health Warren Hospital
  - Warren, Michigan, Förenta staterna, 48093
    - Henry Ford Warren Hospital - GLCMS
  - Wyoming, Michigan, Förenta staterna, 49519
    - University of Michigan Health - West
- Minnesota
  - Bemidji, Minnesota, Förenta staterna, 56601
    - Sanford Joe Lueken Cancer Center
  - Burnsville, Minnesota, Förenta staterna, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, Förenta staterna, 55433
    - Mercy Hospital
  - Duluth, Minnesota, Förenta staterna, 55805
    - Essentia Health Cancer Center
  - Duluth, Minnesota, Förenta staterna, 55805
    - Essentia Health Saint Mary's Medical Center
  - Duluth, Minnesota, Förenta staterna, 55805
    - Miller-Dwan Hospital
  - Edina, Minnesota, Förenta staterna, 55435
    - Fairview Southdale Hospital
  - Fergus Falls, Minnesota, Förenta staterna, 56537
    - Lake Region Healthcare Corporation-Cancer Care
  - Fridley, Minnesota, Förenta staterna, 55432
    - Unity Hospital
  - Maplewood, Minnesota, Förenta staterna, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, Förenta staterna, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, Förenta staterna, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, Förenta staterna, 55407
    - Abbott-Northwestern Hospital
  - Saint Louis Park, Minnesota, Förenta staterna, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Paul, Minnesota, Förenta staterna, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, Förenta staterna, 55102
    - United Hospital
  - Waconia, Minnesota, Förenta staterna, 55387
    - Ridgeview Medical Center
  - Woodbury, Minnesota, Förenta staterna, 55125
    - Minnesota Oncology Hematology PA-Woodbury
- Mississippi
  - Jackson, Mississippi, Förenta staterna, 39216
    - University of Mississippi Medical Center
- Missouri
  - Bonne Terre, Missouri, Förenta staterna, 63628
    - Parkland Health Center-Bonne Terre
  - Cape Girardeau, Missouri, Förenta staterna, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, Förenta staterna, 63703
    - Mercy Cancer Center - Cape Girardeau
  - Independence, Missouri, Förenta staterna, 64057
    - Centerpoint Medical Center LLC
  - Jefferson City, Missouri, Förenta staterna, 65109
    - MU Health Care Goldschmidt Cancer Center
  - Kansas City, Missouri, Förenta staterna, 64128
    - Kansas City Veterans Affairs Medical Center
  - Kansas City, Missouri, Förenta staterna, 64154
    - University of Kansas Cancer Center - North
  - Kansas City, Missouri, Förenta staterna, 64131
    - The University of Kansas Cancer Center-South
  - Kansas City, Missouri, Förenta staterna, 64111
    - Saint Luke's Hospital of Kansas City
  - Kansas City, Missouri, Förenta staterna, 64132
    - Research Medical Center
  - Kansas City, Missouri, Förenta staterna, 64118
    - Heartland Hematology and Oncology Associates Incorporated
  - Kansas City, Missouri, Förenta staterna, 64108
    - University Health Truman Medical Center
  - Lee's Summit, Missouri, Förenta staterna, 64064
    - University of Kansas Cancer Center - Lee's Summit
  - Lee's Summit, Missouri, Förenta staterna, 64086
    - Saint Luke's East - Lee's Summit
  - Liberty, Missouri, Förenta staterna, 64068
    - Liberty Hospital
  - Saint Joseph, Missouri, Förenta staterna, 64506
    - Heartland Regional Medical Center
  - Sainte Genevieve, Missouri, Förenta staterna, 63670
    - Sainte Genevieve County Memorial Hospital
  - Springfield, Missouri, Förenta staterna, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, Förenta staterna, 65804
    - Mercy Hospital Springfield
  - St Louis, Missouri, Förenta staterna, 63131
    - Missouri Baptist Medical Center
  - Sullivan, Missouri, Förenta staterna, 63080
    - Missouri Baptist Sullivan Hospital
- Montana
  - Anaconda, Montana, Förenta staterna, 59711
    - Community Hospital of Anaconda
  - Billings, Montana, Förenta staterna, 59101
    - Billings Clinic Cancer Center
  - Billings, Montana, Förenta staterna, 59101
    - Saint Vincent Healthcare
  - Bozeman, Montana, Förenta staterna, 59715
    - Bozeman Health Deaconess Hospital
  - Butte, Montana, Förenta staterna, 59701
    - Saint James Community Hospital and Cancer Treatment Center
  - Great Falls, Montana, Förenta staterna, 59405
    - Great Falls Clinic
  - Great Falls, Montana, Förenta staterna, 59405
    - Benefis Sletten Cancer Institute
  - Helena, Montana, Förenta staterna, 59601
    - Saint Peter's Community Hospital
  - Kalispell, Montana, Förenta staterna, 59901
    - Logan Health Medical Center
  - Missoula, Montana, Förenta staterna, 59802
    - Saint Patrick Hospital - Community Hospital
  - Missoula, Montana, Förenta staterna, 59804
    - Community Medical Center
- Nebraska
  - Grand Island, Nebraska, Förenta staterna, 68803
    - Nebraska Cancer Specialists/Oncology Hematology West PC
  - Lincoln, Nebraska, Förenta staterna, 68506
    - Nebraska Hematology and Oncology
  - Lincoln, Nebraska, Förenta staterna, 68516
    - Cancer Partners of Nebraska
  - Norfolk, Nebraska, Förenta staterna, 68701
    - Faith Regional Health Services Carson Cancer Center
  - Omaha, Nebraska, Förenta staterna, 68114
    - Nebraska Methodist Hospital
  - Omaha, Nebraska, Förenta staterna, 68124
    - Alegent Health Bergan Mercy Medical Center
  - Omaha, Nebraska, Förenta staterna, 68122
    - Alegent Health Immanuel Medical Center
  - Omaha, Nebraska, Förenta staterna, 68130
    - Alegent Health Lakeside Hospital
  - Omaha, Nebraska, Förenta staterna, 68124
    - Nebraska Cancer Specialists - Omaha
  - Scottsbluff, Nebraska, Förenta staterna, 69361
    - Regional West Medical Center Cancer Center
- Nevada
  - Henderson, Nevada, Förenta staterna, 89052
    - Comprehensive Cancer Centers of Nevada - Henderson
  - Henderson, Nevada, Förenta staterna, 89052
    - Cancer and Blood Specialists-Henderson
  - Henderson, Nevada, Förenta staterna, 89052
    - Las Vegas Cancer Center-Henderson
  - Henderson, Nevada, Förenta staterna, 89074
    - Comprehensive Cancer Centers of Nevada-Southeast Henderson
  - Henderson, Nevada, Förenta staterna, 89074
    - Oncology Las Vegas - Henderson
  - Las Vegas, Nevada, Förenta staterna, 89128
    - Comprehensive Cancer Centers of Nevada - Northwest
  - Las Vegas, Nevada, Förenta staterna, 89148
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, Förenta staterna, 89169
    - Comprehensive Cancer Centers of Nevada - Central Valley
  - Las Vegas, Nevada, Förenta staterna, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, Förenta staterna, 89121
    - Cancer Therapy and Integrative Medicine
  - Las Vegas, Nevada, Förenta staterna, 89148-2405
    - Las Vegas Cancer Center-Medical Center
  - Las Vegas, Nevada, Förenta staterna, 89128
    - Ann M Wierman MD LTD
  - Las Vegas, Nevada, Förenta staterna, 89169
    - University Cancer Center
  - Las Vegas, Nevada, Förenta staterna, 89183
    - OptumCare Cancer Care at Fort Apache
- New Hampshire
  - Dover, New Hampshire, Förenta staterna, 03820
    - Wentworth-Douglass Hospital
  - Lebanon, New Hampshire, Förenta staterna, 03756
    - Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
  - Manchester, New Hampshire, Förenta staterna, 03104
    - Dartmouth Cancer Center - Manchester/ DCC Manchester
  - Nashua, New Hampshire, Förenta staterna, 03060
    - Saint Joseph Hospital
  - Nashua, New Hampshire, Förenta staterna, 03063
    - Dartmouth Cancer Center - Nashua
- New Jersey
  - East Orange, New Jersey, Förenta staterna, 07018-1095
    - Veterans Adminstration New Jersey Health Care System
  - Hackensack, New Jersey, Förenta staterna, 07601
    - Hackensack University Medical Center
  - Livingston, New Jersey, Förenta staterna, 07039
    - Cooperman Barnabas Medical Center
  - New Brunswick, New Jersey, Förenta staterna, 08903
    - Rutgers Cancer Institute of New Jersey
- New Mexico
  - Albuquerque, New Mexico, Förenta staterna, 87102
    - Lovelace Medical Center-Saint Joseph Square
  - Albuquerque, New Mexico, Förenta staterna, 87106
    - Southwest Gynecologic Oncology Associates Inc
  - Albuquerque, New Mexico, Förenta staterna, 87106
    - University of New Mexico Cancer Center
- New York
  - Auburn, New York, Förenta staterna, 13021
    - Hematology Oncology Associates of Central New York-Auburn
  - Buffalo, New York, Förenta staterna, 14263
    - Roswell Park Cancer Institute
  - Camillus, New York, Förenta staterna, 13031
    - Hematology Oncology Associates of CNY at Camillus
  - East Syracuse, New York, Förenta staterna, 13057
    - Hematology Oncology Associates of Central New York-East Syracuse
  - Glens Falls, New York, Förenta staterna, 12801
    - Glens Falls Hospital
  - New York, New York, Förenta staterna, 10032
    - NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
  - Rochester, New York, Förenta staterna, 14642
    - University of Rochester
  - Rochester, New York, Förenta staterna, 14621
    - Rochester General Hospital
  - Stony Brook, New York, Förenta staterna, 11794
    - Stony Brook University Medical Center
  - Syracuse, New York, Förenta staterna, 13210
    - State University of New York Upstate Medical University
- North Carolina
  - Chapel Hill, North Carolina, Förenta staterna, 27599
    - UNC Lineberger Comprehensive Cancer Center
  - Clinton, North Carolina, Förenta staterna, 28328
    - Southeastern Medical Oncology Center-Clinton
  - Durham, North Carolina, Förenta staterna, 27710
    - Duke University Medical Center
  - Goldsboro, North Carolina, Förenta staterna, 27534
    - Southeastern Medical Oncology Center-Goldsboro
  - Goldsboro, North Carolina, Förenta staterna, 27534
    - Wayne Memorial Hospital
  - Hendersonville, North Carolina, Förenta staterna, 28791
    - Margaret R Pardee Memorial Hospital
  - Jacksonville, North Carolina, Förenta staterna, 28546
    - Southeastern Medical Oncology Center-Jacksonville
- North Dakota
  - Bismarck, North Dakota, Förenta staterna, 58501
    - Sanford Bismarck Medical Center
  - Fargo, North Dakota, Förenta staterna, 58122
    - Sanford Roger Maris Cancer Center
  - Fargo, North Dakota, Förenta staterna, 58122
    - Sanford Broadway Medical Center
  - Grand Forks, North Dakota, Förenta staterna, 58201
    - Altru Cancer Center
- Ohio
  - Beachwood, Ohio, Förenta staterna, 44122
    - UHHS-Chagrin Highlands Medical Center
  - Belpre, Ohio, Förenta staterna, 45714
    - Strecker Cancer Center-Belpre
  - Centerville, Ohio, Förenta staterna, 45459
    - Miami Valley Hospital South
  - Centerville, Ohio, Förenta staterna, 45459
    - Dayton Physicians LLC-Miami Valley South
  - Chillicothe, Ohio, Förenta staterna, 45601
    - Adena Regional Medical Center
  - Cincinnati, Ohio, Förenta staterna, 45219
    - University of Cincinnati Cancer Center-UC Medical Center
  - Cleveland, Ohio, Förenta staterna, 44106
    - Case Western Reserve University
  - Cleveland, Ohio, Förenta staterna, 44109
    - MetroHealth Medical Center
  - Cleveland, Ohio, Förenta staterna, 44195
    - Cleveland Clinic Foundation
  - Cleveland, Ohio, Förenta staterna, 44111
    - Cleveland Clinic Cancer Center/Fairview Hospital
  - Columbus, Ohio, Förenta staterna, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, Förenta staterna, 43210
    - Ohio State University Comprehensive Cancer Center
  - Columbus, Ohio, Förenta staterna, 43219
    - The Mark H Zangmeister Center
  - Columbus, Ohio, Förenta staterna, 43214
    - Columbus Oncology and Hematology Associates Inc
  - Columbus, Ohio, Förenta staterna, 43228
    - Doctors Hospital
  - Columbus, Ohio, Förenta staterna, 43213
    - Mount Carmel East Hospital
  - Columbus, Ohio, Förenta staterna, 43215
    - Grant Medical Center
  - Columbus, Ohio, Förenta staterna, 43222
    - Mount Carmel Health Center West
  - Dayton, Ohio, Förenta staterna, 45406
    - Good Samaritan Hospital - Dayton
  - Dayton, Ohio, Förenta staterna, 45409
    - Miami Valley Hospital
  - Dayton, Ohio, Förenta staterna, 45415
    - Miami Valley Hospital North
  - Dayton, Ohio, Förenta staterna, 45415
    - Dayton Physician LLC - Englewood
  - Delaware, Ohio, Förenta staterna, 43015
    - Delaware Health Center-Grady Cancer Center
  - Delaware, Ohio, Förenta staterna, 43015
    - Grady Memorial Hospital
  - Findlay, Ohio, Förenta staterna, 45840
    - Blanchard Valley Hospital
  - Findlay, Ohio, Förenta staterna, 45840
    - Armes Family Cancer Center
  - Findlay, Ohio, Förenta staterna, 45840
    - Orion Cancer Care
  - Independence, Ohio, Förenta staterna, 44131
    - Cleveland Clinic Cancer Center Independence
  - Kettering, Ohio, Förenta staterna, 45429
    - Kettering Medical Center
  - Kettering, Ohio, Förenta staterna, 45409
    - Greater Dayton Cancer Center
  - Mansfield, Ohio, Förenta staterna, 44906
    - Cleveland Clinic Cancer Center Mansfield
  - Mansfield, Ohio, Förenta staterna, 44903
    - OhioHealth Mansfield Hospital
  - Marietta, Ohio, Förenta staterna, 45750
    - Marietta Memorial Hospital
  - Marion, Ohio, Förenta staterna, 43302
    - OhioHealth Marion General Hospital
  - Mayfield Heights, Ohio, Förenta staterna, 44124
    - Hillcrest Hospital Cancer Center
  - Mount Vernon, Ohio, Förenta staterna, 43050
    - Knox Community Hospital
  - Newark, Ohio, Förenta staterna, 43055
    - Licking Memorial Hospital
  - Parma, Ohio, Förenta staterna, 44129
    - University Hospitals Parma Medical Center
  - Portsmouth, Ohio, Förenta staterna, 45662
    - Southern Ohio Medical Center
  - Sandusky, Ohio, Förenta staterna, 44870
    - North Coast Cancer Care
  - Sandusky, Ohio, Förenta staterna, 44870
    - UH Seidman Cancer Center at Firelands Regional Medical Center
  - Strongsville, Ohio, Förenta staterna, 44136
    - Cleveland Clinic Cancer Center Strongsville
  - Sylvania, Ohio, Förenta staterna, 43560
    - ProMedica Flower Hospital
  - Toledo, Ohio, Förenta staterna, 43614
    - University of Toledo
  - Warrensville Heights, Ohio, Förenta staterna, 44122
    - South Pointe Hospital
  - Westerville, Ohio, Förenta staterna, 43081
    - Saint Ann's Hospital
  - Wooster, Ohio, Förenta staterna, 44691
    - Cleveland Clinic Wooster Family Health and Surgery Center
  - Zanesville, Ohio, Förenta staterna, 43701
    - Genesis Healthcare System Cancer Care Center
- Oklahoma
  - Oklahoma City, Oklahoma, Förenta staterna, 73104
    - University of Oklahoma Health Sciences Center
  - Oklahoma City, Oklahoma, Förenta staterna, 73120
    - Mercy Hospital Oklahoma City
- Oregon
  - Portland, Oregon, Förenta staterna, 97239
    - Oregon Health and Science University
  - Portland, Oregon, Förenta staterna, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, Förenta staterna, 97227
    - Kaiser Permanente Northwest
- Pennsylvania
  - Abington, Pennsylvania, Förenta staterna, 19001
    - Jefferson Abington Hospital
  - Allentown, Pennsylvania, Förenta staterna, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Bethlehem, Pennsylvania, Förenta staterna, 18015
    - Saint Luke's University Hospital-Bethlehem Campus
  - Danville, Pennsylvania, Förenta staterna, 17822
    - Geisinger Medical Center
  - Ephrata, Pennsylvania, Förenta staterna, 17522
    - Ephrata Cancer Center
  - Ephrata, Pennsylvania, Förenta staterna, 17522
    - Ephrata Community Hospital
  - Erie, Pennsylvania, Förenta staterna, 16505
    - UPMC Hillman Cancer Center Erie
  - Gettysburg, Pennsylvania, Förenta staterna, 17325
    - Adams Cancer Center
  - Hanover, Pennsylvania, Förenta staterna, 17331
    - WellSpan Medical Oncology and Hematology
  - Hazleton, Pennsylvania, Förenta staterna, 18201
    - Geisinger Medical Center-Cancer Center Hazleton
  - Hershey, Pennsylvania, Förenta staterna, 17033-0850
    - Penn State Milton S Hershey Medical Center
  - Philadelphia, Pennsylvania, Förenta staterna, 19111
    - Fox Chase Cancer Center
  - Pittsburgh, Pennsylvania, Förenta staterna, 15212
    - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, Förenta staterna, 15224
    - West Penn Hospital
  - Pittsburgh, Pennsylvania, Förenta staterna, 15232
    - UPMC Hillman Cancer Center
  - Pottsville, Pennsylvania, Förenta staterna, 17901
    - Geisinger Cancer Services-Pottsville
  - West Reading, Pennsylvania, Förenta staterna, 19611
    - Reading Hospital
  - Wexford, Pennsylvania, Förenta staterna, 15090
    - Wexford Health and Wellness Pavilion
  - Wilkes-Barre, Pennsylvania, Förenta staterna, 18711
    - Geisinger Wyoming Valley/Henry Cancer Center
  - Williamsport, Pennsylvania, Förenta staterna, 17701
    - UPMC Susquehanna
  - York, Pennsylvania, Förenta staterna, 17403
    - WellSpan Health-York Cancer Center
  - York, Pennsylvania, Förenta staterna, 17403
    - WellSpan Health-York Hospital
- Rhode Island
  - Newport, Rhode Island, Förenta staterna, 02840
    - Newport Hospital
  - Providence, Rhode Island, Förenta staterna, 02903
    - Rhode Island Hospital
  - Providence, Rhode Island, Förenta staterna, 02906
    - Miriam Hospital
- South Carolina
  - Anderson, South Carolina, Förenta staterna, 29621
    - AnMed Health Cancer Center
  - Charleston, South Carolina, Förenta staterna, 29401
    - Roper Hospital
  - Charleston, South Carolina, Förenta staterna, 29406
    - Lowcountry Hematology Oncology PA-North Charleston
  - Charleston, South Carolina, Förenta staterna, 29414
    - Bon Secours Saint Francis Hospital
  - Charleston, South Carolina, Förenta staterna, 29403
    - Charleston Oncology - Roper
  - Charleston, South Carolina, Förenta staterna, 29414
    - Charleston Oncology - Saint Francis
  - Charleston, South Carolina, Förenta staterna, 29414
    - Lowcountry Oncology Associates - West Ashley
  - Greenville, South Carolina, Förenta staterna, 29607
    - Saint Francis Cancer Center
  - Mt. Pleasant, South Carolina, Förenta staterna, 29464
    - Lowcountry Oncology Associates - Mount Pleasant
- South Dakota
  - Rapid City, South Dakota, Förenta staterna, 57701
    - Rapid City Regional Hospital
  - Sioux Falls, South Dakota, Förenta staterna, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, Förenta staterna, 57104
    - Sanford Cancer Center Oncology Clinic
- Tennessee
  - Germantown, Tennessee, Förenta staterna, 38138
    - The West Clinic - Wolf River
  - Memphis, Tennessee, Förenta staterna, 38163
    - University of Tennessee Health Science Center
  - Memphis, Tennessee, Förenta staterna, 38104
    - The West Clinic - Mid-Town
  - Nashville, Tennessee, Förenta staterna, 37232
    - Vanderbilt University/Ingram Cancer Center
- Texas
  - Austin, Texas, Förenta staterna, 78731
    - Texas Oncology - Central Austin Cancer Center
  - Dallas, Texas, Förenta staterna, 75246
    - Baylor University Medical Center
  - Houston, Texas, Förenta staterna, 77030
    - UT MD Anderson Cancer Center
- Utah
  - American Fork, Utah, Förenta staterna, 84003
    - American Fork Hospital / Huntsman Intermountain Cancer Center
  - Cedar City, Utah, Förenta staterna, 84720
    - Sandra L Maxwell Cancer Center
  - Logan, Utah, Förenta staterna, 84321
    - Logan Regional Hospital
  - Murray, Utah, Förenta staterna, 84107
    - Intermountain Medical Center
  - Ogden, Utah, Förenta staterna, 84403
    - McKay-Dee Hospital Center
  - Provo, Utah, Förenta staterna, 84604
    - Utah Valley Regional Medical Center
  - Salt Lake City, Utah, Förenta staterna, 84112
    - Huntsman Cancer Institute/University of Utah
  - Salt Lake City, Utah, Förenta staterna, 84106
    - Utah Cancer Specialists-Salt Lake City
  - Salt Lake City, Utah, Förenta staterna, 84143
    - LDS Hospital
  - South Jordan, Utah, Förenta staterna, 84009
    - South Jordan Health Center
  - St. George, Utah, Förenta staterna, 84770
    - Saint George Regional Medical Center
- Vermont
  - Berlin Corners, Vermont, Förenta staterna, 05602
    - Central Vermont Medical Center/National Life Cancer Treatment
  - Burlington, Vermont, Förenta staterna, 05401
    - University of Vermont Medical Center
  - Burlington, Vermont, Förenta staterna, 05405
    - University of Vermont and State Agricultural College
- Virginia
  - Lynchburg, Virginia, Förenta staterna, 24501
    - Centra Alan B Pearson Regional Cancer Center
  - Richmond, Virginia, Förenta staterna, 23229
    - Virginia Cancer Institute
  - Richmond, Virginia, Förenta staterna, 23298
    - VCU Massey Comprehensive Cancer Center
  - South Hill, Virginia, Förenta staterna, 23970
    - VCU Community Memorial Health Center
- Washington
  - Aberdeen, Washington, Förenta staterna, 98520
    - Providence Regional Cancer System-Aberdeen
  - Centralia, Washington, Förenta staterna, 98531
    - Providence Regional Cancer System-Centralia
  - Everett, Washington, Förenta staterna, 98201
    - Providence Regional Cancer Partnership
  - Lacey, Washington, Förenta staterna, 98503
    - Providence Regional Cancer System-Lacey
  - Longview, Washington, Förenta staterna, 98632
    - PeaceHealth Saint John Medical Center
  - Seattle, Washington, Förenta staterna, 98122
    - Swedish Medical Center-First Hill
  - Seattle, Washington, Förenta staterna, 98112
    - Kaiser Permanente Washington
  - Shelton, Washington, Förenta staterna, 98584
    - Providence Regional Cancer System-Shelton
  - Vancouver, Washington, Förenta staterna, 98664
    - PeaceHealth Southwest Medical Center
  - Walla Walla, Washington, Förenta staterna, 99362
    - Providence Saint Mary Regional Cancer Center
  - Yelm, Washington, Förenta staterna, 98597
    - Providence Regional Cancer System-Yelm
- West Virginia
  - Bridgeport, West Virginia, Förenta staterna, 26330
    - United Hospital Center
  - Charleston, West Virginia, Förenta staterna, 25304
    - Vandalia Health/CAMC Institute for Academic Medicine
  - Morgantown, West Virginia, Förenta staterna, 26506
    - West Virginia University Healthcare
  - Parkersburg, West Virginia, Förenta staterna, 26101
    - Camden Clark Medical Center
- Wisconsin
  - Antigo, Wisconsin, Förenta staterna, 54409
    - Aspirus Cancer Care-Antigo-Volm Cancer Center
  - Burlington, Wisconsin, Förenta staterna, 53105
    - Aurora Cancer Care-Southern Lakes VLCC
  - Chippewa Falls, Wisconsin, Förenta staterna, 54729
    - Marshfield Clinic-Chippewa Center
  - Eau Claire, Wisconsin, Förenta staterna, 54701
    - Marshfield Clinic Cancer Center at Sacred Heart
  - Fond du Lac, Wisconsin, Förenta staterna, 54937
    - Aurora Health Center-Fond du Lac
  - Fond du Lac, Wisconsin, Förenta staterna, 54935
    - Saint Agnes Hospital/Agnesian Cancer Center
  - Germantown, Wisconsin, Förenta staterna, 53022
    - Aurora Health Care Germantown Health Center
  - Grafton, Wisconsin, Förenta staterna, 53024
    - Aurora Cancer Care-Grafton
  - Green Bay, Wisconsin, Förenta staterna, 54311
    - Aurora BayCare Medical Center
  - Green Bay, Wisconsin, Förenta staterna, 54301
    - Saint Vincent Hospital Cancer Center Green Bay
  - Green Bay, Wisconsin, Förenta staterna, 54303
    - Saint Vincent Hospital Cancer Center at Saint Mary's
  - Green Bay, Wisconsin, Förenta staterna, 54301-3526
    - Green Bay Oncology at Saint Vincent Hospital
  - Kenosha, Wisconsin, Förenta staterna, 53142
    - Aurora Cancer Care-Kenosha South
  - La Crosse, Wisconsin, Förenta staterna, 54601
    - Gundersen Lutheran Medical Center
  - Madison, Wisconsin, Förenta staterna, 53792
    - University of Wisconsin Carbone Cancer Center - University Hospital
  - Marinette, Wisconsin, Förenta staterna, 54143
    - Aurora Bay Area Medical Group-Marinette
  - Marinette, Wisconsin, Förenta staterna, 54143
    - Bay Area Medical Center
  - Marshfield, Wisconsin, Förenta staterna, 54449
    - Marshfield Medical Center-Marshfield
  - Menomonee Falls, Wisconsin, Förenta staterna, 53051
    - Froedtert Menomonee Falls Hospital
  - Milwaukee, Wisconsin, Förenta staterna, 53226
    - Medical College of Wisconsin
  - Milwaukee, Wisconsin, Förenta staterna, 53209
    - Aurora Cancer Care-Milwaukee
  - Milwaukee, Wisconsin, Förenta staterna, 53215
    - Aurora Saint Luke's Medical Center
  - Milwaukee, Wisconsin, Förenta staterna, 53233
    - Aurora Sinai Medical Center
  - Milwaukee, Wisconsin, Förenta staterna, 53210
    - Ascension Southeast Wisconsin Hospital-Saint Joseph-Milwaukee
  - Minocqua, Wisconsin, Förenta staterna, 54548
    - Marshfield Medical Center - Minocqua
  - New Richmond, Wisconsin, Förenta staterna, 54017
    - Cancer Center of Western Wisconsin
  - Oconto Falls, Wisconsin, Förenta staterna, 54154
    - Saint Vincent Hospital Cancer Center at Oconto Falls
  - Oshkosh, Wisconsin, Förenta staterna, 54904
    - Vince Lombardi Cancer Clinic - Oshkosh
  - Racine, Wisconsin, Förenta staterna, 53406
    - Aurora Cancer Care-Racine
  - Rice Lake, Wisconsin, Förenta staterna, 54868
    - Marshfield Medical Center-Rice Lake
  - Rice Lake, Wisconsin, Förenta staterna, 54868
    - Lakeview Medical Center-Marshfield Clinic
  - Sheboygan, Wisconsin, Förenta staterna, 53081
    - Vince Lombardi Cancer Clinic-Sheboygan
  - Sheboygan, Wisconsin, Förenta staterna, 53081
    - HSHS Saint Nicholas Hospital
  - Stevens Point, Wisconsin, Förenta staterna, 54481
    - Aspirus Cancer Care - Stevens Point
  - Sturgeon Bay, Wisconsin, Förenta staterna, 54235-1495
    - Saint Vincent Hospital Cancer Center at Sturgeon Bay
  - Summit, Wisconsin, Förenta staterna, 53066
    - Aurora Medical Center in Summit
  - Two Rivers, Wisconsin, Förenta staterna, 54241
    - Vince Lombardi Cancer Clinic-Two Rivers
  - Wausau, Wisconsin, Förenta staterna, 54401
    - Marshfield Clinic-Wausau Center
  - Wausau, Wisconsin, Förenta staterna, 54401
    - Aspirus Cancer Care-Wausau
  - Wauwatosa, Wisconsin, Förenta staterna, 53226
    - Aurora Cancer Care-Milwaukee West
  - West Allis, Wisconsin, Förenta staterna, 53227
    - Aurora West Allis Medical Center
  - Weston, Wisconsin, Förenta staterna, 54476
    - Marshfield Medical Center - Weston
  - Wisconsin Rapids, Wisconsin, Förenta staterna, 54494
    - Aspirus Cancer Care - Wisconsin Rapids
  - Wisconsin Rapids, Wisconsin, Förenta staterna, 54494
    - Marshfield Clinic - Wisconsin Rapids Center
- Wyoming
  - Cody, Wyoming, Förenta staterna, 82414
    - Big Horn Basin Cancer Center
  - Cody, Wyoming, Förenta staterna, 82414
    - Billings Clinic-Cody
  - Sheridan, Wyoming, Förenta staterna, 82801
    - Welch Cancer Center
Irland
- Co Dublin
  - Dublin, Co Dublin, Irland, 4
    - Saint Vincent's University Hospital
- Co Galway
  - Galway, Co Galway, Irland
    - University College Hospital Galway
- Co Waterford
  - Waterford, Co Waterford, Irland, 9
    - University Hospital Waterford
Kanada
- British Columbia
  - Vancouver, British Columbia, Kanada, V5Z 4E6
    - BCCA-Vancouver Cancer Centre
- New Brunswick
  - Moncton, New Brunswick, Kanada, E1C 8X3
    - The Vitalite Health Network - Dr Leon Richard Oncology Centre
- Ontario
  - Barrie, Ontario, Kanada, L4M 6M2
    - Royal Victoria Regional Health Centre
  - Hamilton, Ontario, Kanada, L8V 5C2
    - Juravinski Cancer Centre at Hamilton Health Sciences
  - Kingston, Ontario, Kanada, K7L 2V7
    - Kingston Health Sciences Centre
  - Kitchener, Ontario, Kanada, N2G 1G3
    - Waterloo Regional Health Network
  - London, Ontario, Kanada, N6A 4L6
    - London Regional Cancer Program
  - Mississauga, Ontario, Kanada, L5M 2N1
    - Trillium Health Partners - Credit Valley Hospital
  - Oshawa, Ontario, Kanada, L1G 2B9
    - Lakeridge Health Oshawa
  - Ottawa, Ontario, Kanada, K1H 8L6
    - Ottawa Hospital and Cancer Center-General Campus
  - Sault Ste. Marie, Ontario, Kanada, P6B 0A8
    - Algoma District Cancer Program Sault Area Hospital
  - Thunder Bay, Ontario, Kanada, P7B 6V4
    - Thunder Bay Regional Health Science Centre
  - Toronto, Ontario, Kanada, M5G 2M9
    - University Health Network-Princess Margaret Hospital
  - Toronto, Ontario, Kanada, M4N 3M5
    - Odette Cancer Centre- Sunnybrook Health Sciences Centre
  - Windsor, Ontario, Kanada, N8W 2X3
    - Windsor Regional Cancer Centre
- Quebec
  - Laval, Quebec, Kanada, H7M 3L9
    - Hopital de la Cite-de-la-Sante
  - Montreal, Quebec, Kanada, H3H 2R9
    - The Research Institute of the McGill University Health Centre (MUHC)
  - Québec, Quebec, Kanada, G1R 2J6
    - CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
  - Sherbrooke, Quebec, Kanada, J1H 5N4
    - Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
- Saskatchewan
  - Regina, Saskatchewan, Kanada, S4T 7T1
    - Allan Blair Cancer Centre
  - Saskatoon, Saskatchewan, Kanada, S7N 4H4
    - Saskatoon Cancer Centre

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:

STEP 1 REGISTRATION:
Patients must have completely resected melanoma of cutaneous origin or of unknown primary in order to be eligible for this study; patients must be classified as stage IIIA (N2a), IIIB, IIIC, or stage IV melanoma; patients with non-ulcerated T1b N1a disease are not eligible; patients with melanoma of mucosal or other non-cutaneous origin are eligible; patients with melanoma of ocular origin are not eligible; patients with a history of brain metastases are ineligible
Patients are eligible for this trial either at initial presentation of their melanoma or at the time of the first detected nodal, satellite/in-transit, distant metastases, or recurrent disease in prior lymphadenectomy basin or distant site; nodal, satellite/in-transit metastasis, distant metastases or disease in a prior complete lymphadenectomy basin must have been confirmed histologically by hematoxylin and eosin (H & E) stained slides
Patients with multiple regional nodal basin involvement are eligible; gross or microscopic extracapsular nodal extension is permitted
Patients at initial presentation of melanoma must undergo an adequate wide excision of the primary lesion, if present; patients with previously diagnosed melanoma must have had all current disease resected with pathologically negative margins and must have no evidence of disease at the primary site or must undergo re-resection of the primary site; a full lymphadenectomy meeting the criteria outlined is required for all node-positive patients including those with positive sentinel nodes; patients with recurrent disease who have had a prior complete lymphadenectomy fulfill this requirement as long as all recurrent disease has been resected; for all patients, all disease must have been resected with negative pathological margins and no clinical, radiologic, or pathological evidence of any incompletely resected melanoma; patients must be registered within 98 days of the last surgery performed to render the patient free of disease
Patients must have available and be willing to submit a minimum of five unstained slides from primary, lymph node, or metastatic site to determine PD-L1 expression; the tumor tissue must be adequate for PD-L1 testing (defined as >= 100 tumor cells as confirmed by the treating institution's local pathologist); this must be documented by having a pathologist sign the S1404 Local Pathology Review form prior to step 1 registration; the specimens may come from an archived block but must be submitted within 20 days from cutting the slides
Patients must be offered the opportunity to participate in specimen banking as outlined
Patients must be willing to have blood draws for PK/ADA analysis as outlined, should the patient be randomized to the MK-3475 arm
Patients may have received prior radiation therapy, including after the surgical resection; all adverse events associated with prior surgery and radiation therapy must have resolved to =< grade 1 prior to registration
Patients must not have received neoadjuvant treatment for their melanoma; patients must not have had prior immunotherapy including, but not limited to ipilimumab, interferon alfa-2b, high dose IL-2, pegylated (PEG)-IFN, anti-PD-1, anti-PD-L1 intra-tumoral, or vaccine therapies; patients must not be planning to receive any of the prohibited therapies during the screening or treatment phases of the study
Patients must not be planning to receive concomitant other biologic therapy, radiation therapy, hormonal therapy, other chemotherapy, surgery or other therapy after step 2 registration
All patients must have disease-free status documented by a complete physical examination and imaging studies within 42 days prior to registration; imaging studies must include a total body positron emission tomography (PET)-computed tomography (CT) scan that is of diagnostic quality (with or without brain) or a CT of the chest, abdomen and pelvis; for patients with melanoma arising from the head and neck, dedicated neck imaging (CT with IV contrast or PET-CT through the region) is required; if the patient has had unknown primary with disease in the axilla, neck imaging is required to assure region is clear of cancer; CT imaging should be done with intravenous contrast if there are no contraindications for it; any other clinically-indicated imaging studies if performed (e.g. bone scan) must show no evidence of disease
All patients must have a CT or magnetic resonance imaging (MRI) of the brain within 90 days prior to registration; the brain CT or MRI should be performed with intravenous contrast (unless contraindicated)
Absolute neutrophil count (ANC) >= 1,500 microliter (mcL) (within 42 days prior to registration)
Platelets >= 100,000 mcL (within 42 days prior to registration)
Hemoglobin >= 10 g/dL (within 42 days prior to registration)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL) (within 42 days prior to registration)
Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2 x IULN (within 42 days prior to registration)
Alkaline phosphatase =< 2 x IULN (within 42 days prior to registration)
Serum creatinine =< IULN OR measured or calculated creatinine clearance >= 60 mL/min (within 42 days prior to registration)
Patients must have lactate dehydrogenase (LDH) performed within 42 days prior to registration
Patients must have Zubrod performance status =< 1
Patients must have a baseline electrocardiogram (ECG) performed within 42 days of registration that is normal or considered not clinically significant by the site investigator
Patients must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
Patients must not have an active infection requiring systemic therapy
Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Patients must not have received live vaccines within 42 days prior to registration; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed
Patients known to be human immunodeficiency virus (HIV) positive are eligible if they meet the following criteria within 30 days prior to registration: stable and adequate cluster of differentiation 4 (CD4) counts (>= 350 mm^3), and serum HIV viral load of < 25,000 IU/ml; patients may be on or off anti-viral therapy so long as they meet the CD4 count criteria
Patients must not have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection prior to registration
Patients must not have a history or current evidence of any condition, therapy or laboratory abnormality that might confound the trial results, interfere with the patient's participation for the full duration of the trial, or indicate that participation in the trial is not in the patient's best interests, in the opinion of the treating investigator
No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, lobular carcinoma of the breast in situ, atypical melanocytic hyperplasia or melanoma in situ, adequately treated stage I or II cancer (including multiple primary melanomas) from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years
Women of childbearing potential must have a negative urine or serum pregnancy test within 28 days prior to registration; women/men of reproductive potential must have agreed to use an effective contraceptive method for the course of the study through 120 days after the last dose of study medication; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures, he/she is responsible for beginning contraceptive measures; patients must not be pregnant or nursing due to unknown teratogenic side effects
Patients who are able to complete questionnaires in English, Spanish or French must participate in the quality of life assessments; (those patients who cannot complete the quality of life questionnaires in English, Spanish or French can be registered to S1404 without contributing to the quality of life studies)
Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines
As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
STEP 2 REGISTRATION (RANDOMIZATION CRITERIA):
Patients must not be registered until receiving confirmation from the Southwest Oncology Group (SWOG) Statistical Center that the patient's tissue specimen was adequate for PD-L1 testing; patients must be registered within 7 working days of receiving the e-mail notification
Women of childbearing potential must plan to have a urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a negative serum pregnancy test will be required
No tests or exams are required to be repeated for step 2 registration (randomization); however, patients who are known to have a change in eligibility status after step 1 registration are not eligible for step 2 registration; for example, ANC is not required to be repeated between step 1 and step 2 registration, but the most recent ANC performed before step 2 registration is required to be >= 1,500 mcL

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: Randomiserad
Interventionsmodell: Parallellt uppdrag
Maskning: Dubbel

Antal vapen

Vapen och interventioner

Deltagargrupp / Arm	Intervention / Behandling
Aktiv komparator: Arm I (high-dose recombinant interferon alfa-2B, ipilimumab) INDUCTION THERAPY: Patients receive high-dose recombinant interferon alfa-2B intravenously (IV) over 20 minutes on days 1-5. Treatment repeats weekly for 4 weeks in the absence of disease progression or unacceptable toxicity. Or patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 3 weeks for a total of 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive high-dose recombinant interferon alfa-2B subcutaneously (SC) on days 1, 3, and 5. Treatment repeats every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity. Or patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for 3 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan, MRI and blood sample collection throughout the study.	Övrig: Quality-of-Life Assessment Ancillary studies Andra namn: Livskvalitetsbedömning Procedur: Biospecimen Collection Undergo blood sample collection Andra namn: Biologisk provsamling Bioprov insamlat Provsamling Provuppsamling Biologisk: Ipilimumab Given IV Andra namn: Anti-cytotoxisk T-lymfocyt-associerad antigen-4 monoklonal antikropp BMS-734016 Ipilimumab Biosimilar CS1002 MDX-010 MDX-CTLA4 Yervoy MDX010 BMS734016 BMS 734016 MDX 010 Biologisk: Recombinant Interferon Alfa-2b Given IV and SC Andra namn: Alfatronol Glukoferon Heberon Alfa IFN alfa-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A Sch 30500 Urifron Viraferon Bioferon Bioferon (TM) Procedur: Magnetic Resonance Imaging Undergo MRI Andra namn: MRI Magnetisk resonans Magnetic Resonance Imaging Scan Medicinsk bildbehandling, magnetisk resonans / kärnmagnetisk resonans HERR MR-avbildning MRI-skanning NMR-avbildning NMRI Kärnmagnetisk resonanstomografi Magnetisk resonanstomografi (MRT) sMRI Magnetisk resonanstomografi (förfarande) Strukturell MRI Procedur: Computed Tomography Undergo CT scan Andra namn: CT KATT Datortomografi Beräknad axiell tomografi Datoriserad axialtomografi tomografi Datoriserad axiell tomografi (förfarande) Datortomografi (CT) skanning Diagnostisk kattskanning Diagnostisk kattskanningstjänsttyp Procedur: Positron Emission Tomography Undergo PET scan Andra namn: Medicinsk avbildning, Positron Emission Tomografi SÄLLSKAPSDJUR Djur Scan Positron Emission Tomography Scan Positronemissionstomografi PT Positronemissionstomografi (förfarande)
Experimentell: Arm II (pembrolizumab) Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan, MRI and blood sample collection throughout the study.	Övrig: Quality-of-Life Assessment Ancillary studies Andra namn: Livskvalitetsbedömning Procedur: Biospecimen Collection Undergo blood sample collection Andra namn: Biologisk provsamling Bioprov insamlat Provsamling Provuppsamling Procedur: Magnetic Resonance Imaging Undergo MRI Andra namn: MRI Magnetisk resonans Magnetic Resonance Imaging Scan Medicinsk bildbehandling, magnetisk resonans / kärnmagnetisk resonans HERR MR-avbildning MRI-skanning NMR-avbildning NMRI Kärnmagnetisk resonanstomografi Magnetisk resonanstomografi (MRT) sMRI Magnetisk resonanstomografi (förfarande) Strukturell MRI Biologisk: Pembrolizumab Given IV Andra namn: Keytruda MK-3475 Lambrolizumab SCH 900475 MK3475 SCH-900475 BCD-201 Pembrolizumab Biosimilar BCD-201 Pembrolizumab Biosimilar QL2107 QL2107 GME 751 GME751 Pembrolizumab Biosimilar GME751 MK 3475 SCH900475 Pembrolizumab Biosimilar RPH-075 RPH 075 RPH-075 RPH075 Pembrolizumab biosimilar sb27 SB 27 SB-27 Sb27 Procedur: Positron Emission Tomography Undergo PET scan Andra namn: Medicinsk avbildning, Positron Emission Tomografi SÄLLSKAPSDJUR Djur Scan Positron Emission Tomography Scan Positronemissionstomografi PT Positronemissionstomografi (förfarande)

Deltagargrupp / Arm

Intervention / Behandling

Aktiv komparator: Arm I (high-dose recombinant interferon alfa-2B, ipilimumab)

Patients undergo CT scan, PET scan, MRI and blood sample collection throughout the study.

Övrig: Quality-of-Life Assessment

Ancillary studies

Andra namn:

Livskvalitetsbedömning

Procedur: Biospecimen Collection

Undergo blood sample collection

Andra namn:

Biologisk provsamling
Bioprov insamlat
Provsamling
Provuppsamling

Biologisk: Ipilimumab

Given IV

Andra namn:

Anti-cytotoxisk T-lymfocyt-associerad antigen-4 monoklonal antikropp
BMS-734016
Ipilimumab Biosimilar CS1002
MDX-010
MDX-CTLA4
Yervoy
MDX010
BMS734016
BMS 734016
MDX 010

Biologisk: Recombinant Interferon Alfa-2b

Given IV and SC

Andra namn:

Alfatronol
Glukoferon
Heberon Alfa
IFN alfa-2B
Interferon alfa 2b
Interferon Alfa-2B
Interferon Alpha-2b
Intron A
Sch 30500
Urifron
Viraferon
Bioferon
Bioferon (TM)

Procedur: Magnetic Resonance Imaging

Undergo MRI

Andra namn:

MRI
Magnetisk resonans
Magnetic Resonance Imaging Scan
Medicinsk bildbehandling, magnetisk resonans / kärnmagnetisk resonans
HERR
MR-avbildning
MRI-skanning
NMR-avbildning
NMRI
Kärnmagnetisk resonanstomografi
Magnetisk resonanstomografi (MRT)
sMRI
Magnetisk resonanstomografi (förfarande)
Strukturell MRI

Procedur: Computed Tomography

Undergo CT scan

Andra namn:

CT
KATT
Datortomografi
Beräknad axiell tomografi
Datoriserad axialtomografi
tomografi
Datoriserad axiell tomografi (förfarande)
Datortomografi (CT) skanning
Diagnostisk kattskanning
Diagnostisk kattskanningstjänsttyp

Procedur: Positron Emission Tomography

Undergo PET scan

Andra namn:

Medicinsk avbildning, Positron Emission Tomografi
SÄLLSKAPSDJUR
Djur Scan
Positron Emission Tomography Scan
Positronemissionstomografi
PT
Positronemissionstomografi (förfarande)

Experimentell: Arm II (pembrolizumab)

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan, MRI and blood sample collection throughout the study.

Övrig: Quality-of-Life Assessment

Ancillary studies

Andra namn:

Livskvalitetsbedömning

Procedur: Biospecimen Collection

Undergo blood sample collection

Andra namn:

Biologisk provsamling
Bioprov insamlat
Provsamling
Provuppsamling

Procedur: Magnetic Resonance Imaging

Undergo MRI

Andra namn:

MRI
Magnetisk resonans
Magnetic Resonance Imaging Scan
Medicinsk bildbehandling, magnetisk resonans / kärnmagnetisk resonans
HERR
MR-avbildning
MRI-skanning
NMR-avbildning
NMRI
Kärnmagnetisk resonanstomografi
Magnetisk resonanstomografi (MRT)
sMRI
Magnetisk resonanstomografi (förfarande)
Strukturell MRI

Biologisk: Pembrolizumab

Given IV

Andra namn:

Keytruda
MK-3475
Lambrolizumab
SCH 900475
MK3475
SCH-900475
BCD-201
Pembrolizumab Biosimilar BCD-201
Pembrolizumab Biosimilar QL2107
QL2107
GME 751
GME751
Pembrolizumab Biosimilar GME751
MK 3475
SCH900475
Pembrolizumab Biosimilar RPH-075
RPH 075
RPH-075
RPH075
Pembrolizumab biosimilar sb27
SB 27
SB-27
Sb27

Procedur: Positron Emission Tomography

Undergo PET scan

Andra namn:

Medicinsk avbildning, Positron Emission Tomografi
SÄLLSKAPSDJUR
Djur Scan
Positron Emission Tomography Scan
Positronemissionstomografi
PT
Positronemissionstomografi (förfarande)

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Overall Survival (OS) Tidsram: 5 years after last randomization	Time from date of randomization to date of death due to any cause. Patients known to be alive are censored at date of last contact. The results were presented as 5-year OS estimate.	5 years after last randomization

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Relapse-free Survival (RFS) Tidsram: 5 years after last randomization	Time from date of randomization to date of first documentation of relapse or death due to any cause. Patients last known to be alive and relapse-free are censored at date of last contact.	5 years after last randomization
Overall Survival (OS) in Participants Who Are PD-L1 Positive Tidsram: 94 months; from study start November 10, 2015 to September 15, 2023	Time from date of randomization to date of death due to any cause. Patients known to be alive are censored at date of last contact.	94 months; from study start November 10, 2015 to September 15, 2023
Relapse-free Survival (RFS) in Participants Who Are PD-L1 Positive Tidsram: 5 years after last randomization	Time from date of randomization to date of first documentation of relapse or death due to any cause. Patients last known to be alive and relapse-free are censored at date of last contact.	5 years after last randomization
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Tidsram: Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.	Only adverse events that are possibly, probably or definitely related to study drug are reported. CTCAE Version 5.0 was used for all AE reporting.	Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Cancer Institute (NCI)

Utredare

Huvudutredare: Sapna Patel, SWOG Cancer Research Network

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Unger JM, Darke A, Othus M, Truong TG, Khushalani N, Kendra K, Lewis KD, Faller B, Funchain P, Buchbinder EI, Tarhini AA, Kirkwood JM, Sharon E, Sondak V, Guild SR, Grossmann K, Ribas A, Patel SP. Effectiveness of Adjuvant Pembrolizumab vs High-Dose Interferon or Ipilimumab for Quality-of-Life Outcomes in Patients With Resected Melanoma: A Secondary Analysis of the SWOG S1404 Randomized Clinical Trial. JAMA Oncol. 2023 Feb 1;9(2):251-260. doi: 10.1001/jamaoncol.2022.5486.

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)

10 november 2015

Primärt slutförande (Faktisk)

15 september 2023

Avslutad studie (Beräknad)

23 januari 2027

Studieregistreringsdatum

Först inskickad

22 juli 2015

Först inskickad som uppfyllde QC-kriterierna

22 juli 2015

Första postat (Beräknad)

23 juli 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 september 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

NCI-2014-02676
U10CA180888 (U.S.S. NIH-anslag/kontrakt)
NCI-2014-02676 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
S1404 (Annan identifierare: CTEP)
S1404 (Annan identifierare: SWOG)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Högdos rekombinant interferon Alfa-2B, Ipilimumab eller Pembrolizumab vid behandling av patienter med steg III-IV högriskmelanom som har tagits bort genom kirurgi

En randomiserad fas III-studie som jämför läkare/patients val av antingen hög dos interferon eller Ipilimumab med MK-3475 (Pembrolizumab) hos patienter med högriskresekerat melanom

Studieöversikt

Status

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Studietyp

Inskrivning (Faktisk)

Fas

Kontakter och platser

Studieorter

Deltagandekriterier

Urvalskriterier

Åldrar som är berättigade till studier

Tar emot friska volontärer

Kön som är behöriga för studier

Beskrivning

Studieplan

Hur är studien utformad?

Designdetaljer

Antal vapen

Vapen och interventioner

Deltagargrupp / Arm

Intervention / Behandling

Vad mäter studien?

Primära resultatmått

Resultatmått

Åtgärdsbeskrivning

Tidsram

Sekundära resultatmått

Resultatmått

Åtgärdsbeskrivning

Tidsram

Samarbetspartners och utredare

Sponsor

Utredare

Publikationer och användbara länkar

Allmänna publikationer

Studieavstämningsdatum

Studera stora datum

Studiestart (Faktisk)

Primärt slutförande (Faktisk)

Avslutad studie (Beräknad)

Studieregistreringsdatum

Först inskickad

Först inskickad som uppfyllde QC-kriterierna

Första postat (Beräknad)

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

Senast verifierad

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer