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Hooggedoseerde recombinant interferon-alfa-2B, ipilimumab of pembrolizumab bij de behandeling van patiënten met stadium III-IV hoogrisicomelanoom dat operatief is verwijderd

30 september 2026 bijgewerkt door: National Cancer Institute (NCI)

Een gerandomiseerde fase III-studie waarin de keuze van de arts/patiënt van een hoge dosis interferon of ipilimumab wordt vergeleken met MK-3475 (pembrolizumab) bij patiënten met een gereseceerd melanoom met een hoog risico

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

1301

Fase

Fase 3

Contacten en locaties

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Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling
Toewijzing: Gerandomiseerd
Interventioneel model: Parallelle opdracht
Masker: Dubbele

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm	Interventie / Behandeling
Actieve vergelijker: 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.	Ander: Quality-of-Life Assessment Ancillary studies Andere namen: Beoordeling van de kwaliteit van leven Procedure: Biospecimen Collection Undergo blood sample collection Andere namen: Biologische monsterverzameling Biospecimen verzameld Specimenverzameling Monsterverzameling Biologisch: Ipilimumab Given IV Andere namen: Anti-cytotoxisch T-lymfocyt-geassocieerd antigeen-4 monoklonaal antilichaam BMS-734016 Ipilimumab Biosimilar CS1002 MDX-010 MDX-CTLA4 Yervoy MDX010 BMS734016 GBS 734016 Biologisch: Recombinant Interferon Alfa-2b Given IV and SC Andere namen: Alfatronol Glucoferon Heberon Alfa IFN alfa-2B Interferon alfa 2b Interferon Alfa-2B Interferon alfa-2b Intron A Sch 30500 Urifron Viraferon Bioferon Bioferon (TM) Procedure: Magnetic Resonance Imaging Undergo MRI Andere namen: MRI Magnetische resonantie Magnetic Resonance Imaging-scan Medische beeldvorming, magnetische resonantie / nucleaire magnetische resonantie DHR MR-beeldvorming MRI scan NMR-beeldvorming NMRI Nucleaire magnetische resonantie beeldvorming Magnetische resonantiebeeldvorming (MRI) sMRI Magnetische resonantiebeeldvorming (procedure) MRI's Structurele MRI Procedure: Computed Tomography Undergo CT scan Andere namen: CT KAT CT-scan Axiale computertomografie Computergestuurde axiale tomografie Computergestuurde tomografie tomografie Geautomatiseerde axiale tomografie (procedure) Computertomografie (CT)-scan Diagnostische kattencan Diagnostisch CAT -scanservice type Procedure: Positron Emission Tomography Undergo PET scan Andere namen: Medische beeldvorming, positronemissietomografie HUISDIER PET-scan Positron Emissie Tomografie Scan Positron-emissietomografie PT Positronemissietomografie (procedure)
Experimenteel: 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.	Ander: Quality-of-Life Assessment Ancillary studies Andere namen: Beoordeling van de kwaliteit van leven Procedure: Biospecimen Collection Undergo blood sample collection Andere namen: Biologische monsterverzameling Biospecimen verzameld Specimenverzameling Monsterverzameling Procedure: Magnetic Resonance Imaging Undergo MRI Andere namen: MRI Magnetische resonantie Magnetic Resonance Imaging-scan Medische beeldvorming, magnetische resonantie / nucleaire magnetische resonantie DHR MR-beeldvorming MRI scan NMR-beeldvorming NMRI Nucleaire magnetische resonantie beeldvorming Magnetische resonantiebeeldvorming (MRI) sMRI Magnetische resonantiebeeldvorming (procedure) MRI's Structurele MRI Biologisch: Pembrolizumab Given IV Andere namen: 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 SCH900475 Pembrolizumab Biosimilar RPH-075 RPH 075 RPH-075 RPH075 Pembrolizumab biosimilar SB27 SB 27 SB-27 SB27 Procedure: Positron Emission Tomography Undergo PET scan Andere namen: Medische beeldvorming, positronemissietomografie HUISDIER PET-scan Positron Emissie Tomografie Scan Positron-emissietomografie PT Positronemissietomografie (procedure)

Deelnemersgroep / Arm

Interventie / Behandeling

Actieve vergelijker: Arm I (high-dose recombinant interferon alfa-2B, ipilimumab)

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

Ander: Quality-of-Life Assessment

Ancillary studies

Andere namen:

Beoordeling van de kwaliteit van leven

Procedure: Biospecimen Collection

Undergo blood sample collection

Andere namen:

Biologische monsterverzameling
Biospecimen verzameld
Specimenverzameling
Monsterverzameling

Biologisch: Ipilimumab

Given IV

Andere namen:

Anti-cytotoxisch T-lymfocyt-geassocieerd antigeen-4 monoklonaal antilichaam
BMS-734016
Ipilimumab Biosimilar CS1002
MDX-010
MDX-CTLA4
Yervoy
MDX010
BMS734016
GBS 734016

Biologisch: Recombinant Interferon Alfa-2b

Given IV and SC

Andere namen:

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

Procedure: Magnetic Resonance Imaging

Undergo MRI

Andere namen:

MRI
Magnetische resonantie
Magnetic Resonance Imaging-scan
Medische beeldvorming, magnetische resonantie / nucleaire magnetische resonantie
DHR
MR-beeldvorming
MRI scan
NMR-beeldvorming
NMRI
Nucleaire magnetische resonantie beeldvorming
Magnetische resonantiebeeldvorming (MRI)
sMRI
Magnetische resonantiebeeldvorming (procedure)
MRI's
Structurele MRI

Procedure: Computed Tomography

Undergo CT scan

Andere namen:

CT
KAT
CT-scan
Axiale computertomografie
Computergestuurde axiale tomografie
Computergestuurde tomografie
tomografie
Geautomatiseerde axiale tomografie (procedure)
Computertomografie (CT)-scan
Diagnostische kattencan
Diagnostisch CAT -scanservice type

Procedure: Positron Emission Tomography

Undergo PET scan

Andere namen:

Medische beeldvorming, positronemissietomografie
HUISDIER
PET-scan
Positron Emissie Tomografie Scan
Positron-emissietomografie
PT
Positronemissietomografie (procedure)

Experimenteel: 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.

Ander: Quality-of-Life Assessment

Ancillary studies

Andere namen:

Beoordeling van de kwaliteit van leven

Procedure: Biospecimen Collection

Undergo blood sample collection

Andere namen:

Biologische monsterverzameling
Biospecimen verzameld
Specimenverzameling
Monsterverzameling

Procedure: Magnetic Resonance Imaging

Undergo MRI

Andere namen:

MRI
Magnetische resonantie
Magnetic Resonance Imaging-scan
Medische beeldvorming, magnetische resonantie / nucleaire magnetische resonantie
DHR
MR-beeldvorming
MRI scan
NMR-beeldvorming
NMRI
Nucleaire magnetische resonantie beeldvorming
Magnetische resonantiebeeldvorming (MRI)
sMRI
Magnetische resonantiebeeldvorming (procedure)
MRI's
Structurele MRI

Biologisch: Pembrolizumab

Given IV

Andere namen:

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
SCH900475
Pembrolizumab Biosimilar RPH-075
RPH 075
RPH-075
RPH075
Pembrolizumab biosimilar SB27
SB 27
SB-27
SB27

Procedure: Positron Emission Tomography

Undergo PET scan

Andere namen:

Medische beeldvorming, positronemissietomografie
HUISDIER
PET-scan
Positron Emissie Tomografie Scan
Positron-emissietomografie
PT
Positronemissietomografie (procedure)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Overall Survival (OS) Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Relapse-free Survival (RFS) Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Cancer Institute (NCI)

Onderzoekers

Hoofdonderzoeker: Sapna Patel, SWOG Cancer Research Network

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

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.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 november 2015

Primaire voltooiing (Werkelijk)

15 september 2023

Studie voltooiing (Geschat)

23 januari 2027

Studieregistratiedata

Eerst ingediend

22 juli 2015

Eerst ingediend dat voldeed aan de QC-criteria

22 juli 2015

Eerst geplaatst (Geschat)

23 juli 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

30 september 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

NCI-2014-02676
U10CA180888 (Subsidie/contract van de Amerikaanse NIH)
NCI-2014-02676 (Register-ID: CTRP (Clinical Trial Reporting Program))
S1404 (Andere identificatie: CTEP)
S1404 (Andere identificatie: SWOG)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Hooggedoseerde recombinant interferon-alfa-2B, ipilimumab of pembrolizumab bij de behandeling van patiënten met stadium III-IV hoogrisicomelanoom dat operatief is verwijderd

Een gerandomiseerde fase III-studie waarin de keuze van de arts/patiënt van een hoge dosis interferon of ipilimumab wordt vergeleken met MK-3475 (pembrolizumab) bij patiënten met een gereseceerd melanoom met een hoog risico

Studie Overzicht

Toestand

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Studietype

Inschrijving (Werkelijk)

Fase

Contacten en locaties

Studie Locaties

Deelname Criteria

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Beschrijving

Studie plan

Hoe is de studie opgezet?

Ontwerpdetails

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm

Interventie / Behandeling

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat

Maatregel Beschrijving

Tijdsspanne

Secundaire uitkomstmaten

Uitkomstmaat

Maatregel Beschrijving

Tijdsspanne

Medewerkers en onderzoekers

Sponsor

Onderzoekers

Publicaties en nuttige links

Algemene publicaties

Studie record data

Bestudeer belangrijke data

Studie start (Werkelijk)

Primaire voltooiing (Werkelijk)

Studie voltooiing (Geschat)

Studieregistratiedata

Eerst ingediend

Eerst ingediend dat voldeed aan de QC-criteria

Eerst geplaatst (Geschat)

Updates van studierecords

Laatste update geplaatst (Werkelijk)

Laatste update ingediend die voldeed aan QC-criteria

Laatst geverifieerd

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers