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Interferone alfa-2B ricombinante ad alto dosaggio, ipilimumab o pembrolizumab nel trattamento di pazienti con melanoma ad alto rischio in stadio III-IV che è stato rimosso chirurgicamente

30 settembre 2026 aggiornato da: National Cancer Institute (NCI)

Uno studio randomizzato di fase III che confronta la scelta del medico/paziente tra interferone ad alto dosaggio o ipilimumab con MK-3475 (pembrolizumab) in pazienti con melanoma resecato ad alto rischio

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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1301

Fase

Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm Gruppo di partecipanti / Arm Un gruppo o sottogruppo di partecipanti a uno studio clinico che riceve un intervento/trattamento specifico o nessun intervento, secondo il protocollo dello studio.	Intervento / Trattamento Intervento / Trattamento Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
Comparatore attivo: 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.	Altro: Quality-of-Life Assessment Ancillary studies Altri nomi: Valutazione della qualità della vita Procedura: Biospecimen Collection Undergo blood sample collection Altri nomi: Raccolta di campioni biologici Biocampione raccolto Raccolta di campioni Raccolta campione Biologico: Ipilimumab Given IV Altri nomi: Anticorpo monoclonale antigene-4 anti-citotossico associato ai linfociti T BMS-734016 Ipilimumab biosimilare CS1002 MDX-010 MDX-CTLA4 Yevoy MDX010 BMS734016 BMS 734016 Biologico: Recombinant Interferon Alfa-2b Given IV and SC Altri nomi: Alfatronolo Glucoferone Heberon Alfa IFN alfa-2B Interferone alfa 2b Interferone Alfa-2B Interferone alfa-2b Intron A Sch 30500 Urifron Viraferon Bioferon Bioferon (TM) Procedura: Magnetic Resonance Imaging Undergo MRI Altri nomi: Risonanza magnetica Scansione di immagini a risonanza magnetica Imaging medico, risonanza magnetica/risonanza magnetica nucleare SIG Imaging RM Scansione MRI Imaging NMR RMN Risonanza Magnetica Nucleare Imaging a risonanza magnetica (MRI) sMRI Imaging a risonanza magnetica (procedura) RM strutturale Procedura: Computed Tomography Undergo CT scan Altri nomi: CT GATTO TAC Tomografia assiale computerizzata Tomografia computerizzata tomografia Tomografia assiale computerizzata (procedura) Scansione tomografia computerizzata (CT). Scansione CAT diagnostica Tipo di servizio di scansione CAT diagnostica Procedura: Positron Emission Tomography Undergo PET scan Altri nomi: Imaging medico, tomografia a emissione di positroni ANIMALE DOMESTICO Scansione animale Scansione di tomografia a emissione di positroni Tomografia ad emissione di positroni P.T Tomografia a emissione di positroni (procedura)
Sperimentale: 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.	Altro: Quality-of-Life Assessment Ancillary studies Altri nomi: Valutazione della qualità della vita Procedura: Biospecimen Collection Undergo blood sample collection Altri nomi: Raccolta di campioni biologici Biocampione raccolto Raccolta di campioni Raccolta campione Procedura: Magnetic Resonance Imaging Undergo MRI Altri nomi: Risonanza magnetica Scansione di immagini a risonanza magnetica Imaging medico, risonanza magnetica/risonanza magnetica nucleare SIG Imaging RM Scansione MRI Imaging NMR RMN Risonanza Magnetica Nucleare Imaging a risonanza magnetica (MRI) sMRI Imaging a risonanza magnetica (procedura) RM strutturale Biologico: Pembrolizumab Given IV Altri nomi: Chiavetruda MK-3475 Lambrolizumab SCH 900475 MK3475 SCH-900475 BCD-201 Pembrolizumab biosimilare BCD-201 Pembrolizumab biosimilare QL2107 QL2107 GME751 Pembrolizumab biosimilare GME751 SCH900475 Pembrolizumab biosimilare RPH-075 RPH 075 RPH-075 RPH075 Pembrolizumab Biosimilar SB27 SB 27 SB-27 SB27 Procedura: Positron Emission Tomography Undergo PET scan Altri nomi: Imaging medico, tomografia a emissione di positroni ANIMALE DOMESTICO Scansione animale Scansione di tomografia a emissione di positroni Tomografia ad emissione di positroni P.T Tomografia a emissione di positroni (procedura)

Gruppo di partecipanti / Arm

Intervento / Trattamento

Comparatore attivo: Arm I (high-dose recombinant interferon alfa-2B, ipilimumab)

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

Altro: Quality-of-Life Assessment

Ancillary studies

Altri nomi:

Valutazione della qualità della vita

Procedura: Biospecimen Collection

Undergo blood sample collection

Altri nomi:

Raccolta di campioni biologici
Biocampione raccolto
Raccolta di campioni
Raccolta campione

Biologico: Ipilimumab

Given IV

Altri nomi:

Anticorpo monoclonale antigene-4 anti-citotossico associato ai linfociti T
BMS-734016
Ipilimumab biosimilare CS1002
MDX-010
MDX-CTLA4
Yevoy
MDX010
BMS734016
BMS 734016

Biologico: Recombinant Interferon Alfa-2b

Given IV and SC

Altri nomi:

Alfatronolo
Glucoferone
Heberon Alfa
IFN alfa-2B
Interferone alfa 2b
Interferone Alfa-2B
Interferone alfa-2b
Intron A
Sch 30500
Urifron
Viraferon
Bioferon
Bioferon (TM)

Procedura: Magnetic Resonance Imaging

Undergo MRI

Altri nomi:

Risonanza magnetica
Scansione di immagini a risonanza magnetica
Imaging medico, risonanza magnetica/risonanza magnetica nucleare
SIG
Imaging RM
Scansione MRI
Imaging NMR
RMN
Risonanza Magnetica Nucleare
Imaging a risonanza magnetica (MRI)
sMRI
Imaging a risonanza magnetica (procedura)
RM strutturale

Procedura: Computed Tomography

Undergo CT scan

Altri nomi:

CT
GATTO
TAC
Tomografia assiale computerizzata
Tomografia computerizzata
tomografia
Tomografia assiale computerizzata (procedura)
Scansione tomografia computerizzata (CT).
Scansione CAT diagnostica
Tipo di servizio di scansione CAT diagnostica

Procedura: Positron Emission Tomography

Undergo PET scan

Altri nomi:

Imaging medico, tomografia a emissione di positroni
ANIMALE DOMESTICO
Scansione animale
Scansione di tomografia a emissione di positroni
Tomografia ad emissione di positroni
P.T
Tomografia a emissione di positroni (procedura)

Sperimentale: 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.

Altro: Quality-of-Life Assessment

Ancillary studies

Altri nomi:

Valutazione della qualità della vita

Procedura: Biospecimen Collection

Undergo blood sample collection

Altri nomi:

Raccolta di campioni biologici
Biocampione raccolto
Raccolta di campioni
Raccolta campione

Procedura: Magnetic Resonance Imaging

Undergo MRI

Altri nomi:

Risonanza magnetica
Scansione di immagini a risonanza magnetica
Imaging medico, risonanza magnetica/risonanza magnetica nucleare
SIG
Imaging RM
Scansione MRI
Imaging NMR
RMN
Risonanza Magnetica Nucleare
Imaging a risonanza magnetica (MRI)
sMRI
Imaging a risonanza magnetica (procedura)
RM strutturale

Biologico: Pembrolizumab

Given IV

Altri nomi:

Chiavetruda
MK-3475
Lambrolizumab
SCH 900475
MK3475
SCH-900475
BCD-201
Pembrolizumab biosimilare BCD-201
Pembrolizumab biosimilare QL2107
QL2107
GME751
Pembrolizumab biosimilare GME751
SCH900475
Pembrolizumab biosimilare RPH-075
RPH 075
RPH-075
RPH075
Pembrolizumab Biosimilar SB27
SB 27
SB-27
SB27

Procedura: Positron Emission Tomography

Undergo PET scan

Altri nomi:

Imaging medico, tomografia a emissione di positroni
ANIMALE DOMESTICO
Scansione animale
Scansione di tomografia a emissione di positroni
Tomografia ad emissione di positroni
P.T
Tomografia a emissione di positroni (procedura)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Overall Survival (OS) Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Relapse-free Survival (RFS) Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Cancer Institute (NCI)

Investigatori

Investigatore principale: Sapna Patel, SWOG Cancer Research Network

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 novembre 2015

Completamento primario (Effettivo)

15 settembre 2023

Completamento dello studio (Stimato)

23 gennaio 2027

Date di iscrizione allo studio

Primo inviato

22 luglio 2015

Primo inviato che soddisfa i criteri di controllo qualità

22 luglio 2015

Primo Inserito (Stimato)

23 luglio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 settembre 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

NCI-2014-02676
U10CA180888 (Sovvenzione/contratto NIH degli Stati Uniti)
NCI-2014-02676 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
S1404 (Altro identificatore: CTEP)
S1404 (Altro identificatore: SWOG)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Interferone alfa-2B ricombinante ad alto dosaggio, ipilimumab o pembrolizumab nel trattamento di pazienti con melanoma ad alto rischio in stadio III-IV che è stato rimosso chirurgicamente

Uno studio randomizzato di fase III che confronta la scelta del medico/paziente tra interferone ad alto dosaggio o ipilimumab con MK-3475 (pembrolizumab) in pazienti con melanoma resecato ad alto rischio

Panoramica dello studio

Stato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Tipo di studio

Iscrizione (Effettivo)

Fase

Contatti e Sedi

Luoghi di studio

Criteri di partecipazione

Criteri di ammissibilità

Età idonea allo studio

Accetta volontari sani

Sessi ammissibili allo studio

Descrizione

Piano di studio

Come è strutturato lo studio?

Dettagli di progettazione

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm

Intervento / Trattamento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Misure di risultato secondarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Collaboratori e investigatori

Sponsor

Investigatori

Pubblicazioni e link utili

Pubblicazioni generali

Studiare le date dei record

Studia le date principali

Inizio studio (Effettivo)

Completamento primario (Effettivo)

Completamento dello studio (Stimato)

Date di iscrizione allo studio

Primo inviato

Primo inviato che soddisfa i criteri di controllo qualità

Primo Inserito (Stimato)

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo verificato

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio