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Højdosis rekombinant interferon Alfa-2B, Ipilimumab eller Pembrolizumab til behandling af patienter med trin III-IV højrisiko melanom, der er blevet fjernet ved kirurgi

30. september 2026 opdateret af: National Cancer Institute (NCI)

Et fase III randomiseret forsøg, der sammenligner læge/patients valg af enten højdosis interferon eller ipilimumab med MK-3475 (Pembrolizumab) hos patienter med højrisiko resekeret melanom

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

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Aktiv, ikke rekrutterende

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

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.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Faktiske)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
1301

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Aktiv komparator: Arm I (high-dose recombinant interferon alfa-2B, ipilimumab)

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

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

Patients undergo CT scan, PET scan, MRI and blood sample collection throughout the study.
Andet: Quality-of-Life Assessment

Ancillary studies

Andre navne:
  • Livskvalitetsvurdering
Procedure: Biospecimen Collection

Undergo blood sample collection

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Biologisk: Ipilimumab

Given IV

Andre navne:
  • Anti-cytotoksisk T-lymfocyt-associeret antigen-4 monoklonalt antistof
  • BMS-734016
  • Ipilimumab Biosimilar CS1002
  • MDX-010
  • MDX-CTLA4
  • Yervoy
  • MDX010
  • BMS734016
  • BMS 734016
  • MDX 010
Biologisk: Recombinant Interferon Alfa-2b

Given IV and SC

Andre navne:
  • Alfatronol
  • Glucoferon
  • Heberon Alfa
  • IFN alfa-2B
  • Interferon alfa 2b
  • Interferon Alfa-2B
  • Interferon Alpha-2b
  • Intron A
  • Sch 30500
  • Urifron
  • Viraferon
  • Bioferon
  • Bioferon (TM)
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andre navne:
  • MR
  • Magnetisk resonans
  • Magnetisk resonansbilledscanning
  • Medicinsk billeddannelse, magnetisk resonans / kernemagnetisk resonans
  • HR
  • MR billeddannelse
  • MR-scanning
  • NMR billeddannelse
  • NMRI
  • Kernemagnetisk resonansbilleddannelse
  • Magnetisk resonansbilleddannelse (MRI)
  • sMRI
  • Magnetisk resonansbilleddannelse (procedure)
  • MRI'er
  • Strukturel MR
Procedure: Computed Tomography

Undergo CT scan

Andre navne:
  • CT
  • KAT
  • CAT-scanning
  • Beregnet aksial tomografi
  • Computerstyret aksial tomografi
  • Computerstyret tomografi
  • CT-scanning
  • tomografi
  • Computerstyret aksial tomografi (procedure)
  • Computerstyret tomografi (CT) scanning
  • Diagnostisk CAT -scanning
  • Diagnostic CAT Scan Service Type
Procedure: Positron Emission Tomography

Undergo PET scan

Andre navne:
  • Medicinsk billeddannelse, Positron Emission Tomografi
  • KÆLEDYR
  • PET-scanning
  • Positron Emission Tomografi Scan
  • Positron-emissionstomografi
  • PT
  • Positron emissionstomografi (procedure)
Eksperimentel: 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.
Andet: Quality-of-Life Assessment

Ancillary studies

Andre navne:
  • Livskvalitetsvurdering
Procedure: Biospecimen Collection

Undergo blood sample collection

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andre navne:
  • MR
  • Magnetisk resonans
  • Magnetisk resonansbilledscanning
  • Medicinsk billeddannelse, magnetisk resonans / kernemagnetisk resonans
  • HR
  • MR billeddannelse
  • MR-scanning
  • NMR billeddannelse
  • NMRI
  • Kernemagnetisk resonansbilleddannelse
  • Magnetisk resonansbilleddannelse (MRI)
  • sMRI
  • Magnetisk resonansbilleddannelse (procedure)
  • MRI'er
  • Strukturel MR
Biologisk: Pembrolizumab

Given IV

Andre navne:
  • Keytruda
  • MK-3475
  • Lambrolizumab
  • SCH 900475
  • MK3475
  • SCH-900475
  • BCD-201
  • Pembrolizumab Biosimilar BCD-201
  • Pembrolizumab Biosimilar QL2107
  • QL2107
  • GME 751
  • GME751
  • Pembrolizumab Biosimilar GME751
  • MK 3475
  • SCH900475
  • Pembrolizumab Biosimilar RPH-075
  • RPH 075
  • RPH-075
  • RPH075
  • Pembrolizumab Biosimilar SB27
  • SB 27
  • SB-27
  • SB27
Procedure: Positron Emission Tomography

Undergo PET scan

Andre navne:
  • Medicinsk billeddannelse, Positron Emission Tomografi
  • KÆLEDYR
  • PET-scanning
  • Positron Emission Tomografi Scan
  • Positron-emissionstomografi
  • PT
  • Positron emissionstomografi (procedure)

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: 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

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relapse-free Survival (RFS)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
National Cancer Institute (NCI)

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Sapna Patel, SWOG Cancer Research Network

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
10. november 2015

Primær færdiggørelse (Faktiske)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
15. september 2023

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
23. januar 2027

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
22. juli 2015

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
22. juli 2015

Først opslået (Anslået)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
23. juli 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
1. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
30. september 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • NCI-2014-02676
  • U10CA180888 (U.S. NIH-bevilling/kontrakt)
  • NCI-2014-02676 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • S1404 (Anden identifikator: CTEP)
  • S1404 (Anden identifikator: SWOG)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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