En studie som utvärderar om Pembrolizumab ensamt eller i kombination med CMP-001 förbättrar effektiviteten hos patienter med operabelt melanom
Randomiserad fas II-studie av neoadjuvant Pembrolizumab ensamt eller i kombination med CMP-001 hos patienter med operabelt melanom: studie av effekt och biomarkör
This phase II trial studies the effect of pembrolizumab alone or in combination with CMP-001 in treating patients with melanoma that can be treated by surgery (operable). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with CMP-001 may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. The addition of CMP-001 to pembrolizumab could improve the ability of the immune system to shrink tumors and to prevent them from returning.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
PRIMARY OBJECTIVE:
I. To evaluate the rate of pathologic complete response (pCR) rate in patients in each arm.
SECONDARY OBJECTIVES:
I. To evaluate the rate of pathologic near-complete/major response (pMR) of the neoadjuvant therapy in each arm.
II. To evaluate the pathologic response rate of un-injected lesions on the combination arm (Arm B).
III. To evaluate relapse-free survival (RFS) in each arm. IV. To evaluate overall survival (OS) in each arm. V. To evaluate the preoperative radiographic response rate in each arm. VI. To evaluate safety and toxicity of neoadjuvant therapy in each arm.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A:
NEOADJUVANT PHASE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
SURGERY: Patients undergo surgery 1-2 weeks after completion of neoadjuvant phase.
ADJUVANT PHASE: After recovery from surgery, patients receive pembrolizumab IV over 30 minutes on day 1 of every other cycle. Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity.
Patients also undergo computed tomography (CT) or positron emission tomography (PET)/CT throughout the trial and may undergo optional biopsy at baseline and disease progression and optional collection of blood samples throughout the trial.
ARM B:
NEOADJUVANT PHASE: Patients receive VLP-encapsulated TLR9 agonist CMP-001 (CMP-001) subcutaneously (SC) on day 1 of cycle 1 and then intratumorally on days 8 and 15 of cycle 1, days 1, 8, and 15 of cycle 2, and day 1 of cycle 3. Patients also receive pembrolizumab IV over 30 minutes on day 8 of each cycle. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
SURGERY: Patients undergo surgery 1-2 weeks after completion of neoadjuvant phase.
ADJUVANT PHASE: After recovery from surgery, patients receive pembrolizumab IV over 30 minutes on day 1 of every other cycle. Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity.
Patients also undergo CT or PET/CT throughout the trial and may undergo optional biopsy at baseline and disease progression and optional collection of blood samples throughout the trial.
After completion of study treatment, patients are followed up at 30 days and then every 3 months if < 2 years from study entry, every 6 months if 2-5 years from study entry, and every 12 months if > 5 years from study entry for up to 10 years (15 years total follow up).
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Alaska
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Anchorage, Alaska, Förenta staterna, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, Förenta staterna, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, Förenta staterna, 99508
- Alaska Oncology and Hematology LLC
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Anchorage, Alaska, Förenta staterna, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, Förenta staterna, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, Förenta staterna, 99508
- Katmai Oncology Group
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Anchorage, Alaska, Förenta staterna, 99508
- Providence Alaska Medical Center
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Fairbanks, Alaska, Förenta staterna, 99701
- Fairbanks Memorial Hospital
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Arizona
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Tucson, Arizona, Förenta staterna, 85719
- Banner University Medical Center - Tucson
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Tucson, Arizona, Förenta staterna, 85719
- University of Arizona Cancer Center-North Campus
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Arkansas
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Fort Smith, Arkansas, Förenta staterna, 72903
- Mercy Hospital Fort Smith
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California
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Burbank, California, Förenta staterna, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Dublin, California, Förenta staterna, 94568
- Epic Care-Dublin
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Emeryville, California, Förenta staterna, 94608
- Bay Area Breast Surgeons Inc
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Emeryville, California, Förenta staterna, 94608
- Epic Care Partners in Cancer Care
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Martinez, California, Förenta staterna, 94553-3156
- Contra Costa Regional Medical Center
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Oakland, California, Förenta staterna, 94609
- Alta Bates Summit Medical Center - Summit Campus
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Oakland, California, Förenta staterna, 94609
- Bay Area Tumor Institute
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Orange, California, Förenta staterna, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
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Orange, California, Förenta staterna, 92868
- Saint Joseph Hospital - Orange
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Walnut Creek, California, Förenta staterna, 94597
- Epic Care Cyberknife Center
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Colorado
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Aurora, Colorado, Förenta staterna, 80012
- Rocky Mountain Cancer Centers-Aurora
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Aurora, Colorado, Förenta staterna, 80012
- The Medical Center of Aurora
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Boulder, Colorado, Förenta staterna, 80304
- Rocky Mountain Cancer Centers-Boulder
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Centennial, Colorado, Förenta staterna, 80112
- Rocky Mountain Cancer Centers - Centennial
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Denver, Colorado, Förenta staterna, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
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Denver, Colorado, Förenta staterna, 80218
- Rocky Mountain Cancer Centers-Midtown
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Denver, Colorado, Förenta staterna, 80220
- Rocky Mountain Cancer Centers-Rose
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Englewood, Colorado, Förenta staterna, 80113
- Mountain Blue Cancer Care Center - Swedish
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Englewood, Colorado, Förenta staterna, 80113
- Swedish Medical Center
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Englewood, Colorado, Förenta staterna, 80113
- Rocky Mountain Cancer Centers - Swedish
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Englewood, Colorado, Förenta staterna, 80113
- The Melanoma and Skin Cancer Institute
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Greeley, Colorado, Förenta staterna, 80631
- Banner North Colorado Medical Center
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Littleton, Colorado, Förenta staterna, 80120
- Rocky Mountain Cancer Centers-Littleton
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Lone Tree, Colorado, Förenta staterna, 80124
- Sky Ridge Medical Center
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Lone Tree, Colorado, Förenta staterna, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
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Loveland, Colorado, Förenta staterna, 80539
- Banner North Colorado Medical Center - Loveland Campus
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Thornton, Colorado, Förenta staterna, 80260
- Rocky Mountain Cancer Centers-Thornton
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Florida
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Aventura, Florida, Förenta staterna, 33180
- UM Sylvester Comprehensive Cancer Center at Aventura
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Coral Gables, Florida, Förenta staterna, 33146
- UM Sylvester Comprehensive Cancer Center at Coral Gables
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Deerfield Beach, Florida, Förenta staterna, 33442
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Miami, Florida, Förenta staterna, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Plantation, Florida, Förenta staterna, 33324
- UM Sylvester Comprehensive Cancer Center at Plantation
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Idaho
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Boise, Idaho, Förenta staterna, 83712
- Saint Luke's Cancer Institute - Boise
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Fruitland, Idaho, Förenta staterna, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Förenta staterna, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Förenta staterna, 83687
- Saint Luke's Cancer Institute - Nampa
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Twin Falls, Idaho, Förenta staterna, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Bloomington, Illinois, Förenta staterna, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, Förenta staterna, 61520
- Illinois CancerCare-Canton
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Carbondale, Illinois, Förenta staterna, 62902
- Memorial Hospital of Carbondale
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Carterville, Illinois, Förenta staterna, 62918
- SIH Cancer Institute
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Carthage, Illinois, Förenta staterna, 62321
- Illinois CancerCare-Carthage
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Centralia, Illinois, Förenta staterna, 62801
- Centralia Oncology Clinic
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Chicago, Illinois, Förenta staterna, 60612
- University of Illinois
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Decatur, Illinois, Förenta staterna, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Förenta staterna, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, Förenta staterna, 61021
- Illinois CancerCare-Dixon
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Effingham, Illinois, Förenta staterna, 62401
- Crossroads Cancer Center
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Eureka, Illinois, Förenta staterna, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, Förenta staterna, 61401
- Western Illinois Cancer Treatment Center
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Galesburg, Illinois, Förenta staterna, 61401
- Illinois CancerCare-Galesburg
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Kewanee, Illinois, Förenta staterna, 61443
- Illinois CancerCare-Kewanee Clinic
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Macomb, Illinois, Förenta staterna, 61455
- Illinois CancerCare-Macomb
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Mount Vernon, Illinois, Förenta staterna, 62864
- SSM Health Good Samaritan
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O'Fallon, Illinois, Förenta staterna, 62269
- Cancer Care Center of O'Fallon
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Ottawa, Illinois, Förenta staterna, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, Förenta staterna, 61554
- Illinois CancerCare-Pekin
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Peoria, Illinois, Förenta staterna, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Förenta staterna, 61615
- Illinois CancerCare-Peoria
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Peru, Illinois, Förenta staterna, 61354
- Illinois CancerCare-Peru
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Peru, Illinois, Förenta staterna, 61354
- Valley Radiation Oncology
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Princeton, Illinois, Förenta staterna, 61356
- Illinois CancerCare-Princeton
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Springfield, Illinois, Förenta staterna, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Förenta staterna, 62702
- Springfield Clinic
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Springfield, Illinois, Förenta staterna, 62781
- Springfield Memorial Hospital
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Washington, Illinois, Förenta staterna, 61571
- Illinois CancerCare - Washington
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Indiana
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Richmond, Indiana, Förenta staterna, 47374
- Reid Health
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Iowa
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Ames, Iowa, Förenta staterna, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Förenta staterna, 50010
- McFarland Clinic - Ames
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Boone, Iowa, Förenta staterna, 50036
- McFarland Clinic - Boone
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Fort Dodge, Iowa, Förenta staterna, 50501
- McFarland Clinic - Trinity Cancer Center
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Jefferson, Iowa, Förenta staterna, 50129
- McFarland Clinic - Jefferson
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Marshalltown, Iowa, Förenta staterna, 50158
- McFarland Clinic - Marshalltown
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Kansas
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Garden City, Kansas, Förenta staterna, 67846
- Central Care Cancer Center - Garden City
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Great Bend, Kansas, Förenta staterna, 67530
- Central Care Cancer Center - Great Bend
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Louisiana
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Baton Rouge, Louisiana, Förenta staterna, 70809
- Louisiana Hematology Oncology Associates LLC
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Baton Rouge, Louisiana, Förenta staterna, 70809
- Mary Bird Perkins Cancer Center
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Houma, Louisiana, Förenta staterna, 70360
- Terrebonne General Medical Center
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Michigan
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Battle Creek, Michigan, Förenta staterna, 49017
- Bronson Battle Creek
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Grand Rapids, Michigan, Förenta staterna, 49503
- Trinity Health Grand Rapids Hospital
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Grand Rapids, Michigan, Förenta staterna, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Grand Rapids, Michigan, Förenta staterna, 49503
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Kalamazoo, Michigan, Förenta staterna, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, Förenta staterna, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Förenta staterna, 49009
- Beacon Kalamazoo Cancer Center
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Kalamazoo, Michigan, Förenta staterna, 49048
- Beacon Kalamazoo
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Muskegon, Michigan, Förenta staterna, 49444
- Trinity Health Muskegon Hospital
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Niles, Michigan, Förenta staterna, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
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Norton Shores, Michigan, Förenta staterna, 49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
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Reed City, Michigan, Förenta staterna, 49677
- Corewell Health Reed City Hospital
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Saint Joseph, Michigan, Förenta staterna, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Saint Joseph, Michigan, Förenta staterna, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
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Traverse City, Michigan, Förenta staterna, 49684
- Munson Medical Center
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Wyoming, Michigan, Förenta staterna, 49519
- University of Michigan Health - West
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Missouri
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Ballwin, Missouri, Förenta staterna, 63011
- Mercy Oncology and Hematology - Clayton-Clarkson
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Bolivar, Missouri, Förenta staterna, 65613
- Central Care Cancer Center - Bolivar
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Cape Girardeau, Missouri, Förenta staterna, 63703
- Saint Francis Medical Center
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Cape Girardeau, Missouri, Förenta staterna, 63703
- Mercy Cancer Center - Cape Girardeau
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Farmington, Missouri, Förenta staterna, 63640
- Parkland Health Center - Farmington
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Jefferson City, Missouri, Förenta staterna, 65109
- MU Health Care Goldschmidt Cancer Center
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Joplin, Missouri, Förenta staterna, 64804
- Freeman Health System
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Joplin, Missouri, Förenta staterna, 64804
- Mercy Hospital Joplin
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Rolla, Missouri, Förenta staterna, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
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Rolla, Missouri, Förenta staterna, 65401
- Phelps Health Delbert Day Cancer Institute
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Saint Joseph, Missouri, Förenta staterna, 64506
- Heartland Regional Medical Center
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Sainte Genevieve, Missouri, Förenta staterna, 63670
- Sainte Genevieve County Memorial Hospital
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Springfield, Missouri, Förenta staterna, 65807
- CoxHealth South Hospital
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Springfield, Missouri, Förenta staterna, 65804
- Mercy Hospital Springfield
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St Louis, Missouri, Förenta staterna, 63131
- Missouri Baptist Medical Center
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St Louis, Missouri, Förenta staterna, 63141
- Mercy Hospital Saint Louis
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St Louis, Missouri, Förenta staterna, 63128
- Mercy Hospital South
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Sullivan, Missouri, Förenta staterna, 63080
- Missouri Baptist Sullivan Hospital
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Montana
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Missoula, Montana, Förenta staterna, 59802
- Saint Patrick Hospital - Community Hospital
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Ohio
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Beavercreek, Ohio, Förenta staterna, 45431
- Indu and Raj Soin Medical Center
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Centerville, Ohio, Förenta staterna, 45459
- Miami Valley Hospital South
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Centerville, Ohio, Förenta staterna, 45459
- Dayton Physicians LLC-Miami Valley South
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Cincinnati, Ohio, Förenta staterna, 45236
- Oncology Hematology Care Inc-Kenwood
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Dayton, Ohio, Förenta staterna, 45409
- Miami Valley Hospital
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Dayton, Ohio, Förenta staterna, 45415
- Miami Valley Hospital North
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Dayton, Ohio, Förenta staterna, 45415
- Dayton Physician LLC - Englewood
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Findlay, Ohio, Förenta staterna, 45840
- Blanchard Valley Hospital
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Findlay, Ohio, Förenta staterna, 45840
- Armes Family Cancer Center
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Findlay, Ohio, Förenta staterna, 45840
- Orion Cancer Care
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Franklin, Ohio, Förenta staterna, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Franklin, Ohio, Förenta staterna, 45005
- Dayton Physicians LLC-Atrium
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Greenville, Ohio, Förenta staterna, 45331
- Wayne Hospital
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Greenville, Ohio, Förenta staterna, 45331
- Dayton Physicians LLC-Wayne
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Kettering, Ohio, Förenta staterna, 45429
- Kettering Medical Center
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Kettering, Ohio, Förenta staterna, 45409
- Greater Dayton Cancer Center
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Springfield, Ohio, Förenta staterna, 45504
- Springfield Regional Cancer Center
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Springfield, Ohio, Förenta staterna, 45504
- Springfield Regional Medical Center
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Troy, Ohio, Förenta staterna, 45373
- Upper Valley Medical Center
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Troy, Ohio, Förenta staterna, 45373
- Dayton Physicians LLC - Troy
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73120
- Mercy Hospital Oklahoma City
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Oregon
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Bend, Oregon, Förenta staterna, 97701
- Saint Charles Health System
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Clackamas, Oregon, Förenta staterna, 97015
- Clackamas Radiation Oncology Center
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Clackamas, Oregon, Förenta staterna, 97015
- Providence Cancer Institute Clackamas Clinic
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Coos Bay, Oregon, Förenta staterna, 97420
- Bay Area Hospital
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Newberg, Oregon, Förenta staterna, 97132
- Providence Newberg Medical Center
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Portland, Oregon, Förenta staterna, 97213
- Providence Portland Medical Center
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Portland, Oregon, Förenta staterna, 97225
- Providence Saint Vincent Medical Center
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Pennsylvania
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Allentown, Pennsylvania, Förenta staterna, 18104
- Saint Luke's Cancer Center - Allentown
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Bethlehem, Pennsylvania, Förenta staterna, 18015
- Saint Luke's University Hospital-Bethlehem Campus
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Easton, Pennsylvania, Förenta staterna, 18045
- Saint Luke's Hospital-Anderson Campus
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Pittsburgh, Pennsylvania, Förenta staterna, 15232
- UPMC Hillman Cancer Center
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Quakertown, Pennsylvania, Förenta staterna, 18951
- Saint Luke's Hospital-Quakertown Campus
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Sayre, Pennsylvania, Förenta staterna, 18840
- Guthrie Medical Group PC-Robert Packer Hospital
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South Dakota
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Aberdeen, South Dakota, Förenta staterna, 57401
- Avera Cancer Institute-Aberdeen
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Sioux Falls, South Dakota, Förenta staterna, 57105
- Avera Cancer Institute
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Utah
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Salt Lake City, Utah, Förenta staterna, 84112
- Huntsman Cancer Institute/University of Utah
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Vermont
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Berlin Corners, Vermont, Förenta staterna, 05602
- Central Vermont Medical Center/National Life Cancer Treatment
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Burlington, Vermont, Förenta staterna, 05401
- University of Vermont Medical Center
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Virginia
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Charlottesville, Virginia, Förenta staterna, 22908
- University of Virginia Cancer Center
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Richmond, Virginia, Förenta staterna, 23298
- VCU Massey Comprehensive Cancer Center
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Washington
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Aberdeen, Washington, Förenta staterna, 98520
- Providence Regional Cancer System-Aberdeen
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Bellingham, Washington, Förenta staterna, 98225
- PeaceHealth Saint Joseph Medical Center
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Centralia, Washington, Förenta staterna, 98531
- Providence Regional Cancer System-Centralia
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Edmonds, Washington, Förenta staterna, 98026
- Swedish Cancer Institute-Edmonds
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Everett, Washington, Förenta staterna, 98201
- Providence Regional Cancer Partnership
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Issaquah, Washington, Förenta staterna, 98029
- Swedish Cancer Institute-Issaquah
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Kennewick, Washington, Förenta staterna, 99336
- Kadlec Clinic Hematology and Oncology
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Lacey, Washington, Förenta staterna, 98503
- Providence Regional Cancer System-Lacey
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Longview, Washington, Förenta staterna, 98632
- PeaceHealth Saint John Medical Center
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Port Townsend, Washington, Förenta staterna, 98368
- Jefferson Healthcare
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Seattle, Washington, Förenta staterna, 98107
- Swedish Medical Center-Ballard Campus
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Seattle, Washington, Förenta staterna, 98122
- Swedish Medical Center-First Hill
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Sedro-Woolley, Washington, Förenta staterna, 98284
- PeaceHealth United General Medical Center
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Vancouver, Washington, Förenta staterna, 98664
- PeaceHealth Southwest Medical Center
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Walla Walla, Washington, Förenta staterna, 99362
- Providence Saint Mary Regional Cancer Center
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Wisconsin
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Eau Claire, Wisconsin, Förenta staterna, 54701
- Marshfield Medical Center-EC Cancer Center
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Marshfield, Wisconsin, Förenta staterna, 54449
- Marshfield Medical Center-Marshfield
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Milwaukee, Wisconsin, Förenta staterna, 53226
- Medical College of Wisconsin
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Minocqua, Wisconsin, Förenta staterna, 54548
- Marshfield Medical Center - Minocqua
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Rice Lake, Wisconsin, Förenta staterna, 54868
- Marshfield Medical Center-Rice Lake
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Stevens Point, Wisconsin, Förenta staterna, 54482
- Marshfield Medical Center-River Region at Stevens Point
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Weston, Wisconsin, Förenta staterna, 54476
- Marshfield Medical Center - Weston
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
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Patient must be >= 18 years of age
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Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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Patient must have a histologic diagnosis of melanoma belonging to the following American Joint Committee on Cancer (AJCC) 8th edition TNM stages:
- T0, Tx or T1-4; and
- N1b, N2b, N2c, N3b or N3c
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Patients may have a presentation with primary melanoma with concurrent regional nodal and/or in-transit metastasis; or patients may have a history of primary melanoma or unknown primary melanoma presenting with clinically detected regional nodal and/or in-transit recurrence; and may belong to any of the following groups:
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Primary cutaneous melanoma with clinically apparent regional lymph node metastases and/or in-transit metastases
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Clinically detected recurrent melanoma at the proximal regional lymph node(s) basin
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Primary cutaneous melanoma with concurrent nodal disease involving a single (or multiple) regional nodal group(s) if considered potentially surgically resectable at baseline
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Clinically detected nodal melanoma (if single site) arising from an unknown primary
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In-transit cutaneous metastases with or without regional lymph node involvement permitted if considered potentially surgically resectable at baseline
- NOTE: Patients with mucosal and/or uveal melanoma are not eligible for the study
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Patient must be a candidate for definitive surgery and have met with the treating surgical oncologist prior to randomization
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Patient must not have received any live vaccine within 30 days prior to randomization and while participating in the study. Live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Patients are permitted to receive inactivated vaccines and any non-live vaccines including those for the seasonal influenza and COVID-19 (Note: intranasal influenza vaccines, such as Flu-Mist [registered trademark] are live attenuated vaccines and are not allowed). If possible, it is recommended to separate study drug administration from vaccine administration by about a week (primarily, in order to minimize an overlap of adverse events)
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Patient must have the presence of injectable and measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, documented by scans obtained within 4 weeks prior to randomization
- NOTE: Injectable disease is defined as an accessible lesion in the skin, subcutaneous tissue or lymph nodes (LN) close to the skin and palpable by physical examination or approachable with ultrasound guidance
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Absolute neutrophil count (ANC) >= 1,500 /mcL (obtained within 4 weeks prior to randomization)
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Hemoglobin (Hgb) >= 9 g/dL or >= 5.6 mmol/L (obtained within 4 weeks prior to randomization)
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Platelets >= 100,000 / mcL (obtained within 4 weeks prior to randomization)
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Serum creatinine =< 1.5 x institutional upper limit of normal (ULN) or measured or calculated creatinine clearance > 60 mL/min (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl] for patients with creatinine levels > 1.5 x institutional ULN) (obtained within 4 weeks prior to randomization)
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Serum total bilirubin =< 1.5 x institutional ULN; for total bilirubin level > 1.5 x ULN but =< 3 x ULN, the direct bilirubin must be =< the institutional ULN (obtained within 4 weeks prior to randomization)
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Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained within 4 weeks prior to randomization)
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International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x institutional ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (obtained within 4 weeks prior to randomization)
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Activated partial thromboplastin time (aPTT) =< 1.5 x institutional ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (obtained within 4 weeks prior to randomization)
-
Patients must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A urine or serum pregnancy test must be repeated within 72 hours prior to receiving the first dose of pembrolizumab if the test done for eligibility/randomization is done outside of this 72 hour window. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
-
Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or abstaining from sexual intercourse from time of randomization, while on study treatment, and continue for 26 weeks after the last dose of protocol treatment
-
Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
-
Patient must not have received prior systemic therapy for melanoma including systemic therapy with an anti-PD-1, anti-PD-L1, anti-CTLA-4, BRAF/MEK inhibitor combination and/or TLR-9 agonist
-
Patient must not have a diagnosis of immunodeficiency or be receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization, except as noted here
- Patients who are currently receiving steroids at a dose of prednisone =< 5 mg daily (or equivalent) are permitted to enroll
- Patients who require topical, ophthalmologic and inhalational steroids are permitted to enroll
- Patients with hypothyroidism who are stable on hormone replacement are permitted to enroll
- Patients who require active immunosuppression with corticosteroids at a dose of prednisone > 5 mg daily (or equivalent) for any reason are ineligible
- Patients with adrenal insufficiency are ineligible
- Patients who have developed autoimmune disorders of grade 4 while on prior immunotherapy are not permitted to enroll on this study. Patients who developed autoimmune disorders of grade =< 3 may enroll if the disorder has resolved to grade =< 1 and the patient has been off systemic corticosteroids at doses > 5 mg for at least 2 weeks prior to randomization
-
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to randomization are eligible for this trial
-
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
-
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
-
Patients with a history of brain metastases are not eligible for this study as they do not meet the eligibility staging criteria
-
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
-
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
-
Patient must not have had an allogeneic tissue/solid organ transplant
-
Patient must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
-
Patient must not have severe hypersensitivity (>= grade 3) to pembrolizumab and/or any of its excipients
-
Patient must not have an active infection requiring systemic therapy
-
Patient must not have a known psychiatric or substance abuse disorder that would interfere with the patient's ability to cooperate with the requirements of the study
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Arm A (pembrolizumab)
NEOADJUVANT PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. SURGERY: Patients undergo surgery 1-2 weeks after completion of neoadjuvant phase. ADJUVANT PHASE: After recovery from surgery, patients receive pembrolizumab IV over 30 minutes on day 1 of every other cycle. Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET/CT throughout the trial and may undergo optional biopsy at baseline and disease progression and optional collection of blood samples throughout the trial. |
Undergo biopsy
Andra namn:
Given IV
Andra namn:
Undergo collection of blood samples
Andra namn:
Undergo CT or PET/CT
Andra namn:
Undergo PET/CT
Andra namn:
Undergo surgery
Andra namn:
|
|
Experimentell: Arm B (CMP-001, pembrolizumab)
NEOADJUVANT PHASE: Patients receive CMP-001 SC on day 1 of cycle 1 and then intratumorally on days 8 and 15 of cycle 1, days 1, 8, and 15 of cycle 2, and day 1 of cycle 3. Patients also receive pembrolizumab IV over 30 minutes on day 8 of each cycle. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. SURGERY: Patients undergo surgery 1-2 weeks after completion of neoadjuvant phase. ADJUVANT PHASE: After recovery from surgery, patients receive pembrolizumab IV over 30 minutes on day 1 of every other cycle. Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET/CT throughout the trial and may undergo optional biopsy at baseline and disease progression and optional collection of blood samples throughout the trial. |
Undergo biopsy
Andra namn:
Given IV
Andra namn:
Undergo collection of blood samples
Andra namn:
Undergo CT or PET/CT
Andra namn:
Undergo PET/CT
Andra namn:
Undergo surgery
Andra namn:
Given SC or intratumorally |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pathologic complete response rate
Tidsram: Up to 15 years
|
Will be estimated by the percentage of patients who achieve complete response, partial response or stable disease by Response Evaluation Criteria in Solid Tumors (RECIST) and Immune-Modified RECIST criteria, with exact 90% confidence intervals. |
Up to 15 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Återfallsfri överlevnad
Tidsram: Från randomisering till återfall eller död (beroende på vilket som inträffar först), bedömd upp till 15 år
|
Från randomisering till återfall eller död (beroende på vilket som inträffar först), bedömd upp till 15 år
|
|
|
Total överlevnad
Tidsram: Från randomisering till död oavsett orsak, bedömd upp till 15 år
|
Från randomisering till död oavsett orsak, bedömd upp till 15 år
|
|
|
Radiographic response rate
Tidsram: Up to 15 years
|
Will be assessed using RECIST. |
Up to 15 years
|
|
Incidence of adverse events
Tidsram: Up to 30 days after the last study drug administration
|
Patients will be monitored for adverse events using the National Cancer Institute's Common Terminology Criteria for Adverse Events. |
Up to 30 days after the last study drug administration
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Ahmad Tarhini, ECOG-ACRIN Cancer Research Group
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Neoplasmer efter histologisk typ
- Hudsjukdomar
- Neuroektodermala tumörer
- Neoplasmer, könsceller och embryonala
- Neoplasmer, nervvävnad
- Neuroendokrina tumörer
- Nevi och melanom
- Neoplasmer i huden
- Hud- och bindvävssjukdomar
- Melanom
- Undersökningstekniker
- Kliniska laboratorietekniker
- Diagnostiska tekniker och procedurer
- Diagnos
- Cytologiska tekniker
- Cytodiagnos
- Diagnostiska tekniker, kirurgiska
- Kemitekniker, analytiska
- Spektrumanalys
- Biopsi
- Provhantering
- pembrolizumab
- Magnetresonansspektroskopi
- Kirurgiska ingrepp, operativ
Andra studie-ID-nummer
- NCI-2020-14174
- U10CA180820 (U.S.S. NIH-anslag/kontrakt)
- NCI-2020-14174 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- EA6194 (Annan identifierare: CTEP)
- EA6194 (Annan identifierare: ECOG-ACRIN Cancer Research Group)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Läkemedels- och apparatinformation, studiedokument
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