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Un estudio que evalúa si pembrolizumab solo o en combinación con CMP-001 mejora la eficacia en pacientes con melanoma operable

26 de septiembre de 2026 actualizado por: National Cancer Institute (NCI)

Estudio aleatorizado de fase II de pembrolizumab neoadyuvante solo o en combinación con CMP-001 en pacientes con melanoma operable: estudio de eficacia y biomarcadores

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.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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).

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Alaska
      • Anchorage, Alaska, Estados Unidos, 98508
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, Estados Unidos, 99508
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, Estados Unidos, 99508
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, Estados Unidos, 99508
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, Estados Unidos, 99508
        • Anchorage Oncology Centre
      • Anchorage, Alaska, Estados Unidos, 99508
        • Katmai Oncology Group
      • Anchorage, Alaska, Estados Unidos, 99508
        • Providence Alaska Medical Center
      • Fairbanks, Alaska, Estados Unidos, 99701
        • Fairbanks Memorial Hospital
    • Arizona
      • Tucson, Arizona, Estados Unidos, 85719
        • Banner University Medical Center - Tucson
      • Tucson, Arizona, Estados Unidos, 85719
        • University of Arizona Cancer Center-North Campus
    • Arkansas
      • Fort Smith, Arkansas, Estados Unidos, 72903
        • Mercy Hospital Fort Smith
    • California
      • Burbank, California, Estados Unidos, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Dublin, California, Estados Unidos, 94568
        • Epic Care-Dublin
      • Emeryville, California, Estados Unidos, 94608
        • Bay Area Breast Surgeons Inc
      • Emeryville, California, Estados Unidos, 94608
        • Epic Care Partners in Cancer Care
      • Martinez, California, Estados Unidos, 94553-3156
        • Contra Costa Regional Medical Center
      • Oakland, California, Estados Unidos, 94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland, California, Estados Unidos, 94609
        • Bay Area Tumor Institute
      • Orange, California, Estados Unidos, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Orange, California, Estados Unidos, 92868
        • Saint Joseph Hospital - Orange
      • Walnut Creek, California, Estados Unidos, 94597
        • Epic Care Cyberknife Center
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80012
        • Rocky Mountain Cancer Centers-Aurora
      • Aurora, Colorado, Estados Unidos, 80012
        • The Medical Center of Aurora
      • Boulder, Colorado, Estados Unidos, 80304
        • Rocky Mountain Cancer Centers-Boulder
      • Centennial, Colorado, Estados Unidos, 80112
        • Rocky Mountain Cancer Centers - Centennial
      • Denver, Colorado, Estados Unidos, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, Estados Unidos, 80218
        • Rocky Mountain Cancer Centers-Midtown
      • Denver, Colorado, Estados Unidos, 80220
        • Rocky Mountain Cancer Centers-Rose
      • Englewood, Colorado, Estados Unidos, 80113
        • Mountain Blue Cancer Care Center - Swedish
      • Englewood, Colorado, Estados Unidos, 80113
        • Swedish Medical Center
      • Englewood, Colorado, Estados Unidos, 80113
        • Rocky Mountain Cancer Centers - Swedish
      • Englewood, Colorado, Estados Unidos, 80113
        • The Melanoma and Skin Cancer Institute
      • Greeley, Colorado, Estados Unidos, 80631
        • Banner North Colorado Medical Center
      • Littleton, Colorado, Estados Unidos, 80120
        • Rocky Mountain Cancer Centers-Littleton
      • Lone Tree, Colorado, Estados Unidos, 80124
        • Sky Ridge Medical Center
      • Lone Tree, Colorado, Estados Unidos, 80124
        • Rocky Mountain Cancer Centers-Sky Ridge
      • Loveland, Colorado, Estados Unidos, 80539
        • Banner North Colorado Medical Center - Loveland Campus
      • Thornton, Colorado, Estados Unidos, 80260
        • Rocky Mountain Cancer Centers-Thornton
    • Florida
      • Aventura, Florida, Estados Unidos, 33180
        • UM Sylvester Comprehensive Cancer Center at Aventura
      • Coral Gables, Florida, Estados Unidos, 33146
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
      • Deerfield Beach, Florida, Estados Unidos, 33442
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
      • Miami, Florida, Estados Unidos, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Plantation, Florida, Estados Unidos, 33324
        • UM Sylvester Comprehensive Cancer Center at Plantation
    • Idaho
      • Boise, Idaho, Estados Unidos, 83712
        • Saint Luke's Cancer Institute - Boise
      • Fruitland, Idaho, Estados Unidos, 83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, Estados Unidos, 83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, Estados Unidos, 83687
        • Saint Luke's Cancer Institute - Nampa
      • Twin Falls, Idaho, Estados Unidos, 83301
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Bloomington, Illinois, Estados Unidos, 61704
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, Estados Unidos, 61520
        • Illinois CancerCare-Canton
      • Carbondale, Illinois, Estados Unidos, 62902
        • Memorial Hospital of Carbondale
      • Carterville, Illinois, Estados Unidos, 62918
        • SIH Cancer Institute
      • Carthage, Illinois, Estados Unidos, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, Estados Unidos, 62801
        • Centralia Oncology Clinic
      • Chicago, Illinois, Estados Unidos, 60612
        • University of Illinois
      • Decatur, Illinois, Estados Unidos, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, Estados Unidos, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Dixon, Illinois, Estados Unidos, 61021
        • Illinois CancerCare-Dixon
      • Effingham, Illinois, Estados Unidos, 62401
        • Crossroads Cancer Center
      • Eureka, Illinois, Estados Unidos, 61530
        • Illinois CancerCare-Eureka
      • Galesburg, Illinois, Estados Unidos, 61401
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, Estados Unidos, 61401
        • Illinois CancerCare-Galesburg
      • Kewanee, Illinois, Estados Unidos, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Macomb, Illinois, Estados Unidos, 61455
        • Illinois CancerCare-Macomb
      • Mount Vernon, Illinois, Estados Unidos, 62864
        • SSM Health Good Samaritan
      • O'Fallon, Illinois, Estados Unidos, 62269
        • Cancer Care Center of O'Fallon
      • Ottawa, Illinois, Estados Unidos, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, Estados Unidos, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, Estados Unidos, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Estados Unidos, 61615
        • Illinois CancerCare-Peoria
      • Peru, Illinois, Estados Unidos, 61354
        • Illinois CancerCare-Peru
      • Peru, Illinois, Estados Unidos, 61354
        • Valley Radiation Oncology
      • Princeton, Illinois, Estados Unidos, 61356
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, Estados Unidos, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, Estados Unidos, 62702
        • Springfield Clinic
      • Springfield, Illinois, Estados Unidos, 62781
        • Springfield Memorial Hospital
      • Washington, Illinois, Estados Unidos, 61571
        • Illinois CancerCare - Washington
    • Indiana
      • Richmond, Indiana, Estados Unidos, 47374
        • Reid Health
    • Iowa
      • Ames, Iowa, Estados Unidos, 50010
        • Mary Greeley Medical Center
      • Ames, Iowa, Estados Unidos, 50010
        • McFarland Clinic - Ames
      • Boone, Iowa, Estados Unidos, 50036
        • McFarland Clinic - Boone
      • Fort Dodge, Iowa, Estados Unidos, 50501
        • McFarland Clinic - Trinity Cancer Center
      • Jefferson, Iowa, Estados Unidos, 50129
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, Estados Unidos, 50158
        • McFarland Clinic - Marshalltown
    • Kansas
      • Garden City, Kansas, Estados Unidos, 67846
        • Central Care Cancer Center - Garden City
      • Great Bend, Kansas, Estados Unidos, 67530
        • Central Care Cancer Center - Great Bend
    • Louisiana
      • Baton Rouge, Louisiana, Estados Unidos, 70809
        • Louisiana Hematology Oncology Associates LLC
      • Baton Rouge, Louisiana, Estados Unidos, 70809
        • Mary Bird Perkins Cancer Center
      • Houma, Louisiana, Estados Unidos, 70360
        • Terrebonne General Medical Center
    • Michigan
      • Battle Creek, Michigan, Estados Unidos, 49017
        • Bronson Battle Creek
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Trinity Health Grand Rapids Hospital
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
      • Kalamazoo, Michigan, Estados Unidos, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, Estados Unidos, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Estados Unidos, 49009
        • Beacon Kalamazoo Cancer Center
      • Kalamazoo, Michigan, Estados Unidos, 49048
        • Beacon Kalamazoo
      • Muskegon, Michigan, Estados Unidos, 49444
        • Trinity Health Muskegon Hospital
      • Niles, Michigan, Estados Unidos, 49120
        • Corewell Health Lakeland Hospitals - Niles Hospital
      • Norton Shores, Michigan, Estados Unidos, 49444
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
      • Reed City, Michigan, Estados Unidos, 49677
        • Corewell Health Reed City Hospital
      • Saint Joseph, Michigan, Estados Unidos, 49085
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
      • Saint Joseph, Michigan, Estados Unidos, 49085
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
      • Traverse City, Michigan, Estados Unidos, 49684
        • Munson Medical Center
      • Wyoming, Michigan, Estados Unidos, 49519
        • University of Michigan Health - West
    • Missouri
      • Ballwin, Missouri, Estados Unidos, 63011
        • Mercy Oncology and Hematology - Clayton-Clarkson
      • Bolivar, Missouri, Estados Unidos, 65613
        • Central Care Cancer Center - Bolivar
      • Cape Girardeau, Missouri, Estados Unidos, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, Estados Unidos, 63703
        • Mercy Cancer Center - Cape Girardeau
      • Farmington, Missouri, Estados Unidos, 63640
        • Parkland Health Center - Farmington
      • Jefferson City, Missouri, Estados Unidos, 65109
        • MU Health Care Goldschmidt Cancer Center
      • Joplin, Missouri, Estados Unidos, 64804
        • Freeman Health System
      • Joplin, Missouri, Estados Unidos, 64804
        • Mercy Hospital Joplin
      • Rolla, Missouri, Estados Unidos, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, Estados Unidos, 65401
        • Phelps Health Delbert Day Cancer Institute
      • Saint Joseph, Missouri, Estados Unidos, 64506
        • Heartland Regional Medical Center
      • Sainte Genevieve, Missouri, Estados Unidos, 63670
        • Sainte Genevieve County Memorial Hospital
      • Springfield, Missouri, Estados Unidos, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Estados Unidos, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, Estados Unidos, 63131
        • Missouri Baptist Medical Center
      • St Louis, Missouri, Estados Unidos, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, Estados Unidos, 63128
        • Mercy Hospital South
      • Sullivan, Missouri, Estados Unidos, 63080
        • Missouri Baptist Sullivan Hospital
    • Montana
      • Missoula, Montana, Estados Unidos, 59802
        • Saint Patrick Hospital - Community Hospital
    • Ohio
      • Beavercreek, Ohio, Estados Unidos, 45431
        • Indu and Raj Soin Medical Center
      • Centerville, Ohio, Estados Unidos, 45459
        • Miami Valley Hospital South
      • Centerville, Ohio, Estados Unidos, 45459
        • Dayton Physicians LLC-Miami Valley South
      • Cincinnati, Ohio, Estados Unidos, 45236
        • Oncology Hematology Care Inc-Kenwood
      • Dayton, Ohio, Estados Unidos, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, Estados Unidos, 45415
        • Miami Valley Hospital North
      • Dayton, Ohio, Estados Unidos, 45415
        • Dayton Physician LLC - Englewood
      • Findlay, Ohio, Estados Unidos, 45840
        • Blanchard Valley Hospital
      • Findlay, Ohio, Estados Unidos, 45840
        • Armes Family Cancer Center
      • Findlay, Ohio, Estados Unidos, 45840
        • Orion Cancer Care
      • Franklin, Ohio, Estados Unidos, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Franklin, Ohio, Estados Unidos, 45005
        • Dayton Physicians LLC-Atrium
      • Greenville, Ohio, Estados Unidos, 45331
        • Wayne Hospital
      • Greenville, Ohio, Estados Unidos, 45331
        • Dayton Physicians LLC-Wayne
      • Kettering, Ohio, Estados Unidos, 45429
        • Kettering Medical Center
      • Kettering, Ohio, Estados Unidos, 45409
        • Greater Dayton Cancer Center
      • Springfield, Ohio, Estados Unidos, 45504
        • Springfield Regional Cancer Center
      • Springfield, Ohio, Estados Unidos, 45504
        • Springfield Regional Medical Center
      • Troy, Ohio, Estados Unidos, 45373
        • Upper Valley Medical Center
      • Troy, Ohio, Estados Unidos, 45373
        • Dayton Physicians LLC - Troy
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73120
        • Mercy Hospital Oklahoma City
    • Oregon
      • Bend, Oregon, Estados Unidos, 97701
        • Saint Charles Health System
      • Clackamas, Oregon, Estados Unidos, 97015
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, Estados Unidos, 97015
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, Estados Unidos, 97420
        • Bay Area Hospital
      • Newberg, Oregon, Estados Unidos, 97132
        • Providence Newberg Medical Center
      • Portland, Oregon, Estados Unidos, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Estados Unidos, 97225
        • Providence Saint Vincent Medical Center
    • Pennsylvania
      • Allentown, Pennsylvania, Estados Unidos, 18104
        • Saint Luke's Cancer Center - Allentown
      • Bethlehem, Pennsylvania, Estados Unidos, 18015
        • Saint Luke's University Hospital-Bethlehem Campus
      • Easton, Pennsylvania, Estados Unidos, 18045
        • Saint Luke's Hospital-Anderson Campus
      • Pittsburgh, Pennsylvania, Estados Unidos, 15232
        • UPMC Hillman Cancer Center
      • Quakertown, Pennsylvania, Estados Unidos, 18951
        • Saint Luke's Hospital-Quakertown Campus
      • Sayre, Pennsylvania, Estados Unidos, 18840
        • Guthrie Medical Group PC-Robert Packer Hospital
    • South Dakota
      • Aberdeen, South Dakota, Estados Unidos, 57401
        • Avera Cancer Institute-Aberdeen
      • Sioux Falls, South Dakota, Estados Unidos, 57105
        • Avera Cancer Institute
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84112
        • Huntsman Cancer Institute/University of Utah
    • Vermont
      • Berlin Corners, Vermont, Estados Unidos, 05602
        • Central Vermont Medical Center/National Life Cancer Treatment
      • Burlington, Vermont, Estados Unidos, 05401
        • University of Vermont Medical Center
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22908
        • University of Virginia Cancer Center
      • Richmond, Virginia, Estados Unidos, 23298
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Aberdeen, Washington, Estados Unidos, 98520
        • Providence Regional Cancer System-Aberdeen
      • Bellingham, Washington, Estados Unidos, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, Estados Unidos, 98531
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, Estados Unidos, 98026
        • Swedish Cancer Institute-Edmonds
      • Everett, Washington, Estados Unidos, 98201
        • Providence Regional Cancer Partnership
      • Issaquah, Washington, Estados Unidos, 98029
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, Estados Unidos, 99336
        • Kadlec Clinic Hematology and Oncology
      • Lacey, Washington, Estados Unidos, 98503
        • Providence Regional Cancer System-Lacey
      • Longview, Washington, Estados Unidos, 98632
        • PeaceHealth Saint John Medical Center
      • Port Townsend, Washington, Estados Unidos, 98368
        • Jefferson Healthcare
      • Seattle, Washington, Estados Unidos, 98107
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, Estados Unidos, 98122
        • Swedish Medical Center-First Hill
      • Sedro-Woolley, Washington, Estados Unidos, 98284
        • PeaceHealth United General Medical Center
      • Vancouver, Washington, Estados Unidos, 98664
        • PeaceHealth Southwest Medical Center
      • Walla Walla, Washington, Estados Unidos, 99362
        • Providence Saint Mary Regional Cancer Center
    • Wisconsin
      • Eau Claire, Wisconsin, Estados Unidos, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Marshfield, Wisconsin, Estados Unidos, 54449
        • Marshfield Medical Center-Marshfield
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Medical College of Wisconsin
      • Minocqua, Wisconsin, Estados Unidos, 54548
        • Marshfield Medical Center - Minocqua
      • Rice Lake, Wisconsin, Estados Unidos, 54868
        • Marshfield Medical Center-Rice Lake
      • Stevens Point, Wisconsin, Estados Unidos, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Weston, Wisconsin, Estados Unidos, 54476
        • Marshfield Medical Center - Weston

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patient must be >= 18 years of age

  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • 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

  • 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:

    • Primary cutaneous melanoma with clinically apparent regional lymph node metastases and/or in-transit metastases

    • Clinically detected recurrent melanoma at the proximal regional lymph node(s) basin

    • Primary cutaneous melanoma with concurrent nodal disease involving a single (or multiple) regional nodal group(s) if considered potentially surgically resectable at baseline

    • Clinically detected nodal melanoma (if single site) arising from an unknown primary

    • 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

  • Patient must be a candidate for definitive surgery and have met with the treating surgical oncologist prior to randomization

  • 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)

  • 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

  • Absolute neutrophil count (ANC) >= 1,500 /mcL (obtained within 4 weeks prior to randomization)

  • Hemoglobin (Hgb) >= 9 g/dL or >= 5.6 mmol/L (obtained within 4 weeks prior to randomization)

  • Platelets >= 100,000 / mcL (obtained within 4 weeks prior to randomization)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Procedimiento: Biopsy Procedure

Undergo biopsy

Otros nombres:
  • Caja
  • BIOPSIA_TIPO
  • Biopsia
Biológico: Pembrolizumab

Given IV

Otros nombres:
  • 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
Procedimiento: Biospecimen Collection

Undergo collection of blood samples

Otros nombres:
  • Recolección de muestras biológicas
  • Muestra biológica recolectada
  • Coleccion de especimenes
  • Recolección de muestras
Procedimiento: Computed Tomography

Undergo CT or PET/CT

Otros nombres:
  • Connecticut
  • GATO
  • Análisis de gato
  • Tomografía Axial Computarizada
  • Tomografía axial computarizada
  • Tomografía computarizada
  • tomografía
  • Tomografía axial computarizada (procedimiento)
  • Tomografía computarizada (TC)
  • Escaneo de gato de diagnóstico
  • Tipo de servicio de escaneo de gato de diagnóstico
Procedimiento: Positron Emission Tomography

Undergo PET/CT

Otros nombres:
  • Imágenes médicas, tomografía por emisión de positrones
  • MASCOTA
  • Escaneo de mascotas
  • Tomografía por emisión de positrones
  • Tomografía de emisión de positrones
  • PT
  • Tomografía por emisión de positrones (procedimiento)
Procedimiento: Surgical Procedure

Undergo surgery

Otros nombres:
  • Operación
  • Cirugía
  • Tipo de cirugía
  • Quirúrgico
  • Intervención quirúrgica
  • Intervenciones Quirúrgicas
  • Procedimientos quirúrgicos
  • Tipo de Cirugía
  • Cirugía, SAI
Experimental: 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.
Procedimiento: Biopsy Procedure

Undergo biopsy

Otros nombres:
  • Caja
  • BIOPSIA_TIPO
  • Biopsia
Biológico: Pembrolizumab

Given IV

Otros nombres:
  • 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
Procedimiento: Biospecimen Collection

Undergo collection of blood samples

Otros nombres:
  • Recolección de muestras biológicas
  • Muestra biológica recolectada
  • Coleccion de especimenes
  • Recolección de muestras
Procedimiento: Computed Tomography

Undergo CT or PET/CT

Otros nombres:
  • Connecticut
  • GATO
  • Análisis de gato
  • Tomografía Axial Computarizada
  • Tomografía axial computarizada
  • Tomografía computarizada
  • tomografía
  • Tomografía axial computarizada (procedimiento)
  • Tomografía computarizada (TC)
  • Escaneo de gato de diagnóstico
  • Tipo de servicio de escaneo de gato de diagnóstico
Procedimiento: Positron Emission Tomography

Undergo PET/CT

Otros nombres:
  • Imágenes médicas, tomografía por emisión de positrones
  • MASCOTA
  • Escaneo de mascotas
  • Tomografía por emisión de positrones
  • Tomografía de emisión de positrones
  • PT
  • Tomografía por emisión de positrones (procedimiento)
Procedimiento: Surgical Procedure

Undergo surgery

Otros nombres:
  • Operación
  • Cirugía
  • Tipo de cirugía
  • Quirúrgico
  • Intervención quirúrgica
  • Intervenciones Quirúrgicas
  • Procedimientos quirúrgicos
  • Tipo de Cirugía
  • Cirugía, SAI
Droga: VLP-encapsulated TLR9 Agonist CMP-001

Given SC or intratumorally

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pathologic complete response rate
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Supervivencia libre de recaídas
Periodo de tiempo: Desde la aleatorización hasta la recaída o la muerte (lo que ocurra primero), evaluado hasta 15 años
Desde la aleatorización hasta la recaída o la muerte (lo que ocurra primero), evaluado hasta 15 años
Sobrevivencia promedio
Periodo de tiempo: Desde la aleatorización hasta la muerte por cualquier causa, evaluada hasta los 15 años
Desde la aleatorización hasta la muerte por cualquier causa, evaluada hasta los 15 años
Radiographic response rate
Periodo de tiempo: Up to 15 years

Will be assessed using RECIST.
Up to 15 years
Incidence of adverse events
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Ahmad Tarhini, ECOG-ACRIN Cancer Research Group

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de octubre de 2021

Finalización primaria (Estimado)

31 de diciembre de 2026

Finalización del estudio (Estimado)

31 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

13 de enero de 2021

Primero enviado que cumplió con los criterios de control de calidad

13 de enero de 2021

Publicado por primera vez (Actual)

14 de enero de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

26 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NCI-2020-14174
  • U10CA180820 (Subvención/contrato del NIH de EE. UU.)
  • NCI-2020-14174 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • EA6194 (Otro identificador: CTEP)
  • EA6194 (Otro identificador: ECOG-ACRIN Cancer Research Group)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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