ペムブロリズマブ単独または CMP-001 との併用が手術可能な黒色腫患者の有効性を改善するかどうかを評価する研究
手術可能な黒色腫患者における術前補助療法ペムブロリズマブ単独または CMP-001 との併用の第 II 相無作為化試験：有効性およびバイオマーカー試験
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.
調査の概要
状態
詳細な説明
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).
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Alaska
-
Anchorage、Alaska、アメリカ、98508
- Anchorage Associates in Radiation Medicine
-
Anchorage、Alaska、アメリカ、99508
- Alaska Breast Care and Surgery LLC
-
Anchorage、Alaska、アメリカ、99508
- Alaska Oncology and Hematology LLC
-
Anchorage、Alaska、アメリカ、99508
- Alaska Women's Cancer Care
-
Anchorage、Alaska、アメリカ、99508
- Anchorage Oncology Centre
-
Anchorage、Alaska、アメリカ、99508
- Katmai Oncology Group
-
Anchorage、Alaska、アメリカ、99508
- Providence Alaska Medical Center
-
Fairbanks、Alaska、アメリカ、99701
- Fairbanks Memorial Hospital
-
-
Arizona
-
Tucson、Arizona、アメリカ、85719
- Banner University Medical Center - Tucson
-
Tucson、Arizona、アメリカ、85719
- University of Arizona Cancer Center-North Campus
-
-
Arkansas
-
Fort Smith、Arkansas、アメリカ、72903
- Mercy Hospital Fort Smith
-
-
California
-
Burbank、California、アメリカ、91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
-
Dublin、California、アメリカ、94568
- Epic Care-Dublin
-
Emeryville、California、アメリカ、94608
- Bay Area Breast Surgeons Inc
-
Emeryville、California、アメリカ、94608
- Epic Care Partners in Cancer Care
-
Martinez、California、アメリカ、94553-3156
- Contra Costa Regional Medical Center
-
Oakland、California、アメリカ、94609
- Alta Bates Summit Medical Center - Summit Campus
-
Oakland、California、アメリカ、94609
- Bay Area Tumor Institute
-
Orange、California、アメリカ、92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
-
Orange、California、アメリカ、92868
- Saint Joseph Hospital - Orange
-
Walnut Creek、California、アメリカ、94597
- Epic Care Cyberknife Center
-
-
Colorado
-
Aurora、Colorado、アメリカ、80012
- Rocky Mountain Cancer Centers-Aurora
-
Aurora、Colorado、アメリカ、80012
- The Medical Center of Aurora
-
Boulder、Colorado、アメリカ、80304
- Rocky Mountain Cancer Centers-Boulder
-
Centennial、Colorado、アメリカ、80112
- Rocky Mountain Cancer Centers - Centennial
-
Denver、Colorado、アメリカ、80218
- Presbyterian - Saint Lukes Medical Center - Health One
-
Denver、Colorado、アメリカ、80218
- Rocky Mountain Cancer Centers-Midtown
-
Denver、Colorado、アメリカ、80220
- Rocky Mountain Cancer Centers-Rose
-
Englewood、Colorado、アメリカ、80113
- Mountain Blue Cancer Care Center - Swedish
-
Englewood、Colorado、アメリカ、80113
- Swedish Medical Center
-
Englewood、Colorado、アメリカ、80113
- Rocky Mountain Cancer Centers - Swedish
-
Englewood、Colorado、アメリカ、80113
- The Melanoma and Skin Cancer Institute
-
Greeley、Colorado、アメリカ、80631
- Banner North Colorado Medical Center
-
Littleton、Colorado、アメリカ、80120
- Rocky Mountain Cancer Centers-Littleton
-
Lone Tree、Colorado、アメリカ、80124
- Sky Ridge Medical Center
-
Lone Tree、Colorado、アメリカ、80124
- Rocky Mountain Cancer Centers-Sky Ridge
-
Loveland、Colorado、アメリカ、80539
- Banner North Colorado Medical Center - Loveland Campus
-
Thornton、Colorado、アメリカ、80260
- Rocky Mountain Cancer Centers-Thornton
-
-
Florida
-
Aventura、Florida、アメリカ、33180
- UM Sylvester Comprehensive Cancer Center at Aventura
-
Coral Gables、Florida、アメリカ、33146
- UM Sylvester Comprehensive Cancer Center at Coral Gables
-
Deerfield Beach、Florida、アメリカ、33442
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
-
Miami、Florida、アメリカ、33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
-
Plantation、Florida、アメリカ、33324
- UM Sylvester Comprehensive Cancer Center at Plantation
-
-
Idaho
-
Boise、Idaho、アメリカ、83712
- Saint Luke's Cancer Institute - Boise
-
Fruitland、Idaho、アメリカ、83619
- Saint Luke's Cancer Institute - Fruitland
-
Meridian、Idaho、アメリカ、83642
- Saint Luke's Cancer Institute - Meridian
-
Nampa、Idaho、アメリカ、83687
- Saint Luke's Cancer Institute - Nampa
-
Twin Falls、Idaho、アメリカ、83301
- Saint Luke's Cancer Institute - Twin Falls
-
-
Illinois
-
Bloomington、Illinois、アメリカ、61704
- Illinois CancerCare-Bloomington
-
Canton、Illinois、アメリカ、61520
- Illinois CancerCare-Canton
-
Carbondale、Illinois、アメリカ、62902
- Memorial Hospital of Carbondale
-
Carterville、Illinois、アメリカ、62918
- SIH Cancer Institute
-
Carthage、Illinois、アメリカ、62321
- Illinois CancerCare-Carthage
-
Centralia、Illinois、アメリカ、62801
- Centralia Oncology Clinic
-
Chicago、Illinois、アメリカ、60612
- University of Illinois
-
Decatur、Illinois、アメリカ、62526
- Decatur Memorial Hospital
-
Decatur、Illinois、アメリカ、62526
- Cancer Care Specialists of Illinois - Decatur
-
Dixon、Illinois、アメリカ、61021
- Illinois CancerCare-Dixon
-
Effingham、Illinois、アメリカ、62401
- Crossroads Cancer Center
-
Eureka、Illinois、アメリカ、61530
- Illinois CancerCare-Eureka
-
Galesburg、Illinois、アメリカ、61401
- Western Illinois Cancer Treatment Center
-
Galesburg、Illinois、アメリカ、61401
- Illinois CancerCare-Galesburg
-
Kewanee、Illinois、アメリカ、61443
- Illinois CancerCare-Kewanee Clinic
-
Macomb、Illinois、アメリカ、61455
- Illinois CancerCare-Macomb
-
Mount Vernon、Illinois、アメリカ、62864
- SSM Health Good Samaritan
-
O'Fallon、Illinois、アメリカ、62269
- Cancer Care Center of O'Fallon
-
Ottawa、Illinois、アメリカ、61350
- Illinois CancerCare-Ottawa Clinic
-
Pekin、Illinois、アメリカ、61554
- Illinois CancerCare-Pekin
-
Peoria、Illinois、アメリカ、61636
- Methodist Medical Center of Illinois
-
Peoria、Illinois、アメリカ、61615
- Illinois CancerCare-Peoria
-
Peru、Illinois、アメリカ、61354
- Illinois CancerCare-Peru
-
Peru、Illinois、アメリカ、61354
- Valley Radiation Oncology
-
Princeton、Illinois、アメリカ、61356
- Illinois CancerCare-Princeton
-
Springfield、Illinois、アメリカ、62702
- Southern Illinois University School of Medicine
-
Springfield、Illinois、アメリカ、62702
- Springfield Clinic
-
Springfield、Illinois、アメリカ、62781
- Springfield Memorial Hospital
-
Washington、Illinois、アメリカ、61571
- Illinois CancerCare - Washington
-
-
Indiana
-
Richmond、Indiana、アメリカ、47374
- Reid Health
-
-
Iowa
-
Ames、Iowa、アメリカ、50010
- Mary Greeley Medical Center
-
Ames、Iowa、アメリカ、50010
- McFarland Clinic - Ames
-
Boone、Iowa、アメリカ、50036
- McFarland Clinic - Boone
-
Fort Dodge、Iowa、アメリカ、50501
- McFarland Clinic - Trinity Cancer Center
-
Jefferson、Iowa、アメリカ、50129
- McFarland Clinic - Jefferson
-
Marshalltown、Iowa、アメリカ、50158
- McFarland Clinic - Marshalltown
-
-
Kansas
-
Garden City、Kansas、アメリカ、67846
- Central Care Cancer Center - Garden City
-
Great Bend、Kansas、アメリカ、67530
- Central Care Cancer Center - Great Bend
-
-
Louisiana
-
Baton Rouge、Louisiana、アメリカ、70809
- Louisiana Hematology Oncology Associates LLC
-
Baton Rouge、Louisiana、アメリカ、70809
- Mary Bird Perkins Cancer Center
-
Houma、Louisiana、アメリカ、70360
- Terrebonne General Medical Center
-
-
Michigan
-
Battle Creek、Michigan、アメリカ、49017
- Bronson Battle Creek
-
Grand Rapids、Michigan、アメリカ、49503
- Trinity Health Grand Rapids Hospital
-
Grand Rapids、Michigan、アメリカ、49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
-
Grand Rapids、Michigan、アメリカ、49503
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
-
Kalamazoo、Michigan、アメリカ、49007
- West Michigan Cancer Center
-
Kalamazoo、Michigan、アメリカ、49007
- Bronson Methodist Hospital
-
Kalamazoo、Michigan、アメリカ、49009
- Beacon Kalamazoo Cancer Center
-
Kalamazoo、Michigan、アメリカ、49048
- Beacon Kalamazoo
-
Muskegon、Michigan、アメリカ、49444
- Trinity Health Muskegon Hospital
-
Niles、Michigan、アメリカ、49120
- Corewell Health Lakeland Hospitals - Niles Hospital
-
Norton Shores、Michigan、アメリカ、49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
-
Reed City、Michigan、アメリカ、49677
- Corewell Health Reed City Hospital
-
Saint Joseph、Michigan、アメリカ、49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
-
Saint Joseph、Michigan、アメリカ、49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
-
Traverse City、Michigan、アメリカ、49684
- Munson Medical Center
-
Wyoming、Michigan、アメリカ、49519
- University of Michigan Health - West
-
-
Missouri
-
Ballwin、Missouri、アメリカ、63011
- Mercy Oncology and Hematology - Clayton-Clarkson
-
Bolivar、Missouri、アメリカ、65613
- Central Care Cancer Center - Bolivar
-
Cape Girardeau、Missouri、アメリカ、63703
- Saint Francis Medical Center
-
Cape Girardeau、Missouri、アメリカ、63703
- Mercy Cancer Center - Cape Girardeau
-
Farmington、Missouri、アメリカ、63640
- Parkland Health Center - Farmington
-
Jefferson City、Missouri、アメリカ、65109
- MU Health Care Goldschmidt Cancer Center
-
Joplin、Missouri、アメリカ、64804
- Freeman Health System
-
Joplin、Missouri、アメリカ、64804
- Mercy Hospital Joplin
-
Rolla、Missouri、アメリカ、65401
- Mercy Clinic-Rolla-Cancer and Hematology
-
Rolla、Missouri、アメリカ、65401
- Phelps Health Delbert Day Cancer Institute
-
Saint Joseph、Missouri、アメリカ、64506
- Heartland Regional Medical Center
-
Sainte Genevieve、Missouri、アメリカ、63670
- Sainte Genevieve County Memorial Hospital
-
Springfield、Missouri、アメリカ、65807
- CoxHealth South Hospital
-
Springfield、Missouri、アメリカ、65804
- Mercy Hospital Springfield
-
St Louis、Missouri、アメリカ、63131
- Missouri Baptist Medical Center
-
St Louis、Missouri、アメリカ、63141
- Mercy Hospital Saint Louis
-
St Louis、Missouri、アメリカ、63128
- Mercy Hospital South
-
Sullivan、Missouri、アメリカ、63080
- Missouri Baptist Sullivan Hospital
-
-
Montana
-
Missoula、Montana、アメリカ、59802
- Saint Patrick Hospital - Community Hospital
-
-
Ohio
-
Beavercreek、Ohio、アメリカ、45431
- Indu and Raj Soin Medical Center
-
Centerville、Ohio、アメリカ、45459
- Miami Valley Hospital South
-
Centerville、Ohio、アメリカ、45459
- Dayton Physicians LLC-Miami Valley South
-
Cincinnati、Ohio、アメリカ、45236
- Oncology Hematology Care Inc-Kenwood
-
Dayton、Ohio、アメリカ、45409
- Miami Valley Hospital
-
Dayton、Ohio、アメリカ、45415
- Miami Valley Hospital North
-
Dayton、Ohio、アメリカ、45415
- Dayton Physician LLC - Englewood
-
Findlay、Ohio、アメリカ、45840
- Blanchard Valley Hospital
-
Findlay、Ohio、アメリカ、45840
- Armes Family Cancer Center
-
Findlay、Ohio、アメリカ、45840
- Orion Cancer Care
-
Franklin、Ohio、アメリカ、45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Franklin、Ohio、アメリカ、45005
- Dayton Physicians LLC-Atrium
-
Greenville、Ohio、アメリカ、45331
- Wayne Hospital
-
Greenville、Ohio、アメリカ、45331
- Dayton Physicians LLC-Wayne
-
Kettering、Ohio、アメリカ、45429
- Kettering Medical Center
-
Kettering、Ohio、アメリカ、45409
- Greater Dayton Cancer Center
-
Springfield、Ohio、アメリカ、45504
- Springfield Regional Cancer Center
-
Springfield、Ohio、アメリカ、45504
- Springfield Regional Medical Center
-
Troy、Ohio、アメリカ、45373
- Upper Valley Medical Center
-
Troy、Ohio、アメリカ、45373
- Dayton Physicians LLC - Troy
-
-
Oklahoma
-
Oklahoma City、Oklahoma、アメリカ、73120
- Mercy Hospital Oklahoma City
-
-
Oregon
-
Bend、Oregon、アメリカ、97701
- Saint Charles Health System
-
Clackamas、Oregon、アメリカ、97015
- Clackamas Radiation Oncology Center
-
Clackamas、Oregon、アメリカ、97015
- Providence Cancer Institute Clackamas Clinic
-
Coos Bay、Oregon、アメリカ、97420
- Bay Area Hospital
-
Newberg、Oregon、アメリカ、97132
- Providence Newberg Medical Center
-
Portland、Oregon、アメリカ、97213
- Providence Portland Medical Center
-
Portland、Oregon、アメリカ、97225
- Providence Saint Vincent Medical Center
-
-
Pennsylvania
-
Allentown、Pennsylvania、アメリカ、18104
- Saint Luke's Cancer Center - Allentown
-
Bethlehem、Pennsylvania、アメリカ、18015
- Saint Luke's University Hospital-Bethlehem Campus
-
Easton、Pennsylvania、アメリカ、18045
- Saint Luke's Hospital-Anderson Campus
-
Pittsburgh、Pennsylvania、アメリカ、15232
- UPMC Hillman Cancer Center
-
Quakertown、Pennsylvania、アメリカ、18951
- Saint Luke's Hospital-Quakertown Campus
-
Sayre、Pennsylvania、アメリカ、18840
- Guthrie Medical Group PC-Robert Packer Hospital
-
-
South Dakota
-
Aberdeen、South Dakota、アメリカ、57401
- Avera Cancer Institute-Aberdeen
-
Sioux Falls、South Dakota、アメリカ、57105
- Avera Cancer Institute
-
-
Utah
-
Salt Lake City、Utah、アメリカ、84112
- Huntsman Cancer Institute/University of Utah
-
-
Vermont
-
Berlin Corners、Vermont、アメリカ、05602
- Central Vermont Medical Center/National Life Cancer Treatment
-
Burlington、Vermont、アメリカ、05401
- University of Vermont Medical Center
-
-
Virginia
-
Charlottesville、Virginia、アメリカ、22908
- University of Virginia Cancer Center
-
Richmond、Virginia、アメリカ、23298
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Aberdeen、Washington、アメリカ、98520
- Providence Regional Cancer System-Aberdeen
-
Bellingham、Washington、アメリカ、98225
- PeaceHealth Saint Joseph Medical Center
-
Centralia、Washington、アメリカ、98531
- Providence Regional Cancer System-Centralia
-
Edmonds、Washington、アメリカ、98026
- Swedish Cancer Institute-Edmonds
-
Everett、Washington、アメリカ、98201
- Providence Regional Cancer Partnership
-
Issaquah、Washington、アメリカ、98029
- Swedish Cancer Institute-Issaquah
-
Kennewick、Washington、アメリカ、99336
- Kadlec Clinic Hematology and Oncology
-
Lacey、Washington、アメリカ、98503
- Providence Regional Cancer System-Lacey
-
Longview、Washington、アメリカ、98632
- PeaceHealth Saint John Medical Center
-
Port Townsend、Washington、アメリカ、98368
- Jefferson Healthcare
-
Seattle、Washington、アメリカ、98107
- Swedish Medical Center-Ballard Campus
-
Seattle、Washington、アメリカ、98122
- Swedish Medical Center-First Hill
-
Sedro-Woolley、Washington、アメリカ、98284
- PeaceHealth United General Medical Center
-
Vancouver、Washington、アメリカ、98664
- PeaceHealth Southwest Medical Center
-
Walla Walla、Washington、アメリカ、99362
- Providence Saint Mary Regional Cancer Center
-
-
Wisconsin
-
Eau Claire、Wisconsin、アメリカ、54701
- Marshfield Medical Center-EC Cancer Center
-
Marshfield、Wisconsin、アメリカ、54449
- Marshfield Medical Center-Marshfield
-
Milwaukee、Wisconsin、アメリカ、53226
- Medical College of Wisconsin
-
Minocqua、Wisconsin、アメリカ、54548
- Marshfield Medical Center - Minocqua
-
Rice Lake、Wisconsin、アメリカ、54868
- Marshfield Medical Center-Rice Lake
-
Stevens Point、Wisconsin、アメリカ、54482
- Marshfield Medical Center-River Region at Stevens Point
-
Weston、Wisconsin、アメリカ、54476
- Marshfield Medical Center - Weston
-
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
他の名前：
Given IV
他の名前：
Undergo collection of blood samples
他の名前：
Undergo CT or PET/CT
他の名前：
Undergo PET/CT
他の名前：
Undergo surgery
他の名前：
|
|
実験的：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
他の名前：
Given IV
他の名前：
Undergo collection of blood samples
他の名前：
Undergo CT or PET/CT
他の名前：
Undergo PET/CT
他の名前：
Undergo surgery
他の名前：
Given SC or intratumorally |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pathologic complete response rate
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
無再発生存
時間枠：無作為化から再発または死亡まで (いずれか早い方)、最大 15 年間評価
|
無作為化から再発または死亡まで (いずれか早い方)、最大 15 年間評価
|
|
|
全生存
時間枠：無作為化からあらゆる原因による死亡まで、最長 15 年間評価
|
無作為化からあらゆる原因による死亡まで、最長 15 年間評価
|
|
|
Radiographic response rate
時間枠：Up to 15 years
|
Will be assessed using RECIST. |
Up to 15 years
|
|
Incidence of adverse events
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Ahmad Tarhini、ECOG-ACRIN Cancer Research Group
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NCI-2020-14174
- U10CA180820 (米国 NIH グラント/契約)
- NCI-2020-14174 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- EA6194 (その他の識別子：CTEP)
- EA6194 (その他の識別子：ECOG-ACRIN Cancer Research Group)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。