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IIIC 期または IV 期の BRAF V600E/K 黒色腫におけるヒドロキシクロロキンの有無にかかわらず、ダブラフェニブおよびトラメチニブの試験

2026年9月11日 更新者：ECOG-ACRIN Cancer Research Group

BAMM2 (BRAF, Autophagy, MEK Inhibition in Melanoma) 研究: 進行性 BRAF V600E/K メラノーマにおけるヒドロキシクロロキンの有無にかかわらず、ダブラフェニブとトラメチニブのランダム化二重盲検第 II 相研究

This phase II trial investigates how well adding hydroxychloroquine to the standard treatment of dabrafenib and trametinib works to overcome resistance and delay disease progression in treating patients with stage IIIC or IV BRAF V600E/K melanoma. Hydroxychloroquine may cause cell death in tumor cells that rely on a process called "autophagy" for survival. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving hydroxychloroquine together with dabrafenib and trametinib may work better than dabrafenib and trametinib alone to shrink and stabilize the cancer.

調査の概要

状態

終了しました

条件

介入・治療

詳細な説明

PRIMARY OBJECTIVE:

I. To determine the rate of one year progression-free survival (PFS) when hydroxychloroquine sulfate (hydroxychloroquine) or placebo is added to dabrafenib mesylate (dabrafenib) and trametinib dimethyl sulfoxide (trametinib) in advanced BRAFV600E/K melanoma with elevated lactate dehydrogenase (LDH).

SECONDARY OBJECTIVES:

I. To compare the PFS of both arms. II. To evaluate the best overall response rate by treatment arm. III. To evaluate the complete response (CR) rate by treatment arm. IV. To evaluate the adverse event rate by treatment arm. V. To evaluate overall survival (OS) by treatment arm.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive dabrafenib mesylate orally (PO) twice daily (BID), trametinib dimethyl sulfoxide PO once daily (QD), and hydroxychloroquine sulfate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive dabrafenib mesylate PO BID, trametinib dimethyl sulfoxide PO QD, and placebo PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 1 year.

研究の種類

介入

入学 (実際)

5

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • 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
      • Anchorage、Alaska、アメリカ、99504
        • Anchorage Radiation Therapy Center
    • Arizona
      • Phoenix、Arizona、アメリカ、85054
        • Mayo Clinic Hospital in Arizona
      • Phoenix、Arizona、アメリカ、85004
        • Cancer Center at Saint Joseph's
      • Scottsdale、Arizona、アメリカ、85259
        • Mayo Clinic in Arizona
    • Arkansas
      • Fort Smith、Arkansas、アメリカ、72903
        • Mercy Hospital Fort Smith
      • Hot Springs、Arkansas、アメリカ、71913
        • CHI Saint Vincent Cancer Center Hot Springs
    • California
      • Arroyo Grande、California、アメリカ、93420
        • Mission Hope Medical Oncology - Arroyo Grande
      • Burbank、California、アメリカ、91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Los Angeles、California、アメリカ、90048
        • Cedars Sinai Medical Center
      • San Luis Obispo、California、アメリカ、93401
        • Pacific Central Coast Health Center-San Luis Obispo
      • Santa Maria、California、アメリカ、93444
        • Mission Hope Medical Oncology - Santa Maria
    • Colorado
      • Colorado Springs、Colorado、アメリカ、80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs、Colorado、アメリカ、80907
        • Rocky Mountain Cancer Centers-Penrose
      • Colorado Springs、Colorado、アメリカ、80923
        • Saint Francis Cancer Center
      • Denver、Colorado、アメリカ、80210
        • Porter Adventist Hospital
      • Durango、Colorado、アメリカ、81301
        • Mercy Medical Center
      • Durango、Colorado、アメリカ、81301
        • Southwest Oncology PC
      • Lakewood、Colorado、アメリカ、80228
        • Saint Anthony Hospital
      • Littleton、Colorado、アメリカ、80122
        • Littleton Adventist Hospital
      • Longmont、Colorado、アメリカ、80501
        • Longmont United Hospital
      • Longmont、Colorado、アメリカ、80501
        • Rocky Mountain Cancer Centers-Longmont
      • Parker、Colorado、アメリカ、80138
        • Parker Adventist Hospital
      • Pueblo、Colorado、アメリカ、81004
        • Saint Mary Corwin Medical Center
    • Delaware
      • Frankford、Delaware、アメリカ、19945
        • Beebe South Coastal Health Campus
      • Lewes、Delaware、アメリカ、19958
        • Beebe Medical Center
      • Newark、Delaware、アメリカ、19713
        • Helen F Graham Cancer Center
      • Newark、Delaware、アメリカ、19713
        • Delaware Clinical and Laboratory Physicians PA
      • Newark、Delaware、アメリカ、19713
        • Medical Oncology Hematology Consultants PA
      • Newark、Delaware、アメリカ、19718
        • Christiana Care Health System-Christiana Hospital
      • Rehoboth Beach、Delaware、アメリカ、19971
        • Beebe Health Campus
      • Seaford、Delaware、アメリカ、19973
        • TidalHealth Nanticoke / Allen Cancer Center
      • Wilmington、Delaware、アメリカ、19801
        • Christiana Care Health System-Wilmington Hospital
    • District of Columbia
      • Washington D.C.、District of Columbia、アメリカ、20007
        • MedStar Georgetown University Hospital
    • 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
      • Miami、Florida、アメリカ、33176
        • UM Sylvester Comprehensive Cancer Center at Kendall
      • 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、83686
        • Saint Luke's Cancer Institute - Nampa
      • Twin Falls、Idaho、アメリカ、83301
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Alton、Illinois、アメリカ、62002
        • Saint Anthony's Health
      • Aurora、Illinois、アメリカ、60504
        • Rush - Copley Medical Center
      • Burr Ridge、Illinois、アメリカ、60527
        • Loyola Center for Health at Burr Ridge
      • Danville、Illinois、アメリカ、61832
        • Carle on Vermilion
      • Effingham、Illinois、アメリカ、62401
        • Carle Physician Group-Effingham
      • Homer Glen、Illinois、アメリカ、60491
        • Loyola Medicine Homer Glen
      • Mattoon、Illinois、アメリカ、61938
        • Carle Physician Group-Mattoon/Charleston
      • Maywood、Illinois、アメリカ、60153
        • Loyola University Medical Center
      • Melrose Park、Illinois、アメリカ、60160
        • Marjorie Weinberg Cancer Center at Loyola-Gottlieb
      • Mount Vernon、Illinois、アメリカ、62864
        • Good Samaritan Regional Health Center
      • Urbana、Illinois、アメリカ、61801
        • Carle Cancer Center
      • Urbana、Illinois、アメリカ、61801
        • The Carle Foundation Hospital
      • Yorkville、Illinois、アメリカ、60560
        • Rush-Copley Healthcare Center
    • Indiana
      • Richmond、Indiana、アメリカ、47374
        • Reid Health
    • Iowa
      • Ames、Iowa、アメリカ、50010
        • McFarland Clinic PC - Ames
      • Ames、Iowa、アメリカ、50010
        • Mary Greeley Medical Center
      • Boone、Iowa、アメリカ、50036
        • McFarland Clinic PC-Boone
      • Carroll、Iowa、アメリカ、51401
        • Saint Anthony Regional Hospital
      • Clive、Iowa、アメリカ、50325
        • Mercy Cancer Center-West Lakes
      • Clive、Iowa、アメリカ、50325
        • Medical Oncology and Hematology Associates-West Des Moines
      • Council Bluffs、Iowa、アメリカ、51503
        • Alegent Health Mercy Hospital
      • Creston、Iowa、アメリカ、50801
        • Greater Regional Medical Center
      • Des Moines、Iowa、アメリカ、50309
        • Iowa Methodist Medical Center
      • Des Moines、Iowa、アメリカ、50314
        • Mercy Medical Center - Des Moines
      • Des Moines、Iowa、アメリカ、50309
        • Medical Oncology and Hematology Associates-Des Moines
      • Des Moines、Iowa、アメリカ、50314
        • Broadlawns Medical Center
      • Des Moines、Iowa、アメリカ、50314
        • Mission Cancer and Blood - Laurel
      • Des Moines、Iowa、アメリカ、50316
        • Iowa Lutheran Hospital
      • Fort Dodge、Iowa、アメリカ、50501
        • McFarland Clinic PC-Trinity Cancer Center
      • Fort Dodge、Iowa、アメリカ、50501
        • Trinity Regional Medical Center
      • Jefferson、Iowa、アメリカ、50129
        • McFarland Clinic PC-Jefferson
      • Marshalltown、Iowa、アメリカ、50158
        • McFarland Clinic PC-Marshalltown
      • West Des Moines、Iowa、アメリカ、50266-7700
        • Methodist West Hospital
      • West Des Moines、Iowa、アメリカ、50266
        • Mercy Medical Center-West Lakes
    • 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
    • Kentucky
      • Bardstown、Kentucky、アメリカ、40004
        • Flaget Memorial Hospital
      • Corbin、Kentucky、アメリカ、40701
        • Commonwealth Cancer Center-Corbin
      • Lexington、Kentucky、アメリカ、40504
        • Saint Joseph Radiation Oncology Resource Center
      • Lexington、Kentucky、アメリカ、40509
        • Saint Joseph Hospital East
      • London、Kentucky、アメリカ、40741
        • Saint Joseph London
      • Louisville、Kentucky、アメリカ、40202
        • Jewish Hospital
      • Louisville、Kentucky、アメリカ、40245
        • UofL Health Medical Center Northeast
      • Louisville、Kentucky、アメリカ、40215
        • Saints Mary and Elizabeth Hospital
      • Shepherdsville、Kentucky、アメリカ、40165
        • Jewish Hospital Medical Center South
    • Maryland
      • Baltimore、Maryland、アメリカ、21237
        • MedStar Franklin Square Medical Center/Weinberg Cancer Institute
    • Minnesota
      • Rochester、Minnesota、アメリカ、55905
        • Mayo Clinic in Rochester
    • Missouri
      • Ballwin、Missouri、アメリカ、63011
        • Saint Louis Cancer and Breast Institute-Ballwin
      • Bolivar、Missouri、アメリカ、65613
        • Central Care Cancer Center - Bolivar
      • Branson、Missouri、アメリカ、65616
        • Cox Cancer Center Branson
      • 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
        • Delbert Day Cancer Institute at PCRMC
      • Rolla、Missouri、アメリカ、65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Saint Joseph、Missouri、アメリカ、64506
        • Heartland Regional Medical Center
      • 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、63141
        • Mercy Hospital Saint Louis
      • St Louis、Missouri、アメリカ、63128
        • Mercy Hospital South
      • St Louis、Missouri、アメリカ、63109
        • Saint Louis Cancer and Breast Institute-South City
      • Washington、Missouri、アメリカ、63090
        • Mercy Hospital Washington
    • Montana
      • Missoula、Montana、アメリカ、59802
        • Saint Patrick Hospital - Community Hospital
    • Nebraska
      • Grand Island、Nebraska、アメリカ、68803
        • CHI Health Saint Francis
      • Kearney、Nebraska、アメリカ、68847
        • CHI Health Good Samaritan
      • Lincoln、Nebraska、アメリカ、68510
        • Saint Elizabeth Regional Medical Center
      • Omaha、Nebraska、アメリカ、68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha、Nebraska、アメリカ、68122
        • Alegent Health Immanuel Medical Center
      • Omaha、Nebraska、アメリカ、68130
        • Alegent Health Lakeside Hospital
      • Omaha、Nebraska、アメリカ、68131
        • Creighton University Medical Center
      • Papillion、Nebraska、アメリカ、68046
        • Midlands Community Hospital
    • New York
      • New York、New York、アメリカ、10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
    • Ohio
      • Beavercreek、Ohio、アメリカ、45431
        • Indu and Raj Soin Medical Center
      • Boardman、Ohio、アメリカ、44512
        • Saint Elizabeth Boardman Hospital
      • 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、45220
        • Good Samaritan Hospital - Cincinnati
      • Cincinnati、Ohio、アメリカ、45242
        • Bethesda North Hospital
      • Cincinnati、Ohio、アメリカ、45236
        • Oncology Hematology Care Inc-Kenwood
      • Cincinnati、Ohio、アメリカ、45247
        • TriHealth Cancer Institute-Westside
      • Cincinnati、Ohio、アメリカ、45255
        • TriHealth Cancer Institute-Anderson
      • Dayton、Ohio、アメリカ、45409
        • Miami Valley Hospital
      • Dayton、Ohio、アメリカ、45415
        • Dayton Physician LLC-Miami Valley Hospital North
      • Dayton、Ohio、アメリカ、45415
        • Miami Valley Hospital North
      • 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、45505
        • Springfield Regional Medical Center
      • Springfield、Ohio、アメリカ、45504
        • Springfield Regional Cancer Center
      • Troy、Ohio、アメリカ、45373
        • Upper Valley Medical Center
      • Troy、Ohio、アメリカ、45373
        • Dayton Physicians LLC-Upper Valley
      • Warren、Ohio、アメリカ、44484
        • Saint Joseph Warren Hospital
      • Youngstown、Ohio、アメリカ、44501
        • Saint Elizabeth Youngstown Hospital
    • 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
      • Redmond、Oregon、アメリカ、97756
        • Saint Charles Health System-Redmond
    • Pennsylvania
      • Chadds Ford、Pennsylvania、アメリカ、19317
        • Christiana Care Health System-Concord Health Center
      • Philadelphia、Pennsylvania、アメリカ、19104
        • University of Pennsylvania/Abramson Cancer Center
      • Pittsburgh、Pennsylvania、アメリカ、15232
        • University of Pittsburgh Cancer Institute (UPCI)
    • Texas
      • Bryan、Texas、アメリカ、77802
        • Saint Joseph Regional Cancer Center
    • Utah
      • Salt Lake City、Utah、アメリカ、84112
        • Huntsman Cancer Institute/University of Utah
    • 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
      • Bremerton、Washington、アメリカ、98310
        • Harrison HealthPartners Hematology and Oncology-Bremerton
      • Bremerton、Washington、アメリカ、98310
        • Harrison Medical Center
      • Burien、Washington、アメリカ、98166
        • Highline Medical Center-Main Campus
      • Centralia、Washington、アメリカ、98531
        • Providence Regional Cancer System-Centralia
      • Edmonds、Washington、アメリカ、98026
        • Swedish Cancer Institute-Edmonds
      • Enumclaw、Washington、アメリカ、98022
        • Saint Elizabeth Hospital
      • Everett、Washington、アメリカ、98201
        • Providence Regional Cancer Partnership
      • Federal Way、Washington、アメリカ、98003
        • Saint Francis Hospital
      • 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
      • Lakewood、Washington、アメリカ、98499
        • Saint Clare Hospital
      • Longview、Washington、アメリカ、98632
        • PeaceHealth Saint John Medical Center
      • Poulsbo、Washington、アメリカ、98370
        • Harrison HealthPartners Hematology and Oncology-Poulsbo
      • Seattle、Washington、アメリカ、98107
        • Swedish Medical Center-Ballard Campus
      • Seattle、Washington、アメリカ、98122
        • Swedish Medical Center-First Hill
      • Seattle、Washington、アメリカ、98104
        • Pacific Gynecology Specialists
      • Seattle、Washington、アメリカ、98122-5711
        • Swedish Medical Center-Cherry Hill
      • Sedro-Woolley、Washington、アメリカ、98284
        • PeaceHealth United General Medical Center
      • Shelton、Washington、アメリカ、98584
        • Providence Regional Cancer System-Shelton
      • Tacoma、Washington、アメリカ、98405
        • Franciscan Research Center-Northwest Medical Plaza
      • 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
      • Yelm、Washington、アメリカ、98597
        • Providence Regional Cancer System-Yelm
    • Wisconsin
      • Chippewa Falls、Wisconsin、アメリカ、54729
        • Marshfield Clinic-Chippewa Center
      • Eau Claire、Wisconsin、アメリカ、54701
        • Marshfield Medical Center-EC Cancer Center
      • Ladysmith、Wisconsin、アメリカ、54848
        • Marshfield Clinic - Ladysmith Center
      • Marshfield、Wisconsin、アメリカ、54449
        • Marshfield Medical Center-Marshfield
      • Minocqua、Wisconsin、アメリカ、54548
        • Marshfield Clinic-Minocqua Center
      • 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
      • Wausau、Wisconsin、アメリカ、54401
        • Marshfield Clinic-Wausau Center
      • Weston、Wisconsin、アメリカ、54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids、Wisconsin、アメリカ、54494
        • Marshfield Clinic - Wisconsin Rapids Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Patient must have locally advanced unresectable stage IIIC or stage IV melanoma

  • Patient must have BRAF V600E or BRAF V600K tumor genotype based on a Clinical Laboratory Improvement Act (CLIA) approved assay

  • Patient must have serum LDH > Upper limit of normal per institution standards

  • Patient must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Baseline measurements of sites of disease must be obtained within 3 weeks prior to study randomization

  • Patient must have been treated with prior immune checkpoint inhibitor therapy (anti PD-1 antibody, anti-CTLA-4 antibody or a combination regimen including either or both agents) either in the adjuvant or metastatic setting. Patient may have received investigational agents in combination with standard therapy, as long as it was adhering to the timeframes below

    • Patient must have discontinued active immunotherapy (IL-2, interferon, anti-CTLA-4 antibody, anti-PD-1 antibody etc.) or chemotherapy at least 4 weeks prior to randomization
    • Patient must have discontinued any oral targeted therapy at least 2 weeks prior to randomization

  • Patient may have been treated with prior adjuvant therapy including combined BRAF and MEK inhibitor therapy. Patients will be eligible if they tolerated this therapy and did not discontinue the therapy due to toxicity AND >= 6 months have elapsed since the end of adjuvant BRAF and MEK inhibition.

  • Patient may have been treated with prior chemotherapy or radiation therapy

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

  • 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

  • All females of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy.

  • Women of childbearing potential and sexually active males must not expect to conceive or father children by using accepted and effective method(s) of contraception or abstaining from sexual intercourse for the duration of their participation in the study and for 4 months after the last dose of protocol treatment

  • Patient must have recovered from clinically significant reversible toxicities from previous treatment prior to randomization. Abnormal laboratory values may be grade 1, as long as they meet the eligibility criteria for organ and marrow function

  • Patient must be able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels

  • 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

  • Absolute neutrophil count >= 1,500/mcL (obtained =< 14 days prior to protocol randomization)

  • Platelets >= 100,000/mcL (obtained =< 14 days prior to protocol randomization)

  • Total bilirubin =< institutional upper limit of normal (ULN) (obtained =< 14 days prior to protocol randomization)

  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional ULN (obtained =< 14 days prior to protocol randomization)

  • Creatinine =< 1.5 x institutional ULN (obtained =< 14 days prior to protocol randomization)

  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months 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

  • Patient with asymptomatic new or progressive brain metastases (active brain metastases) are eligible if the treating physician determines that CNS specific treatment is not required

    • NOTE: Patient with treated brain metastases are eligible. No brain imaging is required, however, 1 week must elapse after gamma knife therapy. Patient treated with whole brain radiation that have been stable for 2 months are eligible. Patient are excluded if they have leptomeningeal disease or metastases causing spinal cord compression that are symptomatic or untreated or not stable (documented by imaging) for at least 3 months or requiring corticosteroids. Patients on a stable dose of corticosteroids for at least 1 month or who have been off of corticosteroids for at least 1 week are eligible

Exclusion Criteria:

  • Receiving any other investigational anticancer therapy during the period on study or the 4 weeks prior to randomization

  • Patients received BRAF and MEK inhibitor therapy in the metastatic setting

  • Patients who are experiencing an objective partial response to immunotherapy at the time of study enrollment

  • 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. A female of childbearing potential is defined as any woman, regardless of sexual orientation or 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)

  • A history of interstitial lung disease (ILD) or chronic pneumonitis

    • NOTE: If there is radiographic evidence of ILD that is clinically insignificant and asymptomatic, the patient would be eligible

  • Porphyria or psoriasis due to risk of disease exacerbation unless the disease is well controlled and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations

  • Previously documented retinal vein occlusion

  • A history or evidence of increased cardiovascular risk including:

    • Left ventricular ejection fraction (LVEF) < institutional lower limit of normal measured within 14 days prior to randomization
    • A QT interval corrected for heart rate using the Bazett's formula >= 480 msec
    • Current clinically significant uncontrolled arrhythmias. Exception: Patients with controlled atrial fibrillation for > 30 days prior to randomization are eligible
    • Acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization
    • Abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram unless a cardiologist concludes the valve abnormality is not clinically significant. Patients with grade 1 abnormalities (i.e., mild regurgitation/stenosis) are eligible
    • 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

  • Serious concurrent infection or medical illness, including psychiatric disorders, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety

  • Receiving concurrent therapy for their tumor (i.e. chemotherapeutics or investigational agents). Radiotherapy delivered to palliate pain is allowed as long as it is not targeting a lesion that meets RECIST criteria for progression. Radiation therapy to the surgical bed with gamma knife radiotherapy while on treatment during the first cycle is allowed for small volume surgically resected brain metastases. Gamma knife radiotherapy for known active, asymptomatic small volume central nervous system (CNS) lesions may be performed during the first cycle while on study. Radiotherapy for new CNS lesions identified beyond the first cycle is not allowed on study

  • Immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug, or excipients or to dimethyl sulfoxide (DMSO)

  • Prior cytochrome P450 enzyme -inducing anticonvulsant drugs (extended-interval aminoglycoside dosing [EIADs]) (i.e. phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine) within 4 weeks prior to randomization

  • Current use of a prohibited medication described in the protocol due to potential drug-drug interaction

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Arm A (dabrafenib, trametinib, hydroxychloroquine)

Patients receive dabrafenib mesylate PO BID, trametinib dimethyl sulfoxide PO QD, and hydroxychloroquine sulfate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
薬：Dabrafenib mesylate

Given PO

他の名前：
  • GSK2118436B
  • タフィンラー®
  • NSC 763760
  • GSK2118436A（フリーベース）
薬：Hydroxychloroquine

Given PO

他の名前：
  • プラケニル
  • 硫酸ヒドロキシクロロキン
薬：Trametinib dimethyl sulfoxide

Given PO

他の名前：
  • JTP-74057
  • トラメチニブ
  • メキニスト®
  • TMT212-NXA
  • JTP-78296
  • JTP-75303
  • GSK1120212B
  • NSC 763093
アクティブコンパレータ：Arm B (dabrafenib, trametinib, placebo)

Patients receive dabrafenib mesylate PO BID, trametinib dimethyl sulfoxide PO QD, and placebo PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
薬：Placebo Administration

Given PO

薬：Dabrafenib mesylate

Given PO

他の名前：
  • GSK2118436B
  • タフィンラー®
  • NSC 763760
  • GSK2118436A（フリーベース）
薬：Trametinib dimethyl sulfoxide

Given PO

他の名前：
  • JTP-74057
  • トラメチニブ
  • メキニスト®
  • TMT212-NXA
  • JTP-78296
  • JTP-75303
  • GSK1120212B
  • NSC 763093

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
One-year Progression-free Survival Rate
時間枠：Assessed every 2 months until 6 months after completion of study treatment, up to 1 year

Progression-free survival is defined as the time from randomization to progression or death, whichever occurs first. Progression is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

One-year progression-free survival rate is estimated from the Kaplan-Meier progression-free survival curve.
Assessed every 2 months until 6 months after completion of study treatment, up to 1 year

二次結果の測定

結果測定
メジャーの説明
時間枠
Progression-free Survival
時間枠：Assessed every 2 months until 6 months after completion of study treatment, up to 3 years

Progression-free survival is defined as the time from randomization to progression or death, whichever occurs first. Progression is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Assessed every 2 months until 6 months after completion of study treatment, up to 3 years
Proportion of Patients With Best Overall Response
時間枠：Assessed every 2 months until 6 months after completion of study treatment, up to 3 years

Best overall response is defined as either complete response or partial response.

Complete response is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

Partial response is defined as persistence of one or more non-target lesion(s) and at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Assessed every 2 months until 6 months after completion of study treatment, up to 3 years
Proportion of Patients With Complete Response
時間枠：Assessed every 2 months until 6 months after completion of study treatment, up to 3 years

Complete response is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Assessed every 2 months until 6 months after completion of study treatment, up to 3 years
Adverse Event Rate
時間枠：Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 3 years

Proportion of patients with treatment-related adverse events of grade 3 or higher.
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 3 years
Overall Survival
時間枠：Assessed every 2 months until 6 months after completion of study treatment, up to 3 years

Overall survival is defined as the time from randomization to death or date last known alive.
Assessed every 2 months until 6 months after completion of study treatment, up to 3 years

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

ECOG-ACRIN Cancer Research Group

協力者

National Cancer Institute (NCI)

捜査官

  • 主任研究者：Ravi Amaravadi、ECOG-ACRIN Cancer Research Group

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年6月1日

一次修了 (実際)

2024年1月8日

研究の完了 (実際)

2024年1月8日

試験登録日

最初に提出

2020年8月24日

QC基準を満たした最初の提出物

2020年8月24日

最初の投稿 (実際)

2020年8月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月6日

QC基準を満たした最後の更新が送信されました

2026年9月11日

最終確認日

2026年9月1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

  • EA6191
  • U10CA180820 (米国 NIH グラント/契約)
  • EA6191 (その他の識別子：CTEP)
  • NCI-2020-04552 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
  • EA6191 (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?

はい

IPD プランの説明

Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.

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

はい

米国FDA規制機器製品の研究

いいえ

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。

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