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Testen von Dabrafenib und Trametinib mit oder ohne Hydroxychloroquin bei BRAF-V600E/K-Melanomen im Stadium IIIC oder IV

11. September 2026 aktualisiert von: ECOG-ACRIN Cancer Research Group

Die BAMM2-Studie (BRAF, Autophagy, MEK Inhibition in Melanoma): Eine randomisierte doppelblinde Phase-II-Studie zu Dabrafenib und Trametinib mit oder ohne Hydroxychloroquin bei fortgeschrittenem BRAF-V600E/K-Melanom

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.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

5

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Alaska
      • Anchorage, Alaska, Vereinigte Staaten, 98508
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, Vereinigte Staaten, 99508
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, Vereinigte Staaten, 99508
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, Vereinigte Staaten, 99508
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, Vereinigte Staaten, 99508
        • Anchorage Oncology Centre
      • Anchorage, Alaska, Vereinigte Staaten, 99508
        • Katmai Oncology Group
      • Anchorage, Alaska, Vereinigte Staaten, 99508
        • Providence Alaska Medical Center
      • Anchorage, Alaska, Vereinigte Staaten, 99504
        • Anchorage Radiation Therapy Center
    • Arizona
      • Phoenix, Arizona, Vereinigte Staaten, 85054
        • Mayo Clinic Hospital in Arizona
      • Phoenix, Arizona, Vereinigte Staaten, 85004
        • Cancer Center at Saint Joseph's
      • Scottsdale, Arizona, Vereinigte Staaten, 85259
        • Mayo Clinic in Arizona
    • Arkansas
      • Fort Smith, Arkansas, Vereinigte Staaten, 72903
        • Mercy Hospital Fort Smith
      • Hot Springs, Arkansas, Vereinigte Staaten, 71913
        • CHI Saint Vincent Cancer Center Hot Springs
    • California
      • Arroyo Grande, California, Vereinigte Staaten, 93420
        • Mission Hope Medical Oncology - Arroyo Grande
      • Burbank, California, Vereinigte Staaten, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Los Angeles, California, Vereinigte Staaten, 90048
        • Cedars Sinai Medical Center
      • San Luis Obispo, California, Vereinigte Staaten, 93401
        • Pacific Central Coast Health Center-San Luis Obispo
      • Santa Maria, California, Vereinigte Staaten, 93444
        • Mission Hope Medical Oncology - Santa Maria
    • Colorado
      • Colorado Springs, Colorado, Vereinigte Staaten, 80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, Vereinigte Staaten, 80907
        • Rocky Mountain Cancer Centers-Penrose
      • Colorado Springs, Colorado, Vereinigte Staaten, 80923
        • Saint Francis Cancer Center
      • Denver, Colorado, Vereinigte Staaten, 80210
        • Porter Adventist Hospital
      • Durango, Colorado, Vereinigte Staaten, 81301
        • Mercy Medical Center
      • Durango, Colorado, Vereinigte Staaten, 81301
        • Southwest Oncology PC
      • Lakewood, Colorado, Vereinigte Staaten, 80228
        • Saint Anthony Hospital
      • Littleton, Colorado, Vereinigte Staaten, 80122
        • Littleton Adventist Hospital
      • Longmont, Colorado, Vereinigte Staaten, 80501
        • Longmont United Hospital
      • Longmont, Colorado, Vereinigte Staaten, 80501
        • Rocky Mountain Cancer Centers-Longmont
      • Parker, Colorado, Vereinigte Staaten, 80138
        • Parker Adventist Hospital
      • Pueblo, Colorado, Vereinigte Staaten, 81004
        • Saint Mary Corwin Medical Center
    • Delaware
      • Frankford, Delaware, Vereinigte Staaten, 19945
        • Beebe South Coastal Health Campus
      • Lewes, Delaware, Vereinigte Staaten, 19958
        • Beebe Medical Center
      • Newark, Delaware, Vereinigte Staaten, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, Vereinigte Staaten, 19713
        • Delaware Clinical and Laboratory Physicians PA
      • Newark, Delaware, Vereinigte Staaten, 19713
        • Medical Oncology Hematology Consultants PA
      • Newark, Delaware, Vereinigte Staaten, 19718
        • Christiana Care Health System-Christiana Hospital
      • Rehoboth Beach, Delaware, Vereinigte Staaten, 19971
        • Beebe Health Campus
      • Seaford, Delaware, Vereinigte Staaten, 19973
        • TidalHealth Nanticoke / Allen Cancer Center
      • Wilmington, Delaware, Vereinigte Staaten, 19801
        • Christiana Care Health System-Wilmington Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, Vereinigte Staaten, 20007
        • MedStar Georgetown University Hospital
    • Florida
      • Aventura, Florida, Vereinigte Staaten, 33180
        • UM Sylvester Comprehensive Cancer Center at Aventura
      • Coral Gables, Florida, Vereinigte Staaten, 33146
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
      • Deerfield Beach, Florida, Vereinigte Staaten, 33442
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
      • Miami, Florida, Vereinigte Staaten, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Miami, Florida, Vereinigte Staaten, 33176
        • UM Sylvester Comprehensive Cancer Center at Kendall
      • Plantation, Florida, Vereinigte Staaten, 33324
        • UM Sylvester Comprehensive Cancer Center at Plantation
    • Idaho
      • Boise, Idaho, Vereinigte Staaten, 83712
        • Saint Luke's Cancer Institute - Boise
      • Fruitland, Idaho, Vereinigte Staaten, 83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, Vereinigte Staaten, 83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, Vereinigte Staaten, 83686
        • Saint Luke's Cancer Institute - Nampa
      • Twin Falls, Idaho, Vereinigte Staaten, 83301
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Alton, Illinois, Vereinigte Staaten, 62002
        • Saint Anthony's Health
      • Aurora, Illinois, Vereinigte Staaten, 60504
        • Rush - Copley Medical Center
      • Burr Ridge, Illinois, Vereinigte Staaten, 60527
        • Loyola Center for Health at Burr Ridge
      • Danville, Illinois, Vereinigte Staaten, 61832
        • Carle on Vermilion
      • Effingham, Illinois, Vereinigte Staaten, 62401
        • Carle Physician Group-Effingham
      • Homer Glen, Illinois, Vereinigte Staaten, 60491
        • Loyola Medicine Homer Glen
      • Mattoon, Illinois, Vereinigte Staaten, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Maywood, Illinois, Vereinigte Staaten, 60153
        • Loyola University Medical Center
      • Melrose Park, Illinois, Vereinigte Staaten, 60160
        • Marjorie Weinberg Cancer Center at Loyola-Gottlieb
      • Mount Vernon, Illinois, Vereinigte Staaten, 62864
        • Good Samaritan Regional Health Center
      • Urbana, Illinois, Vereinigte Staaten, 61801
        • Carle Cancer Center
      • Urbana, Illinois, Vereinigte Staaten, 61801
        • The Carle Foundation Hospital
      • Yorkville, Illinois, Vereinigte Staaten, 60560
        • Rush-Copley Healthcare Center
    • Indiana
      • Richmond, Indiana, Vereinigte Staaten, 47374
        • Reid Health
    • Iowa
      • Ames, Iowa, Vereinigte Staaten, 50010
        • McFarland Clinic PC - Ames
      • Ames, Iowa, Vereinigte Staaten, 50010
        • Mary Greeley Medical Center
      • Boone, Iowa, Vereinigte Staaten, 50036
        • McFarland Clinic PC-Boone
      • Carroll, Iowa, Vereinigte Staaten, 51401
        • Saint Anthony Regional Hospital
      • Clive, Iowa, Vereinigte Staaten, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, Vereinigte Staaten, 50325
        • Medical Oncology and Hematology Associates-West Des Moines
      • Council Bluffs, Iowa, Vereinigte Staaten, 51503
        • Alegent Health Mercy Hospital
      • Creston, Iowa, Vereinigte Staaten, 50801
        • Greater Regional Medical Center
      • Des Moines, Iowa, Vereinigte Staaten, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, Vereinigte Staaten, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Vereinigte Staaten, 50309
        • Medical Oncology and Hematology Associates-Des Moines
      • Des Moines, Iowa, Vereinigte Staaten, 50314
        • Broadlawns Medical Center
      • Des Moines, Iowa, Vereinigte Staaten, 50314
        • Mission Cancer and Blood - Laurel
      • Des Moines, Iowa, Vereinigte Staaten, 50316
        • Iowa Lutheran Hospital
      • Fort Dodge, Iowa, Vereinigte Staaten, 50501
        • McFarland Clinic PC-Trinity Cancer Center
      • Fort Dodge, Iowa, Vereinigte Staaten, 50501
        • Trinity Regional Medical Center
      • Jefferson, Iowa, Vereinigte Staaten, 50129
        • McFarland Clinic PC-Jefferson
      • Marshalltown, Iowa, Vereinigte Staaten, 50158
        • McFarland Clinic PC-Marshalltown
      • West Des Moines, Iowa, Vereinigte Staaten, 50266-7700
        • Methodist West Hospital
      • West Des Moines, Iowa, Vereinigte Staaten, 50266
        • Mercy Medical Center-West Lakes
    • Kansas
      • Garden City, Kansas, Vereinigte Staaten, 67846
        • Central Care Cancer Center - Garden City
      • Great Bend, Kansas, Vereinigte Staaten, 67530
        • Central Care Cancer Center - Great Bend
    • Kentucky
      • Bardstown, Kentucky, Vereinigte Staaten, 40004
        • Flaget Memorial Hospital
      • Corbin, Kentucky, Vereinigte Staaten, 40701
        • Commonwealth Cancer Center-Corbin
      • Lexington, Kentucky, Vereinigte Staaten, 40504
        • Saint Joseph Radiation Oncology Resource Center
      • Lexington, Kentucky, Vereinigte Staaten, 40509
        • Saint Joseph Hospital East
      • London, Kentucky, Vereinigte Staaten, 40741
        • Saint Joseph London
      • Louisville, Kentucky, Vereinigte Staaten, 40202
        • Jewish Hospital
      • Louisville, Kentucky, Vereinigte Staaten, 40245
        • UofL Health Medical Center Northeast
      • Louisville, Kentucky, Vereinigte Staaten, 40215
        • Saints Mary and Elizabeth Hospital
      • Shepherdsville, Kentucky, Vereinigte Staaten, 40165
        • Jewish Hospital Medical Center South
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21237
        • MedStar Franklin Square Medical Center/Weinberg Cancer Institute
    • Minnesota
      • Rochester, Minnesota, Vereinigte Staaten, 55905
        • Mayo Clinic in Rochester
    • Missouri
      • Ballwin, Missouri, Vereinigte Staaten, 63011
        • Saint Louis Cancer and Breast Institute-Ballwin
      • Bolivar, Missouri, Vereinigte Staaten, 65613
        • Central Care Cancer Center - Bolivar
      • Branson, Missouri, Vereinigte Staaten, 65616
        • Cox Cancer Center Branson
      • Joplin, Missouri, Vereinigte Staaten, 64804
        • Freeman Health System
      • Joplin, Missouri, Vereinigte Staaten, 64804
        • Mercy Hospital Joplin
      • Rolla, Missouri, Vereinigte Staaten, 65401
        • Delbert Day Cancer Institute at PCRMC
      • Rolla, Missouri, Vereinigte Staaten, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Saint Joseph, Missouri, Vereinigte Staaten, 64506
        • Heartland Regional Medical Center
      • Springfield, Missouri, Vereinigte Staaten, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Vereinigte Staaten, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, Vereinigte Staaten, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, Vereinigte Staaten, 63128
        • Mercy Hospital South
      • St Louis, Missouri, Vereinigte Staaten, 63109
        • Saint Louis Cancer and Breast Institute-South City
      • Washington, Missouri, Vereinigte Staaten, 63090
        • Mercy Hospital Washington
    • Montana
      • Missoula, Montana, Vereinigte Staaten, 59802
        • Saint Patrick Hospital - Community Hospital
    • Nebraska
      • Grand Island, Nebraska, Vereinigte Staaten, 68803
        • CHI Health Saint Francis
      • Kearney, Nebraska, Vereinigte Staaten, 68847
        • CHI Health Good Samaritan
      • Lincoln, Nebraska, Vereinigte Staaten, 68510
        • Saint Elizabeth Regional Medical Center
      • Omaha, Nebraska, Vereinigte Staaten, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, Vereinigte Staaten, 68122
        • Alegent Health Immanuel Medical Center
      • Omaha, Nebraska, Vereinigte Staaten, 68130
        • Alegent Health Lakeside Hospital
      • Omaha, Nebraska, Vereinigte Staaten, 68131
        • Creighton University Medical Center
      • Papillion, Nebraska, Vereinigte Staaten, 68046
        • Midlands Community Hospital
    • New York
      • New York, New York, Vereinigte Staaten, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
    • Ohio
      • Beavercreek, Ohio, Vereinigte Staaten, 45431
        • Indu and Raj Soin Medical Center
      • Boardman, Ohio, Vereinigte Staaten, 44512
        • Saint Elizabeth Boardman Hospital
      • Centerville, Ohio, Vereinigte Staaten, 45459
        • Miami Valley Hospital South
      • Centerville, Ohio, Vereinigte Staaten, 45459
        • Dayton Physicians LLC-Miami Valley South
      • Cincinnati, Ohio, Vereinigte Staaten, 45220
        • Good Samaritan Hospital - Cincinnati
      • Cincinnati, Ohio, Vereinigte Staaten, 45242
        • Bethesda North Hospital
      • Cincinnati, Ohio, Vereinigte Staaten, 45236
        • Oncology Hematology Care Inc-Kenwood
      • Cincinnati, Ohio, Vereinigte Staaten, 45247
        • TriHealth Cancer Institute-Westside
      • Cincinnati, Ohio, Vereinigte Staaten, 45255
        • TriHealth Cancer Institute-Anderson
      • Dayton, Ohio, Vereinigte Staaten, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, Vereinigte Staaten, 45415
        • Dayton Physician LLC-Miami Valley Hospital North
      • Dayton, Ohio, Vereinigte Staaten, 45415
        • Miami Valley Hospital North
      • Findlay, Ohio, Vereinigte Staaten, 45840
        • Blanchard Valley Hospital
      • Findlay, Ohio, Vereinigte Staaten, 45840
        • Armes Family Cancer Center
      • Findlay, Ohio, Vereinigte Staaten, 45840
        • Orion Cancer Care
      • Franklin, Ohio, Vereinigte Staaten, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Franklin, Ohio, Vereinigte Staaten, 45005
        • Dayton Physicians LLC-Atrium
      • Greenville, Ohio, Vereinigte Staaten, 45331
        • Wayne Hospital
      • Greenville, Ohio, Vereinigte Staaten, 45331
        • Dayton Physicians LLC-Wayne
      • Kettering, Ohio, Vereinigte Staaten, 45429
        • Kettering Medical Center
      • Kettering, Ohio, Vereinigte Staaten, 45409
        • Greater Dayton Cancer Center
      • Springfield, Ohio, Vereinigte Staaten, 45505
        • Springfield Regional Medical Center
      • Springfield, Ohio, Vereinigte Staaten, 45504
        • Springfield Regional Cancer Center
      • Troy, Ohio, Vereinigte Staaten, 45373
        • Upper Valley Medical Center
      • Troy, Ohio, Vereinigte Staaten, 45373
        • Dayton Physicians LLC-Upper Valley
      • Warren, Ohio, Vereinigte Staaten, 44484
        • Saint Joseph Warren Hospital
      • Youngstown, Ohio, Vereinigte Staaten, 44501
        • Saint Elizabeth Youngstown Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Vereinigte Staaten, 73120
        • Mercy Hospital Oklahoma City
    • Oregon
      • Bend, Oregon, Vereinigte Staaten, 97701
        • Saint Charles Health System
      • Clackamas, Oregon, Vereinigte Staaten, 97015
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, Vereinigte Staaten, 97015
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, Vereinigte Staaten, 97420
        • Bay Area Hospital
      • Newberg, Oregon, Vereinigte Staaten, 97132
        • Providence Newberg Medical Center
      • Portland, Oregon, Vereinigte Staaten, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Vereinigte Staaten, 97225
        • Providence Saint Vincent Medical Center
      • Redmond, Oregon, Vereinigte Staaten, 97756
        • Saint Charles Health System-Redmond
    • Pennsylvania
      • Chadds Ford, Pennsylvania, Vereinigte Staaten, 19317
        • Christiana Care Health System-Concord Health Center
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • University of Pennsylvania/Abramson Cancer Center
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15232
        • University of Pittsburgh Cancer Institute (UPCI)
    • Texas
      • Bryan, Texas, Vereinigte Staaten, 77802
        • Saint Joseph Regional Cancer Center
    • Utah
      • Salt Lake City, Utah, Vereinigte Staaten, 84112
        • Huntsman Cancer Institute/University of Utah
    • Washington
      • Aberdeen, Washington, Vereinigte Staaten, 98520
        • Providence Regional Cancer System-Aberdeen
      • Bellingham, Washington, Vereinigte Staaten, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Bremerton, Washington, Vereinigte Staaten, 98310
        • Harrison HealthPartners Hematology and Oncology-Bremerton
      • Bremerton, Washington, Vereinigte Staaten, 98310
        • Harrison Medical Center
      • Burien, Washington, Vereinigte Staaten, 98166
        • Highline Medical Center-Main Campus
      • Centralia, Washington, Vereinigte Staaten, 98531
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, Vereinigte Staaten, 98026
        • Swedish Cancer Institute-Edmonds
      • Enumclaw, Washington, Vereinigte Staaten, 98022
        • Saint Elizabeth Hospital
      • Everett, Washington, Vereinigte Staaten, 98201
        • Providence Regional Cancer Partnership
      • Federal Way, Washington, Vereinigte Staaten, 98003
        • Saint Francis Hospital
      • Issaquah, Washington, Vereinigte Staaten, 98029
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, Vereinigte Staaten, 99336
        • Kadlec Clinic Hematology and Oncology
      • Lacey, Washington, Vereinigte Staaten, 98503
        • Providence Regional Cancer System-Lacey
      • Lakewood, Washington, Vereinigte Staaten, 98499
        • Saint Clare Hospital
      • Longview, Washington, Vereinigte Staaten, 98632
        • PeaceHealth Saint John Medical Center
      • Poulsbo, Washington, Vereinigte Staaten, 98370
        • Harrison HealthPartners Hematology and Oncology-Poulsbo
      • Seattle, Washington, Vereinigte Staaten, 98107
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, Vereinigte Staaten, 98122
        • Swedish Medical Center-First Hill
      • Seattle, Washington, Vereinigte Staaten, 98104
        • Pacific Gynecology Specialists
      • Seattle, Washington, Vereinigte Staaten, 98122-5711
        • Swedish Medical Center-Cherry Hill
      • Sedro-Woolley, Washington, Vereinigte Staaten, 98284
        • PeaceHealth United General Medical Center
      • Shelton, Washington, Vereinigte Staaten, 98584
        • Providence Regional Cancer System-Shelton
      • Tacoma, Washington, Vereinigte Staaten, 98405
        • Franciscan Research Center-Northwest Medical Plaza
      • Vancouver, Washington, Vereinigte Staaten, 98664
        • PeaceHealth Southwest Medical Center
      • Walla Walla, Washington, Vereinigte Staaten, 99362
        • Providence Saint Mary Regional Cancer Center
      • Yelm, Washington, Vereinigte Staaten, 98597
        • Providence Regional Cancer System-Yelm
    • Wisconsin
      • Chippewa Falls, Wisconsin, Vereinigte Staaten, 54729
        • Marshfield Clinic-Chippewa Center
      • Eau Claire, Wisconsin, Vereinigte Staaten, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Ladysmith, Wisconsin, Vereinigte Staaten, 54848
        • Marshfield Clinic - Ladysmith Center
      • Marshfield, Wisconsin, Vereinigte Staaten, 54449
        • Marshfield Medical Center-Marshfield
      • Minocqua, Wisconsin, Vereinigte Staaten, 54548
        • Marshfield Clinic-Minocqua Center
      • Rice Lake, Wisconsin, Vereinigte Staaten, 54868
        • Marshfield Medical Center-Rice Lake
      • Stevens Point, Wisconsin, Vereinigte Staaten, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Wausau, Wisconsin, Vereinigte Staaten, 54401
        • Marshfield Clinic-Wausau Center
      • Weston, Wisconsin, Vereinigte Staaten, 54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids, Wisconsin, Vereinigte Staaten, 54494
        • Marshfield Clinic - Wisconsin Rapids Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: Dabrafenib mesylate

Given PO

Andere Namen:
  • GSK2118436B
  • Tafinlar®
  • NSC 763760
  • GSK2118436A (freie Basis)
Arzneimittel: Hydroxychloroquine

Given PO

Andere Namen:
  • Plaquenil
  • Hydroxychloroquinsulfat
Arzneimittel: Trametinib dimethyl sulfoxide

Given PO

Andere Namen:
  • JTP-74057
  • Trametinib
  • Mekinist®
  • TMT212-NXA
  • JTP-78296
  • JTP-75303
  • GSK1120212B
  • NSC 763093
Aktiver Komparator: 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.
Arzneimittel: Placebo Administration

Given PO

Arzneimittel: Dabrafenib mesylate

Given PO

Andere Namen:
  • GSK2118436B
  • Tafinlar®
  • NSC 763760
  • GSK2118436A (freie Basis)
Arzneimittel: Trametinib dimethyl sulfoxide

Given PO

Andere Namen:
  • JTP-74057
  • Trametinib
  • Mekinist®
  • TMT212-NXA
  • JTP-78296
  • JTP-75303
  • GSK1120212B
  • NSC 763093

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
One-year Progression-free Survival Rate
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression-free Survival
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

ECOG-ACRIN Cancer Research Group

Mitarbeiter

National Cancer Institute (NCI)

Ermittler

  • Hauptermittler: Ravi Amaravadi, ECOG-ACRIN Cancer Research Group

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juni 2021

Primärer Abschluss (Tatsächlich)

8. Januar 2024

Studienabschluss (Tatsächlich)

8. Januar 2024

Studienanmeldedaten

Zuerst eingereicht

24. August 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. August 2020

Zuerst gepostet (Tatsächlich)

26. August 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • EA6191
  • U10CA180820 (US NIH Stipendium/Vertrag)
  • EA6191 (Andere Kennung: CTEP)
  • NCI-2020-04552 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
  • EA6191 (Andere Kennung: ECOG-ACRIN Cancer Research Group)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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