Test di Dabrafenib e Trametinib con o senza idrossiclorochina nel melanoma BRAF V600E/K in stadio IIIC o IV
Lo studio BAMM2 (BRAF, Autophagy, MEK Inhibition in Melanoma): studio randomizzato in doppio cieco di fase II su dabrafenib e trametinib con o senza idrossiclorochina nel melanoma BRAF V600E/K avanzato
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Alaska
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Anchorage, Alaska, Stati Uniti, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, Stati Uniti, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, Stati Uniti, 99508
- Alaska Oncology and Hematology LLC
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Anchorage, Alaska, Stati Uniti, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, Stati Uniti, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, Stati Uniti, 99508
- Katmai Oncology Group
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Anchorage, Alaska, Stati Uniti, 99508
- Providence Alaska Medical Center
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Anchorage, Alaska, Stati Uniti, 99504
- Anchorage Radiation Therapy Center
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Arizona
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Phoenix, Arizona, Stati Uniti, 85054
- Mayo Clinic Hospital in Arizona
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Phoenix, Arizona, Stati Uniti, 85004
- Cancer Center at Saint Joseph's
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Scottsdale, Arizona, Stati Uniti, 85259
- Mayo Clinic in Arizona
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Arkansas
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Fort Smith, Arkansas, Stati Uniti, 72903
- Mercy Hospital Fort Smith
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Hot Springs, Arkansas, Stati Uniti, 71913
- CHI Saint Vincent Cancer Center Hot Springs
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California
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Arroyo Grande, California, Stati Uniti, 93420
- Mission Hope Medical Oncology - Arroyo Grande
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Burbank, California, Stati Uniti, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Los Angeles, California, Stati Uniti, 90048
- Cedars Sinai Medical Center
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San Luis Obispo, California, Stati Uniti, 93401
- Pacific Central Coast Health Center-San Luis Obispo
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Santa Maria, California, Stati Uniti, 93444
- Mission Hope Medical Oncology - Santa Maria
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Colorado
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Colorado Springs, Colorado, Stati Uniti, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Stati Uniti, 80907
- Rocky Mountain Cancer Centers-Penrose
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Colorado Springs, Colorado, Stati Uniti, 80923
- Saint Francis Cancer Center
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Denver, Colorado, Stati Uniti, 80210
- Porter Adventist Hospital
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Durango, Colorado, Stati Uniti, 81301
- Mercy Medical Center
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Durango, Colorado, Stati Uniti, 81301
- Southwest Oncology PC
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Lakewood, Colorado, Stati Uniti, 80228
- Saint Anthony Hospital
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Littleton, Colorado, Stati Uniti, 80122
- Littleton Adventist Hospital
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Longmont, Colorado, Stati Uniti, 80501
- Longmont United Hospital
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Longmont, Colorado, Stati Uniti, 80501
- Rocky Mountain Cancer Centers-Longmont
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Parker, Colorado, Stati Uniti, 80138
- Parker Adventist Hospital
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Pueblo, Colorado, Stati Uniti, 81004
- Saint Mary Corwin Medical Center
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Delaware
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Frankford, Delaware, Stati Uniti, 19945
- Beebe South Coastal Health Campus
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Lewes, Delaware, Stati Uniti, 19958
- Beebe Medical Center
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Newark, Delaware, Stati Uniti, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Stati Uniti, 19713
- Delaware Clinical and Laboratory Physicians PA
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Newark, Delaware, Stati Uniti, 19713
- Medical Oncology Hematology Consultants PA
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Newark, Delaware, Stati Uniti, 19718
- Christiana Care Health System-Christiana Hospital
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Rehoboth Beach, Delaware, Stati Uniti, 19971
- Beebe Health Campus
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Seaford, Delaware, Stati Uniti, 19973
- TidalHealth Nanticoke / Allen Cancer Center
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Wilmington, Delaware, Stati Uniti, 19801
- Christiana Care Health System-Wilmington Hospital
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District of Columbia
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Washington D.C., District of Columbia, Stati Uniti, 20007
- MedStar Georgetown University Hospital
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Florida
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Aventura, Florida, Stati Uniti, 33180
- UM Sylvester Comprehensive Cancer Center at Aventura
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Coral Gables, Florida, Stati Uniti, 33146
- UM Sylvester Comprehensive Cancer Center at Coral Gables
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Deerfield Beach, Florida, Stati Uniti, 33442
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Miami, Florida, Stati Uniti, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Miami, Florida, Stati Uniti, 33176
- UM Sylvester Comprehensive Cancer Center at Kendall
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Plantation, Florida, Stati Uniti, 33324
- UM Sylvester Comprehensive Cancer Center at Plantation
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Idaho
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Boise, Idaho, Stati Uniti, 83712
- Saint Luke's Cancer Institute - Boise
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Fruitland, Idaho, Stati Uniti, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Stati Uniti, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Stati Uniti, 83686
- Saint Luke's Cancer Institute - Nampa
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Twin Falls, Idaho, Stati Uniti, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Alton, Illinois, Stati Uniti, 62002
- Saint Anthony's Health
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Aurora, Illinois, Stati Uniti, 60504
- Rush - Copley Medical Center
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Burr Ridge, Illinois, Stati Uniti, 60527
- Loyola Center for Health at Burr Ridge
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Danville, Illinois, Stati Uniti, 61832
- Carle on Vermilion
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Effingham, Illinois, Stati Uniti, 62401
- Carle Physician Group-Effingham
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Homer Glen, Illinois, Stati Uniti, 60491
- Loyola Medicine Homer Glen
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Mattoon, Illinois, Stati Uniti, 61938
- Carle Physician Group-Mattoon/Charleston
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Maywood, Illinois, Stati Uniti, 60153
- Loyola University Medical Center
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Melrose Park, Illinois, Stati Uniti, 60160
- Marjorie Weinberg Cancer Center at Loyola-Gottlieb
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Mount Vernon, Illinois, Stati Uniti, 62864
- Good Samaritan Regional Health Center
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Urbana, Illinois, Stati Uniti, 61801
- Carle Cancer Center
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Urbana, Illinois, Stati Uniti, 61801
- The Carle Foundation Hospital
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Yorkville, Illinois, Stati Uniti, 60560
- Rush-Copley Healthcare Center
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Indiana
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Richmond, Indiana, Stati Uniti, 47374
- Reid Health
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Iowa
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Ames, Iowa, Stati Uniti, 50010
- McFarland Clinic PC - Ames
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Ames, Iowa, Stati Uniti, 50010
- Mary Greeley Medical Center
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Boone, Iowa, Stati Uniti, 50036
- McFarland Clinic PC-Boone
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Carroll, Iowa, Stati Uniti, 51401
- Saint Anthony Regional Hospital
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Clive, Iowa, Stati Uniti, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Stati Uniti, 50325
- Medical Oncology and Hematology Associates-West Des Moines
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Council Bluffs, Iowa, Stati Uniti, 51503
- Alegent Health Mercy Hospital
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Creston, Iowa, Stati Uniti, 50801
- Greater Regional Medical Center
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Des Moines, Iowa, Stati Uniti, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Stati Uniti, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Stati Uniti, 50309
- Medical Oncology and Hematology Associates-Des Moines
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Des Moines, Iowa, Stati Uniti, 50314
- Broadlawns Medical Center
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Des Moines, Iowa, Stati Uniti, 50314
- Mission Cancer and Blood - Laurel
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Des Moines, Iowa, Stati Uniti, 50316
- Iowa Lutheran Hospital
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Fort Dodge, Iowa, Stati Uniti, 50501
- McFarland Clinic PC-Trinity Cancer Center
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Fort Dodge, Iowa, Stati Uniti, 50501
- Trinity Regional Medical Center
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Jefferson, Iowa, Stati Uniti, 50129
- McFarland Clinic PC-Jefferson
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Marshalltown, Iowa, Stati Uniti, 50158
- McFarland Clinic PC-Marshalltown
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West Des Moines, Iowa, Stati Uniti, 50266-7700
- Methodist West Hospital
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West Des Moines, Iowa, Stati Uniti, 50266
- Mercy Medical Center-West Lakes
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Kansas
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Garden City, Kansas, Stati Uniti, 67846
- Central Care Cancer Center - Garden City
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Great Bend, Kansas, Stati Uniti, 67530
- Central Care Cancer Center - Great Bend
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Kentucky
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Bardstown, Kentucky, Stati Uniti, 40004
- Flaget Memorial Hospital
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Corbin, Kentucky, Stati Uniti, 40701
- Commonwealth Cancer Center-Corbin
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Lexington, Kentucky, Stati Uniti, 40504
- Saint Joseph Radiation Oncology Resource Center
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Lexington, Kentucky, Stati Uniti, 40509
- Saint Joseph Hospital East
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London, Kentucky, Stati Uniti, 40741
- Saint Joseph London
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Louisville, Kentucky, Stati Uniti, 40202
- Jewish Hospital
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Louisville, Kentucky, Stati Uniti, 40245
- UofL Health Medical Center Northeast
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Louisville, Kentucky, Stati Uniti, 40215
- Saints Mary and Elizabeth Hospital
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Shepherdsville, Kentucky, Stati Uniti, 40165
- Jewish Hospital Medical Center South
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Maryland
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Baltimore, Maryland, Stati Uniti, 21237
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
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Minnesota
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic in Rochester
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Missouri
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Ballwin, Missouri, Stati Uniti, 63011
- Saint Louis Cancer and Breast Institute-Ballwin
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Bolivar, Missouri, Stati Uniti, 65613
- Central Care Cancer Center - Bolivar
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Branson, Missouri, Stati Uniti, 65616
- Cox Cancer Center Branson
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Joplin, Missouri, Stati Uniti, 64804
- Freeman Health System
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Joplin, Missouri, Stati Uniti, 64804
- Mercy Hospital Joplin
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Rolla, Missouri, Stati Uniti, 65401
- Delbert Day Cancer Institute at PCRMC
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Rolla, Missouri, Stati Uniti, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
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Saint Joseph, Missouri, Stati Uniti, 64506
- Heartland Regional Medical Center
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Springfield, Missouri, Stati Uniti, 65807
- CoxHealth South Hospital
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Springfield, Missouri, Stati Uniti, 65804
- Mercy Hospital Springfield
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St Louis, Missouri, Stati Uniti, 63141
- Mercy Hospital Saint Louis
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St Louis, Missouri, Stati Uniti, 63128
- Mercy Hospital South
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St Louis, Missouri, Stati Uniti, 63109
- Saint Louis Cancer and Breast Institute-South City
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Washington, Missouri, Stati Uniti, 63090
- Mercy Hospital Washington
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Montana
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Missoula, Montana, Stati Uniti, 59802
- Saint Patrick Hospital - Community Hospital
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Nebraska
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Grand Island, Nebraska, Stati Uniti, 68803
- CHI Health Saint Francis
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Kearney, Nebraska, Stati Uniti, 68847
- CHI Health Good Samaritan
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Lincoln, Nebraska, Stati Uniti, 68510
- Saint Elizabeth Regional Medical Center
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Omaha, Nebraska, Stati Uniti, 68124
- Alegent Health Bergan Mercy Medical Center
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Omaha, Nebraska, Stati Uniti, 68122
- Alegent Health Immanuel Medical Center
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Omaha, Nebraska, Stati Uniti, 68130
- Alegent Health Lakeside Hospital
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Omaha, Nebraska, Stati Uniti, 68131
- Creighton University Medical Center
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Papillion, Nebraska, Stati Uniti, 68046
- Midlands Community Hospital
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New York
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New York, New York, Stati Uniti, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
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Ohio
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Beavercreek, Ohio, Stati Uniti, 45431
- Indu and Raj Soin Medical Center
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Boardman, Ohio, Stati Uniti, 44512
- Saint Elizabeth Boardman Hospital
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Centerville, Ohio, Stati Uniti, 45459
- Miami Valley Hospital South
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Centerville, Ohio, Stati Uniti, 45459
- Dayton Physicians LLC-Miami Valley South
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Cincinnati, Ohio, Stati Uniti, 45220
- Good Samaritan Hospital - Cincinnati
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Cincinnati, Ohio, Stati Uniti, 45242
- Bethesda North Hospital
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Cincinnati, Ohio, Stati Uniti, 45236
- Oncology Hematology Care Inc-Kenwood
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Cincinnati, Ohio, Stati Uniti, 45247
- TriHealth Cancer Institute-Westside
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Cincinnati, Ohio, Stati Uniti, 45255
- TriHealth Cancer Institute-Anderson
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Dayton, Ohio, Stati Uniti, 45409
- Miami Valley Hospital
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Dayton, Ohio, Stati Uniti, 45415
- Dayton Physician LLC-Miami Valley Hospital North
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Dayton, Ohio, Stati Uniti, 45415
- Miami Valley Hospital North
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Findlay, Ohio, Stati Uniti, 45840
- Blanchard Valley Hospital
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Findlay, Ohio, Stati Uniti, 45840
- Armes Family Cancer Center
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Findlay, Ohio, Stati Uniti, 45840
- Orion Cancer Care
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Franklin, Ohio, Stati Uniti, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Franklin, Ohio, Stati Uniti, 45005
- Dayton Physicians LLC-Atrium
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Greenville, Ohio, Stati Uniti, 45331
- Wayne Hospital
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Greenville, Ohio, Stati Uniti, 45331
- Dayton Physicians LLC-Wayne
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Kettering, Ohio, Stati Uniti, 45429
- Kettering Medical Center
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Kettering, Ohio, Stati Uniti, 45409
- Greater Dayton Cancer Center
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Springfield, Ohio, Stati Uniti, 45505
- Springfield Regional Medical Center
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Springfield, Ohio, Stati Uniti, 45504
- Springfield Regional Cancer Center
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Troy, Ohio, Stati Uniti, 45373
- Upper Valley Medical Center
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Troy, Ohio, Stati Uniti, 45373
- Dayton Physicians LLC-Upper Valley
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Warren, Ohio, Stati Uniti, 44484
- Saint Joseph Warren Hospital
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Youngstown, Ohio, Stati Uniti, 44501
- Saint Elizabeth Youngstown Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73120
- Mercy Hospital Oklahoma City
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Oregon
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Bend, Oregon, Stati Uniti, 97701
- Saint Charles Health System
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Clackamas, Oregon, Stati Uniti, 97015
- Clackamas Radiation Oncology Center
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Clackamas, Oregon, Stati Uniti, 97015
- Providence Cancer Institute Clackamas Clinic
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Coos Bay, Oregon, Stati Uniti, 97420
- Bay Area Hospital
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Newberg, Oregon, Stati Uniti, 97132
- Providence Newberg Medical Center
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Portland, Oregon, Stati Uniti, 97213
- Providence Portland Medical Center
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Portland, Oregon, Stati Uniti, 97225
- Providence Saint Vincent Medical Center
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Redmond, Oregon, Stati Uniti, 97756
- Saint Charles Health System-Redmond
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Pennsylvania
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Chadds Ford, Pennsylvania, Stati Uniti, 19317
- Christiana Care Health System-Concord Health Center
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- University of Pennsylvania/Abramson Cancer Center
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Pittsburgh, Pennsylvania, Stati Uniti, 15232
- University of Pittsburgh Cancer Institute (UPCI)
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Texas
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Bryan, Texas, Stati Uniti, 77802
- Saint Joseph Regional Cancer Center
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Utah
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Salt Lake City, Utah, Stati Uniti, 84112
- Huntsman Cancer Institute/University of Utah
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Washington
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Aberdeen, Washington, Stati Uniti, 98520
- Providence Regional Cancer System-Aberdeen
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Bellingham, Washington, Stati Uniti, 98225
- PeaceHealth Saint Joseph Medical Center
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Bremerton, Washington, Stati Uniti, 98310
- Harrison HealthPartners Hematology and Oncology-Bremerton
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Bremerton, Washington, Stati Uniti, 98310
- Harrison Medical Center
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Burien, Washington, Stati Uniti, 98166
- Highline Medical Center-Main Campus
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Centralia, Washington, Stati Uniti, 98531
- Providence Regional Cancer System-Centralia
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Edmonds, Washington, Stati Uniti, 98026
- Swedish Cancer Institute-Edmonds
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Enumclaw, Washington, Stati Uniti, 98022
- Saint Elizabeth Hospital
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Everett, Washington, Stati Uniti, 98201
- Providence Regional Cancer Partnership
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Federal Way, Washington, Stati Uniti, 98003
- Saint Francis Hospital
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Issaquah, Washington, Stati Uniti, 98029
- Swedish Cancer Institute-Issaquah
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Kennewick, Washington, Stati Uniti, 99336
- Kadlec Clinic Hematology and Oncology
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Lacey, Washington, Stati Uniti, 98503
- Providence Regional Cancer System-Lacey
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Lakewood, Washington, Stati Uniti, 98499
- Saint Clare Hospital
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Longview, Washington, Stati Uniti, 98632
- PeaceHealth Saint John Medical Center
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Poulsbo, Washington, Stati Uniti, 98370
- Harrison HealthPartners Hematology and Oncology-Poulsbo
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Seattle, Washington, Stati Uniti, 98107
- Swedish Medical Center-Ballard Campus
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Seattle, Washington, Stati Uniti, 98122
- Swedish Medical Center-First Hill
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Seattle, Washington, Stati Uniti, 98104
- Pacific Gynecology Specialists
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Seattle, Washington, Stati Uniti, 98122-5711
- Swedish Medical Center-Cherry Hill
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Sedro-Woolley, Washington, Stati Uniti, 98284
- PeaceHealth United General Medical Center
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Shelton, Washington, Stati Uniti, 98584
- Providence Regional Cancer System-Shelton
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Tacoma, Washington, Stati Uniti, 98405
- Franciscan Research Center-Northwest Medical Plaza
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Vancouver, Washington, Stati Uniti, 98664
- PeaceHealth Southwest Medical Center
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Walla Walla, Washington, Stati Uniti, 99362
- Providence Saint Mary Regional Cancer Center
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Yelm, Washington, Stati Uniti, 98597
- Providence Regional Cancer System-Yelm
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Wisconsin
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Chippewa Falls, Wisconsin, Stati Uniti, 54729
- Marshfield Clinic-Chippewa Center
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Eau Claire, Wisconsin, Stati Uniti, 54701
- Marshfield Medical Center-EC Cancer Center
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Ladysmith, Wisconsin, Stati Uniti, 54848
- Marshfield Clinic - Ladysmith Center
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Marshfield, Wisconsin, Stati Uniti, 54449
- Marshfield Medical Center-Marshfield
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Minocqua, Wisconsin, Stati Uniti, 54548
- Marshfield Clinic-Minocqua Center
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Rice Lake, Wisconsin, Stati Uniti, 54868
- Marshfield Medical Center-Rice Lake
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Stevens Point, Wisconsin, Stati Uniti, 54482
- Marshfield Medical Center-River Region at Stevens Point
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Wausau, Wisconsin, Stati Uniti, 54401
- Marshfield Clinic-Wausau Center
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Weston, Wisconsin, Stati Uniti, 54476
- Marshfield Medical Center - Weston
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Wisconsin Rapids, Wisconsin, Stati Uniti, 54494
- Marshfield Clinic - Wisconsin Rapids Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
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Patient must have locally advanced unresectable stage IIIC or stage IV melanoma
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Patient must have BRAF V600E or BRAF V600K tumor genotype based on a Clinical Laboratory Improvement Act (CLIA) approved assay
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Patient must have serum LDH > Upper limit of normal per institution standards
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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
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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
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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.
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Patient may have been treated with prior chemotherapy or radiation therapy
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Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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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
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All females of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy.
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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
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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
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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
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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
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Absolute neutrophil count >= 1,500/mcL (obtained =< 14 days prior to protocol randomization)
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Platelets >= 100,000/mcL (obtained =< 14 days prior to protocol randomization)
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Total bilirubin =< institutional upper limit of normal (ULN) (obtained =< 14 days prior to protocol randomization)
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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)
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Creatinine =< 1.5 x institutional ULN (obtained =< 14 days prior to protocol randomization)
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Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
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For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
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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
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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:
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Receiving any other investigational anticancer therapy during the period on study or the 4 weeks prior to randomization
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Patients received BRAF and MEK inhibitor therapy in the metastatic setting
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Patients who are experiencing an objective partial response to immunotherapy at the time of study enrollment
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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)
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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
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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
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Previously documented retinal vein occlusion
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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
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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
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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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
Given PO
Altri nomi:
Given PO
Altri nomi:
Given PO
Altri nomi:
|
|
Comparatore attivo: 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. |
Given PO Given PO
Altri nomi:
Given PO
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
One-year Progression-free Survival Rate
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Progression-free Survival
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Ravi Amaravadi, ECOG-ACRIN Cancer Research Group
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- EA6191
- U10CA180820 (Sovvenzione/contratto NIH degli Stati Uniti)
- EA6191 (Altro identificatore: CTEP)
- NCI-2020-04552 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
- EA6191 (Altro identificatore: ECOG-ACRIN Cancer Research Group)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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