Testen van dabrafenib en trametinib met of zonder hydroxychloroquine in stadium IIIC of IV BRAF V600E/K melanoom
De BAMM2-studie (BRAF, autofagie, MEK-inhibitie bij melanoom): een gerandomiseerde dubbelblinde fase II-studie van dabrafenib en trametinib met of zonder hydroxychloroquine bij gevorderd BRAF V600E/K-melanoom
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Alaska
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Anchorage, Alaska, Verenigde Staten, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, Verenigde Staten, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, Verenigde Staten, 99508
- Alaska Oncology and Hematology LLC
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Anchorage, Alaska, Verenigde Staten, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, Verenigde Staten, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, Verenigde Staten, 99508
- Katmai Oncology Group
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Anchorage, Alaska, Verenigde Staten, 99508
- Providence Alaska Medical Center
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Anchorage, Alaska, Verenigde Staten, 99504
- Anchorage Radiation Therapy Center
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85054
- Mayo Clinic Hospital in Arizona
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Phoenix, Arizona, Verenigde Staten, 85004
- Cancer Center at Saint Joseph's
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Scottsdale, Arizona, Verenigde Staten, 85259
- Mayo Clinic in Arizona
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Arkansas
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Fort Smith, Arkansas, Verenigde Staten, 72903
- Mercy Hospital Fort Smith
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Hot Springs, Arkansas, Verenigde Staten, 71913
- CHI Saint Vincent Cancer Center Hot Springs
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California
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Arroyo Grande, California, Verenigde Staten, 93420
- Mission Hope Medical Oncology - Arroyo Grande
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Burbank, California, Verenigde Staten, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Los Angeles, California, Verenigde Staten, 90048
- Cedars Sinai Medical Center
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San Luis Obispo, California, Verenigde Staten, 93401
- Pacific Central Coast Health Center-San Luis Obispo
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Santa Maria, California, Verenigde Staten, 93444
- Mission Hope Medical Oncology - Santa Maria
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Colorado
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Colorado Springs, Colorado, Verenigde Staten, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Verenigde Staten, 80907
- Rocky Mountain Cancer Centers-Penrose
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Colorado Springs, Colorado, Verenigde Staten, 80923
- Saint Francis Cancer Center
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Denver, Colorado, Verenigde Staten, 80210
- Porter Adventist Hospital
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Durango, Colorado, Verenigde Staten, 81301
- Mercy Medical Center
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Durango, Colorado, Verenigde Staten, 81301
- Southwest Oncology PC
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Lakewood, Colorado, Verenigde Staten, 80228
- Saint Anthony Hospital
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Littleton, Colorado, Verenigde Staten, 80122
- Littleton Adventist Hospital
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Longmont, Colorado, Verenigde Staten, 80501
- Longmont United Hospital
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Longmont, Colorado, Verenigde Staten, 80501
- Rocky Mountain Cancer Centers-Longmont
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Parker, Colorado, Verenigde Staten, 80138
- Parker Adventist Hospital
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Pueblo, Colorado, Verenigde Staten, 81004
- Saint Mary Corwin Medical Center
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Delaware
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Frankford, Delaware, Verenigde Staten, 19945
- Beebe South Coastal Health Campus
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Lewes, Delaware, Verenigde Staten, 19958
- Beebe Medical Center
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Newark, Delaware, Verenigde Staten, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Verenigde Staten, 19713
- Delaware Clinical and Laboratory Physicians PA
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Newark, Delaware, Verenigde Staten, 19713
- Medical Oncology Hematology Consultants PA
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Newark, Delaware, Verenigde Staten, 19718
- Christiana Care Health System-Christiana Hospital
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Rehoboth Beach, Delaware, Verenigde Staten, 19971
- Beebe Health Campus
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Seaford, Delaware, Verenigde Staten, 19973
- TidalHealth Nanticoke / Allen Cancer Center
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Wilmington, Delaware, Verenigde Staten, 19801
- Christiana Care Health System-Wilmington Hospital
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District of Columbia
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Washington D.C., District of Columbia, Verenigde Staten, 20007
- MedStar Georgetown University Hospital
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Florida
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Aventura, Florida, Verenigde Staten, 33180
- UM Sylvester Comprehensive Cancer Center at Aventura
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Coral Gables, Florida, Verenigde Staten, 33146
- UM Sylvester Comprehensive Cancer Center at Coral Gables
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Deerfield Beach, Florida, Verenigde Staten, 33442
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Miami, Florida, Verenigde Staten, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Miami, Florida, Verenigde Staten, 33176
- UM Sylvester Comprehensive Cancer Center at Kendall
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Plantation, Florida, Verenigde Staten, 33324
- UM Sylvester Comprehensive Cancer Center at Plantation
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Idaho
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Boise, Idaho, Verenigde Staten, 83712
- Saint Luke's Cancer Institute - Boise
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Fruitland, Idaho, Verenigde Staten, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Verenigde Staten, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Verenigde Staten, 83686
- Saint Luke's Cancer Institute - Nampa
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Twin Falls, Idaho, Verenigde Staten, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Alton, Illinois, Verenigde Staten, 62002
- Saint Anthony's Health
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Aurora, Illinois, Verenigde Staten, 60504
- Rush - Copley Medical Center
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Burr Ridge, Illinois, Verenigde Staten, 60527
- Loyola Center for Health at Burr Ridge
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Danville, Illinois, Verenigde Staten, 61832
- Carle on Vermilion
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Effingham, Illinois, Verenigde Staten, 62401
- Carle Physician Group-Effingham
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Homer Glen, Illinois, Verenigde Staten, 60491
- Loyola Medicine Homer Glen
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Mattoon, Illinois, Verenigde Staten, 61938
- Carle Physician Group-Mattoon/Charleston
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Maywood, Illinois, Verenigde Staten, 60153
- Loyola University Medical Center
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Melrose Park, Illinois, Verenigde Staten, 60160
- Marjorie Weinberg Cancer Center at Loyola-Gottlieb
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Mount Vernon, Illinois, Verenigde Staten, 62864
- Good Samaritan Regional Health Center
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Urbana, Illinois, Verenigde Staten, 61801
- Carle Cancer Center
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Urbana, Illinois, Verenigde Staten, 61801
- The Carle Foundation Hospital
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Yorkville, Illinois, Verenigde Staten, 60560
- Rush-Copley Healthcare Center
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Indiana
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Richmond, Indiana, Verenigde Staten, 47374
- Reid Health
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Iowa
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Ames, Iowa, Verenigde Staten, 50010
- McFarland Clinic PC - Ames
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Ames, Iowa, Verenigde Staten, 50010
- Mary Greeley Medical Center
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Boone, Iowa, Verenigde Staten, 50036
- McFarland Clinic PC-Boone
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Carroll, Iowa, Verenigde Staten, 51401
- Saint Anthony Regional Hospital
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Clive, Iowa, Verenigde Staten, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Verenigde Staten, 50325
- Medical Oncology and Hematology Associates-West Des Moines
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Council Bluffs, Iowa, Verenigde Staten, 51503
- Alegent Health Mercy Hospital
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Creston, Iowa, Verenigde Staten, 50801
- Greater Regional Medical Center
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Des Moines, Iowa, Verenigde Staten, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Verenigde Staten, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Verenigde Staten, 50309
- Medical Oncology and Hematology Associates-Des Moines
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Des Moines, Iowa, Verenigde Staten, 50314
- Broadlawns Medical Center
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Des Moines, Iowa, Verenigde Staten, 50314
- Mission Cancer and Blood - Laurel
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Des Moines, Iowa, Verenigde Staten, 50316
- Iowa Lutheran Hospital
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Fort Dodge, Iowa, Verenigde Staten, 50501
- McFarland Clinic PC-Trinity Cancer Center
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Fort Dodge, Iowa, Verenigde Staten, 50501
- Trinity Regional Medical Center
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Jefferson, Iowa, Verenigde Staten, 50129
- McFarland Clinic PC-Jefferson
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Marshalltown, Iowa, Verenigde Staten, 50158
- McFarland Clinic PC-Marshalltown
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West Des Moines, Iowa, Verenigde Staten, 50266-7700
- Methodist West Hospital
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West Des Moines, Iowa, Verenigde Staten, 50266
- Mercy Medical Center-West Lakes
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Kansas
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Garden City, Kansas, Verenigde Staten, 67846
- Central Care Cancer Center - Garden City
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Great Bend, Kansas, Verenigde Staten, 67530
- Central Care Cancer Center - Great Bend
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Kentucky
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Bardstown, Kentucky, Verenigde Staten, 40004
- Flaget Memorial Hospital
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Corbin, Kentucky, Verenigde Staten, 40701
- Commonwealth Cancer Center-Corbin
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Lexington, Kentucky, Verenigde Staten, 40504
- Saint Joseph Radiation Oncology Resource Center
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Lexington, Kentucky, Verenigde Staten, 40509
- Saint Joseph Hospital East
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London, Kentucky, Verenigde Staten, 40741
- Saint Joseph London
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Louisville, Kentucky, Verenigde Staten, 40202
- Jewish Hospital
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Louisville, Kentucky, Verenigde Staten, 40245
- UofL Health Medical Center Northeast
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Louisville, Kentucky, Verenigde Staten, 40215
- Saints Mary and Elizabeth Hospital
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Shepherdsville, Kentucky, Verenigde Staten, 40165
- Jewish Hospital Medical Center South
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21237
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
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Minnesota
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic in Rochester
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Missouri
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Ballwin, Missouri, Verenigde Staten, 63011
- Saint Louis Cancer and Breast Institute-Ballwin
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Bolivar, Missouri, Verenigde Staten, 65613
- Central Care Cancer Center - Bolivar
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Branson, Missouri, Verenigde Staten, 65616
- Cox Cancer Center Branson
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Joplin, Missouri, Verenigde Staten, 64804
- Freeman Health System
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Joplin, Missouri, Verenigde Staten, 64804
- Mercy Hospital Joplin
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Rolla, Missouri, Verenigde Staten, 65401
- Delbert Day Cancer Institute at PCRMC
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Rolla, Missouri, Verenigde Staten, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
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Saint Joseph, Missouri, Verenigde Staten, 64506
- Heartland Regional Medical Center
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Springfield, Missouri, Verenigde Staten, 65807
- CoxHealth South Hospital
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Springfield, Missouri, Verenigde Staten, 65804
- Mercy Hospital Springfield
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St Louis, Missouri, Verenigde Staten, 63141
- Mercy Hospital Saint Louis
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St Louis, Missouri, Verenigde Staten, 63128
- Mercy Hospital South
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St Louis, Missouri, Verenigde Staten, 63109
- Saint Louis Cancer and Breast Institute-South City
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Washington, Missouri, Verenigde Staten, 63090
- Mercy Hospital Washington
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Montana
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Missoula, Montana, Verenigde Staten, 59802
- Saint Patrick Hospital - Community Hospital
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Nebraska
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Grand Island, Nebraska, Verenigde Staten, 68803
- CHI Health Saint Francis
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Kearney, Nebraska, Verenigde Staten, 68847
- CHI Health Good Samaritan
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Lincoln, Nebraska, Verenigde Staten, 68510
- Saint Elizabeth Regional Medical Center
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Omaha, Nebraska, Verenigde Staten, 68124
- Alegent Health Bergan Mercy Medical Center
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Omaha, Nebraska, Verenigde Staten, 68122
- Alegent Health Immanuel Medical Center
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Omaha, Nebraska, Verenigde Staten, 68130
- Alegent Health Lakeside Hospital
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Omaha, Nebraska, Verenigde Staten, 68131
- Creighton University Medical Center
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Papillion, Nebraska, Verenigde Staten, 68046
- Midlands Community Hospital
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New York
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New York, New York, Verenigde Staten, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
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Ohio
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Beavercreek, Ohio, Verenigde Staten, 45431
- Indu and Raj Soin Medical Center
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Boardman, Ohio, Verenigde Staten, 44512
- Saint Elizabeth Boardman Hospital
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Centerville, Ohio, Verenigde Staten, 45459
- Miami Valley Hospital South
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Centerville, Ohio, Verenigde Staten, 45459
- Dayton Physicians LLC-Miami Valley South
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Cincinnati, Ohio, Verenigde Staten, 45220
- Good Samaritan Hospital - Cincinnati
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Cincinnati, Ohio, Verenigde Staten, 45242
- Bethesda North Hospital
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Cincinnati, Ohio, Verenigde Staten, 45236
- Oncology Hematology Care Inc-Kenwood
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Cincinnati, Ohio, Verenigde Staten, 45247
- TriHealth Cancer Institute-Westside
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Cincinnati, Ohio, Verenigde Staten, 45255
- TriHealth Cancer Institute-Anderson
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Dayton, Ohio, Verenigde Staten, 45409
- Miami Valley Hospital
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Dayton, Ohio, Verenigde Staten, 45415
- Dayton Physician LLC-Miami Valley Hospital North
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Dayton, Ohio, Verenigde Staten, 45415
- Miami Valley Hospital North
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Findlay, Ohio, Verenigde Staten, 45840
- Blanchard Valley Hospital
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Findlay, Ohio, Verenigde Staten, 45840
- Armes Family Cancer Center
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Findlay, Ohio, Verenigde Staten, 45840
- Orion Cancer Care
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Franklin, Ohio, Verenigde Staten, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Franklin, Ohio, Verenigde Staten, 45005
- Dayton Physicians LLC-Atrium
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Greenville, Ohio, Verenigde Staten, 45331
- Wayne Hospital
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Greenville, Ohio, Verenigde Staten, 45331
- Dayton Physicians LLC-Wayne
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Kettering, Ohio, Verenigde Staten, 45429
- Kettering Medical Center
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Kettering, Ohio, Verenigde Staten, 45409
- Greater Dayton Cancer Center
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Springfield, Ohio, Verenigde Staten, 45505
- Springfield Regional Medical Center
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Springfield, Ohio, Verenigde Staten, 45504
- Springfield Regional Cancer Center
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Troy, Ohio, Verenigde Staten, 45373
- Upper Valley Medical Center
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Troy, Ohio, Verenigde Staten, 45373
- Dayton Physicians LLC-Upper Valley
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Warren, Ohio, Verenigde Staten, 44484
- Saint Joseph Warren Hospital
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Youngstown, Ohio, Verenigde Staten, 44501
- Saint Elizabeth Youngstown Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73120
- Mercy Hospital Oklahoma City
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Oregon
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Bend, Oregon, Verenigde Staten, 97701
- Saint Charles Health System
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Clackamas, Oregon, Verenigde Staten, 97015
- Clackamas Radiation Oncology Center
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Clackamas, Oregon, Verenigde Staten, 97015
- Providence Cancer Institute Clackamas Clinic
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Coos Bay, Oregon, Verenigde Staten, 97420
- Bay Area Hospital
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Newberg, Oregon, Verenigde Staten, 97132
- Providence Newberg Medical Center
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Portland, Oregon, Verenigde Staten, 97213
- Providence Portland Medical Center
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Portland, Oregon, Verenigde Staten, 97225
- Providence Saint Vincent Medical Center
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Redmond, Oregon, Verenigde Staten, 97756
- Saint Charles Health System-Redmond
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Pennsylvania
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Chadds Ford, Pennsylvania, Verenigde Staten, 19317
- Christiana Care Health System-Concord Health Center
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- University of Pennsylvania/Abramson Cancer Center
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Pittsburgh, Pennsylvania, Verenigde Staten, 15232
- University of Pittsburgh Cancer Institute (UPCI)
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Texas
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Bryan, Texas, Verenigde Staten, 77802
- Saint Joseph Regional Cancer Center
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84112
- Huntsman Cancer Institute/University of Utah
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Washington
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Aberdeen, Washington, Verenigde Staten, 98520
- Providence Regional Cancer System-Aberdeen
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Bellingham, Washington, Verenigde Staten, 98225
- PeaceHealth Saint Joseph Medical Center
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Bremerton, Washington, Verenigde Staten, 98310
- Harrison HealthPartners Hematology and Oncology-Bremerton
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Bremerton, Washington, Verenigde Staten, 98310
- Harrison Medical Center
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Burien, Washington, Verenigde Staten, 98166
- Highline Medical Center-Main Campus
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Centralia, Washington, Verenigde Staten, 98531
- Providence Regional Cancer System-Centralia
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Edmonds, Washington, Verenigde Staten, 98026
- Swedish Cancer Institute-Edmonds
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Enumclaw, Washington, Verenigde Staten, 98022
- Saint Elizabeth Hospital
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Everett, Washington, Verenigde Staten, 98201
- Providence Regional Cancer Partnership
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Federal Way, Washington, Verenigde Staten, 98003
- Saint Francis Hospital
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Issaquah, Washington, Verenigde Staten, 98029
- Swedish Cancer Institute-Issaquah
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Kennewick, Washington, Verenigde Staten, 99336
- Kadlec Clinic Hematology and Oncology
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Lacey, Washington, Verenigde Staten, 98503
- Providence Regional Cancer System-Lacey
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Lakewood, Washington, Verenigde Staten, 98499
- Saint Clare Hospital
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Longview, Washington, Verenigde Staten, 98632
- PeaceHealth Saint John Medical Center
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Poulsbo, Washington, Verenigde Staten, 98370
- Harrison HealthPartners Hematology and Oncology-Poulsbo
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Seattle, Washington, Verenigde Staten, 98107
- Swedish Medical Center-Ballard Campus
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Seattle, Washington, Verenigde Staten, 98122
- Swedish Medical Center-First Hill
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Seattle, Washington, Verenigde Staten, 98104
- Pacific Gynecology Specialists
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Seattle, Washington, Verenigde Staten, 98122-5711
- Swedish Medical Center-Cherry Hill
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Sedro-Woolley, Washington, Verenigde Staten, 98284
- PeaceHealth United General Medical Center
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Shelton, Washington, Verenigde Staten, 98584
- Providence Regional Cancer System-Shelton
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Tacoma, Washington, Verenigde Staten, 98405
- Franciscan Research Center-Northwest Medical Plaza
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Vancouver, Washington, Verenigde Staten, 98664
- PeaceHealth Southwest Medical Center
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Walla Walla, Washington, Verenigde Staten, 99362
- Providence Saint Mary Regional Cancer Center
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Yelm, Washington, Verenigde Staten, 98597
- Providence Regional Cancer System-Yelm
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Wisconsin
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Chippewa Falls, Wisconsin, Verenigde Staten, 54729
- Marshfield Clinic-Chippewa Center
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Eau Claire, Wisconsin, Verenigde Staten, 54701
- Marshfield Medical Center-EC Cancer Center
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Ladysmith, Wisconsin, Verenigde Staten, 54848
- Marshfield Clinic - Ladysmith Center
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Marshfield, Wisconsin, Verenigde Staten, 54449
- Marshfield Medical Center-Marshfield
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Minocqua, Wisconsin, Verenigde Staten, 54548
- Marshfield Clinic-Minocqua Center
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Rice Lake, Wisconsin, Verenigde Staten, 54868
- Marshfield Medical Center-Rice Lake
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Stevens Point, Wisconsin, Verenigde Staten, 54482
- Marshfield Medical Center-River Region at Stevens Point
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Wausau, Wisconsin, Verenigde Staten, 54401
- Marshfield Clinic-Wausau Center
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Weston, Wisconsin, Verenigde Staten, 54476
- Marshfield Medical Center - Weston
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Wisconsin Rapids, Wisconsin, Verenigde Staten, 54494
- Marshfield Clinic - Wisconsin Rapids Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
-
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)
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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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
Andere namen:
Given PO
Andere namen:
Given PO
Andere namen:
|
|
Actieve vergelijker: 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
Andere namen:
Given PO
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
One-year Progression-free Survival Rate
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Progression-free Survival
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Ravi Amaravadi, ECOG-ACRIN Cancer Research Group
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- EA6191
- U10CA180820 (Subsidie/contract van de Amerikaanse NIH)
- EA6191 (Andere identificatie: CTEP)
- NCI-2020-04552 (Register-ID: CTRP (Clinical Trial Reporting Program))
- EA6191 (Andere identificatie: ECOG-ACRIN Cancer Research Group)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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