EA9171 / BLAST MRD CML 1 [USA]
Study title
Testing Pembrolizumab with Existing Cancer Therapy in Patients with Evidence of Residual Chronic Myelogenous Leukemia
Scientific title
Phase II Study of Adding the Anti-PD-1 Pembrolizumab to Tyrosine Kinase Inhibitors in Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease
Type of study
Therapy optimization trial
Phase
Current status
Recruiting
Other trial ID
ClinicalTrials.gov NCT03516279
What is the purpose of the study
This is a study to determine the effects of adding pembrolizumab to the usual treatment – dasatinib, imatinib mesylate, nilotinib, or bosutinib – of patients with chronic myeloid leukemia and persistent detection of minimal residual disease (MRD).
Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Dasatinib, imatinib mesylate, nilotinib, and bosutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and dasatinib, imatinib mesylate, nilotinib, or bosutinib may work better in treating patients with chronic myeloid leukemia compared to dasatinib, imatinib mesylate, nilotinib, or bosutinib alone.
What will happen during the study
Patients will receive pembrolizumab by vein (intravenously) once every 3 weeks for a total duration of 54 weeks. During this time, patients will also receive dasatinib, imatinib mesylate, nilotinib, or bosutinib as clinically indicated per the treating physician.
After completing 54 weeks of treatment,
- patients with detectable minimal residual disease (where the fusion gene bcr-abl remains detectable in the blood) will continue to receive pembrolizumab and dasatinib, imatinib mesylate, nilotinib, or bosutinib for another year.
- patients with undetectable minimal residual disease (where bcr-abl is undetectable) will stop receiving pembrolizumab and only continue dasatinib, imatinib mesylate, nilotinib, or bosutinib.
Key inclusion criteria
This study includes patients of all sexes who:
- are aged 18 years or older
- have been diagnosed with BCR-ABL positive CML in chronic phase (CP)
- have been on tyrosine kinase (TKI) therapy (first, second, and third line line) for at least 2 years. Allowed TKIs include dasatinib, imatinib, nilotinib and bosutinib.
- have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2.
Further criteria may apply. Please discuss these with your doctor or study staff.
Key exclusion criteria
This study does not include patients who:
- have been diagnosed with accelerated or blast phase CML
- have received a previous allogeneic stem cell transplant
- have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
- have a history of hypersensitivity to pembrolizumab or any of its excipients.
Further criteria may apply. Please discuss these with your doctor or study staff.
Estimated primary completion date
Where can I find additional information
You can find a study summary for patients provided by the study sponsor ECOG-ACRIN Cancer Research Group, part of the National Cancer Institute’s (NCI) National Clinical Trial’s Network.
You can also find a study description in the US register ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.
Study sponsor
ECOG-ACRIN Cancer Research Group in collaboration with the National Cancer Institute (NCI)
Scientific lead / contact
ECOG-ACRIN Cancer Research Group
Principal investigator
Amer Zeidan, ECOG-ACRIN Cancer Research Group
Study centers / principal investigators
United States
Alaska
Fairbanks Memorial Hospital – recruiting
Fairbanks
Arizona
CTCA at Western Regional Medical Center – recruiting
Goddyear
Cancer Center at Saint Joseph’s – active, not recruiting
Phoenix
Arkansas
Mercy Hospital Fort Smith – recruiting
Fort Smith
CHI Saint Vincent Cancer Center Hot Springs – suspended
Hot Springs
CARTI Cancer Center – recruiting
Little Rock
California
Mission Hope Medical Oncology – active, not recruiting
Arroyo Grande
Mercy Cancer Center – active, not recruiting
Carmichael
Mercy San Juan Medical Center – active, not recruiting
Carmichael
Mercy Cancer Center – active, not recruiting
Elk Grove
Contra Costa Regional Medical Center – recruiting
Martinez
Mercy Cancer Center – active, not recruiting
Merced
Mercy Cancer Center – active, not recruiting
Rocklin
Mercy Cancer Center – active, not recruiting
Sacramento
Pacific Central Coast Health Center – active, not recruiting
San Luis Obispo
Mission Hope Medical Oncology – active, not recruiting
Santa Maria
BASS Medical Grupu – Lennon – recruiting
Walnut Creek
Woodland Memorial Hospital – active, not recruiting
Woodland
Colorado
Rocky Mountain Cancer Centers – recruiting
Aurora
Boulder Community Foothills Hospital – recruiting
Boulder
Rocky Mountain Cancer Centers – recruiting
Boulder
Rocky Mountain Cancer Centers – recruiting
Centennial
Penrose-Saint Francis Healthcare – active, not recruiting
Colorado Springs
Rocky Mountain Cancer Centers-Penrose – active, not recruiting
Colorado Springs
Saint Francis Cancer Center – active, not recruiting
Colorado Springs
Colorado Blood Cancer Institute – suspended
Denver
Porter Adventist Hospital – suspended
Denver
Presbyterian – Saint Lukes Medical Center – Health One – recruiting
Denver
Rocky Mountain Cancer Centers-Midtown – recruiting
Denver
Rocky Mountain Cancer Centers-Rose – recruiting
Denver
Rose Medical Center – suspended
Denver
The Women’s Imaging Center – recruiting
Denver
Mercy Medical Center – active, not recruiting
Durango
Southwest Oncology PC – active, not recruiting
Durango
Mountain Blue Cancer Care Center – Swedish – suspended
Englewood
Rocky Mountain Cancer Centers – Swedish – recruiting
Englewood
Swedish Medical Center – suspended
Englewood
The Melanoma and Skin Cancer Institute – recruiting
Englewood
Mountain Blue Cancer Care Center – suspended
Golden
Rocky Mountain Cancer Centers – recruiting
Lakewood
Saint Anthony Hospital – active, not recruiting
Lakewood
Littleton Adventist Hospital – suspended
Littleton
Rocky Mountain Cancer Centers – recruiting
Littleton
Rocky Mountain Cancer Centers-Sky Ridge – recruiting
Lone Tree
Longmont United Hospital – active, not recruiting
Longmont
Rocky Mountain Cancer Centers – recruiting
Longmont
Parker Adventist Hospital – suspended
Parker
Rocky Mountain Cancer Centers – suspended
Parker
Rocky Mountain Cancer Centers – active, not recruiting
Pueblo
Saint Mary Corwin Medical Center – active, not recruiting
Pueblo
Rocky Mountain Cancer Centers – recruiting
Thornton
Connecticut
Smilow Cancer Hospital-Derby Care Center – recruiting
Derby
Smilow Cancer Hospital Care Center – recruiting
Fairfield
Smilow Cancer Hospital Care Center – recruiting
Glastonbury
Smilow Cancer Hospital Care Center – recruiting
Guilford
Smilow Cancer Hospital Care Center at Saint Francis – recruiting
Hartfort
Smilow Cancer Center/Yale-New Haven Hospital – recruiting
New Haven
Yale University – recruiting
New Haven
Yale-New Haven Hospital North Haven Medical Center – recruiting
North Haven
Smilow Cancer Hospital-Torrington Care Center – recruiting
Torrington
Smilow Cancer Hospital Care Center – recruiting
Trumbull
Smilow Cancer Hospital-Waterbury Care Center – recruiting
Waterbury
Smilow Cancer Hospital Care Center – recruiting
Waterford
Delaware
Beebe South Coastal Health Campus – active, not recruiting
Frankford
Beebe Medical Center – active, not recruiting
Lewes
Christiana Care Health System-Christiana Hospital – active, not recruiting
Newark
Delaware Clinical and Laboratory Physicians PA – active, not recruiting
Newark
Helen F Graham Cancer Center – active, not recruiting
Newark
Medical Oncology Hematology Consultants PA – active, not recruiting
Newark
Beebe Health Campus – active, not recruiting
Rehoboth Beach
TidalHealth Nanticoke / Allen Cancer Center – active, not recruiting
Seaford
Christiana Care Health System-Wilmington Hospital – active, not recruiting
Wilmington
Idaho
Saint Alphonsus Cancer Care Center – recruiting
Boise
Saint Alphonsus Cancer Care Center – recruiting
Caldwell
Kootenai Health – recruiting
Coeur d’Alene
Walter Knox Memorial Hospital – recruiting
Emmett
Idaho Urologic Institute – recruiting
Meridian
Saint Alphonsus Cancer Care Center – recruiting
Nampa
Kootenai Clinic Cancer Services – recruiting
Post Falls
Kootenai Cancer Clinic – recruiting
Sandpoint
Illinois
Saint Anthony’s Health – recruiting
Alton
Rush – Copley Medical Center – recruiting
Aurora
Illinois CancerCare – recruiting
Bloomington
Illinois CancerCare – recruiting
Canton
Memorial Hospital of Carbondale – recruiting
Carbondale
SIH Cancer Institute – recruiting
Carterville
Illinois CancerCare – recruiting
Carthage
Centralia Oncology Clinic – recruiting
Centralia
Saint Mary’s Hospital – recruiting
Centralia
Northwestern University – recruiting
Chicago
University of Illinois – recruiting
Chicago
Carle at The Riverfront – recruiting
Danville
Cancer Care Specialists of Illinois – recruiting
Decatur
Decatur Memorial Hospital – recruiting
Decatur
Illinois CancerCare – recruiting
Dixon
Carle Physician Group – recruiting
Effingham
Crossroads Cancer Center – recruiting
Effingham
Illinois CancerCare – recruiting
Eureka
Illinois CancerCare – recruiting
Galesburg
Western Illinois Cancer Treatment Center – recruiting
Galesburg
Illinois CancerCare-Kewanee Clinic – recruiting
Kewanee
Northwestern Medicine Lake Forest Hospital – active, not recruiting
Lake Forest
Illinois CancerCare – recruiting
Macomb
Carle Physician Group-Mattoon/Charleston – recruiting
Mattoon
Good Samaritan Regional Health Center – recruiting
Mount Vernon
Cancer Care Center of O’Fallon – recruiting
O’Fallon
Illinois CancerCare-Ottawa Clinic – recruiting
Ottawa
Illinois CancerCare – recruiting
Pekin
Illinois CancerCare – recruiting
Peoria
Methodist Medical Center of Illinois – recruiting
Peoria
Illinois CancerCare – recruiting
Peru
Valley Radiation Oncology – recruiting
Peru
Illinois CancerCare – recruiting
Princeton
Memorial Medical Center – recruiting
Springfield
Southern Illinois University School of Medicine – recruiting
Springfield
Springfield Clinic – recruiting
Springfield
Southwest Illinois Health Services LLP – suspended
Swansea
Carle Cancer Center – recruiting
Urbana
The Carle Foundation Hospital – recruiting
Urbana
Illinois CancerCare – recruiting
Washington
Rush-Copley Healthcare Center – recruiting
Yorkville
Iowa
Mary Greeley Medical Center – recruiting
Ames
McFarland Clinic – recruiting
Ames
Mission Cancer and Blood – recruiting
Ankeny
McFarland Clinic – recruiting
Boone
Saint Anthony Regional Hospital – active, not recruiting
Carroll
Mercy Cancer Center-West Lakes – recruiting
Clive
Mission Cancer and Blood – West Des Moines – recruiting
Clive
Alegent Health Mercy Hospital – active, not recruiting
Council Bluffs
Greater Regional Medical Center – recruiting
Creston
Broadlawns Medical Center – active, not recruiting
Des Moines
Iowa Lutheran Hospital – active, not recruiting
Des Moines
Iowa Methodist Medical Center – active, not recruiting
Des Moines
Mercy Medical Center – recruiting
Des Moines
Mission Cancer and Blood – active, not recruiting
Des Moines
Mission Cancer and Blood – Laurel – recruiting
Des Moines
McFarland Clinic – Trinity Cancer Center – recruiting
Fort Dodge
Trinity Regional Medical Center – active, not recruiting
Fort Dodge
McFarland Clinic – recruiting
Jeffersion
McFarland Clinic – recruiting
Marshalltown
Mercy Medical Center-West Lakes – recruiting
West Des Moines
Methodist West Hospital – active, not recruiting
West Des Moines
Kansas
Central Care Cancer Center – recruiting
Garden City
Central Care Cancer Center – recruiting
Great Bend
Lawrence Memorial Hospital – suspended
Lawrence
Ascension Via Christi Hospitals Wichita – recruiting
Wichita
Cancer Center of Kansas – recruiting
Wichita
Cancer Center of Kansas-Wichita Medical Arts Tower – recruiting
Wichita
Wesley Medical Center – recruiting
Wichita
Kentucky
Flaget Memorial Hospital – active, not recruiting
Bardstown
Commonwealth Cancer Center – active, not recruiting
Corbin
Saint Joseph Hospital – active, not recruiting
Lexington
Saint Joseph Hospital East – active, not recruiting
Lexington
Saint Joseph Radiation Oncology Resource Center – active, not recruiting
Lexington
Saint Joseph London – active, not recruiting
London
Jewish Hospital – suspended
Louisville
Saints Mary and Elizabeth Hospital – suspended
Louisville
UofL Health Medical Center Northeast – suspended
Louisville
Saint Joseph Mount Sterling – active, not recruiting
Mount Sterling
Mercy Health – Paducah Medical Oncology and Hematology – recruiting
Paducah
Jewish Hospital Medical Center South – active, not recruiting
Shepherdsville
Maryland
Saint Agnes Hospital – recruiting
Baltimore
Michigan
Hickman Cancer Center – recruiting
Adrian
Toledo Clinic Cancer Centers – recruiting
Monroe
Minnesota
Mayo Clinic in Rochester – completed
Rochester
Coborn Cancer Center at Saint Cloud Hospital – recruiting
Saint Cloud
Missouri
Saint Louis Cancer and Breast Institute – recruiting
Ballwin
Central Care Cancer Center – recruiting
Bolivar
Parkland Health Center – suspended
Bonne Terre
Cox Cancer Center Branson – recruiting
Branson
Saint Francis Medical Center – recruiting
Cape Girardeau
Southeast Cancer Center – recruiting
Cape Girardeau
Saint Luke’s Hospital – recruiting
Chesterfield
Parkland Health Center – recruiting
Farmington
MU Health Care Goldschmidt Cancer Center – suspended
Jefferson City
Freeman Health System – recruiting
Joplin
Mercy Hospital Joplin – recruiting
Joplin
Lake Regional Hospital – recruiting
Osage Beach
Delbert Day Cancer Institute at PCRMC – recruiting
Rolla
Mercy Clinic-Rolla-Cancer and Hematology – recruiting
Rolla
Heartland Regional Medical Center – recruiting
Saint Joseph
Mercy Hospital Saint Louis – recruiting
Saint Louis
Mercy Hospital South – recruiting
Saint Louis
Missouri Baptist Medical Center – recruiting
Saint Louis
Saint Louis Cancer and Breast Institute-South City – recruiting
Saint Louis
Sainte Genevieve County Memorial Hospital – recruiting
Sainte Genevieve
CoxHealth South Hospital – recruiting
Springfield
Mercy Hospital Springfield – recruiting
Springfield
Missouri Baptist Sullivan Hospital – recruiting
Sullivan
BJC Outpatient Center at Sunset Hills – recruiting
Sunset Hills
Mercy Hospital Washington – recruiting
Washington
Montana
Community Hospital of Anaconda – recruiting
Anaconda
Billings Clinic Cancer Center – recruiting
Billings
Bozeman Health Deaconess Hospital – recruiting
Bozeman
Benefis Sletten Cancer Institute – recruiting
Great Falls
Great Falls Clinic – recruiting
Great Falls
Saint Peter’s Community Hospital – suspended
Helena
Kalispell Regional Medical Center – recruiting
Kalispell
Community Medical Center – recruiting
Missoula
Nebraska
Nebraska Medicine-Bellevue – recruiting
Bellevue
Nebraska Cancer Specialists/Oncology Hematology West PC – suspended
Grand Island
Heartland Hematology and Oncology – suspended
Kearney
CHI Health Good Samaritan HI Health Good Samaritan – active, not recruiting
Kearney
Saint Elizabeth Regional Medical Center – active, not recruiting
Lincoln
Alegent Health Bergan Mercy Medical Center – active, not recruiting
Omaha
Alegent Health Immanuel Medical Center – active, not recruiting
Omaha
Alegent Health Lakeside Hospital – active, not recruiting
Omaha
Creighton University Medical Center – active, not recruiting
Omaha
Hematology and Oncology Consultants PC – suspended
Omaha
Nebraska Medicine-Village Pointe – active, not recruiting
Omaha
University of Nebraska Medical Center – active, not recruiting
Omaha
Midlands Community Hospital – active, not recruiting
Papillion
New Jersey
Morristown Medical Center – recruiting
Morristown
Overlook Hospital – recruiting
Summit
New York
Garnet Health Medical Center – recruiting
Middletown
North Carolina
Southeastern Medical Oncology Center – recruiting
Clinton
Southeastern Medical Oncology Center – active, not recruiting
Goldsboro
Wayne Memorial Hospital – active, not recruiting
Goldsboro
Onslow Memorial Hospital – active, not recruiting
Jacksonville
Southeastern Medical Oncology Center – recruiting
Jacksonville
Ohio
Bethesda North Hospital – active, not recruiting
Cincinnati
Good Samaritan Hospital – active, not recruiting
Cincinnati
TriHealth Cancer Institute-Anderson – active, not recruiting
Cincinnati
TriHealth Cancer Institute-Westside – active, not recruiting
Cincinnati
MetroHealth Medical Center – active, not recruiting
Cleveland
Toledo Clinic Cancer Centers – recruiting
Maumee
Mercy Health Perrysburg Cancer Center – suspended
Perrysburg
Mercy Health – Saint Anne Hospital – suspended
Toledo
Toledo Clinic Cancer Centers – recruiting
Toledo
Oklahoma
Cancer Centers of Southwest Oklahoma Research – active, not recruiting
Lawton
Mercy Hospital Oklahoma City – recruiting
Oklahoma City
University of Oklahoma Health Sciences Center – active, not recruiting
Oklahoma City
Oklahoma Cancer Specialists and Research Institute – active, not recruiting
Tulsa
Oregon
Saint Alphonsus Medical Center-Baker City – recruiting
Baker City
Saint Alphonsus Medical Center-Ontario – recruiting
Ontario
Pennsylvania
Christiana Care Health System-Concord Health Center – active, not recruiting
Chadds Ford
Geisinger Medical Center – recruiting
Danville
Geisinger Medical Center-Cancer Center – recruiting
Hazleton
Geisinger Medical Oncology – recruiting
Lewisburg
Lewistown Hospital – recruiting
Lewistown
Geisinger Cancer Services – recruiting
Pottsville
Community Medical Center – recruiting
Scranton
Geisinger Medical Oncology – recruiting
Selinsgrove
Geisinger Medical Group – recruiting
State College
Geisinger Wyoming Valley/Henry Cancer Center – recruiting
Wilkes-Barre
South Carolina
Prisma Health Cancer Institute – Spartanburg – recruiting
Boiling Springs
Prisma Health Cancer Institute – Laurens – recruiting
Clinton
Prisma Health Cancer Institute – Easley – recruiting
Easley
BI-LO Charities Children’s Cancer Center – recruiting
Greenville
Prisma Health Cancer Institute – Butternut – recruiting
Greenville
Prisma Health Cancer Institute – Eastside – recruiting
Greenville
Prisma Health Cancer Institute – Faris – recruiting
Greenville
Prisma Health Greenville Memorial Hospital – recruiting
Greenville
Prisma Health Cancer Institute – recruiting
Greer
Prisma Health Cancer Institute – recruiting
Seneca
Tennessee
Memorial Hospital – suspended
Chattanooga
Vanderbilt-Ingram Cancer Center Cool Springs – active, not recruiting
Franklin
Pulmonary Medicine Center of Chattanooga – suspended
Hixson
Vanderbilt Breast Center at One Hundred Oaks – active, not recruiting
Nashville
Vanderbilt University/Ingram Cancer Center – active, not recruiting
Nashville
Memorial GYN Plus – suspended
Ooltewah
Texas
Saint Joseph Regional Cancer Center – active, not recruiting
Bryan
Virginia
Sovah Health Martinsville – recruiting
Martinsville
Washington
Harrison HealthPartners Hematology and Oncology – recruiting
Bremerton
Highline Medical Center-Main Campus – active, not recruiting
Burien
Saint Elizabeth Hospital – active, not recruiting
Enumclaw
Saint Francis Hospital – active, not recruiting
Federal Way
Saint Clare Hospital – active, not recruiting
Lakewood
Jefferson Healthcare – recruiting
Port Townsend
Harrison HealthPartners Hematology and Oncology – active, not recruiting
Poulsbo
Saint Michael Cancer Center – active, not recruiting
Silverdale
Franciscan Research Center-Northwest Medical Plaza – active, not recruiting
Tacoma
Northwest Medical Specialties PLLC – suspended
Tacoma
West Virginia
West Virginia University Healthcare – recruiting
Morgantown
Wisconsin
ThedaCare Regional Cancer Center – recruiting
Appleton
Marshfield Medical Center-EC Cancer Center – recruiting
Eau Claire
Mayo Clinic Health System Eau Claire Hospital-Luther Campus – completed
Eau Claire
Mayo Clinic Health System-Eau Claire Clinic – active, not recruiting
Eau Claire
Marshfield Medical Center – recruiting
Ladysmith
Marshfield Medical Center – recruiting
Marshfield
Medical College of Wisconsin – recruiting
Milwaukee
Marshfield Clinic-Minocqua Center – recruiting
Minocqua
Froedtert and MCW Moorland Reserve Health Center – recruiting
New Berlin
Marshfield Medical Center – recruiting
Rice Lake
Marshfield Medical Center-River Region at Stevens Point – recruiting
Stevens Point
Marshfield Clinic-Wausau Center – recruiting
Wausau
Marshfield Medical Center – recruiting
Weston
Marshfield Clinic – Wisconsin Rapids Center – recruiting
Wisconsin Rapids
West Virginia
West Virginia University Healthcare – recruiting
Morgantown
Wyoming
Cheyenne Regional Medical Center-West – suspended
Cheyenne
Billings Clinic – recruiting
Cody
Welch Cancer Center – recruiting
Sheridan