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

2

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

August 2028

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
Fairbanks

Arizona

CTCA at Western Regional Medical Center
Goddyear

Cancer Center at Saint Joseph’s
Phoenis

Arkansas

Mercy Hospital Fort Smith
Fort Smith

CHI Saint Vincent Cancer Center Hot Springs
Hot Springs

CARTI Cancer Center
Little Rock

California

Mission Hope Medical Oncology
Arroyo Grande

Mercy Cancer Center
Carmichael

Mercy San Juan Medical Center
Carmichael

Mercy Cancer Center
Elk Grove

Mercy Cancer Center
Merced

Mercy Cancer Center
Rocklin

Mercy Cancer Center
Sacramento

Pacific Central Coast Health Center
San Luis Obispo

Mission Hope Medical Oncology
Santa Maria

Woodland Memorial Hospital
Woodland

Colorado

Rocky Mountain Cancer Centers
Aurora

Boulder Community Foothills Hospital
Boulder

Rocky Mountain Cancer Centers
Boulder

Rocky Mountain Cancer Centers
Centennial

Penrose-Saint Francis Healthcare
Colorado Springs

Rocky Mountain Cancer Centers-Penrose
Colorado Springs

Saint Francis Cancer Center
Colorado Springs

Colorado Blood Cancer Institute
Denver

Porter Adventist Hospital
Denver

Presbyterian – Saint Lukes Medical Center – Health One
Denver

Rocky Mountain Cancer Centers-Midtown
Denver

Rocky Mountain Cancer Centers-Rose
Denver

Rose Medical Center
Denver

The Women’s Imaging Center
Denver

Mercy Medical Center
Durango

Southwest Oncology PC
Durango

Mountain Blue Cancer Care Center – Swedish
Englewood

Rocky Mountain Cancer Centers – Swedish
Englewood

Swedish Medical Center
Englewood

The Melanoma and Skin Cancer Institute
Englewood

Mountain Blue Cancer Care Center
Golden

Rocky Mountain Cancer Centers
Lakewood

Saint Anthony Hospital
Lakewood

Littleton Adventist Hospital
Littleton

Rocky Mountain Cancer Centers
Littleton

Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree

Longmont United Hospital
Longmont

Rocky Mountain Cancer Centers
Longmont

Parker Adventist Hospital
Parker

Rocky Mountain Cancer Centers
Parker

Rocky Mountain Cancer Centers
Pueblo

Saint Mary Corwin Medical Center
Pueblo

Rocky Mountain Cancer Centers
Thornton

Connecticut

Smilow Cancer Hospital-Derby Care Center
Derby

Smilow Cancer Hospital Care Center
Fairfield

Smilow Cancer Hospital Care Center
Glastonbury

Smilow Cancer Hospital Care Center
Guilford

Smilow Cancer Hospital Care Center at Saint Francis
Hartfort

Smilow Cancer Center/Yale-New Haven Hospital
New Haven

Yale University
New Haven

Yale-New Haven Hospital North Haven Medical Center
North Haven

Smilow Cancer Hospital-Torrington Care Center
Torrington

Smilow Cancer Hospital Care Center
Trumbull

Smilow Cancer Hospital-Waterbury Care Center
Waterbury

Smilow Cancer Hospital Care Center
Waterford

Delaware

Beebe South Coastal Health Campus
Frankford

Beebe Medical Center
Lewes

Christiana Care Health System-Christiana Hospital
Newark

Delaware Clinical and Laboratory Physicians PA
Newark

Helen F Graham Cancer Center
Newark

Medical Oncology Hematology Consultants PA
Newark

Beebe Health Campus
Rehoboth Beach

TidalHealth Nanticoke / Allen Cancer Center
Seaford

Christiana Care Health System-Wilmington Hospital
Wilmington


Idaho

Saint Alphonsus Cancer Care Center
Boise

Saint Alphonsus Cancer Care Center
Caldwell

Kootenai Health
Coeur d’Alene

Walter Knox Memorial Hospital
Emmett

Idaho Urologic Institute
Meridian

Saint Alphonsus Cancer Care Center
Nampa

Kootenai Clinic Cancer Services
Post Falls

Kootenai Cancer Clinic
Sandpoint

Illinois

Saint Anthony’s Health
Alton

Rush – Copley Medical Center
Aurora

Illinois CancerCare
Bloomington

Illinois CancerCare
Canton

Memorial Hospital of Carbondale
Carbondale

SIH Cancer Institute
Carterville

Illinois CancerCare
Carthage

Centralia Oncology Clinic
Centralia

Saint Mary’s Hospital
Centralia

Northwestern University
Chicago

University of Illinois
Chicago

Carle at The Riverfront
Danville

Cancer Care Specialists of Illinois
Decatur

Decatur Memorial Hospital
Decatur

Illinois CancerCare
Dixon

Carle Physician Group
Effingham

Crossroads Cancer Center
Effingham

Illinois CancerCare
Eureka

Illinois CancerCare
Galesburg

Western Illinois Cancer Treatment Center
Galesburg

Illinois CancerCare-Kewanee Clinic
Kewanee

Northwestern Medicine Lake Forest Hospital
Lake Forest

Illinois CancerCare
Macomb

Carle Physician Group-Mattoon/Charleston
Mattoon

Good Samaritan Regional Health Center
Mount Vernon

Cancer Care Center of O’Fallon
O’Fallon

Illinois CancerCare-Ottawa Clinic
Ottawa

Illinois CancerCare
Pekin

Illinois CancerCare
Peoria

Methodist Medical Center of Illinois
Peoria

Illinois CancerCare
Peru

Valley Radiation Oncology
Peru

Illinois CancerCare
Princeton

Memorial Medical Center
Springfield

Southern Illinois University School of Medicine
Springfield

Springfield Clinic
Springfield

Southwest Illinois Health Services LLP
Swansea

Carle Cancer Center
Urbana

The Carle Foundation Hospital
Urbana

Illinois CancerCare
Washington

Rush-Copley Healthcare Center
Yorkville

Iowa

Mary Greeley Medical Center
Ames

McFarland Clinic
Ames

Mission Cancer and Blood
Ankeny

McFarland Clinic
Boone

Saint Anthony Regional Hospital
Carroll

Mercy Cancer Center-West Lakes
Clive

Mission Cancer and Blood – West Des Moines
Clive

Alegent Health Mercy Hospital
Council Bluffs

Greater Regional Medical Center
Creston

Broadlawns Medical Center
Des Moines

Iowa Lutheran Hospital
Des Moines

Iowa Methodist Medical Center
Des Moines

Mercy Medical Center
Des Moines

Mission Cancer and Blood
Des Moines

Mission Cancer and Blood – Laurel
Des Moines

McFarland Clinic – Trinity Cancer Center
Fort Dodge

Trinity Regional Medical Center
Fort Dodge

McFarland Clinic
Jeffersion

McFarland Clinic
Marshalltown

Mercy Medical Center-West Lakes
West Des Moines

Methodist West Hospital
West Des Moines


Kansas

Central Care Cancer Center
Garden City

Central Care Cancer Center
Great Bend

Lawrence Memorial Hospital
Lawrence

Ascension Via Christi Hospitals Wichita
Wichita

Cancer Center of Kansas
Wichita

Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita

Wesley Medical Center
Wichita

Kentucky

Flaget Memorial Hospital
Bardstown

Commonwealth Cancer Center
Corbin

Saint Joseph Hospital
Lexington

Saint Joseph Hospital East
Lexington

Saint Joseph Radiation Oncology Resource Center
Lexington

Saint Joseph London
London

Jewish Hospital
Louisville

Saints Mary and Elizabeth Hospital
Louisville

UofL Health Medical Center Northeast
Louisville

Saint Joseph Mount Sterling
Mount Sterling

Mercy Health – Paducah Medical Oncology and Hematology
Paducah

Jewish Hospital Medical Center South
Shepherdsville

Maryland

Saint Agnes Hospital
Baltimore

Michigan

Hickman Cancer Center
Adrian

Toledo Clinic Cancer Centers
Monroe

Minnesota

Mayo Clinic in Rochester
Rochester

Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud

Missouri

Saint Louis Cancer and Breast Institute
Ballwin

Central Care Cancer Center
Bolivar

Parkland Health Center
Bonne Terre

Cox Cancer Center Branson
Branson

Saint Francis Medical Center
Cape Girardeau

Southeast Cancer Center
Cape Girardeau

Saint Luke’s Hospital
Chesterfield

Parkland Health Center
Farmington

MU Health Care Goldschmidt Cancer Center
Jefferson City

Freeman Health System
Joplin

Mercy Hospital Joplin
Joplin

Lake Regional Hospital
Osage Beach

Delbert Day Cancer Institute at PCRMC
Rolla

Mercy Clinic-Rolla-Cancer and Hematology
Rolla

Heartland Regional Medical Center
Saint Joseph

Mercy Hospital Saint Louis
Saint Louis

Mercy Hospital South
Saint Louis

Missouri Baptist Medical Center
Saint Louis

Saint Louis Cancer and Breast Institute-South City
Saint Louis

Sainte Genevieve County Memorial Hospital
Sainte Genevieve

CoxHealth South Hospital
Springfield

Mercy Hospital Springfield
Springfield

Missouri Baptist Sullivan Hospital
Sullivan

BJC Outpatient Center at Sunset Hills
Sunset Hills

Mercy Hospital Washington
Washington

Montana

Community Hospital of Anaconda
Anaconda

Billings Clinic Cancer Center
Billings

Bozeman Health Deaconess Hospital
Bozeman

Benefis Sletten Cancer Institute
Great Falls

Great Falls Clinic
Great Falls

Saint Peter’s Community Hospital
Helena

Kalispell Regional Medical Center
Kalispell

Community Medical Center
Missoula

North Carolina

Southeastern Medical Oncology Center
Clinton

Southeastern Medical Oncology Center
Goldsboro

Wayne Memorial Hospital
Goldsboro

Onslow Memorial Hospital
Jacksonville

Southeastern Medical Oncology Center
Jacksonville

Nebraska

Nebraska Medicine
Bellevue

Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island

CHI Health Good Samaritan
Kearney

Heartland Hematology and Oncology
Kearney

Saint Elizabeth Regional Medical Center
Lincoln

Alegent Health Bergan Mercy Medical Center
Omaha

Alegent Health Immanuel Medical Center
Omaha

Alegent Health Lakeside Hospital
Omaha

Creighton University Medical Center
Omaha

Hematology and Oncology Consultants PC
Omaha

Nebraska Medicine-Village Pointe
Omaha

University of Nebraska Medical Center
Omaha

Midlands Community Hospital
Papillion

New Jersey

Morristown Medical Center
Morristown

Overlook Hospital
Summit

New York

Garnet Health Medical Center
Middletown

Ohio

Bethesda North Hospital
Cincinnati

Good Samaritan Hospital
Cincinnati

TriHealth Cancer Institute-Anderson
Cincinnati

TriHealth Cancer Institute-Westside
Cincinnati

MetroHealth Medical Center
Cleveland

Toledo Clinic Cancer Centers
Maumee

Mercy Health Perrysburg Cancer Center
Perrysburg

Mercy Health – Saint Anne Hospital
Toledo

Toledo Clinic Cancer Centers
Toledo

Oklahoma

Cancer Centers of Southwest Oklahoma Research
Lastwon

Mercy Hospital Oklahoma City
Oklahoma City

University of Oklahoma Health Sciences Center
Oklahoma City

Oklahoma Cancer Specialists and Research Institute
Tulsa

Oregon

Saint Alphonsus Medical Center-Baker City
Baker City

Saint Alphonsus Medical Center-Ontario
Ontario

Pennsylvania

Christiana Care Health System-Concord Health Center
Chadds Ford

Geisinger Medical Center
Danville

Geisinger Medical Center-Cancer Center
Hazleton

Geisinger Medical Oncology
Lewisburg

Lewistown Hospital
Lewistown

Geisinger Cancer Services
Pottsville

Community Medical Center
Scranton

Geisinger Medical Oncology
Selinsgrove

Geisinger Medical Group
State College

Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre

South Carolina

Prisma Health Cancer Institute – Spartanburg
Boiling Springs

Prisma Health Cancer Institute – Laurens
Clinton

Prisma Health Cancer Institute – Easley
Easley

BI-LO Charities Children’s Cancer Center
Greenville

Prisma Health Cancer Institute – Butternut
Greenville

Prisma Health Cancer Institute – Eastside
Greenville

Prisma Health Cancer Institute – Faris
Greenville

Prisma Health Greenville Memorial Hospital
Greenville

Prisma Health Cancer Institute
Greer

Prisma Health Cancer Institute
Seneca

Tennessee

Memorial Hospital
Chattanooga

Vanderbilt-Ingram Cancer Center Cool Springs
Franklin

Pulmonary Medicine Center of Chattanooga
Hixson

Vanderbilt Breast Center at One Hundred Oaks
Nashville

Vanderbilt University/Ingram Cancer Center
Nashville

Memorial GYN Plus
Ooltewah

Texas

Saint Joseph Regional Cancer Center
Bryan

Virginia

Sovah Health Martinsville
Martinsville

Washington