Blood Cancer

EA9171 / BLAST MRD CML 1



Testing Pembrolizumab with Existing Cancer Therapy in Patients with Evidence of Residual Chronic Myelogenous Leukemia

STATUS: Active


This phase II trial studies how well pembrolizumab and dasatinib, imatinib mesylate, nilotinib, or bosutinib work in treating patients with chronic myeloid leukemia and persistent detection of minimal residual disease, defined as the levels of a gene product called bcr-abl in the blood. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the bodyโ€™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.
  • PREREGISTRATION (STEP 0): NOTE: Following consent and preregistration to Step 0, peripheral blood must be collected for submission to Fred Hutchinson Cancer Research Center for central assessment of the establishment of BCR/ABL status to confirm patientโ€™s eligibility for registration to Step 1; Fred Hutchinson will typically forward results within 1-2 business days of receipt of the peripheral blood to the submitting institution

  • PREREGISTRATION (STEP 0): Patient must be >= 18 years of age

  • PREREGISTRATION (STEP 0): Patient must have pathologically-confirmed chronic phase-CML by one of the following the following criteria: * Patient has been in CCyR by FISH karyotype or PCR and with detectable BCR/ABL transcript by a standard real-time quantitative polymerase chain reaction RQ-PCR (equal or less than 1% or MR^2) assay for at least 12 months from the first documentation of the CCyr * Patient has not maintained MR^4.5 (CMR) after initiation of last line TKI therapy; patient can have intermittent values of CMR (at or below MR^4.5); however the patient has to have detectable disease (i.e. cannot be in CMR) in the last one assessment before pre-registration to Step 0 AND Patient must have a diagnosis of chronic phase-CML and MMR status and BCR/ABL results meets the criteria within 21 days after consenting and pre-registration to Step 0. A bone marrow biopsy prior to enrollment is not required * NOTE: Please be aware of the required timeframe restrictions; patients are required to enroll on Step 1 within 21 days from the date of consenting (step 0, pre-registration)

  • PREREGISTRATION (STEP 0): Patients with diagnoses of accelerated or blast phase CML are not eligible

  • PREREGISTRATION (STEP 0): Patient has been on TKI therapy (first, second, and third line line) for at least 2 years (starting from when first TKI was initiated) prior to step 0 pre-registration * Allowed TKIs include: ** Dasatinib: 50 โ€“ 180 mg per day ** Imatinib: 200 โ€“ 800 mg per day ** Nilotinib: 200 โ€“ 400 mg every 12-24 hours ** Bosutinib: 200 โ€“ 500 mg per day * Patients must have been on a stable dose of the current TKI for at least 3 months prior to start of EA9171 study therapy

  • PREREGISTRATION (STEP 0): Patient must not have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent

  • PREREGISTRATION (STEP 0): Patients must not have received a prior allogeneic transplant

  • REGISTRATION TO TREATMENT (STEP 1): Institution must have received central BCR-ABL test results confirming MRD positive status with detectable level above CMR (0.0032%) but at or below 1% level

  • REGISTRATION TO TREATMENT (STEP 1): Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

  • REGISTRATION TO TREATMENT (STEP 1): The BCR/ABL status must meet the criteria within 21 days prior to Step 1 registration. A bone marrow aspirate and/or biopsy prior to registration is not mandatory

  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have any active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment; patients who have a positive Coombs test but no evidence of hemolysis are NOT excluded from participation

  • REGISTRATION TO TREATMENT (STEP 1): Patient must not receive any corticosteroids from the time of consent to step 1 registration * EXCEPTION: Low doses of steroids (< 10 mg of prednisone or equivalent dose of other steroid) used for treatment of non-hematologic medical condition (e.g. chronic adrenal insufficiency) is permitted

  • REGISTRATION TO TREATMENT (STEP 1): Patients must not be pregnant or breastfeeding due to the potential for congenital abnormalities and of harm to nursing infants due to the treatment regimens used; all patients of childbearing potential must have a negative urine or serum pregnancy test within 14 days prior to Step 1 registration to rule out pregnancy; a urine or serum pregnancy test must be repeated within 72 hours prior to receiving the first dose of pembrolizumab if the test done for eligibility/registration to step 1 is done outside of this 72 hour window; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; a patient of childbearing potential is defined as anyone, 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)

  • REGISTRATION TO TREATMENT (STEP 1): Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sex from the time of step 1 registration, while on study treatment, and continue for 120 days after the last dose of study treatment

  • REGISTRATION TO TREATMENT (STEP 1): Patient may not be currently participating and receiving study therapy or have participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to step 1 registration

  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have a diagnosis of immunodeficiency or be receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment

  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have a known history of active TB (Bacillus tuberculosis)

  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have a history of hypersensitivity to pembrolizumab or any of its excipients

  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have received a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to step 1 registration or have not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier

  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have had prior chemotherapy, targeted small molecule therapy (aside from imatinib, dasatinib, bosutinib or nilotinib), or radiation therapy within 2 weeks prior to registration to step 1; patients also must have recovered from all adverse events due to a previously administered agent * Note: Patients with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study * NOTE: Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis; a 1-week washout is permitted for palliative radiation (=< 2 weeks of radiotherapy) to non-central nervous system [CNS] disease)

  • REGISTRATION TO TREATMENT (STEP 1): Patients who have received major surgery must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy

  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have a known primary or additional malignancy that is progressing or requires active treatment or limiting expected survival to =< 2 years; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer * NOTE: If there is a history of prior malignancy, the patient must not be receiving other specific treatment (other than hormonal therapy for their cancer)

  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of protocol treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to protocol treatment; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability

  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment

  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have known history of, or any evidence of active, non-infectious pneumonitis

  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have an active infection requiring systemic therapy

  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subjectโ€™s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator

  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study

  • REGISTRATION TO TREATMENT (STEP 1): Patients who are human immunodeficiency virus (HIV) positive are eligible if they have undetectable HIV viral load and CD4+ T-cell count >= 250/mm^3

  • REGISTRATION TO TREATMENT (STEP 1): Patients with a known positive test for hepatitis C virus ribonucleic acid (hepatitis C virus [HCV] antibody) indicating acute or chronic infection may be enrolled if the viral load by polymerase chain reaction (PCR) is undetectable with/without active treatment

  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive)

  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have received a live vaccine within 30 days prior to step 1 registration * NOTE: Live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Patients are permitted to receive inactivated vaccines and non-live vaccines including those for the seasonal influenza and COVID-19 (Note: intranasal influenza vaccines, such as Flu-Mist) are live attenuated vaccines, and are not allowed). If possible, it is recommended to separate study drug administration from vaccine administration by about a week (primarily, in order to minimize an overlap of adverse events)

  • REGISTRATION TO TREATMENT (STEP 1): Absolute neutrophil count (ANC) >= 1,500 /mcL (within 14 days prior registration)

  • REGISTRATION TO TREATMENT (STEP 1): Platelet count >= 100,000 /mcL (within 14 days prior to registration)

  • REGISTRATION TO TREATMENT (STEP 1): Hemoglobin (Hgb) >= 9.0 g/dL OR >= 5.6 mmol/L without transfusion of erythropoietin (EPO) dependency (within 14 days prior to registration)

  • REGISTRATION TO TREATMENT (STEP 1): Serum creatinine =< 1.5 X upper limit of normal (ULN) OR creatinine clearance (per institutional standards) >= 60 mL/min for patients with creatinine levels > 1.5 X ULN (within 14 days prior to registration)

  • REGISTRATION TO TREATMENT (STEP 1): Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 X ULN (within 14 days prior to registration)

  • REGISTRATION TO TREATMENT (STEP 1): Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases (within 14 days prior to registration)

  • REGISTRATION TO TREATMENT (STEP 1): Patients should not be receiving concomitant strong CYP3A4 inducers or inhibitors =< 7 days prior to step 1 registration due to their potential to effect the activity or pharmacokinetics of study agents and/or QT interval prolongation toxicity; should treatment with any of these agents be required, consult with study chair and reference section for TKI dose modifications related to concomitant drugs

  • REGISTRATION TO TREATMENT (STEP 1): Patients who received prior allogeneic transplant are not eligible

  • REGISTRATION TO TREATMENT (STEP 2): Institution must have received central BCR-ABL test results confirming MRD positive status at cycle 17 following Step 1 treatment (CCyR or deeper but not in CMR in the last two central lab checks before Step 2) * NOTE: Pembrolizumab therapy will be delayed if second consecutive BCR-ABL test is performed after end of treatment on Step 1

  • REGISTRATION TO TREATMENT (STEP 2): Patients must have an ECOG performance status of 0-1

  • REGISTRATION TO TREATMENT (STEP 2): Patient must have no active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment; patients who have a positive Coombs test but no evidence of hemolysis are NOT excluded from participation

  • REGISTRATION TO TREATMENT (STEP 2): No current use of corticosteroids at any point of the trial including within 30 days prior to Step 1 registration. EXCEPTION: Low doses of steroids (< 10 mg of prednisone or equivalent dose of other steroid) used for treatment of non-hematologic medical condition (e.g., chronic adrenal insufficiency) is permitted

  • REGISTRATION TO TREATMENT (STEP 2): Patient must not have any other active primary malignancy (other than non-melanomatous skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting expected survival to =< 2 years; NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy for their cancer)

  • REGISTRATION TO TREATMENT (STEP 2): Patient must not have a diagnosis of immunodeficiency or be receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment

  • REGISTRATION TO TREATMENT (STEP 2): Patient must not have a known history of active TB (Bacillus tuberculosis)

  • REGISTRATION TO TREATMENT (STEP 2): Patient must not have a history of hypersensitivity to pembrolizumab or any of its excipients

  • REGISTRATION TO TREATMENT (STEP 2): Patients must not be pregnant or breastfeeding due to the potential for congenital abnormalities and of harm to nursing infants due to the treatment regimens used; all patients of childbearing potential must have a negative urine or serum pregnancy within 14 days prior to registration on step 2 to rule out pregnancy; a urine or serum pregnancy test must be repeated within 72 hours prior to receiving the first dose of pembrolizumab on step 2 if the test done for eligibility/registration to Step 2 is done outside of this 72 hour window; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; a patient 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)

  • REGISTRATION TO TREATMENT (STEP 2): Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sex from the time of step 2 registration, while on study treatment, and continue for 120 days after the last dose of study treatment

  • REGISTRATION TO TREATMENT (STEP 2): Patient must not have known history of, or any evidence of active, non-infectious pneumonitis

  • REGISTRATION TO TREATMENT (STEP 2): Patient must not have an active infection requiring systemic therapy

  • REGISTRATION TO TREATMENT (STEP 2): Patient must not have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patientsโ€™s participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator

  • REGISTRATION TO TREATMENT (STEP 2): Patients who are human immunodeficiency virus (HIV) positive are eligible if they have undetectable HIV viral load and CD4+ T-cell count >= 250/mm^3

  • REGISTRATION TO TREATMENT (STEP 2): Patient with a known positive test for hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection might be enrolled if the viral load by PCR is undetectable with/without active treatment

  • REGISTRATION TO TREATMENT (STEP 2): Patients must not have a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive)

  • REGISTRATION TO TREATMENT (STEP 2): Patient must not have received a live vaccine within 30 days of planned start of study therapy; NOTE: Live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Patients are permitted to receive inactivated vaccines and any non-live vaccines including those for the seasonal influenza and COVID-19 (Note: intranasal influenza vaccines, such as Flu-Mist are live attenuated vaccines and are not allowed). If possible, it is recommended to separate study drug administration from vaccine administration by about a week (primarily, in order to minimize an overlap of adverse events)

  • REGISTRATION TO TREATMENT (STEP 2): Absolute neutrophil count (ANC) >= 1,500 /mcL (within 14 days prior to registration)

  • REGISTRATION TO TREATMENT (STEP 2): Platelet count >= 100,000 /mcL (within 14 days prior to registration)

  • REGISTRATION TO TREATMENT (STEP 2): Hgb >= 9.0 g/dL OR >= 5.6 mmol/L without transfusion of EPO dependency (within 14 days prior to registration)

  • REGISTRATION TO TREATMENT (STEP 2): Serum creatinine =< 1.5 X upper limit of normal (ULN) OR creatinine clearance (per institutional standards) >= 60 mL/min for patients with creatinine levels > 1.5 X ULN (within 14 days prior to registration)

  • REGISTRATION TO TREATMENT (STEP 2): Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 X ULN (within 14 days prior to registration)

  • REGISTRATION TO TREATMENT (STEP 2): AST (SGOT) and ALT (SGPT) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases (within 14 days prior to registration)

  • REGISTRATION TO TREATMENT (STEP 2): Patients should not be receiving concomitant strong CYP3A4 inducers or inhibitors =< 7 days prior to step 2 registration due to their potential to effect the activity or pharmacokinetics of study agents and/or QT interval prolongation toxicity; should treatment with any of these agents be required, consult with study chair and reference section for TKI dose modifications related to concomitant drugs

United States
AK
Fairbanks
Fairbanks Memorial Hospital
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Email: Veronica.Stevenson@foundationhealth.org

AR
Ft. Smith
Mercy Hospital Fort Smith
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Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
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AZ
Goodyear
CTCA at Western Regional Medical Center
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Phoenix
Cancer Center at Saint Joseph's
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Email: CancerInstitute@DignityHealth.org

CA
Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
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Email: ResearchInstituteInquiries@CommonSpirit.org

Carmichael
Mercy Cancer Center ๏ฟฝ๏ฟฝ Carmichael
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Email: ecog.rss@jimmy.harvard.edu

Mercy San Juan Medical Center
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Email: OncologyResearch@DignityHealth.org

Elk Grove
Mercy Cancer Center - Elk Grove
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Email: OncologyResearch@DignityHealth.org

Rocklin
Mercy Cancer Center - Rocklin
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Email: OncologyResearch@DignityHealth.org

Sacramento
Mercy Cancer Center - Sacramento
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Email: OncologyResearch@DignityHealth.org

San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
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Email: ResearchInstituteInquiries@CommonSpirit.org

Santa Maria
Mission Hope Medical Oncology - Santa Maria
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Woodland
Woodland Memorial Hospital
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Email: OncologyResearch@DignityHealth.org

CO
Aurora
Rocky Mountain Cancer Centers-Aurora
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Email: info@westernstatesncorp.org

Boulder
Boulder Community Foothills Hospital
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Rocky Mountain Cancer Centers-Boulder
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Centennial
Rocky Mountain Cancer Centers - Centennial
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Email: info@westernstatesncorp.org

Colorado Springs
Penrose-Saint Francis Healthcare
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Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Penrose
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Email: ResearchTracking@Centura.Org

Saint Francis Cancer Center
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Denver
Colorado Blood Cancer Institute
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Porter Adventist Hospital
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Email: ResearchTracking@Centura.Org

Presbyterian - Saint Lukes Medical Center - Health One
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Rocky Mountain Cancer Centers-Midtown
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Rocky Mountain Cancer Centers-Rose
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Rose Medical Center
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Email: ccrp@co-cancerresearch.org

The Women's Imaging Center
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Durango
Mercy Medical Center
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Southwest Oncology PC
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Englewood
Mountain Blue Cancer Care Center - Swedish
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Rocky Mountain Cancer Centers - Swedish
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Swedish Medical Center
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The Melanoma and Skin Cancer Institute
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Email: ryan.weight@theskincancerinstitute.com

Golden
Mountain Blue Cancer Care Center
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Email: clinicaltrials@sfmc-gi.org

Lakewood
Rocky Mountain Cancer Centers-Lakewood
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Email: info@westernstatesncorp.org

Saint Anthony Hospital
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Email: ResearchTracking@Centura.Org

Littleton
Littleton Adventist Hospital
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Rocky Mountain Cancer Centers-Littleton
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Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
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Longmont
Longmont United Hospital
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Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Longmont
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Parker
Parker Adventist Hospital
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Rocky Mountain Cancer Centers-Parker
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Email: info@westernstatesncorp.org

Pueblo
Rocky Mountain Cancer Centers - Pueblo
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Saint Mary Corwin Medical Center
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Thornton
Rocky Mountain Cancer Centers-Thornton
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Email: info@westernstatesncorp.org

CT
Derby
Smilow Cancer Hospital-Derby Care Center
Contact: Site Public Contact
Email: canceranswers@yale.edu

Fairfield
Smilow Cancer Hospital Care Center-Fairfield
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Email: canceranswers@yale.edu

Glastonbury
Smilow Cancer Hospital Care Center at Glastonbury
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Email: canceranswers@yale.edu

Guilford
Smilow Cancer Hospital Care Center - Guilford
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Email: canceranswers@yale.edu

Hartford
Smilow Cancer Hospital Care Center at Saint Francis
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Email: canceranswers@yale.edu

New Haven
Smilow Cancer Center/Yale-New Haven Hospital
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Email: canceranswers@yale.edu

Yale University
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Email: canceranswers@yale.edu

North Haven
Yale-New Haven Hospital North Haven Medical Center
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Email: canceranswers@yale.edu

Torrington
Smilow Cancer Hospital-Torrington Care Center
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Email: canceranswers@yale.edu

Trumbull
Smilow Cancer Hospital Care Center-Trumbull
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Email: canceranswers@yale.edu

Waterbury
Smilow Cancer Hospital-Waterbury Care Center
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Email: canceranswers@yale.edu

Waterford
Smilow Cancer Hospital Care Center - Waterford
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Email: canceranswers@yale.edu

DE
Frankford
Beebe South Coastal Health Campus
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Email: research@beebehealthcare.org

Lewes
Beebe Medical Center
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Email: research@beebehealthcare.org

Newark
Christiana Care Health System-Christiana Hospital
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Email: lbarone@christianacare.org

Delaware Clinical and Laboratory Physicians PA
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Email: mhayden@christianacare.org

Helen F Graham Cancer Center
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Email: lbarone@christianacare.org

Medical Oncology Hematology Consultants PA
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Email: lbarone@christianacare.org

Rehoboth Beach
Beebe Health Campus
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Email: research@beebehealthcare.org

Seaford
TidalHealth Nanticoke / Allen Cancer Center
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Email: anna-maria.howard@peninsula.org

Wilmington
Christiana Care Health System-Wilmington Hospital
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Email: lbarone@christianacare.org

IA
Ames
Mary Greeley Medical Center
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McFarland Clinic PC - Ames
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Email: ksoder@mcfarlandclinic.com

Boone
McFarland Clinic PC-Boone
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Carroll
Saint Anthony Regional Hospital
Contact: Site Public Contact
Email: sbenson@iora.org

Clive
Medical Oncology and Hematology Associates-West Des Moines
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Mercy Cancer Center-West Lakes
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Email: cancerresearch@mercydesmoines.org

Council Bluffs
Alegent Health Mercy Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org

Creston
Greater Regional Medical Center
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Email: cancerresearch@mercydesmoines.org

Des Moines
Broadlawns Medical Center
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Iowa Lutheran Hospital
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Iowa Methodist Medical Center
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Medical Oncology and Hematology Associates-Des Moines
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Mercy Medical Center - Des Moines
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Email: cancerresearch@mercydesmoines.org

Mission Cancer and Blood - Laurel
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Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
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Trinity Regional Medical Center
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Jefferson
McFarland Clinic PC-Jefferson
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Marshalltown
McFarland Clinic PC-Marshalltown
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West Des Moines
Mercy Medical Center-West Lakes
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Email: cancerresearch@mercydesmoines.org

Methodist West Hospital
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ID
Boise
Saint Alphonsus Cancer Care Center-Boise
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Coeur D'Alene
Kootenai Health - Coeur d'Alene
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Email: mccinfo@mtcancer.org

Emmett
Walter Knox Memorial Hospital
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Email: stephanie.couch@stjoeshealth.org

Meridian
Idaho Urologic Institute-Meridian
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Email: stephanie.couch@stjoeshealth.org

Nampa
Saint Alphonsus Cancer Care Center-Nampa
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Email: mccinfo@mtcancer.org

Post Falls
Kootenai Clinic Cancer Services - Post Falls
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Email: mccinfo@mtcancer.org

Sandpoint
Kootenai Cancer Clinic
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Email: mccinfo@mtcancer.org

IL
Alton
Saint Anthony's Health
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Aurora
Rush - Copley Medical Center
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Email: Cancer.Research@rushcopley.com

Bloomington
Illinois CancerCare-Bloomington
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Email: andersonj@illinoiscancercare.com

Canton
Illinois CancerCare-Canton
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Email: andersonj@illinoiscancercare.com

Carbondale
Memorial Hospital of Carbondale
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Email: clinical.research@sih.net

Carterville
SIH Cancer Institute
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Email: clinical.research@sih.net

Carthage
Illinois CancerCare-Carthage
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Email: andersonj@illinoiscancercare.com

Centralia
Centralia Oncology Clinic
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Email: morganthaler.jodi@mhsil.com

Saint Mary's Hospital
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Email: ecog.rss@jimmy.harvard.edu

Chicago
Northwestern University
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Email: cancer@northwestern.edu

University of Illinois
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Danville
Carle at The Riverfront
Contact: Site Public Contact
Email: Research@Carle.com

Decatur
Cancer Care Specialists of Illinois - Decatur
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Dixon
Illinois CancerCare-Dixon
Contact: Site Public Contact

Effingham
Carle Physician Group-Effingham
Contact: Site Public Contact
Email: Research@carle.com

Crossroads Cancer Center
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Eureka
Illinois CancerCare-Eureka
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Galesburg
Illinois CancerCare-Galesburg
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
Contact: Site Public Contact

Kewanee
Illinois CancerCare-Kewanee Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Lake Forest
Northwestern Medicine Lake Forest Hospital
Contact: Site Public Contact
Email: cancertrials@northwestern.edu

Macomb
Illinois CancerCare-Macomb
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Mattoon
Carle Physician Group-Mattoon/Charleston
Contact: Site Public Contact
Email: Research@carle.com

Mount Vernon
Good Samaritan Regional Health Center
Contact: Site Public Contact

O'Fallon
Cancer Care Center of O'Fallon
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Ottawa
Illinois CancerCare-Ottawa Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Pekin
Illinois CancerCare-Pekin
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peoria
Illinois CancerCare-Peoria
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peru
Illinois CancerCare-Peru
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Valley Radiation Oncology
Contact: Site Public Contact

Princeton
Illinois CancerCare-Princeton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Springfield
Memorial Medical Center
Contact: Site Public Contact
Email: pallante.beth@mhsil.com

Southern Illinois University School of Medicine
Contact: Site Public Contact

Springfield Clinic
Contact: Site Public Contact

Swansea
Southwest Illinois Health Services LLP
Contact: Site Public Contact
Email: lynns@thecancercenter.com

Urbana
Carle Cancer Center
Contact: Site Public Contact
Email: Research@carle.com

The Carle Foundation Hospital
Contact: Site Public Contact
Email: Research@carle.com

Washington
Illinois CancerCare - Washington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Yorkville
Rush-Copley Healthcare Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

KS
Garden City
Central Care Cancer Center - Garden City
Contact: Site Public Contact
Email: aroland@kccop.org

Great Bend
Central Care Cancer Center - Great Bend
Contact: Site Public Contact
Email: aroland@kccop.org

Lawrence
Lawrence Memorial Hospital
Contact: Site Public Contact
Email: Stephanie.Norris@LMH.ORG

Wichita
Ascension Via Christi Hospitals Wichita
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Cancer Center of Kansas - Wichita
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Cancer Center of Kansas-Wichita Medical Arts Tower
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Wesley Medical Center
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

KY
Bardstown
Flaget Memorial Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Corbin
Commonwealth Cancer Center-Corbin
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Lexington
Saint Joseph Hospital
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Saint Joseph Hospital East
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Radiation Oncology Resource Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

London
Saint Joseph London
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Louisville
Jewish Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Saints Mary and Elizabeth Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

UofL Health Medical Center Northeast
Contact: Site Public Contact
Email: ctoinfo@louisville.edu

Mount Sterling
Saint Joseph Mount Sterling
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Paducah
Mercy Health - Paducah Medical Oncology and Hematology
Contact: Site Public Contact
Email: BJWarner@mercy.com

Shepherdsville
Jewish Hospital Medical Center South
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

MD
Baltimore
Saint Agnes Hospital
Contact: Site Public Contact

MI
Adrian
Hickman Cancer Center
Contact: Site Public Contact

Monroe
Toledo Clinic Cancer Centers-Monroe
Contact: Site Public Contact

MN
Rochester
Mayo Clinic in Rochester
Contact: Site Public Contact

Saint Cloud
Coborn Cancer Center at Saint Cloud Hospital
Contact: Site Public Contact
Email: coborncancercenter@centracare.com

MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Contact: Site Public Contact

Bolivar
Central Care Cancer Center - Bolivar
Contact: Site Public Contact
Email: aroland@kccop.org

Bonne Terre
Parkland Health Center-Bonne Terre
Contact: Site Public Contact

Branson
Cox Cancer Center Branson
Contact: Site Public Contact

Cape Girardeau
Saint Francis Medical Center
Contact: Site Public Contact
Email: sfmc@sfmc.net

Southeast Cancer Center
Contact: Site Public Contact

Chesterfield
Saint Luke's Hospital
Contact: Site Public Contact

Farmington
Parkland Health Center - Farmington
Contact: Site Public Contact

Jefferson City
Capital Region Southwest Campus
Contact: Site Public Contact
Email: swooden@mail.crmc.org

Joplin
Freeman Health System
Contact: Site Public Contact
Email: LJCrockett@freemanhealth.com

Mercy Hospital Joplin
Contact: Site Public Contact
Email: esmeralda.carrillo@mercy.net

Rolla
Delbert Day Cancer Institute at PCRMC
Contact: Site Public Contact
Email: research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
Contact: Site Public Contact

Saint Joseph
Heartland Regional Medical Center
Contact: Site Public Contact
Email: linda.schumacher@mymlc.com

Saint Louis
Mercy Hospital Saint Louis
Contact: Site Public Contact

Mercy Hospital South
Contact: Site Public Contact
Email: janet.lesko@mercy.net

Missouri Baptist Medical Center
Contact: Site Public Contact

Saint Louis Cancer and Breast Institute-South City
Contact: Site Public Contact

Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Contact: Site Public Contact

Springfield
CoxHealth South Hospital
Contact: Site Public Contact

Mercy Hospital Springfield
Contact: Site Public Contact

Sullivan
Missouri Baptist Sullivan Hospital
Contact: Site Public Contact

Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Contact: Site Public Contact

Washington
Mercy Hospital Washington
Contact: Site Public Contact

MT
Anaconda
Community Hospital of Anaconda
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Billings
Billings Clinic Cancer Center
Contact: Site Public Contact
Email: research@billingsclinic.org

Bozeman
Bozeman Deaconess Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls
Benefis Healthcare- Sletten Cancer Institute
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls Clinic
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Helena
Saint Peter's Community Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Kalispell
Kalispell Regional Medical Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Missoula
Community Medical Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

NC
Clinton
Southeastern Medical Oncology Center-Clinton
Contact: Site Public Contact
Email: jfields@cancersmoc.com

Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Contact: Site Public Contact
Email: jfields@cancersmoc.com

Wayne Memorial Hospital
Contact: Site Public Contact
Email: ecooke@cancersmoc.com

Jacksonville
Onslow Memorial Hospital
Contact: Site Public Contact
Email: ecooke@cancersmoc.com

Southeastern Medical Oncology Center-Jacksonville
Contact: Site Public Contact
Email: jfields@cancersmoc.com

NE
Bellevue
Nebraska Medicine-Bellevue
Contact: Site Public Contact
Email: unmcrsa@unmc.edu

Grand Island
CHI Health Saint Francis
Contact: Site Public Contact

Kearney
CHI Health Good Samaritan
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Heartland Hematology and Oncology
Contact: Site Public Contact

Lincoln
Saint Elizabeth Regional Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Omaha
Alegent Health Bergan Mercy Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Immanuel Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Lakeside Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Creighton University Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Hematology and Oncology Consultants PC
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

Nebraska Medicine-Village Pointe
Contact: Site Public Contact

University of Nebraska Medical Center
Contact: Site Public Contact
Email: unmcrsa@unmc.edu

Papillion
Midlands Community Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

NJ
Morristown
Morristown Medical Center
Contact: Site Public Contact

Summit
Overlook Hospital
Contact: Site Public Contact

NY
Middletown
Garnet Health Medical Center
Contact: Site Public Contact
Email: jgerlach@garnethealth.org

OH
Cincinnati
Bethesda North Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Good Samaritan Hospital - Cincinnati
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Anderson
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Westside
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Cleveland
MetroHealth Medical Center
Contact: Site Public Contact
Email: dstrater@metrohealth.org

Maumee
Toledo Clinic Cancer Centers-Maumee
Contact: Site Public Contact
Email: pshoup@toledoclinic.com

Perrysburg
Mercy Health Perrysburg Cancer Center
Contact: Site Public Contact
Email: sheree@columbusccop.org

Toledo
Mercy Health - Saint Anne Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org

Toledo Clinic Cancer Centers-Toledo
Contact: Site Public Contact

OK
Lawton
Cancer Centers of Southwest Oklahoma Research
Contact: Site Public Contact

Oklahoma City
Mercy Hospital Oklahoma City
Contact: Site Public Contact

University of Oklahoma Health Sciences Center
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu

Tulsa
Oklahoma Cancer Specialists and Research Institute-Tulsa
Contact: Site Public Contact

OR
Baker City
Saint Alphonsus Medical Center-Baker City
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Ontario
Saint Alphonsus Medical Center-Ontario
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

PA
Chadds Ford
Christiana Care Health System-Concord Health Center
Contact: Site Public Contact
Email: lbarone@christianacare.org

Danville
Geisinger Medical Center
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Hazleton
Geisinger Medical Center-Cancer Center Hazleton
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Lewisburg
Geisinger Medical Oncology-Lewisburg
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Lewistown
Lewistown Hospital
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Pottsville
Geisinger Cancer Services-Pottsville
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Scranton
Community Medical Center
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Selinsgrove
Geisinger Medical Oncology-Selinsgrove
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

State College
Geisinger Medical Group
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Wilkes-Barre
Geisinger Wyoming Valley/Henry Cancer Center
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

SC
Boiling Springs
Prisma Health Cancer Institute - Spartanburg
Contact: Site Public Contact

Clinton
Prisma Health Cancer Institute - Laurens
Contact: Site Public Contact

Easley
Prisma Health Cancer Institute - Easley
Contact: Site Public Contact
Email: Kim.Williams3@prismahealth.org

Greenville
BI-LO Charities Children's Cancer Center
Contact: Site Public Contact

Prisma Health Cancer Institute - Butternut
Contact: Site Public Contact

Prisma Health Cancer Institute - Eastside
Contact: Site Public Contact

Prisma Health Cancer Institute - Faris
Contact: Site Public Contact

Prisma Health Greenville Memorial Hospital
Contact: Site Public Contact

Greer
Prisma Health Cancer Institute - Greer
Contact: Site Public Contact

Seneca
Prisma Health Cancer Institute - Seneca
Contact: Site Public Contact

TN
Chattanooga
Memorial Hospital
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

Franklin
Vanderbilt-Ingram Cancer Center Cool Springs
Contact: Site Public Contact

Hixson
Pulmonary Medicine Center of Chattanooga-Hixson
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

Nashville
Vanderbilt Breast Center at One Hundred Oaks
Contact: Site Public Contact

Vanderbilt University/Ingram Cancer Center
Contact: Site Public Contact

Ooltewah
Memorial GYN Plus
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org

TX
Bryan
Saint Joseph Regional Cancer Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

VA
Martinsville
Sovah Health Martinsville
Contact: Site Public Contact
Email: sharon.hubbard@lpnt.net

WI
Eau Claire
Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Mayo Clinic Health System Eau Claire Hospital-Luther Campus
Contact: Site Public Contact

Mayo Clinic Health System-Eau Claire Clinic
Contact: Site Public Contact

Ladysmith
Marshfield Clinic - Ladysmith Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Marshfield
Marshfield Medical Center-Marshfield
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Milwaukee
Medical College of Wisconsin
Contact: Site Public Contact

Minocqua
Marshfield Clinic-Minocqua Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

New Berlin
Froedtert and MCW Moorland Reserve Health Center
Contact: Site Public Contact

Rice Lake
Marshfield Medical Center-Rice Lake
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wausau
Marshfield Clinic-Wausau Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Weston
Marshfield Medical Center - Weston
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

WV
Morgantown
West Virginia University Healthcare
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu

WY
Cheyenne
Cheyenne Regional Medical Center-West
Contact: Site Public Contact
Email: ccrp@co-cancerresearch.org

Cody
Billings Clinic-Cody
Contact: Site Public Contact
Email: research@billingsclinic.org

Sheridan
Welch Cancer Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

PRIMARY OBJECTIVE:
I. Assess the proportion of chronic myelogenous leukemia (CML) patients on stable-dose tyrosine kinase inhibitor (TKI) who convert to undetectable minimal residual disease (UMRD) (molecular response [MR]^4.5) during or within 2 years of initiating pembrolizumab therapy.

SECONDARY OBJECTIVES:
I. Among patients who have converted to UMRD (MR^4.5), assess the proportion of CML patients who maintain UMRD for 6 months and 12 months.
II. Among patients who have converted to UMRD (MR^4.5), assess the proportion of CML patients who discontinue their TKI.
III. Among patients who have converted to UMRD (MR^4.5), assess the proportion of CML patients who are UMRD and TKI-free at 2 years from first determined UMRD.
IV. Assess the proportion of CML patients who develop grade 3 or 4 immune related adverse events related to pembrolizumab treatment during the first 2 years after registration (not including grade 3 events that respond to corticosteroids and improve to grade 1 or less within 4 weeks).

OUTLINE:
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and dasatinib orally (PO) once daily (QD), imatinib mesylate PO QD, nilotinib PO twice daily (BID), or bosutinib PO QD on days 1-21 as clinically indicated per the treating physician. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients with detectable MRD after cycle 18 continue pembrolizumab and dasatinib, imatinib mesylate, nilotinib, or bosutinib every 21 days for up to an additional 18 cycles in the absence of disease progression or unacceptable toxicity. Patients with UMRD at any time before cycle 18 discontinue pembrolizumab after cycle 18 and continue dasatinib, imatinib mesylate, nilotinib, or bosutinib every 21 days for 48 weeks after UMRD first determined in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection and may undergo bone marrow biopsies or bone marrow aspirates throughout the study.

After completion of study treatment, patients are followed up every 6 months for 6 years from the date of registration.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.


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ECOG-ACRIN Cancer Research Group