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Brief Title: Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer

Phase II Trial of Intravesical Gemcitabine and MK-3475 (Pembrolizumab) in the Treatment of Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

INTRODUCTION

  • Org Study ID: NCI-2019-07573
  • Secondary ID: N/A
  • NCT ID: NCT04164082
  • Sponsor: National Cancer Institute (NCI)

BRIEF SUMMARY

This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Chemotherapy drugs, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine may delay the return of BCG-unresponsive bladder cancer for longer period compared to gemcitabine alone.

DETAILED DESCRIPTION

PRIMARY OBJECTIVES:

I. Estimate the 6-month complete response rate of treatment with intravesical gemcitabine hydrochloride (gemcitabine) in combination with MK-3475 (pembrolizumab) in patients with Bacillus Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) that have a carcinoma in situ (CIS) component.

II. Estimate the 18 month event-free survival (EFS) rate for all patients with BCG-unresponsive NMIBC receiving intravesical gemcitabine in combination with MK-3475 (pembrolizumab).

SECONDARY OBJECTIVES:

I. To characterize the safety profile of the combination of intravesical gemcitabine with MK-3475 (pembrolizumab) with BCG-unresponsive NMIBC (CIS or high grade Ta and T1 with or without a CIS component).

II. To estimate progression-free survival (PFS) of patients with BCG-unresponsive NMIBC treated with intravesical gemcitabine in combination with MK-3475 (pembrolizumab).

III. To estimate overall survival (OS) of patients with BCG-unresponsive NMIBC treated with intravesical gemcitabine in combination with MK-3475 (pembrolizumab).

IV. To estimate cystectomy-free survival of patients with BCG-unresponsive NMIBC treated with intravesical gemcitabine in combination with MK-3475 (pembrolizumab).

V. To estimate recurrence-free survival (RFS) for patients with a CIS component only and those without a CIS component.

EXPLORATORY OBJECTIVES:

I. To assess correlation between tumor mutation burden (TMB) and EFS and 6-month complete response (CR) rate.

II. To assess correlation between specific genomic alterations (single nucleotide variant [SNV] and copy number gains/loss) and EFS and 6-month complete response rate.

III. To assess correlation between APOBEC mutational signature and EFS and 6-month complete response rate.

IV. To assess correlation between immune gene signatures (IGS) and EFS and 6-month complete response rate.

V. To assess correlation between PD-L1 ribonucleic acid (RNA) levels and EFS and 6-month complete response rate.

VI. To assess correlation between RNA molecular subtype and EFS and 6-month complete response rate.

VII. To assess correlation between intratumoral T-cell receptor (TCR) clonality and EFS and 6-month complete response rate.

VIII. To assess correlation between changes in peripheral blood TCR clonality and EFS and 6-month complete response rate.

IX. To assess EFS in patients with urine cell free deoxyribonucleic acid (DNA) (cfDNA) + versus (vs.) patients with cfDNA.

OUTLINE:

INDUCTION: Patients receive pembrolizumab intravenously (IV) over 25-40 minutes on day 1 of cycles 1-4. Patients also receive gemcitabine hydrochloride intravesically on days 1, 8 and 15 of cycles 1 and 2. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Beginning cycle 5, patients with no evidence of disease after induction receive pembrolizumab IV over 25-40 minutes and gemcitabine intravesically on day 1. Treatment repeats every 3 weeks for 12 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients with evidence of disease (recurrence or progression) or stop study treatment to receive non-protocol treatment during induction are followed up every 6 months for 5 years. Patients who go off treatment due to any reason other than recurrence/progression or receiving subsequent non-protocol treatment during induction will go to clinical follow-up until evidence of disease progression/recurrence. Thereafter, patients are followed up every 6 months until 5 years from registration. Patients who complete scheduled maintenance treatment according to protocol therapy are followed up every 3 months for 2 years and then every 6 months for 3 years until disease progression/recurrence or receiving subsequent non-protocol treatment. Thereafter, patients are followed up every 6 months until 5 years from registration. Patients who have evidence of disease during maintenance therapy are followed up every 6 months until 5 years from registration.

  • Overall Status
    Recruiting
  • Start Date
    March 18, 2020
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Bladder Urothelial Carcinoma In Situ
  • Invasive Bladder Mixed Carcinoma
  • Stage 0a Bladder Cancer AJCC v8
  • Stage 0is Bladder Cancer AJCC v8
  • Stage I Bladder Cancer AJCC v8

ELIGIBILITY

Inclusion Criteria:
* High grade Ta, T1 or CIS urothelial carcinoma. Accrual of patients with Ta or T1 disease may be closed to ensure adequate patients enrollment to meet the primary endpoint

- * Persistent disease (defined as not achieving disease free status) after completing therapy with at least induction BCG (>= 5 doses) and the first round of maintenance or second induction course (>= 2 doses). The subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG.

- * Persistent high risk NMIBC (T1, high grade Ta and/or CIS) must be within 9 months of the last BCG instillation despite having received adequate BCG as defined above.
* Registration must be within 12 months of last BCG instillation

- * High grade T1 after completing therapy with at least induction BCG (>= 5 doses) or after completing therapy with at least induction BCG (>= 5 doses) and first round of maintenance or second induction course (>= 2 doses). The subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG
* Disease recurrence (T1) must be within 9 months of the last BCG instillation despite having received adequate BCG as defined above

- * Registration must be within 12 months of last BCG instillation

- * Patients who are disease free at 6 months after starting BCG but have high grade recurrence (T1, Ta, CIS) while on maintenance therapy would be eligible
* The recurrence must be within 6 months of the last BCG dose.

- * Registration must be within 12 months of last maintenance BCG instillation

- * Patients must be deemed unfit for radical cystectomy by the treating physician or refuse radical cystectomy

- * All patients must have histologically confirmed urothelial cancer of the bladder within 60 days prior to registration

- * All visible tumor must be completely resected 60 days prior to registration (residual pure CIS is permitted)
* All patients must have had a cystoscopy (or transurethral resection of bladder tumor [TURBT] with complete resection) without papillary tumor and negative urinary cytology within 28 days of registration. (positive cytology is allowed in patients with CIS)

- * All patients with T1 tumors must undergo a re-staging TURBT within 60 days of registration. There must be uninvolved muscularis propria present in the re-staging TURBT. The initial TURBT prior to re-staging TURBT may be greater than 60 days prior to registration

- * Patients must have had imaging with computed tomography (CT) or magnetic resonance imaging (MRI) abdomen/pelvis within 90 days of registration demonstrating no evidence of metastasis.

- * Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
* Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Include as applicable: Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom)

- * A woman of childbearing potential (WOCBP) must not have a positive urine pregnancy test within 7 days prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

- * Patients must not be pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with registration through the last dose of treatment

- * Age >= 18 years

- * Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- * Absolute neutrophil count (ANC) >= 1,500/mm^3

- * Platelet count >= 100,000/mm^3

- * Hemoglobin >= 9.0 g/dL

- * Creatinine =< 1.5 x upper limit of normal (ULN)
* In patients with creatinine > 1.5 x ULN, if measured or calculated creatinine clearance > 30 mL/min, then patient is eligible

- * Total bilirubin =< 1.5 x ULN
* In patients with a total bilirubin > 1.5 x ULN, if direct bilirubin < 1.0 X ULN, then patient is eligible - * Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =< 2.5 x ULN - * Patients with human immunodeficiency virus (HIV) are eligible with the following:
* On effective anti-retroviral therapy with undetectable viral load within 6 months of registration
Exclusion Criteria:
* Mixed variant histology (adenocarcinoma, squamous cell carcinoma) is eligible, but pure variant histology is ineligible.

- * Patients cannot have had a history of urothelial carcinoma in the ureters or prostatic urethra 24 months prior to registration

- * Patients must not be currently participating in or have participated in a study of an investigational agent or have used an investigational device within 4 weeks prior to study registration
* Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been more than 4 weeks after the last dose of the previous investigational agent at time of registration

- * Patients must not have prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)

- * Patients must not have undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years prior to registration. (Participants who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of graft versus host disease [GVHD])

- * Patients must not have received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment
* Note: Participants must have recovered from all adverse events (AEs) due to previous therapies to =< grade 1 or baseline. Participants with =< grade 2 neuropathy may be eligible - * Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment - * Patients must not have received prior radiotherapy within 2 weeks of study registration. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis - * Patients must not have received radiation therapy to the lung that is > 30 Gy within 6 months prior to trial registration

- * Patients must not have had an active autoimmune disease requiring systemic treatment within 24 months prior to registration. Autoimmune diseases include, but not limited to, lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis

- * Patients must not have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration
* Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed

- * Patients must not have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study

- * Patients must not have active tuberculosis

- * Patients must not have been treated with antibiotics for an active infection within 14 days prior to registration. Prophylactic antibiotics are permitted. Treatment for a urinary tract infection (UTI) is allowed but must be deemed adequately treated by the treating physician prior the start of cycle 1 (C1) day 1 (D1)

- * Patients must not have a history of idiopathic pulmonary fibrosis or organizing pneumonia

- * Patients must not have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis

- * HIV-infected participants must not have a history of Kaposi sarcoma and/or multicentric Castleman disease

- * Patients must not have a known additional malignancy that has had progression or has required active treatment in the last three years. Exceptions include basal or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. A history of prostate cancer that was treated with definitive intent is allowed, provided that the prostate-specific antigen (PSA) is undetectable for at least 1 year while off androgen deprivation therapy

- * Patients must not have known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment

- * Patients must not have severe hypersensitivity (>= grade 3) to pembrolizumab and/or any of its excipients

- * Patients must not have an active infection requiring systemic therapy

- * Patients must not have a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected) infection
* Note: No testing for hepatitis B and hepatitis C is required unless mandated by a local health authority

- * Patients must not have received live vaccines within 30 days of study drug administration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed. COVID-19 vaccinations are permitted.

- * Physicians should consider whether any of the following may render the patient inappropriate for this protocol:
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Michael E Woods

Role: Principal Investigator

Affiliation: Alliance for Clinical Trials in Oncology

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact
Facility: University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
United States
Status: Recruiting Contact: Contact
Site Public Contact
205-934-0220
tmyrick@uab.edu

Principal Investigator
Charles C. Peyton

Facility: Fairbanks Memorial Hospital
Fairbanks, Alaska 99701
United States
Status: Recruiting Contact: Contact
Site Public Contact
907-458-3043
Veronica.Stevenson@foundationhealth.org

Principal Investigator
Nicholas DiBella

Facility: Cancer Center at Saint Joseph's
Phoenix, Arizona 85004
United States
Status: Recruiting Contact: Contact
Site Public Contact
602-406-0777
Research-cancerinstitute@dignityhealth.org

Principal Investigator
Shahzad Siddique

Facility: University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Status: Recruiting Contact: Contact
Site Public Contact
916-734-3089

Principal Investigator
Marc Dall'Era

Facility: Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado 80012
United States
Status: Recruiting Contact: Contact
Site Public Contact
303-777-2663
info@westernstatesncorp.org

Principal Investigator
Nicholas DiBella

Facility: Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado 80304
United States
Status: Recruiting Contact: Contact
Site Public Contact
303-777-2663
info@westernstatesncorp.org

Principal Investigator
Nicholas DiBella

Facility: Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado 80112
United States
Status: Recruiting Contact: Contact
Site Public Contact
303-777-2663
info@westernstatesncorp.org

Principal Investigator
Nicholas DiBella

Facility: Rocky Mountain Cancer Centers-Midtown
Denver, Colorado 80218
United States
Status: Recruiting Contact: Contact
Site Public Contact
303-777-2663
info@westernstatesncorp.org

Principal Investigator
Nicholas DiBella

Facility: Rocky Mountain Cancer Centers-Rose
Denver, Colorado 80220
United States
Status: Recruiting Contact: Contact
Site Public Contact
303-777-2663
info@westernstatesncorp.org

Principal Investigator
Nicholas DiBella

Facility: Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado 80120
United States
Status: Recruiting Contact: Contact
Site Public Contact
303-777-2663
info@westernstatesncorp.org

Principal Investigator
Nicholas DiBella

Facility: Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado 80124
United States
Status: Recruiting Contact: Contact
Site Public Contact
303-777-2663
info@westernstatesncorp.org

Principal Investigator
Nicholas DiBella

Facility: MedStar Georgetown University Hospital
Washington, District of Columbia 20007
United States
Status: Recruiting Contact: Contact
Site Public Contact
202-444-2223

Principal Investigator
Lambros Stamatakis

Facility: MedStar Washington Hospital Center
Washington, District of Columbia 20010
United States
Status: Recruiting Contact: Contact
Site Public Contact
202-877-8839

Principal Investigator
Lambros Stamatakis

Facility: University of Florida Health Science Center - Gainesville
Gainesville, Florida 32610
United States
Status: Recruiting Contact: Contact
Site Public Contact
352-273-8010
cancer-center@ufl.edu

Principal Investigator
Paul L. Crispen

Facility: Hawaii Cancer Care - Westridge
'Aiea, Hawaii 96701
United States
Status: Recruiting Contact: Contact
Site Public Contact
808-539-2273
info@hawaiicancercare.com

Principal Investigator
Jeffrey L. Berenberg

Facility: Straub Clinic and Hospital
Honolulu, Hawaii 96813
United States
Status: Recruiting Contact: Contact
Site Public Contact
808-522-4333

Principal Investigator
Jeffrey L. Berenberg

Facility: Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Principal Investigator
John M. Schallenkamp

Facility: Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Principal Investigator
John M. Schallenkamp

Facility: Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Principal Investigator
John M. Schallenkamp

Facility: Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Principal Investigator
John M. Schallenkamp

Facility: Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Principal Investigator
John M. Schallenkamp

Facility: Kootenai Cancer Clinic
Sandpoint, Idaho 83864
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Principal Investigator
John M. Schallenkamp

Facility: Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
United States
Status: Recruiting Contact: Contact
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Principal Investigator
Bryan A. Faller

Facility: Crossroads Cancer Center
Effingham, Illinois 62401
United States
Status: Recruiting Contact: Contact
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Principal Investigator
Bryan A. Faller

Facility: Loyola University Medical Center
Maywood, Illinois 60153
United States
Status: Recruiting Contact: Contact
Site Public Contact
708-226-4357

Principal Investigator
Michael E. Woods

Facility: Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
United States
Status: Recruiting Contact: Contact
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Principal Investigator
Bryan A. Faller

Facility: Southern Illinois University School of Medicine
Springfield, Illinois 62702
United States
Status: Recruiting Contact: Contact
Site Public Contact
217-545-7929

Principal Investigator
Bryan A. Faller

Facility: Springfield Clinic
Springfield, Illinois 62702
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-444-7541

Principal Investigator
Bryan A. Faller

Facility: Memorial Medical Center
Springfield, Illinois 62781
United States
Status: Recruiting Contact: Contact
Site Public Contact
217-528-7541
pallante.beth@mhsil.com

Principal Investigator
Bryan A. Faller

Facility: University of Kansas Cancer Center
Kansas City, Kansas 66160
United States
Status: Recruiting Contact: Contact
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Principal Investigator
Eugene K. Lee

Facility: University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
United States
Status: Recruiting Contact: Contact
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Principal Investigator
Eugene K. Lee

Facility: East Jefferson General Hospital
Metairie, Louisiana 70006
United States
Status: Recruiting Contact: Contact
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

Principal Investigator
Scott E. Delacroix

Facility: LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana 70006
United States
Status: Recruiting Contact: Contact
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

Principal Investigator
Scott E. Delacroix

Facility: UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland 21061
United States
Status: Recruiting Contact: Contact
Site Public Contact
410-553-8100

Principal Investigator
Cherif N. Boutros

Facility: Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator
Tareq Al Baghdadi

Facility: Bronson Battle Creek
Battle Creek, Michigan 49017
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: Saint Joseph Mercy Brighton
Brighton, Michigan 48114
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator
Tareq Al Baghdadi

Facility: Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator
Tareq Al Baghdadi

Facility: Saint Joseph Mercy Canton
Canton, Michigan 48188
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator
Tareq Al Baghdadi

Facility: Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator
Tareq Al Baghdadi

Facility: Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator
Tareq Al Baghdadi

Facility: Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator
Tareq Al Baghdadi

Facility: Ascension Saint John Hospital
Detroit, Michigan 48236
United States
Status: Recruiting Contact: Contact
Site Public Contact
313-343-3166
karen.forman@ascension.org

Principal Investigator
Tareq Al Baghdadi

Facility: Great Lakes Cancer Management Specialists-Doctors Park
East China Township, Michigan 48054
United States
Status: Recruiting Contact: Contact
Site Public Contact
313-343-3166
karen.forman@ascension.org

Principal Investigator
Tareq Al Baghdadi

Facility: Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan 48503
United States
Status: Recruiting Contact: Contact
Site Public Contact
810-762-8038
wstrong@ghci.org

Principal Investigator
Tareq Al Baghdadi

Facility: Genesee Hematology Oncology PC
Flint, Michigan 48503
United States
Status: Recruiting Contact: Contact
Site Public Contact
810-762-8038
wstrong@ghci.org

Principal Investigator
Tareq Al Baghdadi

Facility: Genesys Hurley Cancer Institute
Flint, Michigan 48503
United States
Status: Recruiting Contact: Contact
Site Public Contact
810-762-8038
wstrong@ghci.org

Principal Investigator
Tareq Al Baghdadi

Facility: Hurley Medical Center
Flint, Michigan 48503
United States
Status: Recruiting Contact: Contact
Site Public Contact
810-762-8038
wstrong@ghci.org

Principal Investigator
Tareq Al Baghdadi

Facility: Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: Academic Hematology Oncology Specialists
Grosse Pointe Woods, Michigan 48236
United States
Status: Recruiting Contact: Contact
Site Public Contact
313-343-3166
karen.forman@ascension.org

Principal Investigator
Tareq Al Baghdadi

Facility: Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan 48236
United States
Status: Recruiting Contact: Contact
Site Public Contact
313-343-3166
karen.forman@ascension.org

Principal Investigator
Tareq Al Baghdadi

Facility: Bronson Methodist Hospital
Kalamazoo, Michigan 49007
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: West Michigan Cancer Center
Kalamazoo, Michigan 49007
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: Ascension Borgess Cancer Center
Kalamazoo, Michigan 49009
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: Sparrow Hospital
Lansing, Michigan 48912
United States
Status: Recruiting Contact: Contact
Site Public Contact
517-364-9400

Principal Investigator
Tareq Al Baghdadi

Facility: Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator
Tareq Al Baghdadi

Facility: Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan 48044
United States
Status: Recruiting Contact: Contact
Site Public Contact
313-343-3166
karen.forman@ascension.org

Principal Investigator
Tareq Al Baghdadi

Facility: Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
connie.szczepanek@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: Ascension Saint Mary's Hospital
Saginaw, Michigan 48601
United States
Status: Recruiting Contact: Contact
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Principal Investigator
Tareq Al Baghdadi

Facility: Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan 48604
United States
Status: Recruiting Contact: Contact
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Principal Investigator
Tareq Al Baghdadi

Facility: Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan 48312
United States
Status: Recruiting Contact: Contact
Site Public Contact
313-343-3166
karen.forman@ascension.org

Principal Investigator
Tareq Al Baghdadi

Facility: Ascension Saint Joseph Hospital
Tawas City, Michigan 48764
United States
Status: Recruiting Contact: Contact
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Principal Investigator
Tareq Al Baghdadi

Facility: Munson Medical Center
Traverse City, Michigan 49684
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan 48093
United States
Status: Recruiting Contact: Contact
Site Public Contact
313-343-3166
karen.forman@ascension.org

Principal Investigator
Tareq Al Baghdadi

Facility: Saint John Macomb-Oakland Hospital
Warren, Michigan 48093
United States
Status: Recruiting Contact: Contact
Site Public Contact
313-343-3166
karen.forman@ascension.org

Principal Investigator
Tareq Al Baghdadi

Facility: University of Michigan Health - West
Wyoming, Michigan 49519
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: Huron Gastroenterology PC
Ypsilanti, Michigan 48106
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator
Tareq Al Baghdadi

Facility: Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator
Tareq Al Baghdadi

Facility: Saint Francis Medical Center
Cape Girardeau, Missouri 63703
United States
Status: Recruiting Contact: Contact
Site Public Contact
573-334-2230
sfmc@sfmc.net

Principal Investigator
Bryan A. Faller

Facility: Saint Luke's Hospital
Chesterfield, Missouri 63017
United States
Status: Recruiting Contact: Contact
Site Public Contact
314-205-6936

Principal Investigator
Joseph Sokhn

Facility: MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri 65212
United States
Status: Recruiting Contact: Contact
Site Public Contact
573-882-7440

Principal Investigator
Kushal Naha

Facility: Parkland Health Center - Farmington
Farmington, Missouri 63640
United States
Status: Recruiting Contact: Contact
Site Public Contact
314-996-5569

Principal Investigator
Bryan A. Faller

Facility: Missouri Baptist Medical Center
Saint Louis, Missouri 63131
United States
Status: Recruiting Contact: Contact
Site Public Contact
314-996-5569

Principal Investigator
Bryan A. Faller

Facility: Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
United States
Status: Recruiting Contact: Contact
Site Public Contact
314-251-7066

Principal Investigator
Jay W. Carlson

Facility: Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
United States
Status: Recruiting Contact: Contact
Site Public Contact
314-996-5569

Principal Investigator
Bryan A. Faller

Facility: Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
United States
Status: Recruiting Contact: Contact
Site Public Contact
314-996-5569

Principal Investigator
Bryan A. Faller

Facility: BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri 63127
United States
Status: Recruiting Contact: Contact
Site Public Contact
314-996-5569

Principal Investigator
Bryan A. Faller

Facility: Community Hospital of Anaconda
Anaconda, Montana 59711
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Principal Investigator
John M. Schallenkamp

Facility: Billings Clinic Cancer Center
Billings, Montana 59101
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-996-2663
research@billingsclinic.org

Principal Investigator
John M. Schallenkamp

Facility: Bozeman Deaconess Hospital
Bozeman, Montana 59715
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Principal Investigator
John M. Schallenkamp

Facility: Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Principal Investigator
John M. Schallenkamp

Facility: Kalispell Regional Medical Center
Kalispell, Montana 59901
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Principal Investigator
John M. Schallenkamp

Facility: Community Medical Hospital
Missoula, Montana 59804
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Principal Investigator
John M. Schallenkamp

Facility: Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire 03756
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-639-6918
cancer.research.nurse@dartmouth.edu

Principal Investigator
Einar F. Sverrisson

Facility: Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
United States
Status: Recruiting Contact: Contact
Site Public Contact
212-639-7592

Principal Investigator
Eugene J. Pietzak

Facility: Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
United States
Status: Recruiting Contact: Contact
Site Public Contact
212-639-7592

Principal Investigator
Eugene J. Pietzak

Facility: Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
United States
Status: Recruiting Contact: Contact
Site Public Contact
212-639-7592

Principal Investigator
Eugene J. Pietzak

Facility: Memorial Sloan Kettering Commack
Commack, New York 11725
United States
Status: Recruiting Contact: Contact
Site Public Contact
212-639-7592

Principal Investigator
Eugene J. Pietzak

Facility: Memorial Sloan Kettering Westchester
Harrison, New York 10604
United States
Status: Recruiting Contact: Contact
Site Public Contact
212-639-7592

Principal Investigator
Eugene J. Pietzak

Facility: Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Status: Recruiting Contact: Contact
Site Public Contact
212-639-7592

Principal Investigator
Eugene J. Pietzak

Facility: NYP/Weill Cornell Medical Center
New York, New York 10065
United States
Status: Recruiting Contact: Contact
Site Public Contact
212-746-1848

Principal Investigator
Cora N. Sternberg

Facility: Stony Brook University Medical Center
Stony Brook, New York 11794
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-862-2215

Principal Investigator
Shenhong Wu

Facility: Memorial Sloan Kettering Nassau
Uniondale, New York 11553
United States
Status: Recruiting Contact: Contact
Site Public Contact
212-639-7592

Principal Investigator
Eugene J. Pietzak

Facility: UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United States
Status: Recruiting Contact: Contact
Site Public Contact
877-668-0683
cancerclinicaltrials@med.unc.edu

Principal Investigator
Matthew I. Milowsky

Facility: University of North Carolina-Hillsborough Campus
Hillsborough, North Carolina 27278
United States
Status: Recruiting Contact: Contact
Site Public Contact
877-668-0683
cancerclinicaltrials@med.unc.edu

Principal Investigator
Matthew I. Milowsky

Facility: Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio 43623
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-444-3561

Principal Investigator
Rex B. Mowat

Facility: University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact: Contact
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Principal Investigator
Sanjay G. Patel

Facility: Saint Alphonsus Medical Center-Ontario
Ontario, Oregon 97914
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Principal Investigator
John M. Schallenkamp

Facility: Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
United States
Status: Recruiting Contact: Contact
Site Public Contact
610-402-9543
Morgan_M.Horton@lvhn.org

Principal Investigator
Tareq Al Baghdadi

Facility: Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania 18017
United States
Status: Recruiting Contact: Contact
Site Public Contact
610-402-9543
Morgan_M.Horton@lvhn.org

Principal Investigator
Tareq Al Baghdadi

Facility: Ralph H Johnson VA Medical Center
Charleston, South Carolina 29401
United States
Status: Recruiting Contact: Contact
Site Public Contact
843-789-7020
ashley.salvo@va.gov

Principal Investigator
Stephen J. Savage

Facility: Gibbs Cancer Center-Pelham
Greer, South Carolina 29651
United States
Status: Recruiting Contact: Contact
Site Public Contact
864-560-6104
kmertz-rivera@gibbscc.org

Principal Investigator
Michael Humeniuk

Facility: Spartanburg Medical Center
Spartanburg, South Carolina 29303
United States
Status: Recruiting Contact: Contact
Site Public Contact
864-560-6104
kmertz-rivera@gibbscc.org

Principal Investigator
Michael Humeniuk

Facility: Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Site Public Contact
713-798-1354
burton@bcm.edu

Principal Investigator
Seth P. Lerner

Facility: Audie L Murphy VA Hospital
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Site Public Contact
877-469-5300

Principal Investigator
Paromita Datta

Facility: University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Site Public Contact
210-450-3800
phoresearchoffice@uthscsa.edu

Principal Investigator
Daruka Mahadevan

Facility: Kadlec Clinic Hematology and Oncology
Kennewick, Washington 99336
United States
Status: Recruiting Contact: Contact
Site Public Contact
509-783-4637
research@kadlecmed.org

Principal Investigator
Alison K. Conlin

Facility: Jefferson Healthcare
Port Townsend, Washington 98368
United States
Status: Recruiting Contact: Contact
Site Public Contact
360-344-3091

Principal Investigator
Nicholas DiBella

Facility: PeaceHealth Southwest Medical Center
Vancouver, Washington 98664
United States
Status: Recruiting Contact: Contact
Site Public Contact
360-514-3940
kmakin-bond@peacehealth.org

Principal Investigator
Alison K. Conlin

Facility: Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Principal Investigator
Michael Husak

Facility: Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Principal Investigator
Michael Husak

Facility: Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Status: Recruiting Contact: Contact
Site Public Contact
414-805-3666

Principal Investigator
Scott Johnson

Facility: Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Principal Investigator
Michael Husak

Facility: ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
United States
Status: Recruiting Contact: Contact
Site Public Contact
research.institute@phci.org

Principal Investigator
Timothy R. Wassenaar

Facility: ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
United States
Status: Recruiting Contact: Contact
Site Public Contact
262-928-7878

Principal Investigator
Timothy R. Wassenaar

Facility: Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Principal Investigator
Michael Husak

Facility: Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Principal Investigator
Michael Husak

Facility: ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin 53188
United States
Status: Recruiting Contact: Contact
Site Public Contact
262-928-7632

Principal Investigator
Timothy R. Wassenaar

Facility: UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
United States
Status: Recruiting Contact: Contact
Site Public Contact
262-928-5539
Chanda.miller@phci.org

Principal Investigator
Timothy R. Wassenaar

Facility: Marshfield Medical Center - Weston
Weston, Wisconsin 54476
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Principal Investigator
Michael Husak