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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: NCI-2019-07573, A031803, A031803, U10CA180821
  • NTC 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
    January 6, 2020
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Complete response rate in the carcinoma in situ (CIS) subpopulation

Primary Outcome 1 - Timeframe: At 6 months (end of cycle 8, week 25)

Primary Outcome 2 - Measure: Event-free survival at 18 months

Primary Outcome 2 - Timeframe: From the date of study registration to the first documentation of an event or death whichever comes first, assessed up to 18 months

CONDITION

  • Bladder Urothelial Carcinoma In Situ
  • Infiltrating 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 after completing therapy with at least induction BCG (>= 5 doses) and the first round of maintenance or second induction course (>= 2 doses)
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
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)
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

- Mixed variant histology (adenocarcinoma, squamous cell carcinoma) is eligible, but pure variant histology is ineligible
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

- Patients must be deemed unfit for radical cystectomy by the treating physician or refuse radical cystectomy
All visible tumor must be completely resected 60 days prior to registration (residual pure CIS is permitted)
All patients must have histologically confirmed urothelial cancer of the bladder within 60 days prior to registration. All patients must have had a cystoscopy without papillary tumor and negative urinary cytology within 21 days of registration. (positive cytology is allowed in patients with pure CIS)

- All patients with T1 tumors must undergo a re-staging transurethral resection of bladder tumor (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:
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 7 days 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
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: Michael E Woods

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact
Facility: Fairbanks Memorial Hospital
Fairbanks, Alaska 99701
United States
Status: Recruiting Contact: Principal Investigator
Marc Dall'Era
303-777-2663
info@westernstatesncorp.org
Facility: Mayo Clinic Hospital in Arizona
Phoenix, Arizona 85054
United States
Status: Recruiting Contact: Contact
Site Public Contact
303-777-2663
info@westernstatesncorp.org
Facility: Mayo Clinic in Arizona
Scottsdale, Arizona 85259
United States
Status: Recruiting Contact: Principal Investigator
Nicholas DiBella
303-777-2663
info@westernstatesncorp.org
Facility: Cedars Sinai Medical Center
Los Angeles, California 90048
United States
Status: Recruiting Contact: Contact
Site Public Contact
303-777-2663
stephanie.couch@stjoeshealth.org
Facility: University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Status: Recruiting Contact: Principal Investigator
Nicholas DiBella
303-777-2663
mccinfo@mtcancer.org
Facility: Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado 80012
United States
Status: Recruiting Contact: Contact
Site Public Contact
352-273-8010
mccinfo@mtcancer.org
Facility: Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado 80304
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
morganthaler.jodi@mhsil.com
Facility: Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado 80112
United States
Status: Recruiting Contact: Principal Investigator
Nicholas DiBella
406-969-6060
morganthaler.jodi@mhsil.com
Facility: Rocky Mountain Cancer Centers-Midtown
Denver, Colorado 80218
United States
Status: Recruiting Contact: Principal Investigator
Nicholas DiBella
217-876-4762
emede1@lsuhsc.edu
Facility: Rocky Mountain Cancer Centers-Rose
Denver, Colorado 80220
United States
Status: Recruiting Contact: Principal Investigator
Nicholas DiBella
800-444-7541
crcwm-regulatory@crcwm.org
Facility: Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado 80113
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-284-7370
stephanie.couch@stjoeshealth.org
Facility: Swedish Medical Center
Englewood, Colorado 80113
United States
Status: Recruiting Contact: Contact
Site Public Contact
913-588-3671
stephanie.couch@stjoeshealth.org
Facility: North Colorado Medical Center
Greeley, Colorado 80631
United States
Status: Recruiting Contact: Contact
Site Public Contact
410-553-8100
stephanie.couch@stjoeshealth.org
Facility: Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado 80120
United States
Status: Recruiting Contact: Principal Investigator
John M. Schallenkamp
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado 80124
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: McKee Medical Center
Loveland, Colorado 80539
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
crcwm-regulatory@crcwm.org
Facility: University of Florida Health Science Center - Gainesville
Gainesville, Florida 32610
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
mccinfo@mtcancer.org
Facility: Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
mccinfo@mtcancer.org
Facility: Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
United States
Status: Recruiting Contact: Principal Investigator
Scott E. Delacroix
734-712-3671
mccinfo@mtcancer.org
Facility: Saint Alphonsus Medical Center-Nampa
Nampa, Idaho 83686
United States
Status: Recruiting Contact: Contact
Site Public Contact
573-334-2230
clinical.trials@daytonncorp.org
Facility: Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
United States
Status: Recruiting Contact: Contact
Site Public Contact
314-996-5569
clinical.trials@daytonncorp.org
Facility: Kootenai Cancer Clinic
Sandpoint, Idaho 83864
United States
Status: Recruiting Contact: Principal Investigator
Kathleen J. Yost
314-996-5569
clinical.trials@daytonncorp.org
Facility: Rush University Medical Center
Chicago, Illinois 60612
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
stephanie.couch@stjoeshealth.org
Facility: Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
United States
Status: Recruiting Contact: Principal Investigator
Tareq Al Baghdadi
406-969-6060
stephanie.couch@stjoeshealth.org
Facility: Crossroads Cancer Center
Effingham, Illinois 62401
United States
Status: Recruiting Contact: Contact
Site Public Contact
212-639-7592
kmertz-rivera@gibbscc.org
Facility: Loyola University Medical Center
Maywood, Illinois 60153
United States
Status: Recruiting Contact: Contact
Site Public Contact
212-746-1848
research.institute@phci.org
Facility: Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
United States
Status: Recruiting Contact: Principal Investigator
Tareq Al Baghdadi
877-668-0683
Chanda.miller@phci.org
Facility: Southern Illinois University School of Medicine
Springfield, Illinois 62702
United States
Status: Recruiting Contact: Principal Investigator
Kathleen J. Yost
937-528-2900
Facility: Springfield Clinic
Springfield, Illinois 62702
United States
Status: Recruiting Contact: Contact
Site Public Contact
937-528-2900
Facility: Memorial Medical Center
Springfield, Illinois 62781
United States
Status: Recruiting Contact: Principal Investigator
Tareq Al Baghdadi
937-528-2900
Facility: Reid Health
Richmond, Indiana 47374
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
Facility: Memorial Hospital of South Bend
South Bend, Indiana 46601
United States
Status: Recruiting Contact: Principal Investigator
Kathleen J. Yost
734-712-3671
Facility: University of Kansas Cancer Center
Kansas City, Kansas 66160
United States
Status: Recruiting Contact: Contact
Site Public Contact
864-560-6104
Facility: University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
United States
Status: Recruiting Contact: Principal Investigator
Tareq Al Baghdadi
864-560-6104
Facility: University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
United States
Status: Recruiting Contact: Contact
Site Public Contact
877-469-5300
Facility: East Jefferson General Hospital
Metairie, Louisiana 70006
United States
Status: Recruiting Contact: Principal Investigator
Tareq Al Baghdadi
210-450-3800
Facility: LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana 70006
United States
Status: Recruiting Contact: Contact
Site Public Contact
509-783-4637
Facility: UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland 21061
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-782-8581
Facility: Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
United States
Status: Recruiting Contact: Principal Investigator
Kathleen J. Yost
800-782-8581
Facility: Bronson Battle Creek
Battle Creek, Michigan 49017
United States
Status: Recruiting Contact: Contact
Site Public Contact
262-928-7878
Facility: IHA Hematology Oncology Consultants-Brighton
Brighton, Michigan 48114
United States
Status: Recruiting Contact: Principal Investigator
Tareq Al Baghdadi
800-782-8581
Facility: Saint Joseph Mercy Brighton
Brighton, Michigan 48114
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-782-8581
Facility: IHA Hematology Oncology Consultants-Canton
Canton, Michigan 48188
United States
Status: Recruiting Contact: Principal Investigator
Tareq Al Baghdadi
262-928-7632
Facility: Saint Joseph Mercy Canton
Canton, Michigan 48188
United States
Status: Recruiting Contact: Contact
Site Public Contact
262-928-5539
Facility: IHA Hematology Oncology Consultants-Chelsea
Chelsea, Michigan 48118
United States
Status: Recruiting Contact: Contact
Site Public Contact
787-763-1296
Facility: Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
United States
Status: Recruiting Contact: Principal Investigator
Tareq Al Baghdadi

Facility: Hematology Oncology Consultants-Clarkston
Clarkston, Michigan 48346
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Newland Medical Associates-Clarkston
Clarkston, Michigan 48346
United States
Status: Recruiting Contact: Principal Investigator
Kathleen J. Yost

Facility: Ascension Saint John Hospital
Detroit, Michigan 48236
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Great Lakes Cancer Management Specialists-Doctors Park
East China Township, Michigan 48054
United States
Status: Recruiting Contact: 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

Facility: Genesee Hematology Oncology PC
Flint, Michigan 48503
United States
Status: Recruiting Contact: Principal Investigator
Tareq Al Baghdadi

Facility: Genesys Hurley Cancer Institute
Flint, Michigan 48503
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Hurley Medical Center
Flint, Michigan 48503
United States
Status: Recruiting Contact: Principal Investigator
Kathleen J. Yost

Facility: Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Academic Hematology Oncology Specialists
Grosse Pointe Woods, Michigan 48236
United States
Status: Recruiting Contact: 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

Facility: Bronson Methodist Hospital
Kalamazoo, Michigan 49007
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: West Michigan Cancer Center
Kalamazoo, Michigan 49007
United States
Status: Recruiting Contact: Principal Investigator
Tareq Al Baghdadi

Facility: Hope Cancer Clinic
Livonia, Michigan 48154
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Saint Mary Mercy Hospital
Livonia, Michigan 48154
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller

Facility: Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan 48044
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Mercy Health Mercy Campus
Muskegon, Michigan 49444
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Newland Medical Associates-Pontiac
Pontiac, Michigan 48341
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller

Facility: Saint Joseph Mercy Oakland
Pontiac, Michigan 48341
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Ascension Saint Mary's Hospital
Saginaw, Michigan 48601
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller

Facility: Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan 48604
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan 48312
United States
Status: Recruiting Contact: Principal Investigator
John M. Schallenkamp

Facility: Ascension Saint Joseph Hospital
Tawas City, Michigan 48764
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Munson Medical Center
Traverse City, Michigan 49684
United States
Status: Recruiting Contact: Principal Investigator
John M. Schallenkamp

Facility: Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan 48093
United States
Status: Recruiting Contact: Principal Investigator
John M. Schallenkamp

Facility: Saint John Macomb-Oakland Hospital
Warren, Michigan 48093
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Metro Health Hospital
Wyoming, Michigan 49519
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Huron Gastroenterology PC
Ypsilanti, Michigan 48106
United States
Status: Recruiting Contact: Principal Investigator
Einar F. Sverrisson

Facility: IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan 48197
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Saint Francis Medical Center
Cape Girardeau, Missouri 63703
United States
Status: Recruiting Contact: Principal Investigator
Howard M. Gross

Facility: University of Missouri - Ellis Fischel
Columbia, Missouri 65212
United States
Status: Recruiting Contact: Principal Investigator
Howard M. Gross

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

Facility: Missouri Baptist Medical Center
Saint Louis, Missouri 63131
United States
Status: Recruiting Contact: Principal Investigator
Howard M. Gross

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

Facility: Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
United States
Status: Recruiting Contact: Principal Investigator
Rex B. Mowat

Facility: Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri 63127
United States
Status: Recruiting Contact: Principal Investigator
John M. Schallenkamp

Facility: Community Hospital of Anaconda
Anaconda, Montana 59711
United States
Status: Recruiting Contact: Principal Investigator
Tareq Al Baghdadi

Facility: Billings Clinic Cancer Center
Billings, Montana 59101
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Bozeman Deaconess Hospital
Bozeman, Montana 59715
United States
Status: Recruiting Contact: Principal Investigator
Stephen J. Savage

Facility: Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
United States
Status: Recruiting Contact: Principal Investigator
Michael Humeniuk

Facility: Kalispell Regional Medical Center
Kalispell, Montana 59901
United States
Status: Recruiting Contact: Principal Investigator
Michael Humeniuk

Facility: Community Medical Hospital
Missoula, Montana 59804
United States
Status: Recruiting Contact: Principal Investigator
Paromita Datta

Facility: Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
United States
Status: Recruiting Contact: Principal Investigator
Chethan Ramamurthy

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

Facility: Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
United States
Status: Recruiting Contact: Principal Investigator
Alison K. Conlin

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

Facility: The New York Hospital Medical Center of Queens
Flushing, New York 11355
United States
Status: Recruiting Contact: Principal Investigator
Michael Husak

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

Facility: Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Status: Recruiting Contact: Principal Investigator
Scott Johnson

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

Facility: Memorial Sloan Kettering Nassau
Uniondale, New York 11553
United States
Status: Recruiting Contact: Principal Investigator
Michael Husak

Facility: UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: University of North Carolina-Hillsborough Campus
Hillsborough, North Carolina 27278
United States
Status: Recruiting Contact: Principal Investigator
Timothy R. Wassenaar

Facility: Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Miami Valley Hospital South
Centerville, Ohio 45459
United States
Status: Recruiting Contact: Principal Investigator
Michael Husak

Facility: Miami Valley Hospital
Dayton, Ohio 45409
United States
Status: Recruiting Contact: Principal Investigator
Michael Husak

Facility: Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio 45415
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Miami Valley Hospital North
Dayton, Ohio 45415
United States
Status: Recruiting Contact: Principal Investigator
Timothy R. Wassenaar

Facility: Armes Family Cancer Center
Findlay, Ohio 45840
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Greater Dayton Cancer Center
Kettering, Ohio 45409
United States
Status: Recruiting Contact: N/A
Facility: Kettering Medical Center
Kettering, Ohio 45429
United States
Status: Recruiting Contact: N/A
Facility: Springfield Regional Cancer Center
Springfield, Ohio 45504
United States
Status: Recruiting Contact: N/A
Facility: Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio 43623
United States
Status: Recruiting Contact: N/A
Facility: University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact: N/A
Facility: Saint Alphonsus Medical Center-Ontario
Ontario, Oregon 97914
United States
Status: Recruiting Contact: N/A
Facility: Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
United States
Status: Recruiting Contact: N/A
Facility: Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania 18017
United States
Status: Recruiting Contact: N/A
Facility: Ralph H Johnson VA Medical Center
Charleston, South Carolina 29401
United States
Status: Recruiting Contact: N/A
Facility: Gibbs Cancer Center-Pelham
Greer, South Carolina 29651
United States
Status: Recruiting Contact: N/A
Facility: Spartanburg Medical Center
Spartanburg, South Carolina 29303
United States
Status: Recruiting Contact: N/A
Facility: Audie L Murphy VA Hospital
San Antonio, Texas 78229
United States
Status: Recruiting Contact: N/A
Facility: University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
Status: Recruiting Contact: N/A
Facility: Kadlec Clinic Hematology and Oncology
Kennewick, Washington 99336
United States
Status: Recruiting Contact: N/A
Facility: Jefferson Healthcare
Port Townsend, Washington 98368
United States
Status: Recruiting Contact: N/A
Facility: Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
United States
Status: Recruiting Contact: N/A
Facility: Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
United States
Status: Recruiting Contact: N/A
Facility: Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Status: Recruiting Contact: N/A
Facility: Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
United States
Status: Recruiting Contact: N/A
Facility: ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
United States
Status: Recruiting Contact: N/A
Facility: ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
United States
Status: Recruiting Contact: N/A
Facility: Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
United States
Status: Recruiting Contact: N/A
Facility: Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin 54482
United States
Status: Recruiting Contact: N/A
Facility: ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin 53188
United States
Status: Recruiting Contact: N/A
Facility: UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
United States
Status: Recruiting Contact: N/A
Facility: Marshfield Medical Center - Weston
Weston, Wisconsin 54476
United States
Status: Recruiting Contact: N/A
Facility: San Juan City Hospital
San Juan, 00936
Puerto Rico
Status: Recruiting Contact: N/A