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

April 23, 2024 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

161

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guam
      • Tamuning, Guam, 96913
        • Suspended
        • FHP Health Center-Guam
  • Puerto Rico
      • Bayamon, Puerto Rico, 00959-5060
        • Suspended
        • Cancer Center-Metro Medical Center Bayamon
      • Caguas, Puerto Rico, 00726
        • Suspended
        • HIMA San Pablo Oncologic Hospital
      • Manati, Puerto Rico, 00674
        • Suspended
        • Doctors Cancer Center
      • Ponce, Puerto Rico, 00716
        • Suspended
        • Instituto Oncologia Moderna Ponce
      • San Juan, Puerto Rico, 00936
        • Recruiting
        • San Juan City Hospital
        • Principal Investigator:
          • Luis J. Santos Reyes
        • Contact:
          • Site Public Contact
          • Phone Number: 787-763-1296
      • San Juan, Puerto Rico, 00917
        • Suspended
        • San Juan Community Oncology Group
      • San Juan, Puerto Rico, 00927
        • Suspended
        • Centro Comprensivo de Cancer de UPR
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham Cancer Center
        • Contact:
        • Principal Investigator:
          • Charles C. Peyton
    • Alaska
      • Anchorage, Alaska, United States, 98508
        • Suspended
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, United States, 99504
        • Suspended
        • Anchorage Radiation Therapy Center
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Anchorage Oncology Centre
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Katmai Oncology Group
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Providence Alaska Medical Center
      • Fairbanks, Alaska, United States, 99701
    • Arizona
      • Phoenix, Arizona, United States, 85004
      • Phoenix, Arizona, United States, 85054
        • Active, not recruiting
        • Mayo Clinic Hospital in Arizona
      • Scottsdale, Arizona, United States, 85259
        • Active, not recruiting
        • Mayo Clinic in Arizona
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Suspended
        • Mercy Hospital Fort Smith
    • California
      • Burbank, California, United States, 91505
        • Suspended
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Los Angeles, California, United States, 90048
        • Active, not recruiting
        • Cedars Sinai Medical Center
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 916-734-3089
        • Principal Investigator:
          • Marc Dall'Era
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Suspended
        • The Medical Center of Aurora
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Rocky Mountain Cancer Centers-Aurora
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Boulder, Colorado, United States, 80301
        • Suspended
        • Boulder Community Hospital
      • Boulder, Colorado, United States, 80303
        • Suspended
        • Boulder Community Foothills Hospital
      • Boulder, Colorado, United States, 80304
        • Recruiting
        • Rocky Mountain Cancer Centers-Boulder
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Centennial, Colorado, United States, 80112
        • Recruiting
        • Rocky Mountain Cancer Centers - Centennial
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Denver, Colorado, United States, 80218
        • Suspended
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, United States, 80218
        • Suspended
        • SCL Health Saint Joseph Hospital
      • Denver, Colorado, United States, 80220
        • Suspended
        • Rose Medical Center
      • Denver, Colorado, United States, 80204
        • Suspended
        • Cancer Center of Colorado at Sloan's Lake
      • Denver, Colorado, United States, 80209
        • Suspended
        • The Women's Imaging Center
      • Denver, Colorado, United States, 80218
        • Suspended
        • Colorado Blood Cancer Institute
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Cancer Centers-Midtown
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Denver, Colorado, United States, 80220
        • Recruiting
        • Rocky Mountain Cancer Centers-Rose
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Denver, Colorado, United States, 80220
        • Suspended
        • Western Surgical Care
      • Denver, Colorado, United States, 80206
        • Suspended
        • National Jewish Health-Main Campus
      • Englewood, Colorado, United States, 80113
        • Suspended
        • The Melanoma and Skin Cancer Institute
      • Englewood, Colorado, United States, 80113
        • Suspended
        • Rocky Mountain Cancer Centers - Swedish
      • Englewood, Colorado, United States, 80113
        • Suspended
        • Swedish Medical Center
      • Englewood, Colorado, United States, 80113
        • Suspended
        • Mountain Blue Cancer Care Center - Swedish
      • Golden, Colorado, United States, 80401
        • Suspended
        • National Jewish Health-Western Hematology Oncology
      • Grand Junction, Colorado, United States, 81501
        • Suspended
        • Saint Mary's Hospital and Regional Medical Center
      • Greeley, Colorado, United States, 80631
        • Suspended
        • North Colorado Medical Center
      • Lafayette, Colorado, United States, 80026
        • Suspended
        • Good Samaritan Medical Center
      • Lakewood, Colorado, United States, 80228
        • Suspended
        • Rocky Mountain Cancer Centers-Lakewood
      • Littleton, Colorado, United States, 80120
        • Recruiting
        • Rocky Mountain Cancer Centers-Littleton
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Lone Tree, Colorado, United States, 80124
        • Suspended
        • Sky Ridge Medical Center
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Rocky Mountain Cancer Centers-Sky Ridge
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Loveland, Colorado, United States, 80539
        • Suspended
        • McKee Medical Center
      • Thornton, Colorado, United States, 80260
        • Suspended
        • Rocky Mountain Cancer Centers-Thornton
      • Thornton, Colorado, United States, 80260
        • Suspended
        • National Jewish Health-Northern Hematology Oncology
      • Wheat Ridge, Colorado, United States, 80033
        • Suspended
        • SCL Health Lutheran Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital Center
        • Contact:
          • Site Public Contact
          • Phone Number: 202-877-8839
        • Principal Investigator:
          • Lambros Stamatakis
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • MedStar Georgetown University Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 202-444-2223
        • Principal Investigator:
          • Lambros Stamatakis
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Suspended
        • Holy Cross Hospital
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida Health Science Center - Gainesville
        • Contact:
        • Principal Investigator:
          • Paul L. Crispen
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Recruiting
        • Hawaii Cancer Care - Westridge
        • Contact:
        • Principal Investigator:
          • Jeffrey L. Berenberg
      • 'Aiea, Hawaii, United States, 96701
        • Active, not recruiting
        • Pali Momi Medical Center
      • 'Aiea, Hawaii, United States, 96701
        • Active, not recruiting
        • Queen's Cancer Center - Pearlridge
      • 'Aiea, Hawaii, United States, 96701
        • Active, not recruiting
        • The Cancer Center of Hawaii-Pali Momi
      • 'Ewa Beach, Hawaii, United States, 96706
        • Active, not recruiting
        • The Queen's Medical Center - West Oahu
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Straub Clinic and Hospital
        • Principal Investigator:
          • Jeffrey L. Berenberg
        • Contact:
          • Site Public Contact
          • Phone Number: 808-522-4333
      • Honolulu, Hawaii, United States, 96813
        • Active, not recruiting
        • Hawaii Cancer Care Inc - Waterfront Plaza
      • Honolulu, Hawaii, United States, 96813
        • Active, not recruiting
        • Island Urology
      • Honolulu, Hawaii, United States, 96813
        • Active, not recruiting
        • Queen's Cancer Cenrer - POB I
      • Honolulu, Hawaii, United States, 96813
        • Active, not recruiting
        • Queen's Medical Center
      • Honolulu, Hawaii, United States, 96813
        • Active, not recruiting
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, United States, 96817
        • Active, not recruiting
        • Hawaii Cancer Care Inc-Liliha
      • Honolulu, Hawaii, United States, 96817
        • Active, not recruiting
        • Hawaii Diagnostic Radiology Services LLC
      • Honolulu, Hawaii, United States, 96817
        • Active, not recruiting
        • Kuakini Medical Center
      • Honolulu, Hawaii, United States, 96817
        • Active, not recruiting
        • Queen's Cancer Center - Kuakini
      • Honolulu, Hawaii, United States, 96817
        • Active, not recruiting
        • The Cancer Center of Hawaii-Liliha
      • Honolulu, Hawaii, United States, 96826
        • Active, not recruiting
        • Kapiolani Medical Center for Women and Children
      • Kahului, Hawaii, United States, 96732
        • Active, not recruiting
        • Straub Medical Center - Kahului Clinic
      • Kailua, Hawaii, United States, 96734
        • Suspended
        • Castle Medical Center
      • Lihue, Hawaii, United States, 96766
        • Active, not recruiting
        • Wilcox Memorial Hospital and Kauai Medical Clinic
    • Idaho
      • Boise, Idaho, United States, 83712
        • Suspended
        • Saint Luke's Cancer Institute - Boise
      • Boise, Idaho, United States, 83706
        • Suspended
        • Saint Alphonsus Cancer Care Center-Boise
      • Caldwell, Idaho, United States, 83605
        • Suspended
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene, Idaho, United States, 83814
        • Recruiting
        • Kootenai Health - Coeur d'Alene
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Emmett, Idaho, United States, 83617
        • Suspended
        • Walter Knox Memorial Hospital
      • Fruitland, Idaho, United States, 83619
        • Suspended
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, United States, 83642
        • Suspended
        • Idaho Urologic Institute-Meridian
      • Meridian, Idaho, United States, 83642
        • Suspended
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, United States, 83686
        • Suspended
        • Saint Luke's Cancer Institute - Nampa
      • Nampa, Idaho, United States, 83687
        • Suspended
        • Saint Alphonsus Cancer Care Center-Nampa
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • Kootenai Clinic Cancer Services - Post Falls
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Sandpoint, Idaho, United States, 83864
        • Recruiting
        • Kootenai Cancer Clinic
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Twin Falls, Idaho, United States, 83301
        • Suspended
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Alton, Illinois, United States, 62002
        • Suspended
        • Saint Anthony's Health
      • Bloomington, Illinois, United States, 61704
        • Suspended
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, United States, 61520
        • Suspended
        • Illinois CancerCare-Canton
      • Carbondale, Illinois, United States, 62902
        • Suspended
        • Memorial Hospital of Carbondale
      • Carterville, Illinois, United States, 62918
        • Suspended
        • SIH Cancer Institute
      • Carthage, Illinois, United States, 62321
        • Suspended
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, United States, 62801
        • Suspended
        • Centralia Oncology Clinic
      • Chicago, Illinois, United States, 60612
        • Active, not recruiting
        • Rush University Medical Center
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Suspended
        • Decatur Memorial Hospital
      • Dixon, Illinois, United States, 61021
        • Suspended
        • Illinois CancerCare-Dixon
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Eureka, Illinois, United States, 61530
        • Suspended
        • Illinois CancerCare-Eureka
      • Galesburg, Illinois, United States, 61401
        • Suspended
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, United States, 61401
        • Suspended
        • Illinois CancerCare-Galesburg
      • Kewanee, Illinois, United States, 61443
        • Suspended
        • Illinois CancerCare-Kewanee Clinic
      • Macomb, Illinois, United States, 61455
        • Suspended
        • Illinois CancerCare-Macomb
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 708-226-4357
        • Principal Investigator:
          • Michael E. Woods
      • Melrose Park, Illinois, United States, 60160
        • Suspended
        • Marjorie Weinberg Cancer Center at Loyola-Gottlieb
      • Mount Vernon, Illinois, United States, 62864
        • Suspended
        • Good Samaritan Regional Health Center
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Ottawa, Illinois, United States, 61350
        • Suspended
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, United States, 61554
        • Suspended
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, United States, 61636
        • Suspended
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61615
        • Suspended
        • Illinois CancerCare-Peoria
      • Peru, Illinois, United States, 61354
        • Suspended
        • Valley Radiation Oncology
      • Peru, Illinois, United States, 61354
        • Suspended
        • Illinois CancerCare-Peru
      • Princeton, Illinois, United States, 61356
        • Suspended
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-7541
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Memorial Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Swansea, Illinois, United States, 62226
        • Suspended
        • Southwest Illinois Health Services LLP
      • Washington, Illinois, United States, 61571
        • Suspended
        • Illinois CancerCare - Washington
    • Indiana
      • Richmond, Indiana, United States, 47374
        • Active, not recruiting
        • Reid Health
      • South Bend, Indiana, United States, 46601
        • Suspended
        • Memorial Hospital of South Bend
    • Kansas
      • Garden City, Kansas, United States, 67846
        • Suspended
        • Central Care Cancer Center - Garden City
      • Great Bend, Kansas, United States, 67530
        • Suspended
        • Central Care Cancer Center - Great Bend
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Cancer Center
        • Contact:
        • Principal Investigator:
          • Eugene K. Lee
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Hospital-Westwood Cancer Center
        • Contact:
        • Principal Investigator:
          • Eugene K. Lee
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Active, not recruiting
        • University of Kentucky/Markey Cancer Center
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • East Jefferson General Hospital
        • Contact:
        • Principal Investigator:
          • Scott E. Delacroix
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • LSU Healthcare Network / Metairie Multi-Specialty Clinic
        • Contact:
        • Principal Investigator:
          • Scott E. Delacroix
      • New Orleans, Louisiana, United States, 70112
        • Suspended
        • Louisiana State University Health Science Center
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center New Orleans
        • Contact:
        • Principal Investigator:
          • Scott E. Delacroix
      • New Orleans, Louisiana, United States, 70115
        • Recruiting
        • Touro Infirmary
        • Contact:
        • Principal Investigator:
          • Scott E. Delacroix
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • Recruiting
        • UM Baltimore Washington Medical Center/Tate Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 410-553-8100
        • Principal Investigator:
          • Cherif N. Boutros
    • Massachusetts
      • Lowell, Massachusetts, United States, 01854
        • Active, not recruiting
        • Lowell General Hospital
      • Springfield, Massachusetts, United States, 01104
        • Suspended
        • Mercy Medical Center
    • Michigan
      • Adrian, Michigan, United States, 49221
        • Suspended
        • Hickman Cancer Center
      • Ann Arbor, Michigan, United States, 48106
      • Battle Creek, Michigan, United States, 49017
        • Recruiting
        • Bronson Battle Creek
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Brighton, Michigan, United States, 48114
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Canton, Michigan, United States, 48188
      • Canton, Michigan, United States, 48188
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Caro, Michigan, United States, 48723
        • Suspended
        • Caro Cancer Center
      • Chelsea, Michigan, United States, 48118
      • Chelsea, Michigan, United States, 48118
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Clarkston, Michigan, United States, 48346
        • Suspended
        • Hematology Oncology Consultants-Clarkston
      • Clarkston, Michigan, United States, 48346
        • Suspended
        • Newland Medical Associates-Clarkston
      • Detroit, Michigan, United States, 48236
        • Recruiting
        • Ascension Saint John Hospital
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • East China Township, Michigan, United States, 48054
        • Recruiting
        • Great Lakes Cancer Management Specialists-Doctors Park
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesee Cancer and Blood Disease Treatment Center
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesee Hematology Oncology PC
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesys Hurley Cancer Institute
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Hurley Medical Center
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Spectrum Health at Butterworth Campus
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Grand Rapids, Michigan, United States, 49503
        • Suspended
        • Helen DeVos Children's Hospital at Spectrum Health
      • Grand Rapids, Michigan, United States, 49503
        • Suspended
        • Trinity Health Grand Rapids Hospital
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • Academic Hematology Oncology Specialists
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Suspended
        • Michigan Breast Specialists-Grosse Pointe Woods
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • Bronson Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49009
        • Recruiting
        • Ascension Borgess Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49048
        • Suspended
        • Borgess Medical Center
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • University of Michigan Health - Sparrow Lansing
        • Principal Investigator:
          • Tareq Al Baghdadi
        • Contact:
      • Livonia, Michigan, United States, 48154
        • Suspended
        • Hope Cancer Clinic
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Macomb, Michigan, United States, 48044
        • Recruiting
        • Great Lakes Cancer Management Specialists-Macomb Medical Campus
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Macomb, Michigan, United States, 48044
        • Suspended
        • Michigan Breast Specialists-Macomb Township
      • Marlette, Michigan, United States, 48453
        • Suspended
        • Saint Mary's Oncology/Hematology Associates of Marlette
      • Monroe, Michigan, United States, 48162
        • Suspended
        • Toledo Clinic Cancer Centers-Monroe
      • Muskegon, Michigan, United States, 49444
        • Recruiting
        • Trinity Health Muskegon Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Niles, Michigan, United States, 49120
        • Suspended
        • Corewell Health Lakeland Hospitals - Niles Hospital
      • Norton Shores, Michigan, United States, 49444
        • Recruiting
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
        • Principal Investigator:
          • Kathleen J. Yost
        • Contact:
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • 21st Century Oncology-Pontiac
        • Principal Investigator:
          • Tareq Al Baghdadi
        • Contact:
      • Pontiac, Michigan, United States, 48341
        • Suspended
        • Hope Cancer Center
      • Pontiac, Michigan, United States, 48341
        • Suspended
        • Newland Medical Associates-Pontiac
      • Pontiac, Michigan, United States, 48341
        • Suspended
        • Saint Joseph Mercy Oakland
      • Reed City, Michigan, United States, 49677
        • Suspended
        • Corewell Health Reed City Hospital
      • Rochester Hills, Michigan, United States, 48309
        • Suspended
        • Great Lakes Cancer Management Specialists-Rochester Hills
      • Saginaw, Michigan, United States, 48601
        • Recruiting
        • Ascension Saint Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Saginaw, Michigan, United States, 48604
        • Recruiting
        • Oncology Hematology Associates of Saginaw Valley PC
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Saint Joseph, Michigan, United States, 49085
        • Suspended
        • Lakeland Medical Center Saint Joseph
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Sterling Heights, Michigan, United States, 48312
        • Recruiting
        • Bhadresh Nayak MD PC-Sterling Heights
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Tawas City, Michigan, United States, 48764
        • Recruiting
        • Ascension Saint Joseph Hospital
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Traverse City, Michigan, United States, 49684
        • Recruiting
        • Munson Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Great Lakes Cancer Management Specialists-Macomb Professional Building
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Saint John Macomb-Oakland Hospital
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Warren, Michigan, United States, 48088
        • Suspended
        • Advanced Breast Care Center PLLC
      • Warren, Michigan, United States, 48093
        • Suspended
        • Macomb Hematology Oncology PC
      • Warren, Michigan, United States, 48093
        • Suspended
        • Michigan Breast Specialists-Warren
      • West Branch, Michigan, United States, 48661
        • Suspended
        • Saint Mary's Oncology/Hematology Associates of West Branch
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • University of Michigan Health - West
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Ypsilanti, Michigan, United States, 48106
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Suspended
        • Fairview Ridges Hospital
      • Burnsville, Minnesota, United States, 55337
        • Suspended
        • Minnesota Oncology - Burnsville
      • Cambridge, Minnesota, United States, 55008
        • Suspended
        • Cambridge Medical Center
      • Coon Rapids, Minnesota, United States, 55433
        • Suspended
        • Mercy Hospital
      • Edina, Minnesota, United States, 55435
        • Suspended
        • Fairview Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Active, not recruiting
        • Unity Hospital
      • Maple Grove, Minnesota, United States, 55369
        • Suspended
        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood, Minnesota, United States, 55109
        • Suspended
        • Minnesota Oncology Hematology PA-Maplewood
      • Maplewood, Minnesota, United States, 55109
        • Suspended
        • Saint John's Hospital - Healtheast
      • Minneapolis, Minnesota, United States, 55407
        • Suspended
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55415
        • Suspended
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55454
        • Suspended
        • Health Partners Inc
      • Monticello, Minnesota, United States, 55362
        • Suspended
        • Monticello Cancer Center
      • New Ulm, Minnesota, United States, 56073
        • Suspended
        • New Ulm Medical Center
      • Princeton, Minnesota, United States, 55371
        • Suspended
        • Fairview Northland Medical Center
      • Robbinsdale, Minnesota, United States, 55422
        • Suspended
        • North Memorial Medical Health Center
      • Saint Louis Park, Minnesota, United States, 55416
        • Suspended
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, United States, 55102
        • Suspended
        • United Hospital
      • Saint Paul, Minnesota, United States, 55101
        • Suspended
        • Regions Hospital
      • Shakopee, Minnesota, United States, 55379
        • Suspended
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, United States, 55082
        • Suspended
        • Lakeview Hospital
      • Waconia, Minnesota, United States, 55387
        • Suspended
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Suspended
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Suspended
        • Minnesota Oncology Hematology PA-Woodbury
      • Wyoming, Minnesota, United States, 55092
        • Suspended
        • Fairview Lakes Medical Center
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Suspended
        • Saint Louis Cancer and Breast Institute-Ballwin
      • Bolivar, Missouri, United States, 65613
        • Suspended
        • Central Care Cancer Center - Bolivar
      • Branson, Missouri, United States, 65616
        • Suspended
        • Cox Cancer Center Branson
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Saint Francis Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-334-2230
          • Email: sfmc@sfmc.net
      • Cape Girardeau, Missouri, United States, 63703
        • Suspended
        • Southeast Cancer Center
      • Chesterfield, Missouri, United States, 63017
        • Recruiting
        • Saint Luke's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 314-205-6936
        • Principal Investigator:
          • Joseph Sokhn
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • MU Health - University Hospital/Ellis Fischel Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 573-882-7440
        • Principal Investigator:
          • Kushal Naha
      • Farmington, Missouri, United States, 63640
        • Recruiting
        • Parkland Health Center - Farmington
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Jefferson City, Missouri, United States, 65109
        • Suspended
        • Capital Region Southwest Campus
      • Joplin, Missouri, United States, 64804
        • Suspended
        • Freeman Health System
      • Joplin, Missouri, United States, 64804
        • Suspended
        • Mercy Hospital Joplin
      • Rolla, Missouri, United States, 65401
        • Suspended
        • Delbert Day Cancer Institute at PCRMC
      • Rolla, Missouri, United States, 65401
        • Suspended
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Saint Joseph, Missouri, United States, 64506
        • Suspended
        • Heartland Regional Medical Center
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
      • Saint Louis, Missouri, United States, 63131
        • Recruiting
        • Missouri Baptist Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Saint Louis, Missouri, United States, 63109
        • Suspended
        • Saint Louis Cancer and Breast Institute-South City
      • Saint Louis, Missouri, United States, 63128
        • Suspended
        • Mercy Hospital South
      • Sainte Genevieve, Missouri, United States, 63670
        • Recruiting
        • Sainte Genevieve County Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Springfield, Missouri, United States, 65804
        • Suspended
        • Mercy Hospital Springfield
      • Springfield, Missouri, United States, 65807
        • Suspended
        • CoxHealth South Hospital
      • Sullivan, Missouri, United States, 63080
        • Recruiting
        • Missouri Baptist Sullivan Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sunset Hills, Missouri, United States, 63127
        • Recruiting
        • BJC Outpatient Center at Sunset Hills
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Washington, Missouri, United States, 63090
        • Suspended
        • Mercy Hospital Washington
    • Montana
      • Anaconda, Montana, United States, 59711
        • Recruiting
        • Community Hospital of Anaconda
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Billings, Montana, United States, 59101
        • Suspended
        • Saint Vincent Healthcare
      • Billings, Montana, United States, 59102
        • Suspended
        • Saint Vincent Frontier Cancer Center
      • Bozeman, Montana, United States, 59715
        • Recruiting
        • Bozeman Deaconess Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Butte, Montana, United States, 59701
        • Suspended
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Healthcare- Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Suspended
        • Great Falls Clinic
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Kalispell Regional Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59802
        • Suspended
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Community Medical Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Contact:
        • Principal Investigator:
          • Einar F. Sverrisson
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Eugene J. Pietzak
      • Hackensack, New Jersey, United States, 07601
        • Active, not recruiting
        • Hackensack University Medical Center
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Eugene J. Pietzak
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Eugene J. Pietzak
      • Paramus, New Jersey, United States, 07652
        • Active, not recruiting
        • The Valley Hospital-Luckow Pavilion
      • Ridgewood, New Jersey, United States, 07450
        • Active, not recruiting
        • Valley Hospital
      • Ridgewood, New Jersey, United States, 07450
        • Active, not recruiting
        • Neurosurgeons of New Jersey-Ridgewood
      • Westwood, New Jersey, United States, 07675
        • Active, not recruiting
        • Valley Health System-Hematology/Oncology
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Eugene J. Pietzak
      • Elmira, New York, United States, 14905
        • Suspended
        • Arnot Ogden Medical Center/Falck Cancer Center
      • Flushing, New York, United States, 11355
        • Active, not recruiting
        • The New York Hospital Medical Center of Queens
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Eugene J. Pietzak
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Eugene J. Pietzak
      • New York, New York, United States, 10065
        • Recruiting
        • NYP/Weill Cornell Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 212-746-1848
        • Principal Investigator:
          • Cora N. Sternberg
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-862-2215
        • Principal Investigator:
          • Shenhong Wu
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Eugene J. Pietzak
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Matthew I. Milowsky
      • Hillsborough, North Carolina, United States, 27278
        • Recruiting
        • University of North Carolina-Hillsborough Campus
        • Contact:
        • Principal Investigator:
          • Matthew I. Milowsky
    • Ohio
      • Beavercreek, Ohio, United States, 45431
        • Active, not recruiting
        • Indu and Raj Soin Medical Center
      • Boardman, Ohio, United States, 44512
        • Active, not recruiting
        • Saint Elizabeth Boardman Hospital
      • Centerville, Ohio, United States, 45459
        • Suspended
        • Miami Valley Hospital South
      • Centerville, Ohio, United States, 45459
        • Active, not recruiting
        • Dayton Physicians LLC-Miami Valley South
      • Cincinnati, Ohio, United States, 45236
        • Active, not recruiting
        • Oncology Hematology Care Inc-Kenwood
      • Dayton, Ohio, United States, 45409
        • Active, not recruiting
        • Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Suspended
        • Miami Valley Hospital North
      • Dayton, Ohio, United States, 45415
        • Active, not recruiting
        • Dayton Physician LLC-Miami Valley Hospital North
      • Findlay, Ohio, United States, 45840
        • Active, not recruiting
        • Armes Family Cancer Center
      • Findlay, Ohio, United States, 45840
        • Active, not recruiting
        • Blanchard Valley Hospital
      • Findlay, Ohio, United States, 45840
        • Active, not recruiting
        • Orion Cancer Care
      • Franklin, Ohio, United States, 45005-1066
        • Suspended
        • Atrium Medical Center-Middletown Regional Hospital
      • Franklin, Ohio, United States, 45005
        • Active, not recruiting
        • Dayton Physicians LLC-Atrium
      • Greenville, Ohio, United States, 45331
        • Active, not recruiting
        • Dayton Physicians LLC-Wayne
      • Greenville, Ohio, United States, 45331
        • Active, not recruiting
        • Wayne Hospital
      • Kettering, Ohio, United States, 45420
        • Suspended
        • First Dayton Cancer Care
      • Kettering, Ohio, United States, 45409
        • Active, not recruiting
        • Greater Dayton Cancer Center
      • Kettering, Ohio, United States, 45429
        • Active, not recruiting
        • Kettering Medical Center
      • Perrysburg, Ohio, United States, 43551
        • Suspended
        • Mercy Health Perrysburg Cancer Center
      • Springfield, Ohio, United States, 45505
        • Suspended
        • Springfield Regional Medical Center
      • Springfield, Ohio, United States, 45504
        • Suspended
        • Springfield Regional Cancer Center
      • Toledo, Ohio, United States, 43623
        • Suspended
        • Mercy Health - Saint Anne Hospital
      • Toledo, Ohio, United States, 43623
        • Recruiting
        • Toledo Clinic Cancer Centers-Toledo
        • Principal Investigator:
          • Rex B. Mowat
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-3561
      • Troy, Ohio, United States, 45373
        • Suspended
        • Upper Valley Medical Center
      • Troy, Ohio, United States, 45373
        • Active, not recruiting
        • Dayton Physicians LLC - Troy
      • Warren, Ohio, United States, 44484
        • Active, not recruiting
        • Saint Joseph Warren Hospital
      • Youngstown, Ohio, United States, 44501
        • Active, not recruiting
        • Saint Elizabeth Youngstown Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Sanjay G. Patel
      • Oklahoma City, Oklahoma, United States, 73120
        • Suspended
        • Mercy Hospital Oklahoma City
    • Oregon
      • Baker City, Oregon, United States, 97814
        • Suspended
        • Saint Alphonsus Medical Center-Baker City
      • Bend, Oregon, United States, 97701
        • Suspended
        • Saint Charles Health System
      • Clackamas, Oregon, United States, 97015
        • Suspended
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, United States, 97015
        • Suspended
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, United States, 97420
        • Suspended
        • Bay Area Hospital
      • Newberg, Oregon, United States, 97132
        • Suspended
        • Providence Newberg Medical Center
      • Ontario, Oregon, United States, 97914
        • Suspended
        • Saint Alphonsus Medical Center-Ontario
      • Portland, Oregon, United States, 97213
        • Suspended
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Suspended
        • Providence Saint Vincent Medical Center
      • Redmond, Oregon, United States, 97756
        • Suspended
        • Saint Charles Health System-Redmond
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Hospital-Cedar Crest
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • Bethlehem, Pennsylvania, United States, 18017
        • Recruiting
        • Lehigh Valley Hospital - Muhlenberg
        • Contact:
        • Principal Investigator:
          • Tareq Al Baghdadi
      • East Stroudsburg, Pennsylvania, United States, 18301
        • Suspended
        • Pocono Medical Center
      • Hazleton, Pennsylvania, United States, 18201
        • Suspended
        • Lehigh Valley Hospital-Hazleton
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Recruiting
        • Ralph H Johnson VA Medical Center
        • Contact:
        • Principal Investigator:
          • Stephen J. Savage
      • Gaffney, South Carolina, United States, 29341
        • Suspended
        • Gibbs Cancer Center-Gaffney
      • Greer, South Carolina, United States, 29651
        • Recruiting
        • Gibbs Cancer Center-Pelham
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Spartanburg Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
      • Spartanburg, South Carolina, United States, 29303
        • Suspended
        • North Grove Medical Park
      • Spartanburg, South Carolina, United States, 29307
        • Suspended
        • Spartanburg Medical Center - Mary Black Campus
      • Union, South Carolina, United States, 29379
        • Suspended
        • MGC Hematology Oncology-Union
    • Texas
      • Galveston, Texas, United States, 77555-0565
        • Active, not recruiting
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 713-798-1354
          • Email: burton@bcm.edu
        • Principal Investigator:
          • Seth P. Lerner
      • League City, Texas, United States, 77573
        • Active, not recruiting
        • UTMB Cancer Center at Victory Lakes
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Contact:
        • Principal Investigator:
          • Daruka Mahadevan
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Audie L Murphy VA Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 877-469-5300
        • Principal Investigator:
          • Paromita Datta
    • Utah
      • American Fork, Utah, United States, 84003
        • Suspended
        • American Fork Hospital / Huntsman Intermountain Cancer Center
      • Cedar City, Utah, United States, 84720
        • Suspended
        • Sandra L Maxwell Cancer Center
      • Logan, Utah, United States, 84321
        • Suspended
        • Logan Regional Hospital
      • Murray, Utah, United States, 84107
        • Suspended
        • Intermountain Medical Center
      • Ogden, Utah, United States, 84403
        • Suspended
        • McKay-Dee Hospital Center
      • Provo, Utah, United States, 84604
        • Suspended
        • Utah Valley Regional Medical Center
      • Riverton, Utah, United States, 84065
        • Suspended
        • Riverton Hospital
      • Saint George, Utah, United States, 84770
        • Suspended
        • Saint George Regional Medical Center
      • Salt Lake City, Utah, United States, 84106
        • Suspended
        • Utah Cancer Specialists-Salt Lake City
      • Salt Lake City, Utah, United States, 84143
        • Suspended
        • LDS Hospital
    • Washington
      • Aberdeen, Washington, United States, 98520
        • Suspended
        • Providence Regional Cancer System-Aberdeen
      • Auburn, Washington, United States, 98001
        • Suspended
        • MultiCare Auburn Medical Center
      • Bellingham, Washington, United States, 98225
        • Suspended
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, United States, 98531
        • Suspended
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, United States, 98026
        • Suspended
        • Swedish Cancer Institute-Edmonds
      • Everett, Washington, United States, 98201
        • Suspended
        • Providence Regional Cancer Partnership
      • Gig Harbor, Washington, United States, 98335
        • Suspended
        • MultiCare Gig Harbor Medical Park
      • Issaquah, Washington, United States, 98029
        • Suspended
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, United States, 99336
        • Recruiting
        • Kadlec Clinic Hematology and Oncology
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Lacey, Washington, United States, 98503
        • Suspended
        • Providence Regional Cancer System-Lacey
      • Longview, Washington, United States, 98632
        • Suspended
        • PeaceHealth Saint John Medical Center
      • Port Townsend, Washington, United States, 98368
        • Recruiting
        • Jefferson Healthcare
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
          • Site Public Contact
          • Phone Number: 360-344-3091
      • Puyallup, Washington, United States, 98372
        • Suspended
        • MultiCare Good Samaritan Hospital
      • Seattle, Washington, United States, 98104
        • Suspended
        • Pacific Gynecology Specialists
      • Seattle, Washington, United States, 98107
        • Suspended
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, United States, 98122-5711
        • Suspended
        • Swedish Medical Center-Cherry Hill
      • Seattle, Washington, United States, 98122
        • Suspended
        • Swedish Medical Center-First Hill
      • Sedro-Woolley, Washington, United States, 98284
        • Suspended
        • PeaceHealth United General Medical Center
      • Shelton, Washington, United States, 98584
        • Suspended
        • Providence Regional Cancer System-Shelton
      • Spokane, Washington, United States, 99204
        • Suspended
        • MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
      • Spokane, Washington, United States, 99218
        • Suspended
        • MultiCare Deaconess Cancer and Blood Specialty Center - North
      • Spokane Valley, Washington, United States, 99216
        • Suspended
        • MultiCare Deaconess Cancer and Blood Specialty Center - Valley
      • Tacoma, Washington, United States, 98405
        • Suspended
        • MultiCare Tacoma General Hospital
      • Vancouver, Washington, United States, 98664
        • Recruiting
        • PeaceHealth Southwest Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Walla Walla, Washington, United States, 99362
        • Suspended
        • Providence Saint Mary Regional Cancer Center
      • Yelm, Washington, United States, 98597
        • Suspended
        • Providence Regional Cancer System-Yelm
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54701
      • Marshfield, Wisconsin, United States, 54449
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College Of Wisconsin
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-3666
        • Principal Investigator:
          • Scott Johnson
      • Minocqua, Wisconsin, United States, 54548
      • Mukwonago, Wisconsin, United States, 53149
        • Recruiting
        • ProHealth D N Greenwald Center
        • Contact:
        • Principal Investigator:
          • Timothy R. Wassenaar
      • New Richmond, Wisconsin, United States, 54017
        • Suspended
        • Cancer Center of Western Wisconsin
      • Oconomowoc, Wisconsin, United States, 53066
        • Recruiting
        • ProHealth Oconomowoc Memorial Hospital
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
          • Site Public Contact
          • Phone Number: 262-928-7878
      • Rice Lake, Wisconsin, United States, 54868
      • Stevens Point, Wisconsin, United States, 54482
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • ProHealth Waukesha Memorial Hospital
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
          • Site Public Contact
          • Phone Number: 262-928-7632
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • UW Cancer Center at ProHealth Care
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
      • Weston, Wisconsin, United States, 54476
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Suspended
        • Cheyenne Regional Medical Center-West
      • Cody, Wyoming, United States, 82414
        • Suspended
        • Billings Clinic-Cody
      • Sheridan, Wyoming, United States, 82801
        • Suspended
        • Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (pembrolizumab, gemcitabine hydrochloride)

INDUCTION: Patients receive pembrolizumab 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.
Biological: Pembrolizumab
Given IV
Other Names:
  • Keytruda
  • MK-3475
  • Lambrolizumab
  • SCH 900475
  • BCD-201
  • Pembrolizumab Biosimilar BCD-201
Drug: Gemcitabine Hydrochloride
Given intravesically
Other Names:
  • Gemzar
  • dFdCyd
  • Difluorodeoxycytidine Hydrochloride
  • Gemcitabine HCI
  • LY-188011
  • LY188011

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate in the carcinoma in situ (CIS) subpopulation
Time Frame: At 6 months (end of cycle 8, week 25)
A complete response, only for patients with a CIS component, is a cystoscopy without evidence of bladder tumor and negative biopsy (including directed biopsies to any suspicious areas and in addition random bladder biopsies including trigone, left lateral wall, right lateral wall, posterior bladder, dome of bladder, and the prostatic urethra in men), and negative cytology for high grade disease.
At 6 months (end of cycle 8, week 25)
Event-free survival at 18 months
Time Frame: From the date of study registration to the first documentation of an event or death whichever comes first, assessed up to 18 months
For patients without a documented event and who are still alive, they will be censored at last disease assessment. For patients who start any subsequent ant-cancer therapy without any reported events will be censored at their last disease assessment. will be obtained with a Kaplan-Meier estimator (using the Greenwood formula to estimate the variance) for the entire 153 patient group consisting of patients with CIS, CIS with Ta/T1 or Ta or T1 disease. A 90% confidence interval will be generated for the 18-month EFS estimate.
From the date of study registration to the first documentation of an event or death whichever comes first, assessed up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Up to 5 years post treatment
Adverse events will be assessed based on the National Cancer Institute (NCI) common toxicity criteria (Common Terminology Criteria for Adverse Events [CTACAE] version [v] 5.0).
Up to 5 years post treatment
Duration of response (DOR)
Time Frame: From the time a patient had a documented response (the time would start at the time a response was first noted) until disease-progression, assessed up to 5 years
Analysis will only include those patients in the CIS population who achieve a response. Patients who are alive and without a documented progression at the time of analysis will be censored at the time of the last disease status evaluation. The Kaplan-Meier product-limit estimator will be used to estimate DOR, medians and 95% confidence intervals (CI).
From the time a patient had a documented response (the time would start at the time a response was first noted) until disease-progression, assessed up to 5 years
Progression-free survival (PFS)
Time Frame: From the date of study registration to the date of progression or death due to any cause, whichever occurs first, assessed up to 5 years
Surviving patients without any documented progressions will be censored at the date of last known contact. Progression will be defined as the development of muscle invasive bladder cancer or metastatic urothelial cancer (nodal and/or distant). The Kaplan-Meier product-limit estimator will be used to estimate PFS, medians and 95% CI.
From the date of study registration to the date of progression or death due to any cause, whichever occurs first, assessed up to 5 years
Overall survival (OS)
Time Frame: From the date of study registration to date of death due to any cause, assessed up to 5 years
Surviving patients will be censored at the date of last known contact. The Kaplan-Meier product-limit estimator will be used to estimate OS, medians and 95% CI.
From the date of study registration to date of death due to any cause, assessed up to 5 years
Cystectomy-free survival
Time Frame: From the date of study registration to the date of cystectomy for all patients
The Kaplan-Meier product-limit estimator will be used to estimate cystectomy-free survival, medians and 95% CI.
From the date of study registration to the date of cystectomy for all patients
Recurrence free survival (RFS)
Time Frame: From the date of study registration to the first documentation of recurrence or death due to any cause, assessed up to 5 years
Surviving patients without any documented recurrence will be censored at the date of last known contact. Recurrence will be defined as the development of high-grade bladder cancer for patients with a CIS component only and those without a CIS component. The Kaplan-Meier product-limit estimator will be used to estimate RFS, medians and 95% CI.
From the date of study registration to the first documentation of recurrence or death due to any cause, assessed up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Michael E Woods, Alliance for Clinical Trials in Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2020

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (Actual)

November 15, 2019

Study Record Updates

Last Update Posted (Estimated)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2019-07573 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180821 (U.S. NIH Grant/Contract)
  • A031803 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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