Clinical Research Directory
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Testing MK-3475 (Pembrolizumab) After Surgery for Localized Muscle-Invasive Bladder Cancer and Locally Advanced Urothelial Cancer
Sponsor: National Cancer Institute (NCI)
Summary
This phase III trial studies how well pembrolizumab works in treating patients with bladder cancer that has spread into the deep muscle of the bladder wall (muscle-invasive) or urothelial cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Monoclonal antibodies recognizing and blocking checkpoint molecules can enhance the patient's immune response and therefore help fight cancer. Pembrolizumab is one of the monoclonal antibodies that block the PD-1 axis and can interfere with the ability of tumor cells to grow.
Official title: Phase III Randomized Adjuvant Study of Pembrolizumab in muScle invaSive and locAlly aDvanced urOthelial caRcinoma (AMBASSADOR) Versus Observation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
739
Start Date
2017-11-03
Completion Date
2027-01-01
Last Updated
2026-10-26
Healthy Volunteers
No
Conditions
Interventions
Biospecimen Collection
Undergo blood sample collection
Clinical Observation
Undergo observation
Computed Tomography
Undergo a CT scan
CT Urography
Undergo a CT urography
Cystoscopy
Undergo a cystoscopy
Magnetic Resonance Imaging
Undergo a MRI
Pembrolizumab
Given IV
Pharmacological Study
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Locations (914)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Anchorage Oncology Centre
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
CTCA at Western Regional Medical Center
Goodyear, Arizona, United States
Kingman Regional Medical Center
Kingman, Arizona, United States
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, United States
John L McClellan Memorial Veterans Hospital
Little Rock, Arkansas, United States
Kaiser Permanente-Anaheim
Anaheim, California, United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, United States
PCR Oncology
Arroyo Grande, California, United States
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, United States
Kaiser Permanente-Baldwin Park
Baldwin Park, California, United States
Kaiser Permanente-Bellflower
Bellflower, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
Epic Care-Dublin
Dublin, California, United States
Bay Area Breast Surgeons Inc
Emeryville, California, United States
Epic Care Partners in Cancer Care
Emeryville, California, United States
Kaiser Permanente-Fontana
Fontana, California, United States
Kaiser Permanente South Bay
Harbor City, California, United States
Kaiser Permanente-Irvine
Irvine, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Kaiser Permanente West Los Angeles
Los Angeles, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Fremont - Rideout Cancer Center
Marysville, California, United States
Community Hospital of Monterey Peninsula
Monterey, California, United States
Pacific Cancer Care-Monterey
Monterey, California, United States
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
Bay Area Tumor Institute
Oakland, California, United States
Kaiser Permanente-Ontario
Ontario, California, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
Kaiser Permanente - Panorama City
Panorama City, California, United States
Keck Medical Center of USC Pasadena
Pasadena, California, United States
Kaiser Permanente-Riverside
Riverside, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Kaiser Permanente-Rio San Diego
San Diego, California, United States
Kaiser Permanente-San Diego Zion
San Diego, California, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, United States
Kaiser Permanente-San Marcos
San Marcos, California, United States
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, United States
Epic Care Cyberknife Center
Walnut Creek, California, United States
Kaiser Permanente-Woodland Hills
Woodland Hills, California, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States
The Medical Center of Aurora
Aurora, Colorado, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Boulder Community Foothills Hospital
Boulder, Colorado, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, United States
Memorial Hospital North
Colorado Springs, Colorado, United States
Cancer Center of Colorado at Sloan's Lake
Denver, Colorado, United States
Kaiser Permanente-Franklin
Denver, Colorado, United States
National Jewish Health-Main Campus
Denver, Colorado, United States
The Women's Imaging Center
Denver, Colorado, United States
AdventHealth Porter
Denver, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Western Surgical Care
Denver, Colorado, United States
CommonSpirit Cancer Center Mercy
Durango, Colorado, United States
Mercy Medical Center
Durango, Colorado, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, United States
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
The Melanoma and Skin Cancer Institute
Englewood, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
National Jewish Health-Western Hematology Oncology
Golden, Colorado, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States
Grand Valley Oncology
Grand Junction, Colorado, United States
Banner North Colorado Medical Center
Greeley, Colorado, United States
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, United States
Good Samaritan Hospital - Cancer Centers of Colorado
Lafayette, Colorado, United States
Kaiser Permanente-Rock Creek
Lafayette, Colorado, United States
CommonSpirit Saint Anthony Hospital Cancer Center
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States
AdventHealth Littleton
Littleton, Colorado, United States
Kaiser Permanente-Lone Tree
Lone Tree, Colorado, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States