Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy (IMAGINE)
Locally Advanced Bladder Urothelial Carcinoma, Locally Advanced Renal Pelvis Urothelial Carcinoma, Locally Advanced Ureter Urothelial Carcinoma
About this trial
This is an interventional treatment trial for Locally Advanced Bladder Urothelial Carcinoma
Eligibility Criteria
Documentation of disease
- Histologic documentation: Histologically or cytologically confirmed urothelial carcinoma (UC) with predominantly transitional-cell features
- Stage: Locally advanced or metastatic disease prior to starting immune checkpoint blockade
- Tumor Site: Bladder, renal pelvis, ureter, urethra, or prostate
- Patients must have received at least one cycle of current active treatment with standard of care (SOC) Food and Drug Administration (FDA) approved PD-1/L1 immune checkpoint inhibitor (ICI)-containing therapy for locally advance or metastatic UC
- Patients without progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 guidelines (i.e., with an ongoing [complete response] CR, partial response [PR], or stable disease [SD]) following completion of 12-15 months of ICI treatment
No history of tuberculosis, active hepatitis B (HBV) or hepatitis C (HCV), or uncontrolled human immunodeficiency virus (HIV)
- Patients with resolved HBV infection, defined as positive hepatitis B core antibody (anti-Hb) and negative hepatitis B surface antigen (HbsAg), are eligible
- Patients with positive HCV antibody are eligible if HCV ribonucleic acid (RNA) polymerase chain reaction (PCR) is negative
- Patients with HIV who are compliant with highly active antiretroviral therapy (HAART) and have normal CD4 count and undetectable viral load are eligible
- No history of allogeneic organ transplantation
No current immunosuppressive medication exceeding 10 mg/day of prednisone or its equivalent
* Patients with pre-existing or treatment-emergent autoimmune or inflammatory disorders which do not require systemic immunosuppressive treatment exceeding 10 mg/day of prednisone or its equivalent may be included
- No history of another primary malignancy except for malignancy treated with curative intent with no known active disease for >= 2 years, and adequately treated non-melanomatous skin cancer or carcinoma in situ (e.g. cervical carcinoma in situ [CIS]) without evidence of disease
- No female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not willing to employ effective birth control, because this study involves investigational agents whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test pregnancy test done =< 14 days prior to registration is required
REGISTRATION ELIGIBILITY CRITERIA:
- Patients without progressive disease per RECIST v 1.1 guidelines (i.e., with an ongoing CR, PR or SD) following completion of 12-15 months of ICI treatment
- No toxicity from ICI therapy that makes continuation of treatment clinically unacceptable
- Adequate bone marrow and organ functions to continue PD-1/L1 ICI as judged by the treating physician
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Central nervous system (CNS) metastasis is allowed if radiographically stable, clinically asymptomatic, and prior local therapy (if received) was completed > 6 months before registration
No history of tuberculosis, active hepatitis B (HBV) or hepatitis C (HCV), or uncontrolled human immunodeficiency virus (HIV)
- Patients with resolved HBV infection, defined as positive hepatitis B core antibody (anti-Hb) and negative hepatitis B surface antigen (HbsAg), are eligible
- Patients with positive HCV antibody are eligible if HCV RNA PCR is negative
- Patients with HIV who are compliant with highly active antiretroviral therapy (HAART) and have normal CD4 count and undetectable viral load are eligible
Sites / Locations
- Anchorage Associates in Radiation Medicine
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Fairbanks Memorial Hospital
- Cancer Center at Saint Joseph's
- Mercy Hospital Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs
- University of Arkansas for Medical Sciences
- Kaiser Permanente-Deer Valley Medical Center
- Mission Hope Medical Oncology - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Kaiser Permanente Dublin
- Kaiser Permanente-Fremont
- Fresno Cancer Center
- Kaiser Permanente-Fresno
- Kaiser Permanente-Modesto
- Kaiser Permanente Oakland-Broadway
- Kaiser Permanente-Oakland
- Stanford Cancer Institute Palo Alto
- Kaiser Permanente-Rancho Cordova Cancer Center
- Kaiser Permanente- Marshall Medical Offices
- Kaiser Permanente-Richmond
- Rohnert Park Cancer Center
- Kaiser Permanente-Roseville
- The Permanente Medical Group-Roseville Radiation Oncology
- Kaiser Permanente Downtown Commons
- Kaiser Permanente-South Sacramento
- South Sacramento Cancer Center
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Pacific Central Coast Health Center-San Luis Obispo
- Kaiser San Rafael-Gallinas
- Kaiser Permanente Medical Center - Santa Clara
- Mission Hope Medical Oncology - Santa Maria
- Kaiser Permanente-Santa Rosa
- Kaiser Permanente Cancer Treatment Center
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Kaiser Permanente-Walnut Creek
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- Boulder Community Foothills Hospital
- Rocky Mountain Cancer Centers-Boulder
- Rocky Mountain Cancer Centers - Centennial
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Saint Francis Cancer Center
- The Women's Imaging Center
- Porter Adventist Hospital
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Western Surgical Care
- Mercy Medical Center
- Southwest Oncology PC
- Mountain Blue Cancer Care Center - Swedish
- Rocky Mountain Cancer Centers - Swedish
- Swedish Medical Center
- The Melanoma and Skin Cancer Institute
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- Parker Adventist Hospital
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers-Thornton
- Holy Cross Hospital
- Kaiser Permanente Moanalua Medical Center
- Saint Luke's Cancer Institute - Boise
- Saint Luke's Cancer Institute - Fruitland
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Saint Luke's Cancer Institute - Twin Falls
- Saint Anthony's Health
- Rush - Copley Medical Center
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- SIH Cancer Institute
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Rush University Medical Center
- Carle at The Riverfront
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Illinois CancerCare-Dixon
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Good Samaritan Regional Health Center
- Cancer Care Center of O'Fallon
- Illinois CancerCare-Ottawa Clinic
- Illinois CancerCare-Pekin
- Illinois CancerCare-Peoria
- Methodist Medical Center of Illinois
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Carle Cancer Center
- The Carle Foundation Hospital
- Illinois CancerCare - Washington
- Rush-Copley Healthcare Center
- Baptist Health Floyd
- Mary Greeley Medical Center
- McFarland Clinic - Ames
- McFarland Clinic - Boone
- Saint Anthony Regional Hospital
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Alegent Health Mercy Hospital
- Greater Regional Medical Center
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Broadlawns Medical Center
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- McFarland Clinic - Trinity Cancer Center
- Trinity Regional Medical Center
- McFarland Clinic - Jefferson
- McFarland Clinic - Marshalltown
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Central Care Cancer Center - Garden City
- Central Care Cancer Center - Great Bend
- Flaget Memorial Hospital
- Baptist Health Corbin
- Commonwealth Cancer Center-Corbin
- Baptist Health Hardin
- Baptist Health Lexington
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- Saint Joseph London
- Jewish Hospital
- Baptist Health Louisville
- Saints Mary and Elizabeth Hospital
- UofL Health Medical Center Northeast
- Baptist Health Madisonville/Merle Mahr Cancer Center
- Baptist Health Paducah
- Baptist Health Richmond
- Jewish Hospital Medical Center South
- East Jefferson General Hospital
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
- Louisiana State University Health Science Center
- Dana-Farber Cancer Institute
- Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
- Dana-Farber Cancer Institute - Chestnut Hill
- Dana-Farber/Brigham and Women's Cancer Center at South Shore
- Hickman Cancer Center
- Saint Joseph Mercy Hospital
- Saint Joseph Mercy Brighton
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
- Henry Ford Cancer Institute-Downriver
- Saint Joseph Mercy Canton
- Trinity Health IHA Medical Group Hematology Oncology - Canton
- Caro Cancer Center
- Saint Joseph Mercy Chelsea
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
- Hematology Oncology Consultants-Clarkston
- Newland Medical Associates-Clarkston
- Henry Ford Hematology Oncology - Hayes
- Henry Ford Macomb Hospital-Clinton Township
- Henry Ford Medical Center-Fairlane
- Henry Ford Hospital
- Ascension Saint John Hospital
- Great Lakes Cancer Management Specialists-Doctors Park
- Genesee Cancer and Blood Disease Treatment Center
- Genesee Hematology Oncology PC
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Academic Hematology Oncology Specialists
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
- Michigan Breast Specialists-Grosse Pointe Woods
- Allegiance Health
- Sparrow Hospital
- Hope Cancer Clinic
- Trinity Health Saint Mary Mercy Livonia Hospital
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of Marlette
- Toledo Clinic Cancer Centers-Monroe
- Henry Ford Medical Center-Columbus
- 21st Century Oncology-Pontiac
- Hope Cancer Center
- Newland Medical Associates-Pontiac
- Saint Joseph Mercy Oakland
- Ascension Saint Mary's Hospital
- Oncology Hematology Associates of Saginaw Valley PC
- Henry Ford Macomb Health Center - Shelby Township
- Bhadresh Nayak MD PC-Sterling Heights
- Ascension Saint Joseph Hospital
- Advanced Breast Care Center PLLC
- Great Lakes Cancer Management Specialists-Macomb Professional Building
- Macomb Hematology Oncology PC
- Michigan Breast Specialists-Warren
- Saint John Macomb-Oakland Hospital
- Henry Ford West Bloomfield Hospital
- Saint Mary's Oncology/Hematology Associates of West Branch
- Henry Ford Wyandotte Hospital
- Huron Gastroenterology PC
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
- Sanford Joe Lueken Cancer Center
- Fairview Ridges Hospital
- Minnesota Oncology - Burnsville
- Cambridge Medical Center
- Mercy Hospital
- Saint Luke's Hospital of Duluth
- Fairview Southdale Hospital
- Unity Hospital
- Fairview Clinics and Surgery Center Maple Grove
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- Monticello Cancer Center
- New Ulm Medical Center
- Fairview Northland Medical Center
- North Memorial Medical Health Center
- Coborn Cancer Center at Saint Cloud Hospital
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Sanford Thief River Falls Medical Center
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Sanford Cancer Center Worthington
- Fairview Lakes Medical Center
- University of Mississippi Medical Center
- Saint Louis Cancer and Breast Institute-Ballwin
- Central Care Cancer Center - Bolivar
- Cox Cancer Center Branson
- Saint Francis Medical Center
- Southeast Cancer Center
- Siteman Cancer Center at West County Hospital
- Parkland Health Center - Farmington
- Capital Region Southwest Campus
- Freeman Health System
- Mercy Hospital Joplin
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Mercy Hospital South
- Siteman Cancer Center-South County
- Missouri Baptist Medical Center
- Siteman Cancer Center at Christian Hospital
- Mercy Hospital Saint Louis
- Siteman Cancer Center at Saint Peters Hospital
- Sainte Genevieve County Memorial Hospital
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Mercy Hospital Washington
- Saint Patrick Hospital - Community Hospital
- CHI Health Saint Francis
- CHI Health Good Samaritan
- Saint Elizabeth Regional Medical Center
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- Midlands Community Hospital
- The Dana-Farber Cancer Institute at Londonderry
- University of New Mexico Cancer Center
- Roswell Park Cancer Institute
- Queens Medical Associates PC
- Northwell Health/Center for Advanced Medicine
- Upstate Cancer Center at Oneida
- Upstate Cancer Center at Oswego
- Stony Brook University Medical Center
- State University of New York Upstate Medical University
- Southeastern Medical Oncology Center-Clinton
- Southeastern Medical Oncology Center-Goldsboro
- Southeastern Medical Oncology Center-Jacksonville
- Wake Forest University Health Sciences
- Sanford Bismarck Medical Center
- Sanford South University Medical Center
- Southpointe-Sanford Medical Center Fargo
- Sanford Medical Center Fargo
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- Good Samaritan Hospital - Cincinnati
- Bethesda North Hospital
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Mercy Health - Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Cancer Institute Clackamas Clinic
- Bay Area Hospital
- Providence Newberg Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Saint Charles Health System-Redmond
- Lehigh Valley Hospital-Cedar Crest
- Lehigh Valley Hospital - Muhlenberg
- Pocono Medical Center
- Lehigh Valley Hospital-Hazleton
- Sanford Cancer Center Oncology Clinic
- Sanford USD Medical Center - Sioux Falls
- The West Clinic - Wolf River
- Saint Joseph Regional Cancer Center
- UT Southwestern/Simmons Cancer Center-Dallas
- UT Southwestern/Simmons Cancer Center-Fort Worth
- UT Southwestern Clinical Center at Richardson/Plano
- Providence Regional Cancer System-Aberdeen
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-Edmonds
- Saint Elizabeth Hospital
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and Oncology
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical Center
- Jefferson Healthcare
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard Campus
- Swedish Medical Center-Cherry Hill
- Swedish Medical Center-First Hill
- PeaceHealth United General Medical Center
- Providence Regional Cancer System-Shelton
- Franciscan Research Center-Northwest Medical Plaza
- Northwest Medical Specialties PLLC
- PeaceHealth Southwest Medical Center
- Providence Saint Mary Regional Cancer Center
- Providence Regional Cancer System-Yelm
- Marshfield Medical Center-EC Cancer Center
- Marshfield Medical Center-Marshfield
- Marshfield Clinic-Minocqua Center
- ProHealth D N Greenwald Center
- Cancer Center of Western Wisconsin
- ProHealth Oconomowoc Memorial Hospital
- Marshfield Medical Center-Rice Lake
- Marshfield Medical Center-River Region at Stevens Point
- ProHealth Waukesha Memorial Hospital
- UW Cancer Center at ProHealth Care
- Marshfield Medical Center - Weston
- Cheyenne Regional Medical Center-West
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm A (immune checkpoint inhibitor)
Arm B (immune checkpoint inhibitor)
CONTINUATION OF ICI TREATMENT: Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity.
DISCONTINUATION OF ICI TREATMENT: Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion.