Clinical trial NCT04637594: Trying to Find the Correct Length of Treatment with Immune Checkpoint Therapy
Official title: Duration of Immune Checkpoint Therapy in Locally Advanced or Metastatic Urothelial Carcinoma: a Randomized Phase 3 Non-Inferiority Trial (IMAGINE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Locally Advanced Bladder Urothelial Carcinoma
Locally Advanced Renal Pelvis Urothelial Carcinoma
Locally Advanced Ureter Urothelial Carcinoma
Locally Advanced Urethral Urothelial Carcinoma
Locally Advanced Urothelial Carcinoma
Metastatic Bladder Urothelial Carcinoma
Metastatic Renal Pelvis Urothelial Carcinoma
Metastatic Ureter Urothelial Carcinoma
Metastatic Urethral Urothelial Carcinoma
Metastatic Urothelial Carcinoma
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-11-20
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase III trial compares survival in urothelial cancer patients who stop immune checkpoint inhibitor treatment after being treated for about a year to those patients who continue treatment with immune checkpoint inhibitors. Immunotherapy with monoclonal antibodies, such as avelumab, durvalumab, pembrolizumab, atezolizumab, and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stopping immune checkpoint inhibitors early may still make the tumor shrink and patients may have similar survival rates as the patients who continue treatment. Stopping treatment early may also lead to fewer treatment-related side effects, an improvement in mental health, and a lower cost burden to patients.

Detailed description: PRIMARY OBJECTIVE:

I. To compare overall survival (OS).

SECONDARY OBJECTIVES:

I. To compare progression free survival (PFS) by (Response Evaluation Criteria in Solid Tumors) RECIST 1.1 criteria.

II. To compare PFS by immune-related (ir)RECIST criteria. III. To determine treatment-free interval (TFI) after immune checkpoint inhibitor (ICI) discontinuation. (Arm B) IV. To determine the rate of response by RECIST 1.1 criteria after ICI rechallenge. (Arm B) V. To assess adverse events in each study arm by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

OUTLINE: Patient are randomized to 1 of 2 arms.

ARM A (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.

After completion of study treatment, starting new treatment or withdrawn consent, patients are followed up at 4 weeks, and then every 6 months for 5 years following registration.

ARM B (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.

After completion of study treatment, patients are followed up at 4 weeks, and then every 6 months for 5 years following registration.

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

Primary outcomes:
measure: Overall survival (OS)
timeFrame: From randomization until death due to any cause, assessed up to 5 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: From randomization until disease progression or death due to any cause, assessed up to 5 years
measure: Immune-related progression-free survival (iPFS)
timeFrame: From randomization until disease progression as assessed by irRECIST criteria or death due to any cause, assessed up to 5 years
measure: Treatment-free interval (Arm B)
timeFrame: From last dose of immune checkpoint inhibitor (ICI) to initiation of a subsequent systemic treatment or death, assessed up to 5 years
measure: Rate of response after immune checkpoint inhibitor (ICI) rechallenge (Arm B)
timeFrame: Up to 5 years
measure: Incidence of adverse events (AEs)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Anchorage Associates in Radiation Medicine
state: Alaska
city: Anchorage
country: United States
facility: Anchorage Radiation Therapy Center
state: Alaska
city: Anchorage
country: United States
facility: Alaska Breast Care and Surgery LLC
state: Alaska
city: Anchorage
country: United States
facility: Alaska Oncology and Hematology LLC
state: Alaska
city: Anchorage
country: United States
facility: Alaska Women's Cancer Care
state: Alaska
city: Anchorage
country: United States
facility: Anchorage Oncology Centre
state: Alaska
city: Anchorage
country: United States
facility: Katmai Oncology Group
state: Alaska
city: Anchorage
country: United States
facility: Providence Alaska Medical Center
state: Alaska
city: Fairbanks
country: United States
facility: Fairbanks Memorial Hospital
state: Alaska
city: Phoenix
country: United States
facility: Cancer Center at Saint Joseph's
state: Arizona
city: Ft. Smith
country: United States
facility: Mercy Hospital Fort Smith
state: Arkansas
city: Hot Springs
country: United States
facility: CHI Saint Vincent Cancer Center Hot Springs
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Antioch
country: United States
facility: Kaiser Permanente-Deer Valley Medical Center
state: California
city: Arroyo Grande
country: United States
facility: Mission Hope Medical Oncology - Arroyo Grande
state: California
city: Burbank
country: United States
facility: Providence Saint Joseph Medical Center/Disney Family Cancer Center
state: California
city: Dublin
country: United States
facility: Kaiser Permanente Dublin
state: California
city: Fremont
country: United States
facility: Kaiser Permanente-Fremont
state: California
city: Fresno
country: United States
facility: Fresno Cancer Center
state: California
city: Fresno
country: United States
facility: Kaiser Permanente-Fresno
state: California
city: Modesto
country: United States
facility: Kaiser Permanente-Modesto
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Oakland-Broadway
state: California
city: Oakland
country: United States
facility: Kaiser Permanente-Oakland
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Institute Palo Alto
state: California
city: Rancho Cordova
country: United States
facility: Kaiser Permanente-Rancho Cordova Cancer Center
state: California
city: Redwood City
country: United States
facility: Kaiser Permanente- Marshall Medical Offices
state: California
city: Richmond
country: United States
facility: Kaiser Permanente-Richmond
state: California
city: Rohnert Park
country: United States
facility: Rohnert Park Cancer Center
state: California
city: Roseville
country: United States
facility: Kaiser Permanente-Roseville
state: California
city: Roseville
country: United States
facility: The Permanente Medical Group-Roseville Radiation Oncology
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Downtown Commons
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente-South Sacramento
state: California
city: Sacramento
country: United States
facility: South Sacramento Cancer Center
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente-San Francisco
state: California
city: San Jose
country: United States
facility: Kaiser Permanente-Santa Teresa-San Jose
state: California
city: San Leandro
country: United States
facility: Kaiser Permanente San Leandro
state: California
city: San Luis Obispo
country: United States
facility: Pacific Central Coast Health Center-San Luis Obispo
state: California
city: San Rafael
country: United States
facility: Kaiser San Rafael-Gallinas
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Medical Center - Santa Clara
state: California
city: Santa Maria
country: United States
facility: Mission Hope Medical Oncology - Santa Maria
state: California
city: Santa Rosa
country: United States
facility: Kaiser Permanente-Santa Rosa
state: California
city: South San Francisco
country: United States
facility: Kaiser Permanente Cancer Treatment Center
state: California
city: South San Francisco
country: United States
facility: Kaiser Permanente-South San Francisco
state: California
city: Stockton
country: United States
facility: Kaiser Permanente-Stockton
state: California
city: Vacaville
country: United States
facility: Kaiser Permanente Medical Center-Vacaville
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente-Vallejo
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente-Walnut Creek
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers-Aurora
state: Colorado
city: Aurora
country: United States
facility: The Medical Center of Aurora
state: Colorado
city: Boulder
country: United States
facility: Boulder Community Foothills Hospital
state: Colorado
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers-Boulder
state: Colorado
city: Centennial
country: United States
facility: Rocky Mountain Cancer Centers - Centennial
state: Colorado
city: Colorado Springs
country: United States
facility: Penrose-Saint Francis Healthcare
state: Colorado
city: Colorado Springs
country: United States
facility: Rocky Mountain Cancer Centers-Penrose
state: Colorado
city: Colorado Springs
country: United States
facility: Saint Francis Cancer Center
state: Colorado
city: Denver
country: United States
facility: The Women's Imaging Center
state: Colorado
city: Denver
country: United States
facility: Porter Adventist Hospital
state: Colorado
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Denver
country: United States
facility: Presbyterian - Saint Lukes Medical Center - Health One
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers-Midtown
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers-Rose
state: Colorado
city: Denver
country: United States
facility: Rose Medical Center
state: Colorado
city: Denver
country: United States
facility: Western Surgical Care
state: Colorado
city: Durango
country: United States
facility: Mercy Medical Center
state: Colorado
city: Durango
country: United States
facility: Southwest Oncology PC
state: Colorado
city: Englewood
country: United States
facility: Mountain Blue Cancer Care Center - Swedish
state: Colorado
city: Englewood
country: United States
facility: Rocky Mountain Cancer Centers - Swedish
state: Colorado
city: Englewood
country: United States
facility: Swedish Medical Center
state: Colorado
city: Englewood
country: United States
facility: The Melanoma and Skin Cancer Institute
state: Colorado
city: Lakewood
country: United States
facility: Rocky Mountain Cancer Centers-Lakewood
state: Colorado
city: Lakewood
country: United States
facility: Saint Anthony Hospital
state: Colorado
city: Littleton
country: United States
facility: Rocky Mountain Cancer Centers-Littleton
state: Colorado
city: Littleton
country: United States
facility: Littleton Adventist Hospital
state: Colorado
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Centers-Sky Ridge
state: Colorado
city: Lone Tree
country: United States
facility: Sky Ridge Medical Center
state: Colorado
city: Longmont
country: United States
facility: Longmont United Hospital
state: Colorado
city: Longmont
country: United States
facility: Rocky Mountain Cancer Centers-Longmont
state: Colorado
city: Parker
country: United States
facility: Parker Adventist Hospital
state: Colorado
city: Pueblo
country: United States
facility: Saint Mary Corwin Medical Center
state: Colorado
city: Thornton
country: United States
facility: Rocky Mountain Cancer Centers-Thornton
state: Colorado
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Honolulu
country: United States
facility: Kaiser Permanente Moanalua Medical Center
state: Hawaii
city: Boise
country: United States
facility: Saint Luke's Cancer Institute - Boise
state: Idaho
city: Fruitland
country: United States
facility: Saint Luke's Cancer Institute - Fruitland
state: Idaho
city: Meridian
country: United States
facility: Saint Luke's Cancer Institute - Meridian
state: Idaho
city: Nampa
country: United States
facility: Saint Luke's Cancer Institute - Nampa
state: Idaho
city: Twin Falls
country: United States
facility: Saint Luke's Cancer Institute - Twin Falls
state: Idaho
city: Alton
country: United States
facility: Saint Anthony's Health
state: Illinois
city: Aurora
country: United States
facility: Rush - Copley Medical Center
state: Illinois
city: Bloomington
country: United States
facility: Illinois CancerCare-Bloomington
state: Illinois
city: Canton
country: United States
facility: Illinois CancerCare-Canton
state: Illinois
city: Carbondale
country: United States
facility: Memorial Hospital of Carbondale
state: Illinois
city: Carterville
country: United States
facility: SIH Cancer Institute
state: Illinois
city: Carthage
country: United States
facility: Illinois CancerCare-Carthage
state: Illinois
city: Centralia
country: United States
facility: Centralia Oncology Clinic
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Danville
country: United States
facility: Carle at The Riverfront
state: Illinois
city: Decatur
country: United States
facility: Cancer Care Specialists of Illinois - Decatur
state: Illinois
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Dixon
country: United States
facility: Illinois CancerCare-Dixon
state: Illinois
city: Effingham
country: United States
facility: Carle Physician Group-Effingham
state: Illinois
city: Effingham
country: United States
facility: Crossroads Cancer Center
state: Illinois
city: Eureka
country: United States
facility: Illinois CancerCare-Eureka
state: Illinois
city: Galesburg
country: United States
facility: Illinois CancerCare-Galesburg
state: Illinois
city: Galesburg
country: United States
facility: Western Illinois Cancer Treatment Center
state: Illinois
city: Kewanee
country: United States
facility: Illinois CancerCare-Kewanee Clinic
state: Illinois
city: Macomb
country: United States
facility: Illinois CancerCare-Macomb
state: Illinois
city: Mattoon
country: United States
facility: Carle Physician Group-Mattoon/Charleston
state: Illinois
city: Mount Vernon
country: United States
facility: Good Samaritan Regional Health Center
state: Illinois
city: O'Fallon
country: United States
facility: Cancer Care Center of O'Fallon
state: Illinois
city: Ottawa
country: United States
facility: Illinois CancerCare-Ottawa Clinic
state: Illinois
city: Pekin
country: United States
facility: Illinois CancerCare-Pekin
state: Illinois
city: Peoria
country: United States
facility: Illinois CancerCare-Peoria
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Peru
country: United States
facility: Illinois CancerCare-Peru
state: Illinois
city: Peru
country: United States
facility: Valley Radiation Oncology
state: Illinois
city: Princeton
country: United States
facility: Illinois CancerCare-Princeton
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Springfield
country: United States
facility: Memorial Medical Center
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Urbana
country: United States
facility: The Carle Foundation Hospital
state: Illinois
city: Washington
country: United States
facility: Illinois CancerCare - Washington
state: Illinois
city: Yorkville
country: United States
facility: Rush-Copley Healthcare Center
state: Illinois
city: New Albany
country: United States
facility: Baptist Health Floyd
state: Indiana
city: Ames
country: United States
facility: Mary Greeley Medical Center
state: Iowa
city: Ames
country: United States
facility: McFarland Clinic - Ames
state: Iowa
city: Boone
country: United States
facility: McFarland Clinic - Boone
state: Iowa
city: Carroll
country: United States
facility: Saint Anthony Regional Hospital
state: Iowa
city: Clive
country: United States
facility: Medical Oncology and Hematology Associates-West Des Moines
state: Iowa
city: Clive
country: United States
facility: Mercy Cancer Center-West Lakes
state: Iowa
city: Council Bluffs
country: United States
facility: Alegent Health Mercy Hospital
state: Iowa
city: Creston
country: United States
facility: Greater Regional Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Iowa Methodist Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Medical Oncology and Hematology Associates-Des Moines
state: Iowa
city: Des Moines
country: United States
facility: Broadlawns Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Mercy Medical Center - Des Moines
state: Iowa
city: Des Moines
country: United States
facility: Mission Cancer and Blood - Laurel
state: Iowa
city: Des Moines
country: United States
facility: Iowa Lutheran Hospital
state: Iowa
city: Fort Dodge
country: United States
facility: McFarland Clinic - Trinity Cancer Center
state: Iowa
city: Fort Dodge
country: United States
facility: Trinity Regional Medical Center
state: Iowa
city: Jefferson
country: United States
facility: McFarland Clinic - Jefferson
state: Iowa
city: Marshalltown
country: United States
facility: McFarland Clinic - Marshalltown
state: Iowa
city: West Des Moines
country: United States
facility: Methodist West Hospital
state: Iowa
city: West Des Moines
country: United States
facility: Mercy Medical Center-West Lakes
state: Iowa
city: Garden City
country: United States
facility: Central Care Cancer Center - Garden City
state: Kansas
city: Great Bend
country: United States
facility: Central Care Cancer Center - Great Bend
state: Kansas
city: Bardstown
country: United States
facility: Flaget Memorial Hospital
state: Kentucky
city: Corbin
country: United States
facility: Baptist Health Corbin
state: Kentucky
city: Corbin
country: United States
facility: Commonwealth Cancer Center-Corbin
state: Kentucky
city: Elizabethtown
country: United States
facility: Baptist Health Hardin
state: Kentucky
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Lexington
country: United States
facility: Saint Joseph Radiation Oncology Resource Center
state: Kentucky
city: Lexington
country: United States
facility: Saint Joseph Hospital East
state: Kentucky
city: London
country: United States
facility: Saint Joseph London
state: Kentucky
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Louisville
country: United States
facility: Baptist Health Louisville
state: Kentucky
city: Louisville
country: United States
facility: Saints Mary and Elizabeth Hospital
state: Kentucky
city: Louisville
country: United States
facility: UofL Health Medical Center Northeast
state: Kentucky
city: Madisonville
country: United States
facility: Baptist Health Madisonville/Merle Mahr Cancer Center
state: Kentucky
city: Paducah
country: United States
facility: Baptist Health Paducah
state: Kentucky
city: Richmond
country: United States
facility: Baptist Health Richmond
state: Kentucky
city: Shepherdsville
country: United States
facility: Jewish Hospital Medical Center South
state: Kentucky
city: Metairie
country: United States
facility: East Jefferson General Hospital
state: Louisiana
city: Metairie
country: United States
facility: LSU Healthcare Network / Metairie Multi-Specialty Clinic
state: Louisiana
city: New Orleans
country: United States
facility: Louisiana State University Health Science Center
state: Louisiana
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Milford
country: United States
facility: Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
state: Massachusetts
city: Newton
country: United States
facility: Dana-Farber Cancer Institute - Chestnut Hill
state: Massachusetts
city: South Weymouth
country: United States
facility: Dana-Farber/Brigham and Women's Cancer Center at South Shore
state: Massachusetts
city: Adrian
country: United States
facility: Hickman Cancer Center
state: Michigan
city: Ann Arbor
country: United States
facility: Saint Joseph Mercy Hospital
state: Michigan
city: Brighton
country: United States
facility: Saint Joseph Mercy Brighton
state: Michigan
city: Brighton
country: United States
facility: Trinity Health IHA Medical Group Hematology Oncology - Brighton
state: Michigan
city: Brownstown
country: United States
facility: Henry Ford Cancer Institute-Downriver
state: Michigan
city: Canton
country: United States
facility: Saint Joseph Mercy Canton
state: Michigan
city: Canton
country: United States
facility: Trinity Health IHA Medical Group Hematology Oncology - Canton
state: Michigan
city: Caro
country: United States
facility: Caro Cancer Center
state: Michigan
city: Chelsea
country: United States
facility: Saint Joseph Mercy Chelsea
state: Michigan
city: Chelsea
country: United States
facility: Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
state: Michigan
city: Clarkston
country: United States
facility: Hematology Oncology Consultants-Clarkston
state: Michigan
city: Clarkston
country: United States
facility: Newland Medical Associates-Clarkston
state: Michigan
city: Clinton Township
country: United States
facility: Henry Ford Hematology Oncology - Hayes
state: Michigan
city: Clinton Township
country: United States
facility: Henry Ford Macomb Hospital-Clinton Township
state: Michigan
city: Dearborn
country: United States
facility: Henry Ford Medical Center-Fairlane
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Ascension Saint John Hospital
state: Michigan
city: East China
country: United States
facility: Great Lakes Cancer Management Specialists-Doctors Park
state: Michigan
city: Flint
country: United States
facility: Genesee Cancer and Blood Disease Treatment Center
state: Michigan
city: Flint
country: United States
facility: Genesee Hematology Oncology PC
state: Michigan
city: Flint
country: United States
facility: Genesys Hurley Cancer Institute
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Academic Hematology Oncology Specialists
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Michigan Breast Specialists-Grosse Pointe Woods
state: Michigan
city: Jackson
country: United States
facility: Allegiance Health
state: Michigan
city: Lansing
country: United States
facility: Sparrow Hospital
state: Michigan
city: Livonia
country: United States
facility: Hope Cancer Clinic
state: Michigan
city: Livonia
country: United States
facility: Trinity Health Saint Mary Mercy Livonia Hospital
state: Michigan
city: Macomb Township
country: United States
facility: Great Lakes Cancer Management Specialists-Macomb Medical Campus
state: Michigan
city: Macomb Township
country: United States
facility: Michigan Breast Specialists-Macomb Township
state: Michigan
city: Marlette
country: United States
facility: Saint Mary's Oncology/Hematology Associates of Marlette
state: Michigan
city: Monroe
country: United States
facility: Toledo Clinic Cancer Centers-Monroe
state: Michigan
city: Novi
country: United States
facility: Henry Ford Medical Center-Columbus
state: Michigan
city: Pontiac
country: United States
facility: 21st Century Oncology-Pontiac
state: Michigan
city: Pontiac
country: United States
facility: Hope Cancer Center
state: Michigan
city: Pontiac
country: United States
facility: Newland Medical Associates-Pontiac
state: Michigan
city: Pontiac
country: United States
facility: Saint Joseph Mercy Oakland
state: Michigan
city: Saginaw
country: United States
facility: Ascension Saint Mary's Hospital
state: Michigan
city: Saginaw
country: United States
facility: Oncology Hematology Associates of Saginaw Valley PC
state: Michigan
city: Shelby Township
country: United States
facility: Henry Ford Macomb Health Center - Shelby Township
state: Michigan
city: Sterling Heights
country: United States
facility: Bhadresh Nayak MD PC-Sterling Heights
state: Michigan
city: Tawas City
country: United States
facility: Ascension Saint Joseph Hospital
state: Michigan
city: Warren
country: United States
facility: Advanced Breast Care Center PLLC
state: Michigan
city: Warren
country: United States
facility: Great Lakes Cancer Management Specialists-Macomb Professional Building
state: Michigan
city: Warren
country: United States
facility: Macomb Hematology Oncology PC
state: Michigan
city: Warren
country: United States
facility: Michigan Breast Specialists-Warren
state: Michigan
city: Warren
country: United States
facility: Saint John Macomb-Oakland Hospital
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford West Bloomfield Hospital
state: Michigan
city: West Branch
country: United States
facility: Saint Mary's Oncology/Hematology Associates of West Branch
state: Michigan
city: Wyandotte
country: United States
facility: Henry Ford Wyandotte Hospital
state: Michigan
city: Ypsilanti
country: United States
facility: Huron Gastroenterology PC
state: Michigan
city: Ypsilanti
country: United States
facility: Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
state: Michigan
city: Bemidji
country: United States
facility: Sanford Joe Lueken Cancer Center
state: Minnesota
city: Burnsville
country: United States
facility: Fairview Ridges Hospital
state: Minnesota
city: Burnsville
country: United States
facility: Minnesota Oncology - Burnsville
state: Minnesota
city: Cambridge
country: United States
facility: Cambridge Medical Center
state: Minnesota
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Duluth
country: United States
facility: Saint Luke's Hospital of Duluth
state: Minnesota
city: Edina
country: United States
facility: Fairview Southdale Hospital
state: Minnesota
city: Fridley
country: United States
facility: Unity Hospital
state: Minnesota
city: Maple Grove
country: United States
facility: Fairview Clinics and Surgery Center Maple Grove
state: Minnesota
city: Maplewood
country: United States
facility: Minnesota Oncology Hematology PA-Maplewood
state: Minnesota
city: Maplewood
country: United States
facility: Saint John's Hospital - Healtheast
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott-Northwestern Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: Health Partners Inc
state: Minnesota
city: Monticello
country: United States
facility: Monticello Cancer Center
state: Minnesota
city: New Ulm
country: United States
facility: New Ulm Medical Center
state: Minnesota
city: Princeton
country: United States
facility: Fairview Northland Medical Center
state: Minnesota
city: Robbinsdale
country: United States
facility: North Memorial Medical Health Center
state: Minnesota
city: Saint Cloud
country: United States
facility: Coborn Cancer Center at Saint Cloud Hospital
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Clinic - Saint Louis Park
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: United Hospital
state: Minnesota
city: Shakopee
country: United States
facility: Saint Francis Regional Medical Center
state: Minnesota
city: Stillwater
country: United States
facility: Lakeview Hospital
state: Minnesota
city: Thief River Falls
country: United States
facility: Sanford Thief River Falls Medical Center
state: Minnesota
city: Waconia
country: United States
facility: Ridgeview Medical Center
state: Minnesota
city: Willmar
country: United States
facility: Rice Memorial Hospital
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Oncology Hematology PA-Woodbury
state: Minnesota
city: Worthington
country: United States
facility: Sanford Cancer Center Worthington
state: Minnesota
city: Wyoming
country: United States
facility: Fairview Lakes Medical Center
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Ballwin
country: United States
facility: Saint Louis Cancer and Breast Institute-Ballwin
state: Missouri
city: Bolivar
country: United States
facility: Central Care Cancer Center - Bolivar
state: Missouri
city: Branson
country: United States
facility: Cox Cancer Center Branson
state: Missouri
city: Cape Girardeau
country: United States
facility: Saint Francis Medical Center
state: Missouri
city: Cape Girardeau
country: United States
facility: Southeast Cancer Center
state: Missouri
city: Creve Coeur
country: United States
facility: Siteman Cancer Center at West County Hospital
state: Missouri
city: Farmington
country: United States
facility: Parkland Health Center - Farmington
state: Missouri
city: Jefferson City
country: United States
facility: Capital Region Southwest Campus
state: Missouri
city: Joplin
country: United States
facility: Freeman Health System
state: Missouri
city: Joplin
country: United States
facility: Mercy Hospital Joplin
state: Missouri
city: Rolla
country: United States
facility: Delbert Day Cancer Institute at PCRMC
state: Missouri
city: Rolla
country: United States
facility: Mercy Clinic-Rolla-Cancer and Hematology
state: Missouri
city: Saint Joseph
country: United States
facility: Heartland Regional Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis Cancer and Breast Institute-South City
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital South
state: Missouri
city: Saint Louis
country: United States
facility: Siteman Cancer Center-South County
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Siteman Cancer Center at Christian Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital Saint Louis
state: Missouri
city: Saint Peters
country: United States
facility: Siteman Cancer Center at Saint Peters Hospital
state: Missouri
city: Sainte Genevieve
country: United States
facility: Sainte Genevieve County Memorial Hospital
state: Missouri
city: Springfield
country: United States
facility: Mercy Hospital Springfield
state: Missouri
city: Springfield
country: United States
facility: CoxHealth South Hospital
state: Missouri
city: Sullivan
country: United States
facility: Missouri Baptist Sullivan Hospital
state: Missouri
city: Sunset Hills
country: United States
facility: Missouri Baptist Outpatient Center-Sunset Hills
state: Missouri
city: Washington
country: United States
facility: Mercy Hospital Washington
state: Missouri
city: Missoula
country: United States
facility: Saint Patrick Hospital - Community Hospital
state: Montana
city: Grand Island
country: United States
facility: CHI Health Saint Francis
state: Nebraska
city: Kearney
country: United States
facility: CHI Health Good Samaritan
state: Nebraska
city: Lincoln
country: United States
facility: Saint Elizabeth Regional Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Alegent Health Immanuel Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Alegent Health Bergan Mercy Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Alegent Health Lakeside Hospital
state: Nebraska
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
city: Papillion
country: United States
facility: Midlands Community Hospital
state: Nebraska
city: Londonderry
country: United States
facility: The Dana-Farber Cancer Institute at Londonderry
state: New Hampshire
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Fresh Meadows
country: United States
facility: Queens Medical Associates PC
state: New York
city: Lake Success
country: United States
facility: Northwell Health/Center for Advanced Medicine
state: New York
city: Oneida
country: United States
facility: Upstate Cancer Center at Oneida
state: New York
city: Oswego
country: United States
facility: Upstate Cancer Center at Oswego
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Syracuse
country: United States
facility: State University of New York Upstate Medical University
state: New York
city: Clinton
country: United States
facility: Southeastern Medical Oncology Center-Clinton
state: North Carolina
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center-Goldsboro
state: North Carolina
city: Jacksonville
country: United States
facility: Southeastern Medical Oncology Center-Jacksonville
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Bismarck
country: United States
facility: Sanford Bismarck Medical Center
state: North Dakota
city: Fargo
country: United States
facility: Sanford South University Medical Center
state: North Dakota
city: Fargo
country: United States
facility: Southpointe-Sanford Medical Center Fargo
state: North Dakota
city: Fargo
country: United States
facility: Sanford Medical Center Fargo
state: North Dakota
city: Fargo
country: United States
facility: Sanford Broadway Medical Center
state: North Dakota
city: Fargo
country: United States
facility: Sanford Roger Maris Cancer Center
state: North Dakota
city: Cincinnati
country: United States
facility: Good Samaritan Hospital - Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
city: Cincinnati
country: United States
facility: TriHealth Cancer Institute-Westside
state: Ohio
city: Cincinnati
country: United States
facility: TriHealth Cancer Institute-Anderson
state: Ohio
city: Toledo
country: United States
facility: Mercy Health - Saint Anne Hospital
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic Cancer Centers-Toledo
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Mercy Hospital Oklahoma City
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute-Tulsa
state: Oklahoma
city: Bend
country: United States
facility: Saint Charles Health System
state: Oregon
city: Clackamas
country: United States
facility: Clackamas Radiation Oncology Center
state: Oregon
city: Clackamas
country: United States
facility: Providence Cancer Institute Clackamas Clinic
state: Oregon
city: Coos Bay
country: United States
facility: Bay Area Hospital
state: Oregon
city: Newberg
country: United States
facility: Providence Newberg Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence Saint Vincent Medical Center
state: Oregon
city: Redmond
country: United States
facility: Saint Charles Health System-Redmond
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital-Cedar Crest
state: Pennsylvania
city: Bethlehem
country: United States
facility: Lehigh Valley Hospital - Muhlenberg
state: Pennsylvania
city: East Stroudsburg
country: United States
facility: Pocono Medical Center
state: Pennsylvania
city: Hazleton
country: United States
facility: Lehigh Valley Hospital-Hazleton
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Cancer Center Oncology Clinic
state: South Dakota
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center - Sioux Falls
state: South Dakota
city: Germantown
country: United States
facility: The West Clinic - Wolf River
state: Tennessee
city: Bryan
country: United States
facility: Saint Joseph Regional Cancer Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern/Simmons Cancer Center-Dallas
state: Texas
city: Fort Worth
country: United States
facility: UT Southwestern/Simmons Cancer Center-Fort Worth
state: Texas
city: Richardson
country: United States
facility: UT Southwestern Clinical Center at Richardson/Plano
state: Texas
city: Aberdeen
country: United States
facility: Providence Regional Cancer System-Aberdeen
state: Washington
city: Bellingham
country: United States
facility: PeaceHealth Saint Joseph Medical Center
state: Washington
city: Bremerton
country: United States
facility: Harrison HealthPartners Hematology and Oncology-Bremerton
state: Washington
city: Bremerton
country: United States
facility: Harrison Medical Center
state: Washington
city: Burien
country: United States
facility: Highline Medical Center-Main Campus
state: Washington
city: Centralia
country: United States
facility: Providence Regional Cancer System-Centralia
state: Washington
city: Edmonds
country: United States
facility: Swedish Cancer Institute-Edmonds
state: Washington
city: Enumclaw
country: United States
facility: Saint Elizabeth Hospital
state: Washington
city: Everett
country: United States
facility: Providence Regional Cancer Partnership
state: Washington
city: Federal Way
country: United States
facility: Saint Francis Hospital
state: Washington
city: Issaquah
country: United States
facility: Swedish Cancer Institute-Issaquah
state: Washington
city: Kennewick
country: United States
facility: Kadlec Clinic Hematology and Oncology
state: Washington
city: Lacey
country: United States
facility: Providence Regional Cancer System-Lacey
state: Washington
city: Lakewood
country: United States
facility: Saint Clare Hospital
state: Washington
city: Longview
country: United States
facility: PeaceHealth Saint John Medical Center
state: Washington
city: Port Townsend
country: United States
facility: Jefferson Healthcare
state: Washington
city: Poulsbo
country: United States
facility: Harrison HealthPartners Hematology and Oncology-Poulsbo
state: Washington
city: Seattle
country: United States
facility: Pacific Gynecology Specialists
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center-Ballard Campus
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center-Cherry Hill
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center-First Hill
state: Washington
city: Sedro-Woolley
country: United States
facility: PeaceHealth United General Medical Center
state: Washington
city: Shelton
country: United States
facility: Providence Regional Cancer System-Shelton
state: Washington
city: Tacoma
country: United States
facility: Franciscan Research Center-Northwest Medical Plaza
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties PLLC
state: Washington
city: Vancouver
country: United States
facility: PeaceHealth Southwest Medical Center
state: Washington
city: Walla Walla
country: United States
facility: Providence Saint Mary Regional Cancer Center
state: Washington
city: Yelm
country: United States
facility: Providence Regional Cancer System-Yelm
state: Washington
city: Eau Claire
country: United States
facility: Marshfield Medical Center-EC Cancer Center
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Medical Center-Marshfield
state: Wisconsin
city: Minocqua
country: United States
facility: Marshfield Clinic-Minocqua Center
state: Wisconsin
city: Mukwonago
country: United States
facility: ProHealth D N Greenwald Center
state: Wisconsin
city: New Richmond
country: United States
facility: Cancer Center of Western Wisconsin
state: Wisconsin
city: Oconomowoc
country: United States
facility: ProHealth Oconomowoc Memorial Hospital
state: Wisconsin
city: Rice Lake
country: United States
facility: Marshfield Medical Center-Rice Lake
state: Wisconsin
city: Stevens Point
country: United States
facility: Marshfield Medical Center-River Region at Stevens Point
state: Wisconsin
city: Waukesha
country: United States
facility: ProHealth Waukesha Memorial Hospital
state: Wisconsin
city: Waukesha
country: United States
facility: UW Cancer Center at ProHealth Care
state: Wisconsin
city: Weston
country: United States
facility: Marshfield Medical Center - Weston
state: Wisconsin
city: Cheyenne
country: United States
facility: Cheyenne Regional Medical Center-West
state: Wyoming
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Xiao X. Wei, MD, MAS
role: STUDY_CHAIR
References: