Immunotherapy With or Without Radiation Therapy for Metastatic Urothelial Cancer
Stopped early · Phase 2
Conditions studied: Metastatic Urothelial Carcinoma, Platinum-Resistant Urothelial Carcinoma, Stage IV Bladder Cancer AJCC v8
In brief
This phase II trial compares the effect of adding radiation therapy to an immunotherapy drug called pembrolizumab versus pembrolizumab alone in treating patients with urothelial cancer that has spread from where it first started (primary site) to other places in the body (metastatic). The addition of radiation to immunotherapy may shrink the cancer, but it could also cause side effects. Immunotherapy with monoclonal antibodies such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that uses high energy x-rays to kill tumor cells and shrink tumors. This method uses special equipment to position a patient and precisely deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and may cause less damage to normal tissue than conventional radiation therapy. The combination of pembrolizumab and radiation therapy may be more efficient in killing tumor cells.
Key facts
- Study ID
- NCT04936230
- Run by
- National Cancer Institute (NCI)
- People needed
- 1
- Starts
- 2022-11-22
- Expected to finish
- 2024-08-15
- Last updated by the study team
- 2025-08-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed metastatic urothelial carcinoma
- Patients must be either ineligible for platinum treatment or platinum refractory as defined below:
- Platinum-ineligible: If patients meet any one of the following criteria:
- Impaired renal function (creatinine clearance [CrCl] of < 30 mL/min)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of > 2
- Grade > 2 peripheral neuropathy
- New York Heart Association (NYHA) Heart Failure of > 3
- Platinum-refractory: If patients meet any one of the following criteria:
- Prior platinum-based perioperative chemotherapy within 12 months of relapse
- Prior platinum-based chemotherapy for metastatic disease
- Patients must have at least one measurable site >= 1 cm in diameter per RECIST 1.1 and a site targetable for radiotherapy. Measurable site must not overlap with radiated site such that measurable site cannot receive > 2 Gy per fraction
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions)
- Men and women, ages >= 18 years of age
- ECOG performance status =< 2
- Leukocytes >= 2,500/mm\^3
- Absolute neutrophil count >= 1,500/mm\^3
- Platelets >= 100,000/mm\^3
- Hemoglobin >= 8 g/dL
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x upper limit of normal (ULN)
- AST and/or ALT =< 5 x ULN for patients with liver involvement
- Alkaline phosphatase =< 2.5 x ULN
- =< 5 x ULN for patients with documented liver involvement or if due to bone metastases primarily in absence of liver disease, no limitation
- No prior allogeneic bone marrow transplantation or prior solid organ transplantation
- No prior radiotherapy to targetable site or measurable site
Where it is running
- Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
- Illinois CancerCare-Canton — Canton, Illinois, United States
- Illinois CancerCare-Carthage — Carthage, Illinois, United States
- Centralia Oncology Clinic — Centralia, Illinois, United States
- Rush University Medical Center — Chicago, Illinois, United States
- University of Illinois — Chicago, Illinois, United States
- Carle at The Riverfront — Danville, Illinois, United States
- Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States
- Decatur Memorial Hospital — Decatur, Illinois, United States
- Carle Physician Group-Effingham — Effingham, Illinois, United States
- Crossroads Cancer Center — Effingham, Illinois, United States
- Illinois CancerCare-Eureka — Eureka, Illinois, United States
- Illinois CancerCare-Galesburg — Galesburg, Illinois, United States
- Illinois CancerCare-Kewanee Clinic — Kewanee, Illinois, United States
- Illinois CancerCare-Macomb — Macomb, Illinois, United States
- Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois, United States
- Cancer Care Center of O'Fallon — O'Fallon, Illinois, United States
- HSHS Saint Elizabeth's Hospital — O'Fallon, Illinois, United States
- Illinois CancerCare-Ottawa Clinic — Ottawa, Illinois, United States
- Illinois CancerCare-Pekin — Pekin, Illinois, United States
- Illinois CancerCare-Peoria — Peoria, Illinois, United States
- OSF Saint Francis Medical Center — Peoria, Illinois, United States
- Illinois CancerCare-Peru — Peru, Illinois, United States
- Illinois CancerCare-Princeton — Princeton, Illinois, United States
- Littleton Adventist Hospital — Littleton, Colorado, United States
Full record on ClinicalTrials.gov
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