Immunotherapy With or Without Radiation Therapy for Metastatic Urothelial Cancer (NCT04936230) | Clinical Trial Compass
TerminatedPhase 2
Immunotherapy With or Without Radiation Therapy for Metastatic Urothelial Cancer
Stopped: Inadequate accrual rate
United States1 participantsStarted 2022-11-22
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 know…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.