Trial Outcomes & Findings for Immunotherapy With or Without Radiation Therapy for Metastatic Urothelial Cancer (NCT NCT04936230)
NCT ID: NCT04936230
Last Updated: 2025-08-17
Results Overview
Will be defined as a complete response (CR) or partial response (PR) as assessed by the treating physician using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
TERMINATED
PHASE2
1 participants
Up to 6 months from randomization
2025-08-17
Participant Flow
Participant milestones
| Measure |
Arm A (Pembrolizumab)
Patients receive pembrolizumab IV over 25-40 minutes on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, bone scan and/or PET scan, as well as optional urine and blood sample collection throughout the study.
Biospecimen Collection: Undergo urine and blood sample collection
Bone Scan: Undergo bone scan
Computed Tomography: Undergo CT scan
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
Positron Emission Tomography: Undergo PET scan
Questionnaire Administration: Ancillary studies
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Arm B (Pembrolizumab, SBRT)
Patients receive pembrolizumab as in Arm A. Patients also undergo SBRT QD every other day for 3 fractions over 2 weeks that must be completed before 12 weeks after the first dose of pembrolizumab in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, bone scan, and/or PET scan, as well as optional urine and blood sample collection throughout the study.
Biospecimen Collection: Undergo urine and blood sample collection
Bone Scan: Undergo bone scan
Computed Tomography: Undergo CT scan
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
Positron Emission Tomography: Undergo PET scan
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo SBRT
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Overall Study
STARTED
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1
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0
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Overall Study
COMPLETED
|
1
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0
|
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunotherapy With or Without Radiation Therapy for Metastatic Urothelial Cancer
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Up to 6 months from randomizationPopulation: In order to maintain the deidentification of the 1 patient accrued, this outcome measure will not be shared.
Will be defined as a complete response (CR) or partial response (PR) as assessed by the treating physician using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years from randomizationPopulation: In order to maintain the deidentification of the 1 patient accrued, this outcome measure will not be shared.
Will be determined to have a tumor response if they have a CR or PR as assessed by immune modified RECIST.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from randomization until disease progression as assessed by the treating physician using RECIST 1.1 or death due to any cause, assessed up to 3 yearsPopulation: In order to maintain the deidentification of the 1 patient accrued, this outcome measure will not be shared.
Stratified Cox models will be used to compare the outcomes between the two treatment groups. The results will be summarized with a forest plot displaying the estimate of the hazard ratio and corresponding 95% confidence interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from randomization until death due to any cause. Patients who are not known to be dead at time of analysis will be censored at the time of their last follow-up, assessed up to 3 yearsPopulation: In order to maintain the deidentification of the 1 patient accrued, this outcome measure will not be shared.
Stratified Cox models will be used to compare the outcomes between the two treatment groups. The results will be summarized with a forest plot displaying the estimate of the hazard ratio and corresponding 95% confidence interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1 yearPopulation: In order to maintain the deidentification of the 1 patient accrued, this outcome measure will not be shared.
The proportion of patients who discontinue their protocol directed treatment prior to one year from date of study registration will be determined. Patients who stop their protocol directed treatment for any reason prior to one year from study registration will be considered to have discontinued their treatment. The rates of treatment discontinuation at one year will be summarized with a binomial point estimate and corresponding 95% confidence interval by arm. A comparison between the rates will be performed with a chi-square test or a Fisher's exact test if the assumptions of the chi-square test are violated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years from randomizationPopulation: In order to maintain the deidentification of the 1 patient accrued, this outcome measure will not be shared.
Will be assessed by Common Terminology Criteria for Adverse Events version 5.0. Adverse events will be summarized with frequencies and relative frequencies.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Pembrolizumab)
Arm B (Pembrolizumab, SBRT)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60