Study Summary
This trial is testing a combination of two drugs to treat people with urothelial carcinoma who can't take cisplatin. They'll look at how well the drugs work, how long people live, and if there are any side effects.
Eligible Conditions
- Bladder Cancer
- Metastatic Urothelial Carcinoma of the Ureter
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Patients are expected to stay on treatment for approximately 12 months; 18 months
12 months
Occurrence of Adverse Events and Serious Adverse Events
Overall Response Rate (ORR)
6 months
Progression-free survival (PFS) at 6 months (PFS6)
Month 18
Overall Survival (OS)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
1 Treatment Group
Cabozantinib and Pembrolizumab, all patients
1 of 1
Experimental Treatment
39 Total Participants · 1 Treatment Group
Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2
Cabozantinib and Pembrolizumab, all patientsExperimental Group · 2 Interventions: Pembrolizumab, Cabozantinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Cabozantinib
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: patients are expected to stay on treatment for approximately 12 months; 18 months
Who is running the clinical trial?
University of UtahLead Sponsor
1,003 Previous Clinical Trials
1,785,115 Total Patients Enrolled
ExelixisIndustry Sponsor
109 Previous Clinical Trials
17,969 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a medical condition that is responsive to treatment with an immunotherapy using a checkpoint inhibitor.
Measurable disease is required as determined by RECIST v1.1.1.1.1.1.
You are a male or female aged ≥ 18 years.
You have histologically proven transitional cell or urothelial carcinoma.
You have unresectable or metastatic disease.
You have an estimated creatinine clearance between 30 and 60 ml/min (Cockcroft-Gault formula).
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Conditions
Cancer Related
Treatments