Pembrolizumab for Bladder Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Bladder Cancer+1 MorePembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

1 of 3

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

2 of 3
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).