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Taxanes

Arm A (pembrolizumab, docetaxel) for Bladder Cancer

Phase 1
Waitlist Available
Led By Primo Lara
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from enrollment to the first occurrence of disease progression, as determined by recist v1.1, or death from any cause, assessed up to 6 months post-treatment
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of the drug pembrolizumab when given with either of the drugs docetaxel or gemcitabine hydrochloride, in order to treat patients with advanced or metastatic urothelial cancer that has previously been unresponsive to treatment.

Eligible Conditions
  • Bladder Cancer
  • Urethral Cancer
  • Urothelial Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from enrollment to the first occurrence of disease progression, as determined by recist v1.1, or death from any cause, assessed up to 6 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from enrollment to the first occurrence of disease progression, as determined by recist v1.1, or death from any cause, assessed up to 6 months post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose of pembrolizumab based on the incidence of dose limiting toxicity, defined as the Incidence of adverse events, using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Secondary outcome measures
Overall response rate (ORR), assessed using the RECIST version 1.1
PD-L1 expression
Progression free survival (PFS)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (pembrolizumab, gemcitabine hydrochloride)Experimental Treatment2 Interventions
pembrolizumab IV as in Arm A and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8.
Group II: Arm A (pembrolizumab, docetaxel)Experimental Treatment2 Interventions
pembrolizumab IV over 30 minutes on day 1 and docetaxel IV over 60 minutes on day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620
Pembrolizumab
2017
Completed Phase 2
~2010
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,551 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,025 Total Patients Enrolled
Primo LaraPrincipal InvestigatorUniversity of California, Davis
5 Previous Clinical Trials
288 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pembrolizumab and Docetaxel or Gemcitabine Hydrochloride in Treating Patients Urothelial Cancer
2015. "Pembrolizumab and Docetaxel or Gemcitabine Hydrochloride in Treating Patients Urothelial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02437370.
~3 spots leftby Apr 2025
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