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Anti-microtubule agent

Pembrolizumab for Bladder Cancer

Phase 2
Waitlist Available
Led By Michael Goodman, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients diagnosed with platinum-refractory metastatic urothelial cancer that is measureable based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1.36 Platinum-refractory disease is defined as progressive disease on cisplatin or carboplatin therapy or within 12 months of prior platinum treatment (last dose.)
At least 1 prior chemotherapy regimen containing cisplatin or carboplatin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This study is evaluating whether paclitaxel and pembrolizumab works better than paclitaxel alone in treating patients with urothelial cancer that has not responded to previous treatment and has spread to other places in the body.

Eligible Conditions
  • Bladder Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate
Secondary outcome measures
Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Progression Free Survival (Kaplan Meier Method)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, paclitaxel)Experimental Treatment3 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1 and paclitaxel IV over 60 minutes on day 1 and 8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,619 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,231 Previous Clinical Trials
1,001,786 Total Patients Enrolled
Michael Goodman, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
20 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people currently able to sign up for this clinical trial?

"Unfortunately, this trial has already collected the number of participants needed for the study. The clinical trial was first posted on April 6th, 2016 and most recently edited on September 26th, 2022. For those still interested in participating in trials, there are currently 2598 studies actively looking for patients with carcinoma, transitional cell and 1771 studies for Pembrolizumab actively recruiting participants."

Answered by AI

Is Pembrolizumab a new medication?

"Pembrolizumab is being trialled in 1771 studies globally, with 330 of those trials currently in Phase 3. The drug is being tested across 75216 locations, with a significant number of those trials taking place in Shanghai, China."

Answered by AI

How many study subjects are enrolled at this time?

"Unfortunately, this particular clinical trial is no longer recruiting patients. However, there are currently 2598 trials for carcinoma, transitional cell and 1771 studies for Pembrolizumab that are still enrolling participants."

Answered by AI

What are the potential dangers of Pembrolizumab to patients?

"Pembrolizumab falls into the Phase 2 category, which means that while there is some data suggesting it is safe, none of the trials thus far have shown that it is an effective medication."

Answered by AI

Pembrolizumab is most commonly given to treat which type of cancer?

"Pembrolizumab is frequently prescribed to those with unresectable melanoma. It has also been found to be effective in treating microsatellite instability high, patients at a high risk of disease recurrence, and disease itself."

Answered by AI
~3 spots leftby Mar 2025