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Checkpoint Inhibitor

Pembrolizumab for Bladder Cancer

Phase 2
Waitlist Available
Led By Neema Navai
Research Sponsored by M.D. Anderson Cancer Center
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 baseline up to 90 days after surgery
Awards & highlights

Study Summary

This trial is testing pembrolizumab as a treatment for bladder cancer patients undergoing surgery. It will look at side effects and how well the immunotherapy works.

Eligible Conditions
  • Bladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 90 days after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 90 days after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0
Secondary outcome measures
Biomarker activity of Pembrolizumab in Patients with Bladder Cancer Undergoing Radical Cystectomy

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)Experimental Treatment1 Intervention
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. About 4 weeks after treatment, patients then undergo radical cystectomy per standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,426 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,623 Total Patients Enrolled
Neema NavaiPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
10 Total Patients Enrolled

Frequently Asked Questions

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

How many participants are being recruited for this experiment?

"Unfortunately, this trial is no longer seeking participants. Initially posted on November 1st 2018 and last updated October 20th 2022, interested individuals should explore the 315 active trials involving urinary bladder or 961 Pembrolizumab studies currently recruiting."

Answered by AI

What other experiments have been conducted with Pembrolizumab as the focus?

"At present, 961 clinical investigations are underway that focus on Pembrolizumab. Of these studies, 122 have progressed to Phase 3 trials. The majority of the trails for this treatment occur in Houston, Texas, yet there are 35 731 research sites hosting related tests worldwide."

Answered by AI

Are there still opportunities for patients to join this experiment?

"This particular clinical trial is now closed to new participants. Initially posted on November 1st 2018 and last updated October 20th 2022, those searching for alternative medical studies can find 315 trials currently recruiting patients with urinary bladder conditions and 961 trials actively enrolling individuals using Pembrolizumab."

Answered by AI

How is Pembrolizumab typically utilized in treatment?

"Pembrolizumab is regularly prescribed for cancerous neoplasms but can also be used to treat the progression of disease after chemotherapy, unresectable melanoma, and microsatellite instability high."

Answered by AI

Has Pembrolizumab attained regulatory approval from the Food and Drug Administration?

"As this is a Phase 2 trial, meaning there are some data indicating safety but not efficacy, our team at Power assess the risk of Pembrolizumab to be a level 2."

Answered by AI
~3 spots leftby Mar 2025