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Monoclonal Antibodies

Pembrolizumab for Bladder Cancer

Phase 1

Waitlist Available

Led By Joshua Meeks

Research Sponsored by Northwestern University

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 week 4: at minute 0, then 15, 30, and 60 minutes post-dosing

Awards & highlights

Study Summary

This study is evaluating whether pembrolizumab is effective in treating bladder cancer.

Eligible Conditions

Bladder Cancer
Bladder Urothelial Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4: at minute 0, then 15, 30, and 60 minutes post-dosing

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 4: at minute 0, then 15, 30, and 60 minutes post-dosing

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4: at minute 0, then 15, 30, and 60 minutes post-dosing 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 (MTD)

Secondary outcome measures

Dose Limiting Toxicities (DLTs)

Incidence of Adverse Events

Other outcome measures

Body Weight Changes

Expression of PD-1

+7 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab, BCG solution)Experimental Treatment4 Interventions

PRE-INDUCTION PHASE: Patients receive pembrolizumab intravesically once on day -14. INDUCTION PHASE: Patients receive BCG solution intravesically once weekly for 6 weeks at weeks 0-5 and pembrolizumab intravesically every 2 weeks at weeks 0, 2, and 4. MAINTENANCE PHASE: Beginning 2 weeks after the last dose of BCG solution, patients receive pembrolizumab intravesically every 2 weeks for 12 weeks at weeks 7, 9, 11, 13, 15, and 17 for a total of 6 doses. Patients then receive pembrolizumab intravesically every 4 weeks at weeks 21, 25, 29, 33, 37, 41, 45, and 49 for a total of 8 doses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

Bacillus calmette-guerin substrain tice live antigen

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,586 Previous Clinical Trials

917,242 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,888 Previous Clinical Trials

5,055,074 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,925,872 Total Patients Enrolled

Frequently Asked Questions

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

Could you provide an assessment of the potential risks associated with Pembrolizumab?

"Due to the limited data on Pembrolizumab's safety and efficacy, our team ascribes it a score of 1."

Answered by AI

What indications is pembrolizumab commonly employed to address?

"Pembrolizumab is approved as a form of therapy for individuals with unresectable melanoma. It may also be useful in treating microsatellite instability high, those at risk of relapse, and other forms of illness."

Answered by AI

Could you provide a synopsis of the research involving Pembrolizumab thus far?

"At the present time, there are 967 experiments underway for Pembrolizumab with 128 of them being Phase 3. Most trials for this medication occur in Houston, Texas yet 35968 sites have opened their doors to explore its potential therapeutic value."

Answered by AI

Is this research program currently recruiting participants?

"Unfortunately, this medical trial is not currently open for recruitment. It was first listed on February 10th 2017 and the most recent update occured September 27th 2022. Alternatively, there are 2,729 trials accepting patients with urinary bladder cancer and 967 studies recruiting participants to test pembrolizumab's efficacy."

Answered by AI

How many participants has this experiment attracted thus far?

"This trial has ceased recruiting, with the final update occurring on September 27th 2022. If you are still looking for clinical trials to participate in, there are currently 2,729 studies available that involve urinary bladder cancer and 967 related to pembrolizumab."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab and BCG Solution in Treating Patients With Recurrent Non-Muscle-Invasive Bladder Cancer

Joshua Meeks 2017. "Pembrolizumab and BCG Solution in Treating Patients With Recurrent Non-Muscle-Invasive Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02808143.

All > Bladder Cancer