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Alkylating agents

Pembrolizumab for Bladder Cancer

Phase 1

Waitlist Available

Led By Arnold Chin

Research Sponsored by Jonsson Comprehensive 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 up to 3 years

Awards & highlights

Study Summary

This trial is testing pembrolizumab in combination with chemotherapy to treat small cell/neuroendocrine cancers of the urothelium or prostate.

Eligible Conditions

Bladder Cancer
Prostate Cancer
Urethral Cancer
Small Cell Carcinoma
Prostate Carcinoma
Bladder Carcinoma
Prostate Neuroendocrine Tumor
Urothelial Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Durable response rate (DRR) (Cohorts 1 and 2)

Duration of response (DOR) per RECIST 1.1 (Cohorts 1 and 2)

Incidence of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (Cohorts 1 and 2)

+4 more

Other outcome measures

PD-L1 expression biomarkers

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

Pneumothorax

Malnutrition, Hypercalcemia and Weakness

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, platinum-based chemotherapy)Experimental Treatment5 Interventions

Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising either etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1), or etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Cisplatin

2013

Completed Phase 3

~1940

Carboplatin

2014

Completed Phase 3

~6670

Docetaxel

1995

Completed Phase 4

~5620

Etoposide

2010

Completed Phase 3

~2440

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

361 Previous Clinical Trials

27,767 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,896 Previous Clinical Trials

5,062,703 Total Patients Enrolled

Arnold ChinPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

Frequently Asked Questions

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

Are there dangers associated with Pembrolizumab?

"Pembrolizumab falls into the Phase 1 category, meaning that while there is some data supporting its efficacy, there is limited information on its safety. We've given it a score of 1."

Answered by AI

Are we still enrolling patients for this experiment?

"Yes, this trial is still looking for volunteers. According to the information available on clinicaltrials.gov, the study was first posted on December 20th, 2018 and was last updated on March 23rd, 2022."

Answered by AI

What medical conditions does Pembrolizumab usually help alleviate?

"Pembrolizumab is the standard care treatment for esophageal neoplasms malignant. However, this medication can also help patients that have neuroendocrine tumours (nets), disease, and hodgkin disease."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab With Combination Chemotherapy in Treating Participants With Locally Advanced or Metastatic Small Cell/Neuroendocrine Cancers of Urothelium or Prostate

2018. "Pembrolizumab With Combination Chemotherapy in Treating Participants With Locally Advanced or Metastatic Small Cell/Neuroendocrine Cancers of Urothelium or Prostate". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03582475.