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Platinum-containing Compound

Pembrolizumab + Chemotherapy for Bladder Cancer

Phase 2

Waitlist Available

Led By Matthew I Milowsky, MD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has staging scans with abdominal/pelvic CT or MRI scan and CT scan or x-ray of the chest within 4 weeks prior to treatment initiation

Be greater than or equal to 18 years of age on day of signing informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 weeks of treatment plus 5 years of followup

Awards & highlights

Study Summary

This trial will test if adding Keytruda to gemcitabine and cisplatin helps shrink tumors in people with muscle-invasive bladder cancer before surgery.

Who is the study for?

This trial is for adults with muscle-invasive bladder cancer who haven't had systemic chemotherapy for it. They must be fit enough for surgery, have a life expectancy over 3 months, and their cancer should not have spread beyond the bladder. Pregnant or breastfeeding women can't join, nor can those with certain other cancers, active infections, autoimmune diseases treated within the last 2 years, or recent use of immunosuppressants.Check my eligibility

What is being tested?

The study tests if adding pembrolizumab (Keytruda) to gemcitabine and cisplatin before surgery improves tumor shrinkage in bladder cancer patients. It's a phase 2 trial where all participants receive this combination as neoadjuvant therapy prior to having their bladders surgically removed.See study design

What are the potential side effects?

Possible side effects include immune-related reactions like inflammation in various organs, infusion reactions from the drug entering the body, fatigue, nausea from chemotherapy drugs gemcitabine and cisplatin; blood cell count changes leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

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

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I've had recent scans of my chest and abdomen.

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I am 18 years old or older.

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My bladder cancer diagnosis includes urothelial carcinoma.

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I can provide tissue samples from my bladder surgery for testing.

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My bladder cancer is at a stage where it has grown but not spread to distant parts.

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I have not had chemotherapy for bladder cancer, except treatments directly into the bladder.

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I am using two birth control methods or am not having sex to avoid pregnancy during and up to 120 days after the study.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 weeks of treatment plus 5 years of followup

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 weeks of treatment plus 5 years of followup

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 weeks of treatment plus 5 years of followup for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Percentage of Subjects That Reach Pathological Downstaging (Response) at the Time of Cystectomy

Secondary outcome measures

Event Free Survival

Therapeutic procedure

Overall Survival (OS)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: pembrolizumab, gemcitabine and cisplatinExperimental Treatment1 Intervention

There is one arm in this study. Subjects will receive Pembrolizumab 200mg IV on day 1 in combination with cisplatin 35mg/m2 and gemcitabine 1000mg/m2 on day 1 and day 8 every 3 weeks for 4 cycles over 12 weeks.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor

351 Previous Clinical Trials

88,293 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,514 Total Patients Enrolled

Matthew I Milowsky, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center

2 Previous Clinical Trials

32 Total Patients Enrolled

Media Library

Cisplatin (Platinum-containing Compound) Clinical Trial Eligibility Overview. Trial Name: NCT02690558 — Phase 2

Bladder Cancer Research Study Groups: pembrolizumab, gemcitabine and cisplatin

Bladder Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT02690558 — Phase 2

Cisplatin (Platinum-containing Compound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02690558 — Phase 2

Frequently Asked Questions

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

To which conditions are pembrolizumab, gemcitabine and cisplatin commonly prescribed?

"Pembrolizumab, gemcitabine and cisplatin are viable treatments for refractory relapsed mediastinal large B-cell lymphoma, urinary bladder cancer and advanced testicular malignancy."

Answered by AI

Are any more participants being accepted for this trial at the present time?

"Unfortunately, this clinical trial has ceased its recruitment of participants. The study was initially posted on May 1st 2016 and most recently updated on October 11th 2022. If you are in the market for other studies, there are presently 373 trials actively enrolling patients with urinary bladder cancer and 1821 researches accepting volunteers to test out pembrolizumab, gemcitabine and cisplatin."

Answered by AI

What is the aim of this experiment?

"This clinical trial aims to evaluate the efficacy of a given medication over 14 weeks, plus cystectomy within 70 days after treatment. The primary outcome is Percentage of Subjects That Reach Pathological Downstaging (Response) at the Time of Cystectomy while secondary outcomes include Number of Participants With Treatment Related Adverse Events and Proportion of Subjects That Reach Complete Pathologic Response (pT0) at the Time of Cystectomy as well Number of Adverse Events and Severity by Grade (CTCAE). These latter two will be evaluated using NCI Common Terminology Criteria for Adverse Events v4.0 scale grading system"

Answered by AI

What other research projects have been done incorporating pembrolizumab, gemcitabine and cisplatin?

"At present, there are 1821 active clinical trials researching pembrolizumab, gemcitabine and cisplatin. Of those studies, 414 have reached the Phase 3 stage of the medical trial process. Primarily based in Shanghai, these investigations into this drug cocktail span 77605 sites around the world."

Answered by AI

Has the FDA sanctioned pembrolizumab, gemcitabine and cisplatin for therapeutic use?

"There is existing data confirming pembrolizumab, gemcitabine and cisplatin's safety but not their efficacy; therefore, the drug was given a score of 2."

Answered by AI

What is the aggregate of participants enrolled in this experiment?

"Unfortunately, at the current time this clinical trial is not actively accepting new patients. Though it was initially made available on May 1st 2016 and recently updated on October 11th 2022, there are currently 373 medical studies enrolment for urinary bladder cancer as well as 1821 trials admitting participants that are receiving pembrozulimab in combination with gemcitabine and cisplatin."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Phase II Study of Gemcitabine and Split-dose Cisplatin Plus Pembrolizumab as Neoadjuvant Therapy Before Radical Cystectomy in Patients with Muscle-invasive Bladder Cancer

Rose, Tracy L., Michael R. Harrison, Allison M. Deal, Sundhar Ramalingam, Young E. Whang, Blaine Brower, Mary Dunn, et al.. 2021. “Phase II Study of Gemcitabine and Split-dose Cisplatin Plus Pembrolizumab as Neoadjuvant Therapy Before Radical Cystectomy in Patients with Muscle-invasive Bladder Cancer”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.21.01003.

clinicaltrials.govStudy

Phase 2 Study of Pembrolizumab in Combination With Gemcitabine and Cisplatin as Neoadjuvant Therapy

2016. "Phase 2 Study of Pembrolizumab in Combination With Gemcitabine and Cisplatin as Neoadjuvant Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02690558.