Pembrolizumab + Chemotherapy for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byMatthew Milowsky, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: UNC Lineberger Comprehensive Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to evaluate whether adding pembrolizumab (Keytruda) to the combination of gemcitabine and cisplatin will improve shrinkage of the tumor before having a cystectomy, for people with muscle-invasive bladder cancer (MIBC).

Eligibility Criteria

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.

Inclusion Criteria

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

I am a suitable candidate for bladder removal surgery as determined by my urologist.

Consents to whole blood collection prior to initiating therapy and at cystectomy for support of correlative research studies

+12 more

Exclusion Criteria

Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

I have an autoimmune disease treated with medication in the last 2 years.

+16 more

Participant Groups

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.

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.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Platinol for: