Pembrolizumab + Gemcitabine + Radiation for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Scot Niglio, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: NYU Langone Health

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is to assess the efficacy of pembrolizumab (MK3475) added to concurrent radiation and gemcitabine in the management of patients with muscle-invasive urothelial cancer who are not candidates for or decline radical cystectomy.

Research Team

Scot Niglio, MD

Principal Investigator

NYU Perlmutter Cancer Center

Eligibility Criteria

This trial is for adults with muscle-invasive urothelial bladder cancer who can't have or don't want a radical cystectomy. They must be in good health, not pregnant, agree to use contraception, and provide consent. People with certain allergies, recent investigational drug use, major surgery recovery, specific syndromes like Guillain-Barre or Stevens-Johnson Syndrome, active infections or conditions that could affect the trial's outcome are excluded.

Inclusion Criteria

I am using two birth control methods or am not able to have children, and will continue for 120 days after the study.

My bladder cancer is at a specific stage but hasn't spread to lymph nodes or other parts.

I have taken a pregnancy test within the last 72 hours and it was negative.

Exclusion Criteria

I have an active tuberculosis infection.

I am currently being treated for an infection.

I have a history of inflammatory bowel disease or scleroderma.

Treatment Details

Interventions

• External Beam Radiation Therapy (Radiation)
• Gemcitabine (Anti-metabolites)
• Pembrolizumab (PD-1 Inhibitor)
• Transurethral Resection of Bladder Tumor (Procedure)

Trial Overview The study tests if adding pembrolizumab (MK3475) to gemcitabine and radiation therapy improves outcomes for patients with bladder cancer who aren't undergoing surgery. Participants will receive these treatments concurrently to see how effective they are when combined.

Participant Groups

Group I: Pembrolizumab, Gemcitabine, and RT Experimental Treatment 4 Interventions

* Lead-in single dose Pembrolizumab 200 mg, intravenously (IV) * Transurethral Resection of Bladder Tumor (TURBT) at pre-RT (maximal) and completion of therapy (diagnostic) * External Beam Radiation Therapy (EBRT) - 52 Gy in 20 fractions over 4 weeks (1 fraction = 2.6 Gy) * Gemcitabine 27 mg/m\^2 IV twice weekly for 4 weeks concurrent with EBRT * Pembrolizumab 200 mg IV every 3 weeks for total 3 doses starting day 1 of EBRT

External Beam Radiation Therapy is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in Japan as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in China as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in Switzerland as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Dr. Alec C. Kimmelman

NYU Langone Health

Chief Executive Officer

MD and PhD from Mount Sinai School of Medicine

Dr. Nicole M. Adler

NYU Langone Health

Chief Medical Officer since 2023

MD

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University