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Pembrolizumab + Gemcitabine + Radiation for Bladder Cancer

Phase 2
Waitlist Available
Led By Arjun Balar, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
Clinical stage T2-T4a, N0, M0 urothelial bladder cancer
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is to see if adding pembrolizumab to radiation and gemcitabine helps people with muscle-invasive urothelial cancer who are not candidates for or decline radical cystectomy.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation of organs including lungs (pneumonitis), liver problems, skin reactions; also possible are fatigue and infusion reactions. Gemcitabine can lead to blood cell count changes, infection risk increase, nausea and kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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 cannot or will not undergo major bladder surgery as advised by my cancer doctor.
I am 18 years old or older.
I am fully active or restricted in physically strenuous activity but can do light work.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Two-year bladder-intact disease-free survival rate
Secondary outcome measures
Complete response (CR) rate
Metastasis-free survival
Overall survival
+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
Back pain
Shortness of Breath
Abdominal pain
Kidney Injury and/or Infection
Weight Loss
Malnutrition, Hypercalcemia and Weakness
Intractable pain, back pain, hip pain
Activated partial thromboplastin time prolonged
Pleural effusion
Atrial fibrillation with rapid ventricular response
Respiratory failure
Skin rash
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab, Gemcitabine, and RTExperimental Treatment4 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
First Studied
Drug Approval Stage
How many patients have taken this drug
External Beam Radiation Therapy
Completed Phase 3
Completed Phase 2
Completed Phase 3

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,666 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,914 Total Patients Enrolled
Arjun Balar, MDPrincipal InvestigatorNYU Perlmutter Cancer Center
1 Previous Clinical Trials

Media Library

External Beam Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT02621151 — Phase 2
Bladder Cancer Research Study Groups: Pembrolizumab, Gemcitabine, and RT
Bladder Cancer Clinical Trial 2023: External Beam Radiation Therapy Highlights & Side Effects. Trial Name: NCT02621151 — Phase 2
External Beam Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02621151 — Phase 2

Frequently Asked Questions

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

In which locales can one find access to this clinical trial?

"At the moment, 5 sites are in recruitment mode. These locations include Chicago, Chapel Hill and Ann Arbor - as well as 2 other places. To reduce travel-related strain on enrolled patients, it is beneficial to choose a trial site close to your residence."

Answered by AI

Have any other trials been conducted on the efficacy of Pembrolizumab?

"Presently, there are 1368 active studies investigating pembrolizumab with 244 of them being in Phase 3. Primarily taking place in Shanghai, these medical trials for pembrolizumab span across 54125 sites globally."

Answered by AI

What is the current cohort size for this experiment?

"This particular trial has ceased its recruitment process; the original posting was on August 11th 2016 and it last underwent changes on December 1st 2021. If you are seeking other options, there are 314 research initiatives actively recruiting patients suffering from urinary bladder issues and 1368 trials for Pembrolizumab that have open vacancies."

Answered by AI

In what patient populations is pembrolizumab typically used?

"Pembrolizumab is an appropriate treatment for malignant neoplasms, as well as many other medical conditions such as unresectable melanoma, microsatellite instability high and non-small cell lung carcinoma."

Answered by AI

Can you provide data on the safety of Pembrolizumab for individuals?

"Because of the Phase 2 trial data, which shows some safety but no efficacy evidence, our team at Power assigned Pembrolizumab a score of 2."

Answered by AI

Is there currently an opportunity to apply for this research study?

"A perusal of clinicaltrials.gov reveals that this trial, which was originally listed in August 2016 and last updated on December 1st 2021 is not currently recruiting any more participants. However, there are over 1600 other medical trials actively seeking patients at the moment."

Answered by AI
~10 spots leftby Dec 2025