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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
Must not have
Has a known history of active TB (Bacillus Tuberculosis)
Has an active infection requiring systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
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 belowSelect...
I am using two birth control methods or am not able to have children, and will continue for 120 days after the study.
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My bladder cancer is at a specific stage but hasn't spread to lymph nodes or other parts.
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I cannot or will not undergo major bladder surgery as advised by my cancer doctor.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an active tuberculosis infection.
Select...
I am currently being treated for an infection.
Select...
I have a history of inflammatory bowel disease or scleroderma.
Select...
I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.
Select...
I have an autoimmune disease treated with medication in the last 2 years.
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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
Select...
I have a history of inflammatory bowel disease or scleroderma.
Select...
I have a history of or currently have non-infectious lung inflammation.
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I have had radiation therapy to my pelvic area before.
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I have been diagnosed with HIV.
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I have had treatments like chemotherapy for bladder cancer before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
External Beam Radiation Therapy
2006
Completed Phase 3
~3150
Pembrolizumab
2017
Completed Phase 2
~2010
Gemcitabine
2017
Completed Phase 3
~2070
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,379 Previous Clinical Trials
848,058 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,919 Previous Clinical Trials
5,068,203 Total Patients Enrolled
Arjun Balar, MDPrincipal InvestigatorNYU Perlmutter Cancer Center
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active tuberculosis infection.I am using two birth control methods or am not able to have children, and will continue for 120 days after the study.I am currently being treated for an infection.I have a history of inflammatory bowel disease or scleroderma.You currently have active Hepatitis B or C.My bladder cancer is at a specific stage but hasn't spread to lymph nodes or other parts.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks or still have side effects from them.I have an autoimmune disease treated with medication in the last 2 years.I have taken a pregnancy test within the last 72 hours and it was negative.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I am willing to provide a bladder cancer tissue sample if needed.I cannot or will not undergo major bladder surgery as advised by my cancer doctor.My bladder cancer was confirmed by a biopsy within the last 2 months.I have not received a live vaccine in the last 30 days.I have a history of inflammatory bowel disease or scleroderma.I have a history of or currently have non-infectious lung inflammation.I have had radiation therapy to my pelvic area before.I have been diagnosed with HIV.My organ functions are within normal ranges as required.You are allergic to pembrolizumab or any of its ingredients.I am 18 years old or older.I have fully recovered from any major surgery before starting treatment.You have had Guillain-Barre Syndrome or Stevens-Johnson Syndrome in the past.I agree to use birth control during and for 4 months after the study treatment.I have had treatments like chemotherapy for bladder cancer before.I haven't had cancer in the last 5 years, except for certain skin cancers or early-stage prostate cancer.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab, Gemcitabine, and RT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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