Your session is about to expire
← Back to Search
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 belowSelect...
I've had recent scans of my chest and abdomen.
Select...
I am 18 years old or older.
Select...
My bladder cancer diagnosis includes urothelial carcinoma.
Select...
I can provide tissue samples from my bladder surgery for testing.
Select...
My bladder cancer is at a stage where it has grown but not spread to distant parts.
Select...
I have not had chemotherapy for bladder cancer, except treatments directly into the bladder.
Select...
I am using two birth control methods or am not having sex to avoid pregnancy during and up to 120 days after the study.
Select...
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
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 moreTrial 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.
Find a Location
Who is running the clinical trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
353 Previous Clinical Trials
90,374 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,907 Previous Clinical Trials
5,065,997 Total Patients Enrolled
Matthew I Milowsky, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
2 Previous Clinical Trials
32 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am 18 years old or older.My bladder cancer diagnosis includes urothelial carcinoma.I can provide tissue samples from my bladder surgery for testing.I have an autoimmune disease treated with medication in the last 2 years.I have a lung condition not caused by an infection.I have been treated with specific immune therapy drugs before.My bladder cancer is at a stage where it has grown but not spread to distant parts.I haven't had cancer treatment in the last 2 weeks or still have side effects.I have had radiation therapy on my bladder for cancer treatment.I haven't had a monoclonal antibody treatment in the last 4 weeks or still have side effects from one taken more than 4 weeks ago.I have another cancer besides the one being studied, but it's not getting worse or needing treatment, except for certain skin cancers or cervical cancer that's been treated.I am currently being treated for an infection.I have not had chemotherapy for bladder cancer, except treatments directly into the bladder.My recent tests show my organs are functioning well.I have tested negative for pregnancy within the last 72 hours.I am using two birth control methods or am not having sex to avoid pregnancy during and up to 120 days after the study.I agree to use birth control during and for 4 months after the study treatment.You are expected to live for at least 3 more months.I have been diagnosed with HIV.I have significant hearing loss.I have not received a live vaccine in the last 30 days.I am fully active or restricted in physically strenuous activity but can do light work.You have a current, active infection of Hepatitis B or Hepatitis C.You are allergic to pembrolizumab or any of the ingredients in it.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I have a history of active tuberculosis.
Research Study Groups:
This trial has the following groups:- Group 1: pembrolizumab, gemcitabine and cisplatin
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger