Your session is about to expire
← Back to Search
Alkylating agents
Gemcitabine + Cisplatin + Nivolumab for Bladder Cancer
Phase 2
Waitlist Available
Led By Matthew Galsky, MD
Research Sponsored by Matthew Galsky
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Demonstrate adequate organ function per listed criteria: Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9/L, Hemoglobin (Hgb) ≥ 9 g/dL, Platelets ≥ 100 x 10^9/L, Calculated creatinine clearance: Creatinine ≤ 1.5 or creatinine clearance ≥ 60 mL/min, Bilirubin ≤ 1.5 × upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL), Aspartate aminotransferase (AST) ≤ 3 × ULN, Alanine aminotransferase (ALT) ≤ 3 × ULN
Histological evidence of clinically localized muscle-invasive urothelial cancer of the bladder (i.e., ct2-4n0m0) and candidate for cystectomy as per treating physician
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat bladder cancer. It is also looking at whether or not a complete response predicts benefit for patients who choose to avoid surgery.
Who is the study for?
This trial is for adults with muscle-invasive bladder cancer who are fit for cystectomy, have not had chemo for this cancer before, and do not have active infections or other cancers. They must be able to perform daily activities with ease (ECOG ≤1) and have normal organ function. Women of childbearing age must use contraception and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests the combination of Gemcitabine, Cisplatin, plus Nivolumab as a pre-surgery treatment in patients with muscle-invasive bladder cancer. It aims to assess safety and effectiveness while considering non-surgical options based on complete response rates.See study design
What are the potential side effects?
Potential side effects include immune-related reactions that can affect organs, infusion-related symptoms like fever or chills, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, liver enzyme alterations indicating liver stress.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood counts and kidney, liver functions are within the required ranges.
Select...
My bladder cancer is invasive but hasn't spread beyond my pelvis, and I am a candidate for surgical removal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the ability of clinical complete response (cT0 or cTa) to predict benefit from treatment.
Determine the clinical complete response rate (cT0 or cTa) with gemcitabine, cisplatin, plus nivolumab
Secondary outcome measures
Assess Adverse Events
Bladder intact overall survival
Determine the association between a prespecified panel of genomic biomarkers and benefit from treatment in patients achieving a clinical complete response.
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Gemcitabine, Cisplatin and NivolumabExperimental Treatment3 Interventions
Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m^2 IV ,Cisplatin 70mg/m^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with > cTa status will undergo cystectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Gemcitabine
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiOTHER
871 Previous Clinical Trials
527,175 Total Patients Enrolled
Matthew GalskyLead Sponsor
10 Previous Clinical Trials
346 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,756 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood counts and kidney, liver functions are within the required ranges.I have enough tissue samples from previous tests for this study.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I have no active cancers in the last 3 years, except for cured local cancers.I have had chemotherapy for bladder cancer that has spread into the muscle.I am currently on medication for an infection.I have previously received immunotherapy targeting specific immune checkpoints.You have tested positive for hepatitis B or hepatitis C, indicating you have an ongoing infection.I have an autoimmune disease but it's under control or is one of the exceptions listed.My bladder cancer is invasive but hasn't spread beyond my pelvis, and I am a candidate for surgical removal.I am a woman who can have children and have tested negative for pregnancy recently. I am under 62 and my FSH level is below 40 mIU/mL.I agree to use two forms of birth control or abstain from sex as required if I'm taking nivolumab.I can perform all my usual activities without help.I do not have severe numbness or pain from nerve damage.I have had a solid organ or bone marrow transplant.I have a lung condition not caused by an infection.I have had radiation therapy for bladder cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Gemcitabine, Cisplatin and Nivolumab
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.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger