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Platinum-based Chemotherapy
Chemotherapy Combinations with Nivolumab for Bladder Cancer
Phase 2
Waitlist Available
Led By Matthew Galsky, M.D.
Research Sponsored by Matthew Galsky
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically documented, locally advanced or metastatic urothelial carcinoma
No prior chemotherapy for inoperable locally advanced or mUC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights
Study Summary
This trial is testing two different combinations of drugs to see which is better at treating metastatic urothelial cancer in patients who can't have cisplatin.
Who is the study for?
Adults with advanced bladder cancer that can't be treated with cisplatin and haven't had chemotherapy for it. They must have a certain level of kidney, liver, and blood cell function, not be pregnant or breastfeeding, use contraception if needed, and have no serious health issues or recent other cancers. People who've had immune system treatments or suffer from autoimmune diseases (except mild forms), severe heart problems, transplants, active infections requiring treatment, HIV/AIDS or hepatitis are excluded.Check my eligibility
What is being tested?
This phase 2 trial is testing two combinations: Gemcitabine + Carboplatin + Nivolumab versus Gemcitabine + Oxaliplatin + Nivolumab in patients who cannot receive cisplatin for their metastatic urothelial cancer. Participants will be randomly assigned to one of these treatment groups considering their lymph node status.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs; infusion reactions; fatigue; nausea; low blood counts leading to increased infection risk; liver enzyme changes suggesting liver stress; nerve damage causing numbness or pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced bladder cancer confirmed by a biopsy.
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I have not had chemotherapy for my advanced urinary cancer.
Select...
I cannot receive cisplatin due to certain health reasons.
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I can perform daily activities with slight limitations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Assess Safety
Duration of Response
Overall Survival (OS)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment3 Interventions
Gemcitabine plus oxaliplatin plus nivolumab
Group II: Arm AExperimental Treatment3 Interventions
Gemcitabine plus carboplatin plus nivolumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Gemcitabine
FDA approved
Carboplatin
FDA approved
Oxaliplatin
FDA approved
Find a Location
Who is running the clinical trial?
Matthew GalskyLead Sponsor
10 Previous Clinical Trials
373 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,488 Total Patients Enrolled
Hoosier Cancer Research NetworkOTHER
68 Previous Clinical Trials
3,707 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious or uncontrolled health issues.I have not had any cancer except for treatable local cancers in the past 3 years.I have a lung condition not caused by an infection.I have not had chemotherapy for my advanced urinary cancer.My cancer is advanced bladder cancer confirmed by a biopsy.I am currently on medication for an infection.I am on steroids or other drugs that affect my immune system.I have moderate to severe nerve pain or damage.I have been treated with drugs that target the immune system.I am 18 years old or older.I have had a solid organ or tissue transplant, including stem cell transplant.I cannot receive cisplatin due to certain health reasons.My organs are functioning well.I have an autoimmune disease.I can perform daily activities with slight limitations.I have a serious heart condition.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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