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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 below
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My cancer is advanced bladder cancer confirmed by a biopsy.
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I have not had chemotherapy for my advanced urinary cancer.
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I cannot receive cisplatin due to certain health reasons.
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I can perform daily activities with slight limitations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 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
Objective Response Rate (ORR)
Secondary outcome measures
Assess Safety
Duration of Response
Overall Survival (OS)
+1 more

Trial 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

Carboplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03451331 — Phase 2
Bladder Cancer Research Study Groups: Arm A, Arm B
Bladder Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03451331 — Phase 2
Carboplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03451331 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~7 spots leftby Mar 2025