Nivolumab, Cisplatin, & Gemcitabine for Bladder Cancer

Phase 2

Waitlist Available

Led By Badrinath Konety, MD, MBA

Research Sponsored by Masonic Cancer Center, University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days +/- 7 days after last chemotherapy

Awards & highlights

No Placebo-Only Group

Summary

This is a multi-center Phase II study to determine the safety and efficacy of nivolumab when given in combination with cisplatin and gemcitabine as neoadjuvant treatment in patients with muscle-invasive bladder cancer (MIBC) prior to standard of care radical cystectomy. Patients will receive neoadjuvant treatment with nivolumab in combination with gemcitabine-cisplatin (GC) every 3 weeks for 4 treatment cycles over 12 weeks followed by standard of care radical cystectomy.

Eligible Conditions

Bladder Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days +/- 7 days after last chemotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days +/- 7 days after last chemotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days +/- 7 days after last chemotherapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathologic Response Rate (PaR) at Time of Radical Cystectomy. PaR is Defined as Absence of Residual MIBC at Cystectomy in the Surgical Specimen (Pathologic Down-staging to ≤pT1pN0 Which Includes pT0, pT1, pTa and pTis)

Secondary study objectives

Count of Participants Experiencing Progression Free Survival (PFS)

Safety of Nivolumab With Gemcitabine/Cisplatin

Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 1)

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