Brief Title: Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer

INTRODUCTION

• Org Study ID: CA017-078
• Secondary ID: N/A
• NCT ID: NCT03661320
• Sponsor: Bristol-Myers Squibb

DESCRIPTION

Who is this trial for?

Patients with muscle-invasive bladder cancer who are eligible for radical cystectomy

What is the goal of this study?

To study the effects of the combination of drugs over time in patients who remain free of disease complications (EFS) and overall survival.

Summary

A phase 3, research study to evaluate nivolumab + chemotherapy or nivolumab/ BMS-986205 + chemotherapy followed by continued Immuno-Oncology therapy after radical cystectomy (RC) compared with neoadjuvant standard of care (SOC) chemotherapy alone in patients with muscle-invasive bladder cancer.

Background

MIBC patients have a 50% 5 year survival rate after radical cystectomy surgery (surgery to remove bladder and nearby tissue) and a return of cancer rate, 30-54%. 1.  Therefore, additional treatment before and/or after surgery is often considered to lower the chance that the cancer returns.  Clinical studies are research tests of an investigational drug or drugs in people.  A drug must be tested in clinical studies before it may be used for patients in the general public.

You may be eligible for this clinical study if you:

Have muscle -invasive bladder cancer, cancer that has spread to the muscle wall of the bladder

Plan to have a radical cystectomy surgery, surgery to remove bladder and nearby tissue

Do not have an autoimmune disease

Are eligible for cisplatin treatment

Participation in this clinical trial is determined using the full eligibility criteria. Some key eligibility criteria are above. To prescreen for this study or other bladder cancer studies, please take the Bladder Cancer Screener on BMS Study Connect.

Gender: All          Minimum Age: 18 Years          Maximum Age: N/A

Study Design

Patients enrolled in the trial will be randomly assigned to one of the following study treatment arms

1. pre-surgery chemotherapy followed by surgery then standard of care observation
2. pre-surgery chemotherapy plus Nivolumab followed by surgery then chemotherapy and Nivolumab
3. pre-surgery chemotherapy plus Nivolumab and investigational drug followed by surgery then chemotherapy and Nivolumab and investigational drug

Considering a clinical trial?

There is a lot to think about when considering a clinical trial.

Download this pdf to discuss 2 clinical trial options with your doctor.

Visit BMSSTUDYCONNECT.com/ to learn move and to take a screener to see if you qualify for this or other trials.

BRIEF SUMMARY

The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).

• Overall Status
  Active, not recruiting
• Start Date
  November 6, 2018
• Phase
  Phase 3
• Study Type
  Interventional