Clinical Trial 18509

Cancer Type: Genitourinary
Interventions:BMS-936558 (Nivolumab); Nivolumab; Not Applicable; Placebo

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Jingsong Zhang

Overview

Study Title

A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab versus Placebo in Subjects with High Risk Invasive Urothelial Carcinoma

Summary

The purpose of this study is to determine the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558) versus placebo in participants who have undergone radical surgery for invasive urothelial cancer.

Objective

Research Hypothesis: Treatment with nivolumab will extend disease-free survival, compared with placebo, as adjuvant therapy in all randomized patients and in patients with PD-Ll expressing tumors (membranous staining in (great or equal to 1%) with high risk residual disease at radical resection of invasive urothelial carcinoma (IUC). Co-Primary Objectives: To compare the disease free survival (DFS) for nivolumab versus placebo in: Subjects with tumors expressing PD-LI (great or equal to 1% membranous staining in tumor cells) and; All randomized subjects. Secondary Objectives: To compare non-urothelial tract recurrence free survival (NUTRFS) for nivolumab versus placebo in subjects with tumors expressing PD-LI (great or equal to 1% membranous staining in tumor cells) and all randomized subjects. To compare the disease specific survival (DSS) for nivolumab and placebo in subjects with tumors expressing PD-LI (great or equal to 1% membranous staining in tumor cells) and all randomized subjects. To compare the overall survival (OS) for nivolumab versus placebo in subjects with tumors expressing PD-LI ( great or equal to 1% membranous staining in tumor cells) and all randomized subjects.

Inclusion Criteria

  • Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis
  • Must have had radical surgical resection (e.g., radical cystectomy), performed within the last 120 days
  • Must have disease free status as determined by imaging within 4 weeks of dosing
  • Tumor tissue must be provided for biomarker analysis
  • Potential participants who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy
  • Additional criteria may apply

  • Exclusion Criteria

  • Partial bladder or kidney removal (e.g., partial cystectomy)
  • Secondary Treatment (e.g., adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer
  • Active, known or suspected autoimmune disease
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
  • Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration
  • Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
  • Additional criteria may apply