Nivolumab for Bladder Cancer

(NEXT Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Utah

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a phase 2, single arm, open label trial to evaluate the rate of failure free survival at 2 years after start of chemoradiation with adjuvant nivolumab in adult subjects who undergo chemoradiation for localized bladder cancer.

Research Team

Eligibility Criteria

Adults with localized muscle-invasive bladder cancer stages T2-4b, N0/N+, M0 or T1 with N+ who've had chemoradiation and can't have radical cystectomy. Must be ≥18 years old, ECOG ≤2, adequate organ function, no distant metastases/active malignancies/autoimmune diseases/HIV/hepatitis. Women must not be pregnant and agree to contraception.

Inclusion Criteria

I had surgery to remove part of my bladder due to cancer before starting chemoradiation.

I am using two birth control methods or am not able to have children, and will continue for 5 months after the study.

My cancer originates from the bladder, urethra, or lower ureter.

Exclusion Criteria

You have a known or suspected autoimmune disease that is currently active.

I haven't taken high-dose steroids or other immune-weakening drugs in the last 14 days.

My cancer has spread to areas not treated by radiation.

Treatment Details

Interventions

• Nivolumab (Checkpoint Inhibitor)

Trial Overview This phase 2 trial tests if the drug Nivolumab improves failure-free survival over two years in adults after chemoradiation for bladder cancer. It's a single-arm study where all participants receive the same treatment without comparison to a placebo or other therapy.

Participant Groups

Group I: Nivolumab, all patients Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Jeffrey Wilkins

University of Utah

Chief Medical Officer since 2022

MD from Meharry Medical College

Stephen Tullman

University of Utah

Chief Executive Officer since 2022

BS in Accounting from Rutgers University

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania