RecruitingPhase 2NCT06237920

Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab

A Phase 2 Trial in Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab

Sponsor

The Netherlands Cancer Institute

Enrollment

90 participants

Start Date

Feb 19, 2024

Study Type

INTERVENTIONAL

Conditions

Neoplasms Neoplasms by Site Urinary Bladder Neoplasm Urogenital Neoplasms Male Urogenital Diseases Urologic Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Urinary Bladder Diseases Antineoplastics Toxicity

Summary

This is a non-blinded phase 2 trial in Stage II-IIIa urothelial cancer randomizing pre-operative nivolumab with or without relatlimab to assess whether bladder preservation after dual immunotherapy would be a viable treatment option for patients responding to treatment

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving immunotherapy drugs (nivolumab with or without relatlimab) before surgery can improve outcomes for people with muscle-invasive bladder cancer. The goal is to see if these drugs can shrink the cancer before it is surgically removed, potentially improving the chance of cure. **You may be eligible if...** - You are 18 or older - You have muscle-invasive bladder cancer that can be surgically removed (cystectomy) - Your surgeon has recommended surgery as the main treatment - You are not able to receive cisplatin chemotherapy, or you have chosen not to after discussing it with your doctor - Your overall health status is good (WHO performance status 0 or 1) - Urothelial cancer makes up more than 50% of your tumor type **You may NOT be eligible if...** - Your tumor contains small cell or adenocarcinoma components - Your blood counts or organ function (kidneys, liver) do not meet the required levels - You are pregnant or not willing to use reliable contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab

Induction with immune checkpoint blockade nivolumab on day 1. Nivolumab will also be administered on day 29. Response evaluation will be after the last cycle of checkpoint inhibition.

DRUGRelatlimab

Induction with immune checkpoint blockade nivolumab and relatlimab on day 1. Nivolumab and relatlimab will also be administered on day 29. Response evaluation will be after the last cycle of checkpoint inhibition.