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

NCT06237920 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-09-03

No results posted yet for this study

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

Conditions

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

Interventions

DRUG

Nivolumab

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.

DRUG

Relatlimab

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.

Sponsors & Collaborators

Principal Investigators

  • Michiel Van der Heijden, PhD · The Netherlands Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-19
Primary Completion
2026-07-01
Completion
2028-08-01

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06237920 on ClinicalTrials.gov