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

Sponsor
The Netherlands Cancer Institute
Study ID
NCT06237920
Phase
PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    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.
  • Relatlimab — DRUG
    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.

Study Details

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

Key Dates

First listed
Feb 2, 2024
Start date
Feb 19, 2024
Status verified
Jul 2026
Primary completion
Dec 1, 2026
Completion
Aug 1, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    1 cycle of intravenous nivolumab on day 1 and 1 cycle of intraveous nivolumab on day 29. Total administration frequency is twice.
  • Experimental: Nivolumab and relatlimab
    1 cycle of intravenous nivolumab and relatlimab on day 1 and 1 cycle of intraveous nivolumab and relatlimab on day 29. Total administration frequency is twice.

Primary Outcome Measure

Pathological complete response [ Time Frame: Immediately after surgery ]

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