RecruitingPhase IIEN originalBladder cancer

A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

This is a phase 2 open-label two cohort study of durvalumab plus monalizumab in patients with BCG-unresponsive or BCG-exposed CIS NMIBC. Arm A will enroll 43 participants who have cancer in situ (CIS) with or without high grade papillary urothelial cancer. Arm B will enroll 17 participants who do not have cancer in situ (CIS) but do have high grade papillary urothelial cancer. Eligible patients will be enrolled to receive up to 13 cycles of monthly combination of monalizumab and durvalumab. Both monalizumab and durvalumab will be administered intravenously (IV) every 28 days.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek co najmniej 18 lat
  • •Chęć i możliwość udziału w badaniu przez cały jego czas, w tym leczenie i wizyty kontrolne
  • •Dobry ogólny stan zdrowia (ocena ECOG do 1 punktu)
  • •Rak pęcherza niewylegający poza mięśnie (Grupa A: rak zaawansowany bez przebicia mięśni, z guzkoflatością lub bez, Grupa B: tylko guzkoflatość bez zaawansowanego raka)
  • •Ukończone co najmniej 5 dawek wstępnego leczenia BCG i następna faza leczenia
  • •Rak nie poddał się leczeniu BCG lub powrócił mimo leczenia BCG

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
September 14, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (5)

University of California San Francisco

San Francisco, United States

Moffitt Cancer Center

Tampa, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, United States

Icahn School of Medicine at Mount Sinai

New York, United States

Weill Cornell Medical Center

New York, United States

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/15/2026.

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