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Bladder cancer drug combo trial halted early – what we know

NCT ID NCT04586244

First seen Nov 01, 2025 · Last updated Jun 22, 2026 · Updated 28 times

Summary

This phase 2 study tested several drug combinations (retifanlimab, epacadostat, INCAGN02385, INCAGN02390) given before bladder removal surgery in 30 patients with muscle-invasive bladder cancer who could not take the standard chemo drug cisplatin. The trial was terminated early, so the planned analysis of immune cell changes in the tumor could not be fully completed. The main goal was to see if these drugs could boost the body's immune response against the cancer.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)

    Verona, 37124, Italy

  • Hopital Europeen Georges Pompidou (Hegp)

    Paris, 75015, France

  • Hospital Saint Louis

    Paris, 75475, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele

    Milan, 20132, Italy

  • Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

    Bari, 70124, Italy

  • L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi

    Bologna, 40138, Italy

  • Ohio State University Medical Center Division of H

    Columbus, Ohio, 43210, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239-4501, United States

  • Universita Campus Bio Medico Di Roma

    Roma, 00128, Italy

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

retifanlimab, epacadostat, INCAGN02385, INCAGN02390

What this could lead to

If successful, this could point toward effective neoadjuvant treatments for bladder cancer patients who cannot use standard chemotherapy.

What could go wrong

The trial was terminated early with limited data, so results are inconclusive. The combinations may not improve outcomes and could cause side effects.

Conditions

The condition(s) this trial relates to.

transitional cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.