Bladder cancer drug trial pulled before it even started

NCT ID NCT07313891

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This was a planned Phase 3 study comparing a new drug, NDV-01 (a combination of two chemotherapy drugs), against simple observation in people with intermediate-risk non-muscle invasive bladder cancer. The goal was to see if the drug could prevent the cancer from coming back after surgery. However, the trial was withdrawn before enrolling any participants, so no data was collected.

What this could mean

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

Active substance

NDV-01 (sustained-release gemcitabine-docetaxel)

What this could lead to

If it worked, this could offer a new treatment option to reduce bladder cancer recurrence after surgery.

What could go wrong

The trial was withdrawn before any participants enrolled, so no results are available. It is unclear if the drug is safe or effective.

Disclaimer Read more

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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Conditions

The condition(s) this trial relates to.

benign urinary system neoplasm bladder transitional cell carcinoma malignant urinary system neoplasm neoplasm non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms urothelial carcinoma

As listed by the trial registrant

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