New bladder cancer drug could spare patients from bladder removal

NCT ID NCT07464145

Not yet recruiting Disease control Sponsor: Relmada Therapeutics, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests NDV-01, a sustained-release combination of two chemotherapy drugs (gemcitabine and docetaxel), given directly into the bladder. It aims to prevent cancer from coming back in people with non-muscle invasive bladder cancer, including those who have not responded to standard BCG therapy. The study will enroll about 393 participants across two groups: one comparing NDV-01 to observation after tumor removal, and another testing NDV-01 alone in high-risk patients who have already tried other treatments.

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 and docetaxel)
What this could lead to: If successful, NDV-01 could offer a new treatment option for bladder cancer patients, potentially preventing cancer return and avoiding the need for bladder removal surgery.
What could go wrong: This is a Phase 3 trial, but results are not yet known. The drug may not work better than current options, and side effects from the chemotherapy drugs could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for BCG-UNRESPONSIVE HIGH-RISK PAPILLARY-ONLY NON-MUSCLE INVASIVE BLADDER CANCER are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

benign urinary system neoplasm bladder carcinoma in situ bladder papillary urothelial carcinoma 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.

BLADDER (UROTHELIAL, TRANSITIONAL CELL) CANCER BLADDER (UROTHELIAL, TRANSITIONAL CELL) CANCER SUPERFICIAL (NON-INVASIVE) UROLOGIC CANCER UROTHELIAL CARCINOMA BLADDER UROTHELIAL CARCINOMA RECURRENT

More trials for these conditions

Other studies related to the condition(s) this trial covers.