Bladder Cancer Trial Completes Data Collection Phase

The study evaluates if adding a new immunotherapy to standard treatment improves outcomes for bladder cancer patients.

Updated on Oct. 21, 2026 in Cancer

Isometric editorial illustration of a glass medical vial on a laboratory surface, representing clinical research and medical trial data collection. — ImmunityBio has completed data collection for its QUILT-2.005 trial, testing the combination of ANKTIVA and BCG for non-muscle invasive bladder cancer. AI Illustration. Upload story photo >

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ImmunityBio has completed the database lock for the QUILT-2.005 trial, a study investigating the combination of ANKTIVA and BCG for patients with non-muscle invasive bladder cancer. Topline results for this 366-patient trial are expected in November 2026.

Why it matters

This trial explores whether adding ANKTIVA to standard BCG therapy improves complete response rates and durability for patients who are BCG-naïve. If successful, the findings could support an expanded indication for a treatment currently reserved for specific BCG-unresponsive cases.

An interim analysis from the QUILT-2.005 randomized clinical trial involving 183 evaluable patients showed a statistically significant longer duration of complete response with the combination treatment. Full trial results for the 366-enrolled patients are currently pending.

The players

ImmunityBio

A biotechnology company focused on developing immunotherapies for cancer and infectious diseases, including the approved treatment ANKTIVA.

FDA

The federal agency responsible for protecting public health by regulating the safety and efficacy of medical products and pharmaceuticals in the United States.

The details

The trial evaluates if the immunotherapy ANKTIVA boosts the effects of BCG, the standard treatment for non-muscle invasive bladder cancer. By locking the database, the researchers have verified and reconciled all data from randomized participants to prepare for the final analysis. An independent committee previously confirmed the study possesses sufficient statistical power to detect the intended clinically meaningful differences between the combination and BCG alone.

February 2026: Cohort A completed enrollment.
March 2026: An independent committee reviewed data from 183 evaluable patients.
November 2026: The company expects to report topline results.
Q4 2026: The company plans to submit an sBLA to the FDA.

Health Landscape

This trial represents the latest phase in the clinical evaluation of ANKTIVA, aiming to move the drug from its current niche indication to a broader frontline setting. The study builds on the existing therapeutic pipeline for bladder cancer by testing whether immunotherapy can enhance the efficacy of long-standing BCG protocols.

This trial specifically concerns patients who have not yet received BCG treatment for bladder cancer, meaning current patients should monitor updates for potential shifts in treatment standards. Patients interested in how these emerging trials may influence future care options should discuss the evolving standard of care with their oncologist.

The takeaway

The clinical trial process moves forward as investigators prepare to report on the potential for combination therapies in treating bladder cancer. Patients should continue to track major updates in immunotherapy research with their physician to understand how new data may impact long-term treatment strategies.