RecruitingPhase 1Phase 2NCT04106115

DURvalumab in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive Bladder CancEr

A Phase Ib/II Study to Assess the Safety and Activity of DURvalumab (MEDI4736) in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive Bladder CancEr

Sponsor

University College, London

Enrollment

52 participants

Start Date

Mar 25, 2022

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer

Summary

DURANCE is a two part, phase Ib/II, multi-centre study to assess the safety and activity of S-488210/S-488211 in combination with durvalumab, in patients with non-muscle invasive bladder cancer (NMIBC).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination of an immunotherapy drug (durvalumab) with a cancer vaccine in people with high-risk bladder cancer that hasn't spread into the bladder muscle. It is designed for patients whose cancer did not respond to the standard BCG treatment or who can't tolerate BCG. **You may be eligible if...** - You have high-risk non-muscle-invasive bladder cancer confirmed by biopsy - Your cancer did not respond to BCG treatment, or you are unable to tolerate BCG - You have declined or are not a good candidate for bladder removal surgery - You are 18 years old or older and weigh more than 30 kg - Your blood counts and organ function meet required levels - You have had the necessary recent scans and procedures **You may NOT be eligible if...** - Your cancer has spread to the muscle of the bladder or beyond - You have a bladder cancer type other than urothelial (transitional cell) carcinoma as the main type Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDurvalumab

1500 mg IV infusion every 4 weeks for up to 7 doses

BIOLOGICALS-488210/S-488211

S-488210/S-488211 is given as a 1 mL subcutaneous (SC) injection of S-488210/Montanide emulsion and a 1 mL SC injection of S-488211/Montanide emulsion starting the day after first dose of durvalumab and continuing weekly for 6 doses and then every 2 weeks for a further 9 doses