Pembrolizumab in Intermediate Risk Recurrent Non-muscle Invasive Bladder Cancer (NMIBC) — PemBla  

Non-muscle Invasive Bladder Cancer (NMIBC) Clinical Trial

Official title: A Parallel Group Phase I/II Marker Lesion Study to Assess the Safety, Tolerability and Efficacy of Intravenous or Intravesical Pembrolizumab in Intermediate Risk Recurrent Non-muscle Invasive Bladder Cancer

Status Terminated

Clinical Trial Summary

A parallel group, open label, multi-centre, phase I/II marker-lesion study of intravesical or intravenous pembrolizumab in recurrent intermediate risk NMIBC. Thirty patients (fifteen in each of two arms) will be randomised 1:1 to treatment with either intravesical pembrolizumab (Arm A) or intravenous pembrolizumab (Arm B). The main study will be preceded by a single institution safety run-in phase involving intra-patient dose escalation in six patients to confirm the safety and tolerability of intravesical pembrolizumab and the dose to be used in the randomised phase.

Clinical Trial Description

Bladder cancer is the seventh most common cancer in the United Kingdom (UK) and ninth most common cancer worldwide. New strategies for treating this disease are urgently required to reduce recurrence and progression rates. Pembrolizumab is a type of immunotherapy drug that has been approved for use in certain types of melanoma and lung cancer. It is thought to work by helping the body's immune system to recognise and attack cancer. Drugs that work in a similar way have shown some encouraging results in studies treating patients with bladder cancer that has spread to other parts of the body, although they are not currently approved for treating either advanced or localised bladder cancer.

This trial is being performed to assess the safety and tolerability of giving pembrolizumab to patients with localised bladder cancer and to study what effects the drug has on the tumour; Participants will have all but one tumour (referred to as the marker lesion) removed during their transurethral resection of bladder tumour (TURBT) procedure at the start of the trial. After trial treatment, a further TURBT procedure will be carried out to remove the marker lesion, or if the marker lesion is no longer visible, a biopsy will be taken of the area where the growth was before.

After a safety run in with intra-patient dose escalation of intravesical pembrolizumab performed in paired patient cohorts, the trial will test two different ways of giving the pembrolizumab; directly into the bladder (intravesical) with 6 doses being received over 6 weeks and with a further dose approximately 3 weeks later, or into the blood stream via the veins (intravenous) with a dose being received every 3 weeks for a maximum of 4 doses.

36 eligible participants from across 3 UK centres will be randomly allocated to receive treatment by one of these ways. Following the end of treatment visit, patients will return to receiving standard care but receive follow-up for up to 2 years. ;

Related Conditions & MeSH terms

• Non-muscle Invasive Bladder Cancer (NMIBC)
• Urinary Bladder Neoplasms

• NCT number: NCT03167151
• Study type: Interventional
• Source: University of Oxford
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: March 2, 2018
• Completion date: June 26, 2019