PCR MIB Trial

Trial Title:

Pembrolizumab With Chemoradiotherapy as Treatment for Muscle Invasive Bladder Cancer

Trial Acronym:

PCR MIB

Protocol Number:

ANZUP 1502

Trial Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

ANZ Study Chairs:

Andrew Weickhardt

ANZ Coordinating Centre:

Centre for Biostatistics and Clinical Trials

Trial Coordinator:

Laura Galletta

Trial Email:

Contact.Bact@petermac.org 

Patient Population:

Non-metastatic muscle invasive bladder cancer

 

Intervention:

All patients will be planned to be treated with 64Gy of radiation therapy in 32 fractions over 6 weeks and 2 days. All patients will receive cisplatin 35mg/m2 IV concurrently weekly with radiation therapy for 6 doses total. Pembrolizumab will commence concurrently with radiation and be given 200mg IV every 21 days, continuing until the 12 week cystoscopy and assessment.

Surveillance cystoscopy will be performed 12 weeks after the commencement of chemoradiotherapy, and assess the rate of complete response to therapy. A safety follow up visit will occur 4 and 12 weeks post cystoscopy. From week 31 survival follow up will
commence with clinical assessment, cystoscopy and CT staging performed at intervals until 5 years.

 

Primary Outcome:

Number of patients with grade 3 or 4 acute toxicities (excluding grade 3 or 4 urinary toxicities) that are related to study drug, graded according to CTCAE v4.03 (19 weeks of treatment with Pembrolizumab) 

Secondary Outcomes:

The efficacy of the addition of pembrolizumab to concurrent chemoradiation regimen using the best response achieved, as assessed by cystoscopy at weeks 19 and 31 of the trial (12 and 24 weeks post completion of chemoradiotherapy). Week 19 (12 weeks post chemotherapy) and Week 31 (24 weeks post chemotherapy) where cystoscopic examinations take place.

The number of patients to develop metastatic disease (i.e. the rate of metastatic disease), as assessed by CT scan (Through study completion, an average of 7 years).

The number of patients having a salvage cystectomy (i.e. the rate of salvage cystectomy), as assessed by cystoscopy (Through study completion, an average of 7 years).

Status:

Active and Recruiting

Sites Recruiting:


NSW
  • Chris O'Brien Lifehouse
  • Prince of Wales Hospital
VIC
  • Austin Hospital
  • Peter MacCallum Cancer Centre
WA
  • Sir Charles Gairdner Hospital
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