Phase 3 Study of PF-06801591 in Combination with Bacillus Calmette-Guerin (BCG) in Participants with High-Risk Non-Muscle Invasive Bladder Cancer

• Research type

  Research Study

• Full title

  A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an anti-PD-1 antibody, in Combination with Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants with High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer

• IRAS ID

  278525

• Contact name

  Thomas Powles

• Contact email

  Thomas.Powles@bartshealth.nhs.uk

• Sponsor organisation

  Pfizer Inc.

• Eudract number

  2019-003375-19

• Clinicaltrials.gov Identifier

  NCT04165317

• Clinicaltrials.gov Identifier

  IND, 125,681

• Duration of Study in the UK

  6 years, 5 months, 28 days

• Research summary

  Cancer continues to be a major global health burden.
  Overall, incidence and mortality for bladder cancer (BC) has changed very little over the past 20 years. Vaccination using BCG was the first Food and Drug Administration (FDA) approved immunotherapy indication in the 1980s and for patients with high-risk non-muscle invasive bladder cancer (NMIBC) after transurethral resection of the bladder tumour (TURBT; removal of tumour from the bladder through the urethra), induction with BCG followed by maintenance still represents the standard of care (SOC). While treatment with BCG has been shown to reduce the risk of tumour recurrence, approximately 40% of patients with NMIBC will eventually have disease recurrence or progression despite BCG therapy; thus, alternative treatments are urgently required to improve the outcome.

  Research has shown that in some patients, cancer and immune cells start to give off signals that stop the body’s immune system from killing the cancer. PF-06801591 is a humanised, monoclonal antibody (mAb) which has been developed to block this interaction between the cancer and the immune system cells to allow for the bodys immune system to identify, target and kill the cancer cells.

  Based on pre-clinical and clinical data, an intervention in BCG-naïve participants with high risk NMIBC, with PF-06801591 in combination with BCG induction therapy may provide a greater benefit with longer event-free survival and reduction in the rate of subsequent cystectomy as compared to SOC BCG treatment. In addition, PF-06801591 is administered subcutaneously (SC) every 4 weeks which is expected to reduce burden for the participants and for the healthcare system.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  20/NW/0230

• Date of REC Opinion

  18 Jun 2020

• REC opinion

  Further Information Favourable Opinion