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

Official 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

Summary:

CREST: Combination of sasanlimab and alternative BCG Regimens to Evaluate outcomes with Subcutaneous anti-PD-1 Treatment Phase 3 Design with 3 study Arms (A, B and C). Arms A and B consists of two study drugs, PF-06801591 plus BCG. Arm C consists of one study drug, BCG. The study is designed to demonstrate that PF-06801591 plus Bacillus Calmette Guerin (BCG) (induction and maintenance periods) is superior to BCG alone (induction and maintenance periods) in prolonging event free survival (EFS) in participants with high-risk naïve non-muscle invasive bladder cancer (NMIBC) and to demonstrate that PF-06801591 plus BCG (induction period only) is superior to BCG alone (induction and maintenance periods) in prolonging EFS in participants with high-risk NMIBC.

Trial Description

Primary Outcome:

  • Event free survival (Arm A compared to Arm C)
  • Event free survival (Arm B compared to Arm C)
Secondary Outcome:
  • Overall Survival (Arm A compared to Arm C)
  • Overall Survival (Arm B compared to Arm C)
  • Complete response in participants with CIS at randomization
  • Disease-specific survival
  • Health-related quality of life as measured by EORTC QLQ-C30 (European Organization for Treatment of Cancer Quality of Life Questionnaire for cancer patients)
  • ctrough of PF-06801591 when in combination with BCG (induction and maintenance or induction). Arms A and B only.
  • Incidence of ADA/Nab of PF-06801591 when in combination with BCG (induction and maintenance or induction). Arms A and B only.
  • Tumour sample biomarker status based on PD-L1 expression (high or low)
  • Duration of CR for participants with CIS at randomization
  • Time to recurrence of low grade disease
  • Time to cystectomy
  • Health-related quality of life as measured by PTAB (Patient Treatment Administration Burden Questionnaire)
  • Percentage of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs
  • Percentage of Participants With Laboratory Abnormalities
  • Health-related quality of life as measured by EORTC QLQ-NMIBC24 (European Organization for Treatment of Cancer in patients with non-muscle invasion bladder cancer)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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