A Study of Sasanlimab in People With 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 or PF-06801591 as a Single Agent in Participants With BCG-Unresponsive NMIBC

Summary:

The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk (Part A) or was previously treated with BCG (Bacillus Calmette Guerin), a standard treatment for bladder cancer (Part B). In Part A (enrollment closed), each participant was assigned to one of three study treatment groups. One group is given sasanlimab and BCG at the study clinic. The second group is given sasanlimab and BCG at the study clinic. This group will receive BCG for the first six weeks only. The third group is given BCG only and will not receive sasanlimab. In Part B of the study, each new participant will be assigned to a study treatment group based on the type of their bladder tumour. - Both groups will be given sasanlimab at the study clinic.

Trial Description

Primary Outcome:

  • Event free survival (Cohort A: Arm A compared to Arm C)
  • Event free survival (Cohort A: Arm B compared to Arm C)
  • Complete response rate (Cohort B1)
  • Event free survival (Cohort B2)
Secondary Outcome:
  • Overall Survival (Cohort A: Arm A compared to Arm C)
  • Overall Survival (Cohort A: Arm B compared to Arm C)
  • Complete response rate in participants with CIS at randomization (Cohort A: Arm A, B, C)
  • Disease-specific survival (Cohort A: Arm A, B, C)
  • 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). Cohort A: Arms A and B only.
  • Incidence of ADA/Nab of PF-06801591 when in combination with BCG (induction and maintenance or induction). Cohort A: 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 (Cohort A: Arm A, B, C)
  • 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)
  • Complete response rate at 12 months (Cohort B1)
  • Event Free Survival (Cohort B1)
  • Overall Survival (Cohorts B1 and B2)
  • ctrough of PF-06801591 (Cohorts B1 and B2)
  • Incidence of ADA/Nab of PF-06801591 (Cohorts B1 and B2)
  • cmax of PF-06801591 (Cohort B2 only)
CREST: Combination of sasanlimab and alternative BCG Regimens to Evaluate outcomes with Subcutaneous anti-PD-1 Treatment Phase 3 Design with two Cohorts. Cohort A consists of 3 study Arms (A, B and C) of BCG naive participants. Arms A and B consist of two study drugs, PF-06801591 plus BCG. Arm C consists of one study drug, BCG. Cohort B consists of B1 and B2, which test PF-06801591 and include participants who have BCG unresponsive CIS (B1) or BCG unresponsive papillary only disease (B2). 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. The study is also designed to estimate the CR rate of PF-06801591 alone in participants with BCG unresponsive CIS and to evaluate the EFS of PF-06801591 alone in participants with BCG unresponsive NMIBC.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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