Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT04165317) enrolled 1,068 participants across five groups. Three of those groups made up the main comparison (Cohort A), each with around 350 people, and two smaller groups (Cohort B1 and B2) had 5 and 8 participants respectively. The trial was looking at a drug called PF-06801591 (sasanlimab) given alone or alongside BCG — a long-established bladder treatment — in people with a type of bladder cancer that had not yet grown into the muscle wall. The main thing being measured was "event-free survival," meaning how long people went without their cancer coming back in a serious way, getting worse, or dying. The reported data shows that for the primary measure — comparing the combination of PF-06801591 plus BCG (with both induction and maintenance phases) against BCG alone — a median event-free survival figure was not reported (recorded as "NA"), meaning the data had not reached a point where a middle value could be calculated at the time of reporting. For the secondary comparison of PF-06801591 plus BCG (induction only) versus BCG alone, the reported median event-free survival was 50.1 months for the PF-06801591 group, while the BCG-alone figure was again not reported. Figures for overall survival (how long people lived) were not reported in the submitted data for either comparison. For participants who had a specific type of cancer called carcinoma in situ (CIS) at the start of the trial, the percentage who achieved a "complete response" (no detectable cancer) was reported as approximately 89.8% in Arm A, 88.2% in Arm B, and 85.2% in the BCG-alone group. The duration of that complete response was reported as a median of 44.6 months for Arm B, while the figures for Arm A and the BCG-alone group had not yet reached a calculable midpoint at the time of reporting. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 42177753) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Bladder Cancer Trial, Active, Not Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with a specific type of bladder cancer (called transitional cell carcinoma) that is considered high risk but has not spread into the muscle of the bladder wall, confirmed by a tissue sample (biopsy)
- All visible tumour growths in the bladder have been completely removed during a procedure, and this removal took place within the last 12 weeks
- A second removal procedure was carried out if your doctors' guidelines recommended it
- (For certain groups in the trial only): Your bladder cancer did not respond to a standard treatment called BCG, and this was confirmed within the last 12 months (for a certain type of cancer called CIS) or within the last 6 months (for recurring tumour growths)
- You have either declined or are not suitable for an operation to remove the bladder entirely
Who may not be able to join:
- Your bladder cancer has grown into the bladder muscle, spread to nearby areas, or spread to other parts of the body, or there is cancer in the urinary tract outside the bladder
- (For one specific group only): You have received a BCG treatment directly into the bladder within the past 2 years
- (For other specific groups only): You have received any chemotherapy or immune-based treatment — either into the bladder or throughout the body — since your most recent positive biopsy result
- You have previously been treated with certain types of immunotherapy drugs that target specific proteins involved in the immune system (confirm with trial site)
- You have previously received certain treatments designed to stimulate the immune system, such as specific proteins called interleukins or interferon
- You have previously had radiation therapy directed at the bladder
- (For certain groups only): You have already taken part in another part of this same trial
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Pfizer CT.gov Call Center, Pfizer
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Cohort A: Event Free Survival (EFS) as Assessed by the Investigator: Arm A Versus Arm C
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.