# A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer

Source: https://onco.cc/trials/nct04165317/  
OnCo record `nct04165317` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing Sasanlimab in bladder & urothelial cancer, active and no longer recruiting.

## Summary

A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer is a phase 3 interventional study registered as NCT04165317, led by Pfizer, and active but no longer recruiting on the registry. Official title: A Phase 3, Multinational, Randomised, 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. Planned enrolment is 1068 participants (actual). The study started in 2019-12-30 and primary completion is expected in 2024-12-02. Results have been posted on ClinicalTrials.gov; they are not yet summarised here.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-11
- Also known as: CREST
- Tags: ctgov-ingest
- Registry id: NCT04165317
- Phase: 3
- Setting: 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
- Sponsor: Pfizer
- Enrolled: 1068

## Sources

- ClinicalTrials.gov NCT04165317: https://clinicaltrials.gov/study/NCT04165317

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Non-muscle-invasive bladder cancer](https://onco.cc/cancers/non-muscle-invasive-bladder-cancer/)
- drugs: [Sasanlimab](https://onco.cc/drugs/sasanlimab/)
- companies: [Pfizer (incl. Seagen)](https://onco.cc/companies/pfizer/)

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JSON: https://onco.cc/api/v1/entities/nct04165317.json