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

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 tumor. \- Both groups will be given sasanlimab at the study clinic. On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B. The decision to discontinue enrollment to Part B was not made for safety reasons.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Histological confirmed diagnosis of high risk non-muscle invasive transitional cell carcinoma (TCC) of the urothelium of the urinary bladder (tumors of mixed transitional/non-transitional cell histology are allowed, but TCC must be the predominant histology)
* Complete resection of all Ta/T1 papillary disease (including participants with concurrent CIS), with most recent positive TURBT occurring within 12 weeks prior to randomization or study intervention. A second TURBT must have been performed if indicated according to the current locally applicable guidelines, ie, American Urological Association, European Association of Urology
* (Cohorts B1 and B2 only): Histological confirmed diagnosis of BCG-unresponsive high-risk, non-muscle invasive TCC of the urothelium within 12 months (CIS only) or 6 months (recurrent Ta/T1 disease) of completion of adequate BCG therapy.
* Have refused or are ineligible for radical cystectomy

Exclusion Criteria:

* Evidence of muscle-invasive, locally advanced or metastatic urothelial cancer or concurrent extravesical, non-muscle invasive TCC of the urothelium
* (Cohort A only): Intravesical BCG therapy within 2 years prior to randomization. Prior intravesical chemotherapy for NMIBC is allowed.

(Cohorts B1 and B2 only): Any systemic or intravesical chemotherapy or immunotherapy from the time of most recent positive TURBT to initiation of study intervention.

* Prior immunotherapy with anti PD-1, anti PD-L1, anti PD-L2, or anti cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
* Prior treatment with immunostimulatory agents including interleukin (IL)-2, IL-15, interferon (INF)
* Prior radiation therapy to the bladder
* (Cohorts B1 and B2 only): Prior participation in Cohort A of this study.

• DERIVEDShore ND, Powles TB, Bedke J, Galsky MD, Redorta JP, Ku JH, Kretkowski M, Xylinas E, Alekseev B, Ye D, Guerrero-Ramos F, Briganti A, Kulkarni GS, Brinkmann J, Calella AM, Cesari R, Eccleston A, Michelon E, Vermette J, Wei C, Steinberg GD. Sasanlimab taken together with Bacillus Calmette-Guerin (BCG) compared with BCG alone in people with high-risk non-muscle invasive bladder cancer: a plain language summary. Future Oncol. 2026 Jun;22(13):1487-1499. doi: 10.1080/14796694.2026.2671256. Epub 2026 May 24. PMID 42177753
• DERIVEDShore ND, Powles TB, Bedke J, Galsky MD, Palou Redorta J, Ku JH, Kretkowski M, Xylinas E, Alekseev B, Ye D, Guerrero-Ramos F, Briganti A, Kulkarni GS, Brinkmann J, Calella AM, Cesari R, Eccleston A, Michelon E, Vermette J, Wei C, Steinberg GD. Sasanlimab plus BCG in BCG-naive, high-risk non-muscle invasive bladder cancer: the randomized phase 3 CREST trial. Nat Med. 2025 Aug;31(8):2806-2814. doi: 10.1038/s41591-025-03738-z. Epub 2025 May 31. PMID 40450141
• DERIVEDSteinberg GD, Shore ND, Redorta JP, Galsky MD, Bedke J, Ku JH, Kretkowski M, Hu H, Penkov K, Vermette JJ, Tarazi JC, Randall AE, Pierce KJ, Saltzstein D, Powles TB. CREST: phase III study of sasanlimab and Bacillus Calmette-Guerin for patients with Bacillus Calmette-Guerin-naive high-risk non-muscle-invasive bladder cancer. Future Oncol. 2024 May;20(14):891-901. doi: 10.2217/fon-2023-0271. Epub 2024 Jan 8. PMID 38189180