A Study of Eciskafusp Alfa and Bacillus Calmette-Guérin (BCG) in Participants with High-Risk Bladder Cancer Unresponsive to BCG Treatment

Prior treatment

• Prior treatment with IL-2/IL-15

Other illness

• History of muscle-invasive, locally advanced, metastatic and/or extravesical bladder cancer (inclusive of ureter, urethra, or renal pelvis)
• Medical Conditions: Known HIV infection (no testing required at screening)
• Medical Conditions: History of radiotherapy of the bladder
• Medical Conditions: History of perforation of the bladder
• Known hypersensitivity to BCG

• Type of Participants and Disease Characteristics: Pathologically confirmed high risk non muscle invasive transitional cell carcinoma classified according to World Health Organization (WHO) grading system. Only participants with carcinoma in situ (CIS) (with or without Ta/T1 disease) are eligible. Patients with tumors of mixed histology are allowed, but transitional cell carcinoma must be the predominant histology. Participants must have CIS present on the tumor sample from the most recent transurethral resection of bladder tumor (TURBT)
• General conditions: Parameter: Eastern Cooperative Oncology Group (ECOG) performance status Criteria applicable to Phase I: 0 or 1 Criteria applicable to Phase II (Cohorts A and B): 0, 1, or 2
• Type of Participants and Disease Characteristics: Absence of resectable disease after TURBT procedures (residual CIS acceptable; participants with T1 tumors must undergo repeat resection and biopsy [inclusive of muscularis propria] of the T1 tumor site if initial biopsy did not include muscularis propria).
• Type of Participants and Disease Characteristics: Presence of BCG-unresponsive disease defined as persistent or recurrent CIS (± recurrent Ta/T1 disease) within 12 months of receiving adequate BCG therapy (defined as at least 5 of 6 doses of an initial induction course plus either at least 2 of 3 doses of maintenance therapy or at least 2 of 6 doses of a second induction course)
• Type of Participants and Disease Characteristics: The participant is considered ineligible for radical cystectomy or has elected not to undergo the procedure. Reasons for ineligibility or refusal of radical cystectomy should be discussed with the participant as part of the informed consent process and should be captured on the appropriate electronic case report form (eCRF)