A Study of Eciskafusp Alfa and Bacillus Calmette-Guérin (BCG) in Participants with High-Risk Bladder Cancer Unresponsive to BCG Treatment
Key facts
- Where
- Duesseldorf, Herne, Regensburg, Ulm és Wuerzburg, NémetországSee the 5 sites
- Phase
- 1/2. fázis
Where in Németország
- Universitaetsklinikum Duesseldorf AöRDuesseldorf, NémetországNo longer taking part
- St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-RuhrHerne, NémetországNo longer taking part
- Caritas-Krankenhaus St. JosefRegensburg, NémetországNo longer taking part
- Universitaetsklinikum Ulm AoRUlm, NémetországNo longer taking part
- Universitaetsklinikum Wuerzburg AöRWuerzburg, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- F. Hoffmann-La Roche AG
- Trial code
- EU 2024-515410-41-00
- Record updated
- 2025. május 7.
- Original description
Phase I: To evaluate the safety and tolerability of eciskafusp alfa in combination with Bacillus Calmette-Guérin (BCG). Phase I: To determine the maximum-tolerated dose (MTD) and/or the recommended dose for extension (RDE) of eciskafusp alfa in combination with BCG. Phase II (Cohort A): To evaluate the anti-tumor activity of study treatment by evaluating the absence of high-risk non-muscle invasive bladder cancer (NMIBC) or progressive disease, as determined by cystoscopy, and radiologic imaging and retrospective central pathology review of cytology and biopsyRead full original descriptionShow less
A PHASE I/II, OPEN-LABEL, DOSE ESCALATION AND EXTENSION STUDY OF INTRAVESICAL ECISKAFUSP ALFA IN COMBINATION WITH BACILLUS CALMETTE-GUÉRIN (BCG) IN PARTICIPANTS WITH BCG-UNRESPONSIVE HIGH- RISK NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC)
Phase I: To evaluate the safety and tolerability of eciskafusp alfa in combination with Bacillus Calmette-Guérin (BCG). Phase I: To determine the maximum-tolerated dose (MTD) and/or the recommended dose for extension (RDE) of eciskafusp alfa in combination with BCG. Phase II (Cohort A): To evaluate the anti-tumor activity of study treatment by evaluating the absence of high-risk non-muscle invasive bladder cancer (NMIBC) or progressive disease, as determined by cystoscopy, and radiologic imaging and retrospective central pathology review of cytology and biopsy
Inclusion: 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).
Exclusion: Prior treatment with IL-2/IL-15; 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.