Evaluating eciskafusp alfa with BCG for bladder cancer treatment
A Phase I/II, Open-label, Dose Escalation and Extension Study of Intravesical Eciskafusp Alfa in Combination With Bacillus Calmette-guerin (BCG) in Participants With BCG-unresponsive High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
This study is testing if a new drug called eciskafusp alfa, when combined with BCG, can help people with high-risk bladder cancer that hasn't improved with BCG alone.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 9 sites (Macquarie Park, New South Wales and 8 other locations) |
| Trial ID | NCT06816017 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of eciskafusp alfa combined with Bacillus Calmette-Guerin (BCG) in patients with high-risk non-muscle invasive bladder cancer that has not responded to BCG treatment. Participants will receive intravesical administration of the drug, and the study will assess pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity. Following a positive interim analysis, the study may also explore eciskafusp alfa as a standalone treatment.
Who should consider this trial
Good fit: Ideal candidates include individuals with confirmed high-risk non-muscle invasive bladder cancer who have not responded to prior BCG therapy.
Not a fit: Patients with resectable disease or those who are eligible for radical cystectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with BCG-unresponsive bladder cancer.
How similar studies have performed: Other studies have shown promise in using combination therapies for bladder cancer, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically confirmed high risk non muscle invasive transitional cell carcinoma classified according to World Health Organization (WHO) grading system * Absence of resectable disease after transurethral resection of bladder tumor (TURBT) procedures * The most recent cystoscopy/TURBT must have been performed within 12 weeks and up to 14 days of the first dose of study treatment * Presence of BCG-unresponsive disease defined as persistent or recurrent carcinoma in situ \[CIS\] (± recurrent Ta/T1 disease) within 12 months of receiving adequate BCG therapy * The participant is considered ineligible for radical cystectomy or has elected not to undergo the procedure. * Negative hepatitis B surface antigen (HBsAg) test at screening * Positive hepatitis B surface antibody (HBsAb) test at screening * Negative hepatitis C virus (HCV) antibody test at screening Exclusion Criteria: * Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders * Active infections (both systemic and local urinary) * Congenital or acquired immune deficiencies resulting in immunosuppression * Known human immunodeficiency virus (HIV) infection * History of radiotherapy of the bladder * History of perforation of the bladder * Major surgery or significant traumatic injury within 28 days prior to first administration of study treatment or anticipation of the need for major surgery during treatment * Participants currently receiving investigational or commercial anti-cancer agents or anti-cancer therapies other than BCG, and supportive care therapies for active disease * Any intervening intravesical immunotherapy or chemotherapy from the time of the most recent cytoscopy/TURBT to the start of study treatment * Systemic immune-modulating and systemic immunosuppressive agents/medication * Administration of a live, attenuated vaccine within 28 days prior to first administration of study treatment * Recurrence of BCG unresponsive CIS \> 12 months after last BCG instillation * Concurrent second malignancy
Where this trial is running
Macquarie Park, New South Wales and 8 other locations
- Macquarie University Hospital — Macquarie Park, New South Wales, Australia (Recruiting)
- A.O.U di Verona Policlinico G.B. Rossi — Verona, Veneto, Italy (Recruiting)
- Hospital Umum Sarawak — Kuching, Sarawak, Malaysia (Recruiting)
- NKI/AvL — Amsterdam, Netherlands (Recruiting)
- UMC St Radboud — Nijmegen, Netherlands (Recruiting)
- Uniwersyteckie Centrum Kliniczne — Gda?sk, Poland (Recruiting)
- AIDPORT Sp. z o. o. — Skórzewo, Poland (Recruiting)
- Hospital Univ. 12 de Octubre — Madrid, Spain (Recruiting)
- Hospital Clinico Universitario Virgen de la Victoria — Malaga, Spain (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: BP45381 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S.)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.