Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515410-41-00 | Other Identifier | EU Trial Number |
Not provided
Not provided
Not provided
Decision of the Sponsor.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study aims to establish the safety, tolerability, pharmacokinetics (PK), relevant biomarkers, pharmacodynamics (PD) and preliminary anti-tumor activity of the intravesical administration of eciskafusp alfa in combination with BCG in participants with BCG-unresponsive high-risk NMIBC.
The study plans a similar evaluation of eciskafusp alfa in monotherapy following a positive interim analysis of the combination therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I: Dose Escalation | Experimental | Participants will receive multiple ascending doses of eciskafusp alfa in combination with a fixed dose of BCG administered as an intravesicular instillation up to a maximum of 25 months or until detection of high-risk disease or disease progression, toxicity, or withdrawal from study treatment for other reasons, whichever occurs first. |
|
| Phase II: Dose Extension (Cohort A) | Experimental | Participants will receive eciskafusp alfa at the maximum tolerated dose (MTD) and/or the recommended dose for extension (RDE), as determined in Phase 1, in combination with a fixed dose of BCG administered as an intravesical instillation up to a maximum of 25 months or until detection of high-risk disease or disease progression, toxicity, or withdrawal from study treatment for other reasons, whichever occurs first. |
|
| Phase II: Dose Extension (Cohort B) | Experimental | Participants will receive eciskafusp alfa as monotherapy at the MTD or RDE determined in Phase 1, administered as an intravesical instillation up to a maximum of 25 months or until detection of high-risk disease or disease progression, toxicity, or withdrawal from study treatment for other reasons, whichever occurs first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eciskafusp Alfa | Drug | Participants will receive eciskafusp alfa via intravesical instillation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Number of Participants With Adverse Events (AEs) | From Baseline (Day 1) up to 28 days after final dose of study treatment (up to Month 26) | |
| Phase I: Number of Participants With Dose Limiting Toxicities (DLTs) | From Day 1 up to Day 14 | |
| Phase I: Recommended Dose for Extension (RDE) of Eciskafusp Alfa in Combination With BCG | At Month 25 | |
| Phase II (Cohort A): Complete Response Rate (CRR) at 12 Months | At Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I and Phase II: CRR at any Time | Up to Month 36 | |
| Phase I and Phase II: CRR at 6, 18 and 24 Months | At Months 6, 18 and 24 | |
| Phase I and Phase II (Cohort B): CRR at 12 Months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Macquarie University Hospital | Macquarie Park | New South Wales | 2113 | Australia | ||
| A.O.U di Verona Policlinico G.B. Rossi |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| BCG Medac Strain | Drug | Participants will receive BCG via intravesical instillation. |
|
| At Month 12 |
| Phase I and Phase II: Duration of Response (DOR) | Time from the first occurrence of a documented CR until the time of evidence that the participant no longer meets the definition for CR or death from any cause, whichever occurs first (up to Month 36) |
| Phase I and Phase II: DOR Rate at Specific Timepoints | At Months 6, 12, 18, 24, 30 and 36 |
| Phase I and Phase II: Time to Worsening of NMIBC Grade or Stage, or Death | Time from the first dose of study treatment to the first occurrence of documented worsening of grade, stage or death from any cause, whichever occurs first (up to Month 36) |
| Phase I and Phase II: Progression Free Survival (PFS) to Muscle Invasive or Metastatic Disease or Death | Time from the first dose of study treatment to the first occurrence of documented muscle-invasive or metastatic disease or death from any cause, whichever occurs first (up to Month 36) |
| Phase I and II: Time to Cystectomy | Time from the first dose of study treatment to the first occurrence of documented cystectomy or death from any cause, whichever occurs first (up to Month 36) |
| Phase II: Number of Participants With AEs | From Baseline (Day 1) up to 28 days after final dose of study treatment (up to Month 26) |
| Phase I and Phase II: Number of Participants With Anti-drug Antibodies (ADAs) to Eciskafusp Alfa | Up to Month 36 |
| Phase II: Programmed Cell Death Ligand 1 (PD-L1) Expression in the Tumor Microenvironment (TME) Pre-treatment and During the Study | PD-L1 expression may be assessed at other timepoints when on-treatment biopsies will be collected. | Predose (-12 weeks to -14 days or archival) and Postdose at Month 6 |
| Phase II: Number of Participants With Cluster of Differentiation 8+ (CD8+) T cell in TME | Predose (-12 weeks to -14 days or archival) |
| Phase II: Baseline Urine Tumor Deoxyribonucleic Acid (DNA) | Baseline (Day 1 predose) |
| Phase II: Amount of Urine Tumor DNA at Baseline and During the Study | Up to Month 25 |
| Verona |
| Veneto |
| 37134 |
| Italy |
| Hospital Umum Sarawak | Kuching | Sarawak | 93586 | Malaysia |
| NKI/AvL | Amsterdam | 1066 CX | Netherlands |
| UMC St Radboud | Nijmegen | 6525 GA | Netherlands |
| Uniwersyteckie Centrum Kliniczne | Gda?sk | 80-214 | Poland |
| AIDPORT Sp. z o. o. | Skórzewo | 60-185 | Poland |
| Hospital Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Clinico Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| ID | Term |
|---|---|
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided