A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients with Urothelial Carcinoma Morpheus-UC

Phase 1

• Conditions: rothelial carcinoma (UC); MedDRA version: 20.0Level: LLTClassification code: 10064467Term: Urothelial carcinoma Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-511316-25-00
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-06
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 395

Inclusion Criteria

Stage 1: Availability of a representative tumor specimen that is suitable for determination of Programmed death-ligand 1 (PD-L1) and/or additional biomarker status by means of central testing, Stage 1: Disease progression during or following treatment with no more than one platinum containing regimen for inoperable, locally advanced or metastatic UC or disease recurrence, Stage 1 and Stage 2 Measurable disease according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST) v1.1, Stage 1 and Stage 2 Negative HIV test at screening, For the Muscle Invasive Bladder Cancer Cohorts (MIBC) Availability of a TURBT specimen that is suitable for determination of PD-L1 and additional biomarker status by means of central testing, For the Muscle Invasive Bladder Cancer Cohorts (MIBC) N0 or M0 disease assessed by CT or magnetic resonance imaging (MRI) scan (within 4 weeks of study treatment initiation)

Exclusion Criteria

For mUC cohort: Stage 1 Prior treatment with a T-cell co-stimulating therapy or an immune checkpoint inhibitor, or investigational therapy within 28 days before C1D1, or any approved anti-cancer therapy within 3 weeks before study, For mUC cohort: Stage 1 and Stage 2 Prior systemic immunostimulatory treatments within 4 weeks or 5 half-lives of the drug before study, or with systemic immunosuppressants within 2 weeks before study, or need such during study, For mUC cohort: Stage 1 and Stage 2 History of leptomeningeal disease, autoimmune disease, idiopathic pulmonary fibrosis (IPF), organizing pneumonia drug-induced pneumonitis, or idiopathic pneumonitis, or active pneumonitis at screening, For mUC cohort: Stage 1 and Stage 2 Active tuberculosis (TB), For MIBC Cohorts Received a live, attenuated vaccine within 4 weeks before study, or needing such during atezolizumab treatment or within 5 months after the last dose, For MIBC Cohorts Active or history of autoimmune disease or immune deficiency

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified