NCT04690699

LUMINOS-103: A Basket Trial of Safety & Efficacy of Lerapolturev With or Without Checkpoint Inhibitors

LUMINOS-103: A Basket Trial Evaluating the Safety and Efficacy of Lerapolturev (PVSRIPO) and Lerapolturev in Combination With Anti-PD-1/L1 Checkpoint Inhibitors in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Istari Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2, open-label, multi-center, single arm basket study evaluating the administration of lerapolturev ± anti programmed cell death protein 1 (PD 1)/programmed death-ligand 1 (PD L1) monoclonal antibody (mAb) (which will be referred to throughout this protocol as "anti-PD-1/L1 therapy") therapy in adult patients with solid tumor cancers. Non-muscle invasive Bladder Cancer has been selected as the tumor specific cancer of interest for enrollment.

Detailed description

Patients with recurrent non-muscle invasive bladder cancer (NMIBC) intended for transurethral resection of bladder tumor (TURBT) or cystectomy will receive lerapolturev by intravesical instillation. Approximately 12-15 patients will be enrolled.

Conditions

• Solid Tumor
• Bladder Cancer
• Non-muscle-invasive Bladder Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Lerapolturev	Lerapolturev administered via intravesical instillation once
OTHER	5% DDM	5% DDM and saline washes

Timeline

• Start date: 2021-08-01
• Primary completion: 2024-04-04
• Completion: 2024-06-12
• First posted: 2020-12-31
• Last updated: 2024-10-24
• Results posted: 2024-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study