Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

Official Title: 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

Study ID: NCT04690699

Conditions

Solid Tumor

Bladder Cancer

Non-muscle-invasive Bladder Cancer

Interventions

Lerapolturev

5% DDM

Study Description

Brief 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.