TheraCys (PMCJ-9) / Sanofi - LARVOL DELTA

Electromotive Mitomycin-C (EMDA-MMC) in Preventing Recurrences in High-risk Non-muscle-invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Turku University Hospital | Trial primary completion date: Nov 2023 ➔ Nov 2025

Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Electromotive Mitomycin-C (EMDA-MMC) in Preventing Recurrences in High-risk Non-muscle-invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Turku University Hospital

New P3 trial • Bladder Cancer • Oncology • Solid Tumor

Electromotive Mitomycin-C (EMDA-MMC) in Preventing Recurrences in High-risk Non-muscle-invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Turku University Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Oncology • Solid Tumor

A Clinical Study of V940 and BCG in People With Bladder Cancer (V940-011/INTerpath-011) (clinicaltrials.gov) - P2 | N=308 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A Clinical Study of V940 and BCG in People With Bladder Cancer (V940-011/INTerpath-011) (clinicaltrials.gov) - P2 | N=308 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

Monotherapy • New P2 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Comparing Clinical Efficacy of Different Bacillus Calmette-Guérin Strains in Patients With T1 High Grade Bladder Cancer. (PubMed, Anticancer Res) - "Both the Connaught and TICE strains of BCG demonstrated comparable three-year recurrence-free survival rates and three-year progression-free survival rates for T1 high grade bladder cancer, as well as comparable adverse events. Due to the global BCG shortage, further strain comparisons are essential for clinical validation."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

BCG+MMC: Adding Mitomycin to BCG as Adjuvant Intravesical Therapy for High-risk Non-Muscle-invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=501 | Active, not recruiting | Sponsor: University of Sydney | Recruiting ➔ Active, not recruiting

Enrollment closed • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

High-risk non-muscle invasive bladder cancer (HR-NMIBC) treated with sequential BCG / Electromotive Drug Administration Mitomycin-C (EMDA-MMC): 2% disease-specific mortality at 4 years’ follow-up (AUA 2017) - "BCG (Immucyst until June 2012, Oncotice since Sept 2012) was given in weeks 1 and 2, and EMDA-MMC (40mg, intravesical current 20mA for 30 mins) in week 3, and this cycle was repeated 3 times for a total of 9 weeks. Despite the challenge of a 4-year recurrence rate of 35%, a low progression rate to muscle-invasive and metastatic disease of 5% and disease-specific mortality of 2% continue to attest to the oncological efficacy of sequential BCG/EMDA-MMC."

Clinical • Biosimilar • Bladder Cancer • Oncology • Urothelial Cancer

Topical instillation of BCG immunotherapy for biopsy-proven primary upper urinary tract carcinoma in situ: A single institution series and systematic review. (PubMed, Urol Oncol) - "BCG course consisted of 6 weekly instillation of 81 mg Immucyst (Sanofi Pasteur MSD AG, Baar, Switzerland)...Our study is the first to propose a histological diagnosis of UTcis as well as a histological re-evaluation of the response to treatment. Topical instillations of BCG appear to be a promising alternative, avoiding radical treatment in the majority of cases."

Journal • Review • Infectious Disease • Oncology • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Tuberculosis • Urothelial Cancer

BCG+MMC: Adding Mitomycin to BCG as Adjuvant Intravesical Therapy for High-risk Non-Muscle-invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: University of Sydney | Unknown status ➔ Recruiting | Trial completion date: Dec 2020 ➔ Dec 2024 | Trial primary completion date: Dec 2020 ➔ Dec 2024

Enrollment open • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

BCG strain shortage from 2012 to 2014: Evaluation of its impact on the management of patients with high-risk NMIBC (PubMed, Prog Urol) - "In our experience, RFS, PFS, OS or SS were not impacted by the BCG shortage. These data may be explained by a better selection of very high-risk patients including the recommended BCG schedule and more frequently the use of diagnosis bladder fluorescence."

Clinical • Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer