Effects of Oncotherad Immunotherapy in the Treatment of Bacillus Calmette-Guérin (BCG)-Recurrent and Relapsed Non-Muscle Invasive Bladder Cancer

Phase 1

Recruiting

• Conditions: Recurrent Malignant Neoplasm of Bladder; C04.588.945.947.960

• Registration Number: RBR-6swqd2
• Lead Sponsor: niversidade Estadual de Campinas (UNICAMP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-20
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients, 18- to 95-year-old, with BCG-refractory and relapsed non-muscle invasive bladder cancer. In addition, patients refractory to approved first and second line chemotherapy, who are at increased risk of progression to muscle invasive and / or metastatic disease, will be included. Acceptance of the Informed Consent Form (TCLE); multiple (greater than two lesions) and / or recurrent and / or large (greater than 3 cm) tumors TaG1-2; non-muscle invasive tumor (pT1); presence of carcinoma in situ (Cis); urothelial carcinoma of the bladder grade 3.

Exclusion Criteria

Patients with bladder lesion suspected of malignant neoplasm and who were not previously submitted to Transurethral Resection (TUR), ie, treatment-naive patients for the bladder tumor. Histology: adenocarcinoma, squamous cell carcinoma.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is to evaluate the increase in relapse-free survival (RFS) and progression-free survival (PFS) in Bacillus Calmette-Guérin (BCG)-Refractory and Relapsed Non-Muscle Invasive Bladder Cancer patients, submitted to OncoTherad immunotherapy. Recurrence will be defined as histologically proven tumor recurrence. Tumor progression will be defined as tumor recurrence in histological grade higher than the initial diagnosis. The recurrence and progression of the disease will be evaluated through urinary cytology, urinary-volume ultrasound and cystoscopy every three months in the first year, in the second year and in the second year after the third year (follow-up), with biopsies semesters.<br>Cox regression models will be used to evaluate relapse-free survival and progression. The level of significance considered in the analyzes will be 5%.