NCT05564897

Oncolytic Adenovirus Combined With PD-1 Inhibitor in Patients With Non-muscle-invasive Bladder Cancer

Phase II Single Center Open-Label Single-Arm Study of the Safety and Efficacy of Oncolytic Adenovirus H101 Combined With PD-1 Inhibitor in Patients With Non-muscle-invasive Bladder Cancer Who Failed BCG Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

H101 is an E1B55KD deleted oncolytic adenovirus, which is the first and only adenovirus to be approved by China State Food and Drug Administration in 2005 for treating head and neck cancer. The objective of this phase II clinical trial is to investigate the safety and efficacy of H101 combined with PD-1 inhibitor Camrelizumab in patients with non-muscle-invasive bladder cancer who failed BCG therapy.

Detailed description

CHUCAS-030 (Cancer Hospital, University of Chinese Academy of Sciences) is a phase II trial conducted at Cancer Hospital, University of Chinese Academy of Sciences in the Zhejiang Province, China. Eligible patients are 18 to 80 years old with non-muscle-invasive bladder cancer who has previously failed BCG therapy and refuse cystectomy. Patients receive a combination therapy of PD-1 inhibitor Camrelizumab with oncolytic adenovirus H101 for up to 1 year. Camrelizumab are administered at dose of 200 mg i.v. every 3 weeks. H101 are instilled intravesically after 14 days from the most recent biopsy and in the absence of any evidence of hematuria with a fixed dose of 5×10\*11 Vp in a 50 mL normal saline solution via a catheter, and dwell time is 1 to 2 hours, and patients are encouraged to reposition to maximize bladder surface exposure. Intravesical H101 is instilled weekly for 6 weeks for both induction and maintenance treatments. Patients who experienced unacceptable toxicities or clinical or documented progressive disease are discontinued from the study. The duration of any objective response is measured from the date the initial response is observed to the date that disease progression is observed. Response assessment with cystoscopy, bladder biopsy of visually positive lesions and urine cytology are first evaluated after induction at 3 months. Patients with complete response (CR) at 3 months receive no intervention and are reevaluated at 6 months. Patients with stable disease (SD) receive maintenance treatment at 3 to 4 months. Patients with progressive disease (PD) are deemed non-responders and strongly counseled to reconsider cystectomy or alternative treatment. Patients with CR at 6 months receive maintenance treatment (weekly treatments for 6 weeks). All patients were followed up until death from any cause.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	H101, Camrelizumab	Patients receive a combination therapy of Camrelizumab 200 mg i.v. every 3 weeks with intravesical H101 with a dose of 5×10\*11 Vp weekly for 6 weeks for both induction and maintenance treatments up to 1 years.

Timeline

• Start date: 2022-08-26
• Primary completion: 2024-09-30
• Completion: 2024-12-31
• First posted: 2022-10-04
• Last updated: 2022-10-04

Locations

1 site across 1 country: China