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

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT05564897
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • H101, Camrelizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 26, 2022
Status verified
Oct 2022
Primary completion
Sep 30, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination of H101 with Camrelizumab treatment
    Patients receive a combination therapy of PD-1 inhibitor Camrelizumab with oncolytic adenovirus H101 for up to 1 years. Camrelizumab are administered at dose of 200 mg i.v. every 3 weeks. H101 are instilled intravesically with a dose of 5×10\*11 Vp in a 50 mL normal saline solution via a catheter, and dwell time is 1 to 2 hours,. Intravesical H101 is instilled weekly for 6 weeks for both induction and maintenance treatments.

Primary Outcome Measure

complete response (CR) [ Time Frame: One year ]

Central Contacts

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