Safety and Efficacy of Camrelizumab for High-risk NMIBC Failing BCG Treatment

Sponsor
Fudan University
Study ID
NCT04706598
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Immunotherapy
  • Urinary Bladder Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study will evaluate the safety and efficacy of bladder intravesical Camrelizumab in patients with high-risk non-muscle-invasive bladder cancer who failed BCG therapy.

Key Dates

Start date
Jun 9, 2021
Status verified
Jul 2024
Primary completion
Jul 11, 2024
Completion
Dec 31, 2024

Study Design

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

Arms

  • Experimental: Intravesical therapy group
    Camrelizumab(SHR-1210) is administered on the first day of each treatment cycle (D1) at a dose up to 200 mg. The recommended phase II dose(RP2D) to be decided after safety run-in. The cycle is divided into an induction course and a maintenance course. The induction course is initiated 2 weeks after TURBT and repeat once a week for 6 weeks . After that, the maintenance course starts every 3 weeks. The maximum duration of dosing is 2 years.

Primary Outcome Measure

The maximum dose of Camrelizumab for intravesical treatment [ Time Frame: 3 months after trial initiation(Phase I) ]

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