Active — Not RecruitingPhase 1/2

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

China25 participantsStarted 2021-06-09

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years.
✓. Histologically-confirmed diagnosis of high risk non-muscle-invasive urothelial cell carcinoma of the bladder (mixed histology tumors allowed if urothelial carcinoma histology is \>50%).
✓. Fully resected disease at study entry (residual CIS acceptable).
✓. BCG-unresponsive high risk non-muscle-invasive bladder cancer after treatment with adequate BCG therapy(at least five times a week during the induction phase and at least two times a week during the maintenance phase).
✓. Ineligible for radical cystectomy or refusal of radical cystectomy.
✓. Consent to tissue specimen retrieval and testing.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Adequate normal organ and marrow function as defined below:

Exclusion criteria

✕. Muscle-invasive, locally advanced nonresectable, or metastatic urothelial carcinoma.
✕. Concurrent extra-vesical (i.e., urethra, ureter, or renal pelvis)urothelial cell carcinoma.
✕. Have participated in a clinical trial of an investigational drug or device within 4 weeks prior to receiving the first treatment in this project.
✕. Received chemotherapy, targeted small molecule therapy, immunotherapy or radiation therapy following a recent cystoscopy or transurethral resection of a bladder tumour.
✕. History of other malignancies within the last 5 years.
✕. Active autoimmune disease that has required systemic treatment in the past 2 years.
✕. History of idiopathic pulmonary fibrosis (including pneumonia), drug-induced pneumonia, histoplasmosis (i.e. occlusive bronchiolitis, cryptogenic histoplasmosis), or evidence of active pneumonia on chest CT scan (history of fibrosis in radiation pneumonia), patients with active tuberculosis.
✕. Active infection requiring systemic therapy,therapeutic oral or intravenous (IV) antibiotics within 14 days prior to enrolment (patients receiving prophylactic antibiotics (e.g. for the prevention of urinary tract infections or chronic obstructive pulmonary disease) can be enrolled).

What they're measuring

The maximum dose of Camrelizumab for intravesical treatment

Timeframe: 3 months after trial initiation(Phase I)

Event-Free Survival (EFS)

Timeframe: 3 months after patient treatment (Phase II)

Trial details

NCT IDNCT04706598

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-11

View on ClinicalTrials.gov More Urinary Bladder Neoplasms trials