Catumaxomab in Patients With Non-Muscle-Invasive Bladder Cancer Who Have Failed or Are Intolerant to BCG Vaccine
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|ClinicalTrials.gov Identifier: NCT04799847|
Recruitment Status : Not yet recruiting
First Posted : March 16, 2021
Last Update Posted : March 18, 2021
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: Catumaxomab||Phase 1 Phase 2|
This is a multicenter, non-randomized, uncontrolled, open-label phase I/II study to observe the safety and preliminary efficiency of catumaxomab in patients (hereinafter referred to as participants) with non-muscle-invasive bladder cancer (NMIBC) who have failed or are intolerant to Bacillus Calmette-Guerin (BCG) vaccine.
This study is conducted in 3 phases sequentially: dose escalation phase, dose expansion phase and dose extension phase. In the dose escalation phase, the preliminary safety and pharmacokinetic profile of catumaxomab for 4 cycles of instillation in participants are explored. Data will be collected after completing DLT observation in all cohorts, but it is not required to lock database. DSMB will review the data of each dose cohort and decide whether to open the enrollment for the next cohort. DSMB will recommend the dose at dose expansion phase according to the relevant data after the completion of DLT observation and the first efficiency assessment.
In the dose expansion phase, 24 participants will receive the catumaxomab treatment at dosing scheme recommended by the DSMB. DLT events occurred within 28 days after the initial instillation will be investigated. After th DLT observation period, DSMB will evaluate the data from both dose escalation and dose expansion phase and decide whether to initiate the dose extension phase; protocol amendment might be developed.
In the dose extension phase, the elgible participants are enrolled and allocated into three arms according to the type of BCG treatment failure: refractory, relapse, and intolerance. A maximum 125 participants are enrolled in the 3 arms, with at least 30 participants allocated to each.
The participants will have chest and abdominal CT and pelvic MRI scan at baseline to determine the area of lesion and to rule out possible extra-bladder lesions. From the initial instillation, cystoscopy, bladder biopsy, urinary cytology, and pelvic MRI scan are performed every 12 weeks (±7 days); chest and abdominal CT scans are performed every 24 weeks (±7 days)1 until recurrence, progression, consent withdrawal, or 96 weeks (±7 days) from the initial instillation, whichever occurs firstly. Participants who discontinue study treatment early due to any reasons other than disease progression will continue to have the tumor response assessment as planned until the participant has disease progression, withdrawal of consent, loss of follow-up, death, 96 weeks (± 7 days) after the initial instillation or until the end of the study, whichever occurs firstly.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||167 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Non-randomized, Uncontrolled, Open-label Phase I/II Study to Observe the Safety and Preliminary Efficacy of Catumaxomab in Patients With Non-Muscle-Invasive Bladder Cancer Who Have Failed or Are Intolerant to BCG Vaccine|
|Estimated Study Start Date :||July 7, 2021|
|Estimated Primary Completion Date :||November 22, 2023|
|Estimated Study Completion Date :||November 27, 2024|
In the dose escalation phase, 3 dose levels of catumaxomab will be explored.
This study is conducted in 3 phases sequentially: dose escalation phase, dose expansion phase and dose extension phase. In the dose escalation phase, the preliminary safety and pharmacokinetic profile of catumaxomab by instillation, at 3 dose levels, in NMIBC patients are investigated.
- Dose escalation phase and dose expansion phase only: DLT incidence. [ Time Frame: 28 days ]Dose Limited Toxicity
- 1-year recurrence rate since the initial instillation [ Time Frame: 1 year ]1-year recurrence rate since the initial instillation
- Recurrence rate at 3 months / 6 months / 2 years. [ Time Frame: Up to 2 years ]Recurrence rate at 3 months / 6 months / 2 year
- PFS [ Time Frame: 2 years ]Relapse-free survival
- 2-year progression rate to MIBC. [ Time Frame: 2 years ]2-year progression rate to MIBC.
- The incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: 2 years ]The incidence and severity of treatment-emergent adverse events (TEAEs) during intravesical instillation with catumaxomab are observed according to the National Cancer Institute Common Terminology Standard for Adverse Events (NCI-CTCAE) v5.0.
- ADA [ Time Frame: 2 years ]he incidence of anti-drug antibodies (ADA) to catumaxomab by intravesical instillation in serum.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04799847
|The First Affiliated Hospital,Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510080|
|Sun Yat-sen Memorial Hospital, Sun Yat-sen University|
|Guangzhou, Guangdong, China|
|Contact: Shuangxiu Lin 020-81332587 firstname.lastname@example.org|
|Principal Investigator: Jian Huang|