Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04799847
Status:
RECRUITING
Last Update Posted:
2023-02-13
First Post:
2021-03-12
Brief Title:
Catumaxomab in Patients With Non-Muscle-Invasive Bladder Cancer Who Have Failed or Are Intolerant to BCG Vaccine
Sponsor:
LintonPharm CoLtd
Organization:
LintonPharm CoLtd
Study Overview
Official Title:
A Multicenter Non-randomized Uncontrolled Open-label Phase III 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
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Multicenter Non-randomized Uncontrolled Open-label Phase III 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 Bacillus Calmette-Guerin BCG Vaccine
Detailed Description:
This is a multicenter non-randomized uncontrolled open-label phase III 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 20ug group participants and 2cycles of instillation in 100ug group 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 days1 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
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 20ug group participants and 2cycles of instillation in 100ug group 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 days1 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None