Study of TQB2450 Injection in Subjects With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT04002622|
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : October 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Relapsed or Refractory Primary Mediastinal B-cell Lymphoma (rrPMBCL)||Drug: TQB2450||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Multicenter, Open, Single-arm Study of TQB2450 Injection (PD-L1 Antibody) in Subjects With Relapsed or Refractory Primary Mediastinal B-cell Lymphoma (rrPMBCL)|
|Actual Study Start Date :||August 6, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
TQB2450 1200 milligrams (mg) administered intravenously (IV) on Day 1 of each 21-day cycle.
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
- Objective Response Rate (ORR) [ Time Frame: up to 96 weeks ]Percentage of subjects achieving complete response (CR) and partial response (PR).
- Progression-Free Survival (PFS) [ Time Frame: up to 96 weeks ]PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
- Duration of Response (DOR) [ Time Frame: up to 96 weeks ]DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
- Disease Control Rate (DCR) [ Time Frame: up to 24 months ]Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
- Time to Response (TTR) [ Time Frame: up to 24 months ]TTR defined as time from the first dose to the first assessment of PR or CR.
- Overall Survival (OS) [ Time Frame: up to 24 months ]OS defined as the time from randomization to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
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): NCT04002622
|Contact: Daobin Zhou, Doctorfirstname.lastname@example.org|