Atezolizumab
DrugAtezolizumab 1200 mg will be administered by IV on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit.
Other names: MPDL3280A; RO5541267; Tecentriq
NCT Number: NCT04321330
This is a phase II, open-label, single-arm, multicenter study of the efficacy and safety of atezolizumab treatment in participants with advanced thymic carcinoma who failed prior systemic therapy.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Sichuan Cancer Hospital, Chengdu, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Atezolizumab 1200 mg will be administered by IV on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit.
Other names: MPDL3280A; RO5541267; Tecentriq
Time frame: Baseline up to approximately 3.5 years
ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions 4 weeks apart, as determined by the Investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
Time frame: Baseline up to approximately 3.5 years
PFS is defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be calculated based on disease status evaluated by the investigator according to RECIST v1.1.
Time frame: Baseline up to approximately 3.5 years
OS is defined as the time from initiation of study treatment to death from any cause.
Time frame: Baseline up to approximately 3.5 years
DOR is defined as the time from initial response to disease progression or death among patients who have experienced a CR or PR (unconfirmed) during the study. Duration of response will be calculated based on disease status evaluated by the investigator according to RECIST v1.1.
Time frame: Baseline up to approximately 3.5 years
DCR is defined as the proportion of patients who have a best overall response of CR or PR or SD, as determined by the investigator according to RECIST v1.1
Time frame: Baseline up to approximately 3.5 years
Positive is defined as >=10 Muts/Mb. Negative is defined as <10 Muts/Mb.
Time frame: Baseline up to approximately 3.5 years
Positive is defined as TC or IC >=1%. Negative is defined as TC or IC <1%.
Time frame: Baseline up to approximately 3.5 years
Time frame: Baseline up to approximately 3.5 years
Hoffmann-La Roche
Industry
An Open-Label, Single Arm, Multicenter Study to Investigate the Efficacy and Safety of Atezolizumab (Tecentriq) in Previously-Treated Patients With Advanced Thymic Carcinoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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