A Phase 2 interventional study of Atezolizumab in Carcinoma, Thymic, sponsored by Hoffmann-La Roche. Completed at 10 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-11.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 34 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive atezolizumab at a fixed dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit.
Drug: Atezolizumab
Atezolizumab 1200 mg will be administered by IV on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit.
Also known as: MPDL3280A; RO5541267; Tecentriq
Objective response rate (ORR)
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
Progression-Free Survival (PFS)
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
Overall Survival (OS)
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
Duration of Objective Response (DOR)
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
Disease Control Rate (DCR)
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
Distribution of TMB Expression
Positive is defined as \>=10 Muts/Mb. Negative is defined as \<10 Muts/Mb.
Time frame: Baseline up to approximately 3.5 years
Distribution of PD-L1 Expression
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
Percentage of Participants With Adverse Events
Time frame: Baseline up to approximately 3.5 years
Percentage of Participants With Immune-Related Adverse Events
Time frame: Baseline up to approximately 3.5 years
Plan to share: Yes — Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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