Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab 1200 mg will be administered by IV on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline up to approximately 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to approximately 3.5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Cancer Hospital | Chengdu | 610041 | China | |||
| West China Hospital, Sichuan University; Department of Breast |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34393061 | Derived | Remon J, Girard N, Novello S, de Castro J, Bigay-Game L, Bernabe R, Greillier L, Mosquera J, Cousin S, Juan O, Sampayo M, Besse B. PECATI: A Multicentric, Open-Label, Single-Arm Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab and Lenvatinib in Pretreated B3-Thymoma and Thymic Carcinoma Patients. Clin Lung Cancer. 2022 May;23(3):e243-e246. doi: 10.1016/j.cllc.2021.07.008. Epub 2021 Jul 20. |
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Overall Survival (OS) |
OS is defined as the time from initiation of study treatment to death from any cause. |
| 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. | 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 | 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. | 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%. | Baseline up to approximately 3.5 years |
| Percentage of Participants With Adverse Events | Baseline up to approximately 3.5 years |
| Percentage of Participants With Immune-Related Adverse Events | Baseline up to approximately 3.5 years |
| Chengdu |
| 610041 |
| China |
| The Second Affiliated Hospital, Chongqing Medical University | Chongqing | 400010 | China |
| Fujian Medical University Union Hospital | Fuzhou | 350001 | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | 510120 | China |
| The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | 310003 | China |
| The affiliated hospital of Qingdao university | Qingdao | 266042 | China |
| Shanghai Chest Hospital | Shanghai | 200000 | China |
| Tianjin Cancer Hospital | Tianjin | 300060 | China |
| Henan Cancer Hospital | Zhengzhou | 450008 | China |
| ID | Term |
|---|---|
| D013945 | Thymoma |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
Not provided
Not provided
Not provided