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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04321330
Other study ID # ML41253
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date August 7, 2020
Est. completion date June 3, 2024

Study information

Verified date June 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date June 3, 2024
Est. primary completion date July 16, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histological confirmation of thymic carcinoma by the central pathology laboratory - Advanced disease not amenable to curative treatment - At least 1 prior line of chemotherapy - Progression of disease must be documented prior to study entry - Measurable disease, as defined by Response Evaluation Criteria for Solid Tumors, Version 1.1 (RECIST v1.1) - Availability of a representative tumor specimen that is suitable for biomarkers research via central testing - ECOG performance status 0 or1 - Life expectancy > 3 months - Adequate hematologic and end-organ function within 14 days prior to the first study treatment - For patients receiving therapeutic anticoagulation: stable anticoagulant regimen - For women of childbearing potential: agreement to remain abstinent or use contraception Exclusion Criteria: - Disease which is amenable to radical treatment with surgery or radiation or a combination of treatments. - Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases - History of leptomeningeal disease - Uncontrolled tumor-related pain - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures - Uncontrolled or symptomatic hypercalcemia - Active or history of autoimmune disease or immune deficiency - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan - Active tuberculosis - Significant cardiovascular disease within 3 months prior to initiation of study treatment unstable arrhythmia, or unstable angina. - Prior treatment with chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered from adverse events due to a previously administered agent. - Additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China West China Hospital, Sichuan University; Department of Breast Chengdu
China Sichuan Cancer Hospital Chengdu City
China The Second Affiliated Hospital, Chongqing Medical University Chongqing
China Fujian Medical University Union Hospital Fuzhou City
China The First Affiliated Hospital of Guangzhou Medical University Guangzhou
China The First Affiliated Hospital of College of Medicine, Zhejiang University Hangzhou
China The affiliated hospital of Qingdao university Qingdao City
China Shanghai Chest Hospital Shanghai
China Tianjin Cancer Hospital Tianjin
China Henan Cancer Hospital Zhengzhou

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Percentage of Participants With Adverse Events Baseline up to approximately 3.5 years
Secondary Percentage of Participants With Immune-Related Adverse Events Baseline up to approximately 3.5 years
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Recruiting NCT05461430 - Mass Response of Tumor Cells as a Biomarker for Rapid Therapy Guidance (TraveraRTGx)
Active, not recruiting NCT01306045 - Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies Phase 2