Carcinoma, Thymic
Conditions
Brief 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.
Interventions
DRUGAtezolizumab
Atezolizumab 1200 mg will be administered by IV on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Baseline up to approximately 3.5 years | OS is defined as the time from initiation of study treatment to death from any cause. |
| Duration of Objective Response (DOR) | 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. |
| Disease Control Rate (DCR) | 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 |
| Progression-Free Survival (PFS) | 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. |
| Distribution of PD-L1 Expression | Baseline up to approximately 3.5 years | Positive is defined as TC or IC \>=1%. Negative is defined as TC or IC \<1%. |
| 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 | — |
| Distribution of TMB Expression | Baseline up to approximately 3.5 years | Positive is defined as \>=10 Muts/Mb. Negative is defined as \<10 Muts/Mb. |
Countries
China
Outcome results
None listed