Clinical trial NCT04321330: A Study to Investigate the Efficacy and Safety of Atezolizumab (Tecentriq) in Previously-Treated Patients With Advanced Thymic Carcinoma
Official title: An Open-Label, Single Arm, Multicenter Study to Investigate the Efficacy and Safety of Atezolizumab (Tecentriq) in Previously-Treated Patients With Advanced Thymic Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Thymic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2020-03-25
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: Baseline up to approximately 3.5 years
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Baseline up to approximately 3.5 years
measure: Overall Survival (OS)
timeFrame: Baseline up to approximately 3.5 years
measure: Duration of Objective Response (DOR)
timeFrame: Baseline up to approximately 3.5 years
measure: Disease Control Rate (DCR)
timeFrame: Baseline up to approximately 3.5 years
measure: Distribution of TMB Expression
timeFrame: Baseline up to approximately 3.5 years
measure: Distribution of PD-L1 Expression
timeFrame: Baseline up to approximately 3.5 years
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline up to approximately 3.5 years
measure: Percentage of Participants With Immune-Related Adverse Events
timeFrame: Baseline up to approximately 3.5 years
Other outcomes:
Locations:
city: Chengdu City
country: China
facility: Sichuan Cancer Hospital
city: Chengdu
country: China
facility: West China Hospital, Sichuan University; Department of Breast
city: Chongqing
country: China
facility: The Second Affiliated Hospital, Chongqing Medical University
city: Fuzhou City
country: China
facility: Fujian Medical University Union Hospital
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
city: Qingdao City
country: China
facility: The affiliated hospital of Qingdao university
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
References:
citation: 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.