A Study to Investigate the Efficacy and Safety of Atezolizumab (Tecentriq) in Previously-Treated Patients With Advanced Thymic Carcinoma

Carcinoma, Thymic Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04321330
• Other study ID #: ML41253
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 7, 2020
• Est. completion date: June 3, 2024

Study information

• Verified date: March 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• 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: Active, not recruiting
• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Thymic
• Thymoma

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	Shanghai Pulmonary 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