Back to resultsA Study to Investigate the Efficacy and Safety of Atezolizumab (Tecentriq) in Previously-Treated Patients With Advanced Thymic Carcinoma
Primary Purpose
Carcinoma, Thymic
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Atezolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Thymic
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.
Sites / Locations
- Beijing Cancer Hospital
- Sichuan Cancer Hospital
- West China Hospital, Sichuan University; Department of Breast
- The Second Affiliated Hospital, Chongqing Medical University
- Fujian Medical University Union Hospital
- The First Affiliated Hospital of Guangzhou Medical University
- The First Affiliated Hospital of College of Medicine, Zhejiang University
- Qingdao Central Hospital
- Shanghai Chest Hospital
- Shanghai Pulmonary Hospital
- Tianjin Cancer Hospital
- Henan Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Atezolizumab
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Overall Survival (OS)
OS is defined as the time from initiation of study treatment to death from any cause.
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.
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
Distribution of TMB Expression
Positive is defined as >=10 Muts/Mb. Negative is defined as <10 Muts/Mb.
Distribution of PD-L1 Expression
Positive is defined as TC or IC >=1%. Negative is defined as TC or IC <1%.
Percentage of Participants With Adverse Events
Percentage of Participants With Immune-Related Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04321330
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 7, 2020 (Actual)
Primary Completion Date
January 16, 2025 (Anticipated)
Study Completion Date
January 16, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Thymic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atezolizumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
MPDL3280A; RO5541267; Tecentriq
Intervention Description
Atezolizumab 1200 mg will be administered by IV on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
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).
Time Frame
Baseline up to approximately 3.5 years
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
Baseline up to approximately 3.5 years
Title
Overall Survival (OS)
Description
OS is defined as the time from initiation of study treatment to death from any cause.
Time Frame
Baseline up to approximately 3.5 years
Title
Duration of Objective Response (DOR)
Description
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.
Time Frame
Baseline up to approximately 3.5 years
Title
Disease Control Rate (DCR)
Description
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
Time Frame
Baseline up to approximately 3.5 years
Title
Distribution of TMB Expression
Description
Positive is defined as >=10 Muts/Mb. Negative is defined as <10 Muts/Mb.
Time Frame
Baseline up to approximately 3.5 years
Title
Distribution of PD-L1 Expression
Description
Positive is defined as TC or IC >=1%. Negative is defined as TC or IC <1%.
Time Frame
Baseline up to approximately 3.5 years
Title
Percentage of Participants With Adverse Events
Time Frame
Baseline up to approximately 3.5 years
Title
Percentage of Participants With Immune-Related Adverse Events
Time Frame
Baseline up to approximately 3.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Sichuan Cancer Hospital
City
Chengdu City
ZIP/Postal Code
610041
Country
China
Facility Name
West China Hospital, Sichuan University; Department of Breast
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
The Second Affiliated Hospital, Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400010
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou City
ZIP/Postal Code
350001
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Qingdao Central Hospital
City
Qingdao City
ZIP/Postal Code
266042
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Tianjin Cancer Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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).
Citations:
PubMed Identifier
34393061
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.
Results Reference
derived
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A Study to Investigate the Efficacy and Safety of Atezolizumab (Tecentriq) in Previously-Treated Patients With Advanced Thymic Carcinoma
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