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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04321330
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Carcinoma, Thymic Drug: Atezolizumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 7, 2020
Estimated Primary Completion Date : February 27, 2024
Estimated Study Completion Date : February 27, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Atezolizumab
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.
 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.
Other Name: MPDL3280A; RO5541267; Tecentriq


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 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 Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: 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.

  2. Overall Survival (OS) [ Time Frame: Baseline up to approximately 3.5 years ]
    OS is defined as the time from initiation of study treatment to death from any cause.

  3. Duration of Objective Response (DOR) [ Time Frame: 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.

  4. Disease Control Rate (DCR) [ Time Frame: 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

  5. Distribution of TMB Expression [ Time Frame: Baseline up to approximately 3.5 years ]
    Positive is defined as >=10 Muts/Mb. Negative is defined as <10 Muts/Mb.

  6. Distribution of PD-L1 Expression [ Time Frame: Baseline up to approximately 3.5 years ]
    Positive is defined as TC or IC >=1%. Negative is defined as TC or IC <1%.

  7. Percentage of Participants With Adverse Events [ Time Frame: Baseline up to approximately 3.5 years ]
  8. Percentage of Participants With Immune-Related Adverse Events [ Time Frame: Baseline up to approximately 3.5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321330


Contacts
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Contact: Reference Study ID Number: ML41253 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Locations
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China
Peking University People's Hospital Not yet recruiting
Beijing, China, 100044
Beijing Cancer Hospital Recruiting
Beijing, China, 100142
Sichuan Cancer Hospital Recruiting
Chengdu City, China, 610041
West China Hospital, Sichuan University; Department of Breast Recruiting
Chengdu, China, 610041
The Second Affiliated Hospital, Chongqing Medical University Not yet recruiting
Chongqing, China, 400010
Fujian Medical University Union Hospital Active, not recruiting
Fujian, China, 350001
The First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, China, 510120
The First Affiliated Hospital of College of Medicine, Zhejiang University Recruiting
Hangzhou, China, 310003
Harbin Medical University Cancer Hospital Recruiting
Harbin, China, 150081
Qingdao Central Hospital Not yet recruiting
Qingdao, China
Shanghai Chest Hospital Recruiting
Shanghai, China, 200000
Shanghai Pulmonary Hospital Not yet recruiting
Shanghai, China, 200433
Tianjin Cancer Hospital Recruiting
Tianjin, China, 300060
Henan Cancer Hospital Recruiting
Zhengzhou, China, 450008
Sponsors and Collaborators
Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04321330    
Other Study ID Numbers: ML41253
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).

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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
Additional relevant MeSH terms:
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Carcinoma
Thymoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed
 Thymus Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases
Atezolizumab
Antineoplastic Agents