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Carcinoma, ThymicPhase 2NCT04321330

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

A Phase 2 study testing Atezolizumab in people with Carcinoma, Thymic, run by Hoffmann-La Roche at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Thymic
What is being tested?
Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
10 sitesChina
Study dates
7 Aug 2020to 3 Jun 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Sichuan Cancer Hospital

    Chengdu, 610041

  • West China Hospital, Sichuan University; Department of Breast

    Chengdu, 610041

  • The Second Affiliated Hospital, Chongqing Medical University

    Chongqing, 400010

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, 310003

  • The affiliated hospital of Qingdao university

    Qingdao, 266042

  • Shanghai Chest Hospital

    Shanghai, 200000

  • Tianjin Cancer Hospital

    Tianjin, 300060

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

About this study

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

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.

Being tested
Atezolizumab
Medical subject headings
Thymoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called MPDL3280A; RO5541267; Tecentriq

    Atezolizumab 1200 mg will be administered by IV on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit.

Study groups in NCT04321330
Study groupRoleWhat they receive
AtezolizumabExperimentalParticipants 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.
Receives: Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline up to approximately 3.5 years

Secondary outcomes (8)

  1. 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.

    Measured: Baseline up to approximately 3.5 years

  2. Overall Survival (OS)

    OS is defined as the time from initiation of study treatment to death from any cause.

    Measured: Baseline up to approximately 3.5 years

  3. 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.

    Measured: Baseline up to approximately 3.5 years

  4. 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

    Measured: Baseline up to approximately 3.5 years

  5. Distribution of TMB Expression

    Positive is defined as >=10 Muts/Mb. Negative is defined as <10 Muts/Mb.

    Measured: Baseline up to approximately 3.5 years

  6. Distribution of PD-L1 Expression

    Positive is defined as TC or IC >=1%. Negative is defined as TC or IC <1%.

    Measured: Baseline up to approximately 3.5 years

  7. Percentage of Participants With Adverse Events

    Measured: Baseline up to approximately 3.5 years

  8. Percentage of Participants With Immune-Related Adverse Events

    Measured: Baseline up to approximately 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2020
  2. Study start7 Aug 2020
  3. Primary completion16 Jul 2023
  4. Study completion3 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04321330
Sponsor's protocol ID
ML41253
Status last verified
Jun 2024
First submitted
24 Mar 2020
Last updated
11 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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).

Publications

  • 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.

    PubMed 34393061

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab in people with Carcinoma, Thymic, run by Hoffmann-La Roche at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Baseline up to approximately 3.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04321330, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.

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