NCT04321330

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2020

Typical duration for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

August 7, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2024

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

2.9 years

First QC Date

March 24, 2020

Last Update Submit

June 10, 2024

Conditions

Carcinoma, Thymic

Outcome Measures

Primary Outcomes (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).

    Baseline up to approximately 3.5 years

Secondary Outcomes (8)

  • Progression-Free Survival (PFS)

    Baseline up to approximately 3.5 years

  • Overall Survival (OS)

    Baseline up to approximately 3.5 years

  • Duration of Objective Response (DOR)

    Baseline up to approximately 3.5 years

  • Disease Control Rate (DCR)

    Baseline up to approximately 3.5 years

  • Distribution of TMB Expression

    Baseline up to approximately 3.5 years

  • +3 more secondary outcomes

Study Arms (1)

Atezolizumab

EXPERIMENTAL

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

Interventions

AtezolizumabDRUG

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

Also known as: MPDL3280A; RO5541267; Tecentriq
Atezolizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Sichuan Cancer Hospital

Chengdu, 610041, China

Location

West China Hospital, Sichuan University; Department of Breast

Chengdu, 610041, China

Location

The Second Affiliated Hospital, Chongqing Medical University

Chongqing, 400010, China

Location

Fujian Medical University Union Hospital

Fuzhou, 350001, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510120, China

Location

The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, 310003, China

Location

The affiliated hospital of Qingdao university

Qingdao, 266042, China

Location

Shanghai Chest Hospital

Shanghai, 200000, China

Location

Tianjin Cancer Hospital

Tianjin, 300060, China

Location

Henan Cancer Hospital

Zhengzhou, 450008, China

Location

Related Publications (1)

  • 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.

    PMID: 34393061DERIVED

MeSH Terms

Conditions

Thymoma

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Neoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplasmsThymus NeoplasmsThoracic NeoplasmsNeoplasms by SiteLymphatic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 25, 2020

Study Start

August 7, 2020

Primary Completion

July 16, 2023

Study Completion

June 3, 2024

Last Updated

June 11, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

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).

Locations

CN(10)