A Study of Atezolizumab in Unresectable or Advaced Malignant Pleural Mesothelioma
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|ClinicalTrials.gov Identifier: NCT03786419|
Recruitment Status : Not yet recruiting
First Posted : December 26, 2018
Last Update Posted : December 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Mesothelioma, Advanced Malignant Pleural Mesothelioma, Unresectable||Drug: Atezolizumab||Phase 2|
The study includes a screening period a treatment period, a termination treatment visit ≤30 days following the last dose of the study drug, and a follow-up period. Day 1 is defined as the first day in which patients receive atezolizumab. The study is expected to enroll 36 patients.
Enrolled patients will receive a fixed dose of atezolizumab 1200 mg administered intravenously the first day of each cycle. A treatment cycle will last 21 days (± 3 days). Treatment with atezolizumab will continue until investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).
Treatment with atezolizumab may continue while patients experience clinical benefit based on the investigator's assessment (absence of unacceptable toxicity or symptomatic deterioration attributable to disease progression, at the discretion of the investigator after evaluating radiographic data, biopsy results [if available], and clinical status), or until unacceptable toxicity or death.
During treatment, patients treated with atezolizumab, who demonstrate evidence of clinical benefit may continue treatment with atezolizumab after meeting disease progression criteria, based on the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The following need to be met, as specified by the protocol.
All patients must undergo tumor assessments at baseline and every 9 weeks (± 7 days) following cycle 1, day 1, regardless of treatment delays, until radiographic disease progression, as per RECIST v1.1 modified for mesothelioma, or loss of clinical benefit in patients treated with atezolizumab, who continue treatment beyond disease progression, as per RECIST v1.1, withdrawal of consent, death or study termination by principal investigator, whichever occurs first.
The study will end if all enrolled patients die, withdraw their consent, become lost to follow-up, or have been monitored during 12 months from the enrollment of the last patient, whichever occurs first.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study to Evaluate the Efficacy and Safety of Atezolizumab in Subjects With Unresectable or Advanced Malignant Pleural Mesothelioma Who Experienced Progression on Platinum-Based Chemotherapy|
|Estimated Study Start Date :||June 2019|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||June 2022|
Participants with unresectable or advanced malignant pleural mesothelioma who have progressed after platinum-based chemotherapy will receive atezolizumab 1200 mg every 21 days, until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).
Participants will be given 1200 mg of Atezolizumab as single agent by IV infusion every 21 days. First infusion will be over 60 min. Subsequent Atezolizumab cycles may be administered for 30 minutes, if there were no perfusion-related toxicity
- Objective Response Rate [ Time Frame: From the time of initial response until documented tumor progression or death, whichever occurs first (up to approximately 4 years) ]The number of subjects whose best confirmed objective response is a CR or PR, divided by the number of treated subjects
- Progression-free survival [ Time Frame: Baseline up to disease progression or death, whichever occurs first (up to approximately 4 years) ]The time from the date of the start of treatment to the date of the first documented tumor progression as determined by RECIST v 1.1, or death, whichever occurs first
- Duration of response [ Time Frame: Baseline up to disease progression or death, whichever occurs first (up to approximately 4 years) ]The time from documentation of tumor response to disease progression as determined by RECIST v1.1
- Overall survival [ Time Frame: Baseline up to 1 year after treatment discontinuation ]The time from the date of the start of treatment until death from any cause
- Safety of atezolizumab [ Time Frame: Baseline up to 60 days after the last dose of the study drug or until another oncologic treatment is initiated, whichever occurs first ]The incidence of treatment-related adverse events assessed by CTCAE v4.03
- Health Related Quality of Life (HRQoL) Scores [ Time Frame: Baseline until 1 year after treatment discontinuation or death, whichever occurs first ]Change from Baseline in Health Related Quality of Life (HRQoL) Scores as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)
- Patient Functioning and Symptoms Score [ Time Frame: Baseline until 1 year after treatment discontinuation or death, whichever occurs first ]Change from Baseline in Patient Functioning and Symptoms Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module LC-13 (QLQ-LC13)
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): NCT03786419
|Contact: Claudia Lopez Vratny, BDemail@example.com|
|Contact: Jose Guadalupe Romero Portillo, BDfirstname.lastname@example.org|
|Health Pharma Professional Research|
|Mexico City, Mexico, 03810|
|Contact: Claudia Lopez Vratny, BD +525575864856 email@example.com|
|Contact: Jose Guadalupe Romero Portillo, BD +525575864858 firstname.lastname@example.org|
|Principal Investigator: Jorge Arturo Alatorre Alexander, MD|
|Principal Investigator:||Jorge Arturo Alatorre Alexander, MD||Health Pharma Professional Research|