A Study of Atezolizumab in Unresectable or Advaced Malignant Pleural Mesothelioma

NCT03786419 | Withdrawn Phase 2

• 1 other identifier: JCJ-768883
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a national, single arm, phase II trial in patients with diagnosis of unresectable or advanced malignant pleural mesothelioma who experienced progression after platinum-based chemotherapy.

Conditions

Malignant Pleural Mesothelioma, Advanced; Malignant Pleural Mesothelioma, Unresectable

Keywords

Malignant Pleural Mesothelioma; Atezolizumab; Thoracic neoplasms; Antibodies, monoclonal; Antineoplasic, agents

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The number of subjects whose best confirmed objective response is a CR or PR, divided by the number of treated subjects

  From the time of initial response until documented tumor progression or death, whichever occurs first (up to approximately 4 years)

Secondary Outcomes (6)

• Progression-free survival

  Baseline up to disease progression or death, whichever occurs first (up to approximately 4 years)

• Duration of response

  Baseline up to disease progression or death, whichever occurs first (up to approximately 4 years)

• Overall survival

  Baseline up to 1 year after treatment discontinuation

• Safety of atezolizumab

  Baseline up to 60 days after the last dose of the study drug or until another oncologic treatment is initiated, whichever occurs first

• Health Related Quality of Life (HRQoL) Scores

  Baseline until 1 year after treatment discontinuation or death, whichever occurs first

Study Arms (1)

Atezolizumab

EXPERIMENTAL

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).

Drug: Atezolizumab

Interventions

Atezolizumab DRUG

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

Also known as: Tecentriq, RO5541267, MPDL3280A

Atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form.
• Patients have ≥18 years of age.
• Diagnosis of malignant pleural mesothelioma histologically confirmed by certified pathologist.
• Unresectable and/or advanced disease, based on the Seventh Edition American Joint Committee on Cancer (AJCC) Cancer Staging Manual. Patients with MPM diagnosed with early disease and whose comorbidities make them ineligible for surgical procedures or who do not accept surgery treatment.
• Patients should have received at least one platinum-based treatment and should have reported progression after at least two treatment cycles.
• Disease measurable as per the Response Evaluation Criteria in Solid Tumors (RECIST) modified for mesothelioma.
• ECOG performance status ≤2.
• \>12-week life expectancy.
• Patients with adequate organ function
• Patients should have recovered to grade ≤1 in all adverse events associated with previous antineoplastic therapies, excluding alopecia.
• Patients should be able to comply with protocol procedures, at the discretion of the investigator
• Patients of both genders who are potentially fertile should use effective contraceptive methods (barrier methods plus other contraceptive methods) before study entry and during their participation in the study.

You may not qualify if:

• Patients diagnosed with another tumor, except for treated cervical carcinoma in situ, epidermoid carcinoma, or superficial bladder cancer (Ta and Tis), or other malignancy for which healing therapy was administered within 5 years before study enrollment.
• Simultaneous participation in another study on a study drug, or if the patient participated in a study within 28 days before study treatment initiation.
• Medical history of interstitial lung disease (ILD), drug-induced interstitial disease, radiation pneumonitis that required treatment with steroids, or any sign of clinically active interstitial lung disease.
• Use of systemic immunosuppressive therapy (use of steroids with a dose \>10 mg of prednisone or other immunosuppressive therapy).
• Presence of active autoimmune disease.
• Suspicion or certainty of symptomatic brain metastasis or spinal cord compression. Patients with asymptomatic and stable brain metastasis are eligible for the study.
• Pregnant or breastfeeding women. Women of childbearing potential must have a negative pregnancy test carried out within 7 days prior to treatment initiation.
• Patient previously treated with immunotherapy (PD-1/PD-L1 inhibitors).
• Major surgery within 4 weeks prior to study treatment initiation or expected major surgery during the course of the study for non-diagnostic purposes.
• Known seropositivity for human immunodeficiency virus (HIV). tory or symptoms of HIV may enter the study only if there is negative serology.
• Active tuberculosis.
• Administration of a live attenuated vaccine within 4 weeks prior to study treatment initiation or at any moment during the course of the study.
• Last chemotherapy cycle within 30 days prior to first treatment administration.
• Any unstable disease or condition that may threaten the patient's safety and/or the patient's study compliance.
• Drug addiction or clinical, psychological, or social disorders that may undermine the informed consent validity or affect compliance with protocol.

Sponsors & Collaborators

• Health Pharma Professional Research: lead

Study Sites (1)

Health Pharma Professional Research

Mexico City, 03810, Mexico

Location

MeSH Terms

Conditions

Mesothelioma, Malignant; Thoracic Neoplasms

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jorge Arturo Alatorre Alexander, MD

  Health Pharma Professional Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 26, 2018
• Study Start: August 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)