A Study of Atezolizumab in Unresectable or Advaced Malignant Pleural Mesothelioma

Sponsor
Health Pharma Professional Research
Study ID
NCT03786419
Phase
PHASE2
Status
Withdrawn

Conditions

  • Malignant Pleural Mesothelioma, Advanced
  • Malignant Pleural Mesothelioma, Unresectable

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Aug 31, 2020
Status verified
May 2021
Primary completion
Aug 31, 2020
Completion
Aug 31, 2020

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab
    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).

Primary Outcome Measure

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) ]

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