A Study of Atezolizumab in Unresectable or Advaced Malignant Pleural Mesothelioma (NCT03786419) | Clinical Trial Compass
WithdrawnPhase 2
A Study of Atezolizumab in Unresectable or Advaced Malignant Pleural Mesothelioma
Stopped: Publication of study results of ICI use in MPM as first line therapy
Mexico0Started 2020-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 thera…
What they're measuring
1
Objective Response Rate
Timeframe: From the time of initial response until documented tumor progression or death, whichever occurs first (up to approximately 4 years)