A Study of Atezolizumab in Unresectable or Advaced Malignant Pleural Mesothelioma

• Status: Withdrawn
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Health Pharma Professional Research
• Collaborator: ILS Clinical Research
• Treatments: Antibodies, Monoclonal; Atezolizumab

Criteria

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 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.