PHASE III STUDY WITH ATEZOLIZUMAB VERSUS PLACEBO IN MALIGNANT PLEURAL MESOTHELIOMA PATIENTS AFTER PLEURECTOMY/DECORTICATION
Key facts
- Where
- Alessandria, Bari, Ferrara, Genova-Sampierdarena, Meldola, Modena, Orbassano, Padova, Parma, Pavia, Reggio Emilia, Rozzano, Statte és Trieste, OlaszországSee the 14 sites
- Phase
- 3. fázis
Where in Olaszország
- A.O.SS Antonio Biagio e Cesare Arrigo AlessandriaAlessandria, OlaszországTaking people
- Istituto Tumori Bari Giovanni Paolo IIBari, OlaszországTaking people
- University Hospital Of FerraraFerrara, OlaszországTaking people
- Ospedale Villa Scassi - Sampierdarena-ASL3-Azienda sociosanitaria ligureGenova-Sampierdarena, OlaszországTaking people
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, OlaszországTaking people
- Azienda Ospedaliero - Universitaria di ModenaModena, OlaszországTaking people
- Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassano, OlaszországTaking people
- Istituto Oncologico VenetoPadova, OlaszországTaking people
- Azienda Ospedaliero Universitaria ParmaParma, OlaszországTaking people
- Policlinico San Matteo Pavia Fondazione IRCCSPavia, OlaszországTaking people
- Azienda USL IRCCS di Reggio EmiliaReggio Emilia, OlaszországTaking people
- Humanitas Mirasole S.p.A.Rozzano, OlaszországTaking people
- Ospedale S.G. MoscatiStatte, OlaszországTaking people
- Azienda Sanitaria Universitaria Giuliano IsontinaTrieste, OlaszországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica
- Trial code
- EU 2024-519286-21-00
- Record updated
- 2026. november 4.
- Original description
To evaluate the efficacy of atezolizumab in patients with MPM in terms of DFSRead full original descriptionShow less
PHASE III STUDY WITH ATEZOLIZUMAB VERSUS PLACEBO IN MALIGNANT PLEURAL MESOTHELIOMA PATIENTS AFTER PLEURECTOMY/DECORTICATION
To evaluate the efficacy of atezolizumab in patients with MPM in terms of DFS
Inclusion: Age ≥ 18 years on day of signing informed consent • Histologically confirmed malignant pleural mesothelioma • Surgical resection (P/D), without macroscopic residual. In stage I patients without visceral involvement a total pleurectomy is allowed • Patients must have received at least 4 cycles of perioperative platinum/pemetrexed chemotherapy as per local practice. Less than 4 cycles of chemotherapy are allowed for clinical decisions - In patients previously treated with neoadjuvant chemotherapy, randomization should occur within 50 days from surgical resection. - In patients treated with adjuvant chemotherapy, randomization should occur within 30 ± 7 days from last dose of adjuvant treatment. • Performance status of 0-1 on the ECOG Performance Scale • Adequate organ function, all screening labs should be performed within 14 days of treatment initiation. • Availability of 1 tumor block at baseline.
Exclusion: Patient with macroscopic residual disease after surgery • Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll • Additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy • Active infection requiring systemic therapy • History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) • Active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected) • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab • Women with a positive pregnancy test at enrollment or prior to administration of study medication.