2024-519286-21-00RecruitingPhase 3

PHASE III STUDY WITH ATEZOLIZUMAB VERSUS PLACEBO IN MALIGNANT PLEURAL MESOTHELIOMA PATIENTS AFTER PLEURECTOMY/DECORTICATION

Source: EU CTIS (euclinicaltrials.eu) · Last updated 4 Nov 2026

Next steps

Brief summary (registry, in English)

To evaluate the efficacy of atezolizumab in patients with MPM in terms of DFS

Status (registry): Recruiting
Phase (registry): Phase 3
Study type: Interventional
Enrollment: 81 (estimated)
First submitted: 13 Nov 2024
Start date: 17 Dec 2024
Lead sponsor: G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica
Diseases: Mesothelioma
EU CT number: 2024-519286-21-00
EudraCT number: 2020-003762-39

What you commit to

Study type: Interventional · Phase 3
Planned participants: 81
14 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with malignant pleural mesothelioma who had surgery to remove the tumour and have no visible disease left. They get atezolizumab or a placebo.

Age: 18 years or older
Sex: All sexes can join.
Disease stage: Malignant pleural mesothelioma, confirmed by tissue examination, after pleurectomy/decortication surgery with no visible tumour left. In stage I without involvement of the organs, a total pleurectomy is allowed.
Earlier treatment: Must have had at least 4 cycles of platinum/pemetrexed chemotherapy around the time of surgery. Fewer than 4 cycles are allowed for clinical reasons. Joining must happen within 50 days of surgery after chemotherapy before surgery, or within 30 ± 7 days of the last dose after chemotherapy given after surgery.
Biomarker or test result: One tumour tissue block must be available at the start. Performance status of 0-1 on the ECOG scale and adequate organ function in tests done within 14 days of starting treatment.

Main reasons for not taking part

Visible tumour left after surgery
Active, known or suspected autoimmune disease (some mild conditions are allowed)
Another cancer in the last 5 years (a few skin or cervical exceptions)
Active infection needing systemic therapy, or a history of HIV
Active hepatitis B or C

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Who the study is looking for

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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (14)

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
A.O.SS Antonio Biagio e Cesare Arrigo Alessandria	Alessandria	Italy	Recruiting
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy	Recruiting
University Hospital Of Ferrara	Ferrara	Italy	Recruiting
Ospedale Villa Scassi - Sampierdarena-ASL3-Azienda sociosanitaria ligure	Genova-Sampierdarena	Italy	Recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l	Meldola	Italy	Recruiting
Azienda Ospedaliero - Universitaria di Modena	Modena	Italy	Recruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy	Recruiting
Istituto Oncologico Veneto	Padova	Italy	Recruiting
Azienda Ospedaliero Universitaria Parma	Parma	Italy	Recruiting
Policlinico San Matteo Pavia Fondazione IRCCS	Pavia	Italy	Recruiting
Azienda USL IRCCS di Reggio Emilia	Reggio Emilia	Italy	Recruiting
Humanitas Mirasole S.p.A.	Rozzano	Italy	Recruiting
Ospedale S.G. Moscati	Statte	Italy	Recruiting
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy	Recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.