Phase Iii Study with Atezolizumab Versus Placebo in Malignant Pleural Mesothelioma Patients After Pleurectomy/Decortication

Overview

Sponsor-declared trial summary

Key facts

Sponsor

G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

17 Dec 2024 → ongoing

Decision date (initial)

2024-12-17

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Roche

External identifiers

EU CT number

2024-519286-21-00

EudraCT number

2020-003762-39

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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

Secondary objectives 1

1. -To evaluate the safety of atezolizumab in patients with MPM; -To evaluate the efficacy of atezolizumab in patients with MPM in terms of OS; -To evaluate health status utility and HR QoL of atezolizumab in patients with MPM

Conditions and MedDRA coding

MALIGNANT PLEURAL MESOTHELIOMA PATIENTS

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • 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 criteria 1

1. • 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. DFS, defined as the time from initiation of study treatment to first recurrence of disease or death for any cause, whichever occurs first. DFS will be calculated based on disease status evaluated by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).

Secondary endpoints 1

1. -Incidence, nature, frequency, duration, timing and severity of serious adverse events (SAEs) and non-serious adverse events (AEs) related to atezolizumab treatment graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 5. -OS, defined as the time from start of study drug to the date of death from any cause. -EQ-5D-3L questionnaire

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica

Sponsor organisation

G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica

Address

Viale Antonio Gramsci 14

City

Parma

Postcode

43126

Country

Italy

Scientific contact point

Organisation

G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica

Contact name

Scientific Responsible

Public contact point

Organisation

G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica

Contact name

Scientific Responsible

Locations

1 EU/EEA country · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications