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Fianlimab + Cemiplimab + Chemotherapy vs Cemiplimab + Chemotherapy in Treatment-Naive Pleural Mesothelioma

NCT07234058Phase 2

Key facts

Status: Recruiting
Start: Apr 2026
Primary completion: May 2028
Countries: 1
Sponsor: IFCT
Modality: Immune Checkpoint Inhibitors

Drugs: fianlimab
Conditions: pleural mesothelioma

Overview

Phase 2, randomised, open-label trial of fianlimab in pleural mesothelioma (2 arms), sponsored by IFCT. Primary endpoint: Activity of the combination therapy at 6 months. Started Apr 2026; status: recruiting.

Design

2 arms

Study design: RandomizedOpen-label

Arm A: cemplimab + chemotherapy
Cemiplimab + pemetrexed + platinum salt (cisplatin or carboplatin)
Arm B: cemplimab + fianlimab + chemotherapy
Cemiplimab + fianlimab + pemetrexed + platinum salt (cisplatin or carboplatin)

Who it enrols

Patients must have treatment-naive, unresectable malignant pleural mesothelioma with measurable disease, ECOG PS 0-1, and adequate organ function. Patients with controlled HIV, HBV, or HCV are permitted.

Endpoints

Primary

Activity of the combination therapy6 months

Secondary

Tolerance and safety of treatmentUp to 2 years and 3 months
Progression-Free Survival as assessed by an IRCUp to 2 years
Progression-Free Survival as assessed by the investigatorUp to 2 years
Progression-Free Survival according to histological subtypeUp to 2 years
Overall Survival42 months
Best Overall Response RateUp to 2 years
Time until definitive HRQoL score deteriorationUp to 2 years
General health statusUp to 2 years

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