NCT07234058

Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma

A Non-Comparative Phase IIR Trial Assessing Fianlimab Plus Cemiplimab Plus Pemetrexed-Platinum Chemotherapy or Cemiplimab Plus Pemetrexed-Platinum Chemotherapy for Treatment-Naive Pleural Mesothelioma (PM) Patients

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Intergroupe Francophone de Cancerologie Thoracique · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentre, phase IIR, double non-comparative arm trial, with an initial safety run for the anti-LAG3 arm. Approximately 40 sites will participate in the study and will enroll 126 patients with treatment-naive, unresectable malignant PM. Treatment will be administered in 21-day cycles and will continue until disease progression, unacceptable toxicity, withdrawal of consent or for 2 years immunotherapy maximum. Once the patient discontinues study treatment, the treatment period will end and the patient will enter the follow-up period. No cross-over is allowed between arms.

Conditions

• Pleural Mesotheliomas

Interventions

Type	Name	Description
DRUG	Cemiplimab	350mg every 3 weeks for up to 24 months.
DRUG	Fianlimab	1600mg every 3 weeks for up to 24 months.
DRUG	Pemetrexed (Alimta)	500 mg/m² every 3 weeks for 6 cycles.
DRUG	Cisplatin	75 mg/m² every 3 weeks for 6 cycles.
DRUG	Carboplatin (AUC 5)	AUC 5 (recommended maximum dose of 800 mg) every 3 weeks for 6 cycles.

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-05-01
• Completion: 2029-09-01
• First posted: 2025-11-18
• Last updated: 2026-02-11

Locations

37 sites across 1 country: France