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

NCT07234058 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-02-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Dr Myriam LOCATELLI-SANCHEZ · Hôpital Lyon-Sud, Hospices Civils de Lyon

  • Pr Gérard ZALCMAN · Hôpital Bichat, AP-HP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2028-05-31
Completion
2029-09-30

Countries

  • France

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07234058 on ClinicalTrials.gov