drugset / Trial / NCT07234058
Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma
Phase 2
Not yet recruiting
126 enrolled
French Cooperative Thoracic Intergroup
Regeneron Pharmaceuticals · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-02
- Primary completion
- 2028-05
- Completion
- 2029-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fianlimab | Monoclonal antibody | 1600 mg | — |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cemiplimab | Monoclonal antibody | 350 mg | — |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Background | Pemetrexed | Small molecule | 500 mg/m2 | — |