Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Pa… (NCT07234058) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma
France126 participantsStarted 2026-02
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Signed written Informed Consent.
✓. Histological diagnosis (no cytology allowed, thoracoscopy biopsy recommended).
✓. Non resectable PM as evaluated by a specialist MTB comprising a specialized thoracic surgeon.
✓. Measurable disease by CT with iodure injection according to RECIST 1.1 modified criteria for mesothelioma (pleural thickness perpendicular to the chest wall or mediastinum of 7 mm or more, on 2 positions, at 3 separate levels on transverse cuts of CT-scan, at least 1 cm apart, the sum of 6 measurements defining a pleural unidimensional measure), or according to RECIST1.1 criteria for mediastinal nodes or metastatic lesion.
✓. ECOG PS 0 and 1.
✓. Weight loss \<10% within 3 months of study entry.
✓. Chemo-naive and immuno-naive.
✓. Age ≥18 years, \<76 years.
Exclusion criteria
✕. ECOG PS\>2.
What they're measuring
1
To evaluate the activity of the combination of double immunotherapy anti-LAG3+ anti-PD-1 and pemetrexed+platinum chemotherapy
Timeframe: 6 months after randomisation.
Trial details
NCT IDNCT07234058
SponsorIntergroupe Francophone de Cancerologie Thoracique
✕. Previous cancer treatment including chemotherapy or immunotherapy with anti-PD-1, anti-PD-L1, Anti-CTLA4 or any ICI antibody.
✕. Pleural effusion as the only radiological abnormality without measurable pleural thickness or mediastinal node enlargement.
✕. Peritoneal, pericardial or tunica vaginalis testis mesothelioma.
✕. Previous diagnosis of adenocarcinoma from any anatomic site within the previous 5 years, with the exception of prostate adenocarcinoma history within the previous 5 years, in case of localized prostate cancer, with good prognostic factors according to d'Amico classification (\<T2a, score de Gleason ≤6 and PSA ≤10 ng/ml) provided they were treated in a curative way (surgery or radiotherapy, without any chemotherapy). Previous or active cancer within the previous 5 years (except for treated carcinoma in situ of the cervix, or basal cell skin cancer treated or not).
✕. Uncontrolled pleural effusion requiring frequent thoracocentesis (needing thoracoscopic pleural pleurodesis before possible accrual).
✕. Symptomatic untreated brain metastasis (without previous whole brain radiotherapy or stereotactic ablative brain radiotherapy or without surgical resection). At least 2 weeks delay between the end of radiotherapy and the beginning of immuno-chemotherapy treatment should be respected. Asymptomatic brain metastasis, not needing corticosteroids greater than 10 mg prednisone equivalent daily or mannitol infusions, are allowed.
✕. Radiotherapy needed at initiation of tumour treatment, except bone palliative radiotherapy on a painful or compressive metastasis, or radiotherapy on thoracic drain or puncture routes.