OncoMatch/Clinical Trials/NCT06840834
Evaluating Ivonescimab as a Potential Treatment for Pleural Mesothelioma Patients Whose Cancer Has Returned After Previous Immunotherapy and Chemotherapy
Is NCT06840834 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Ivonescimab for pleural mesotheliomas.
Treatment: Ivonescimab — Multicentre, open-label, single arm phase II study for patients with PM previously treated by immunotherapy and standard chemotherapy. 38 patients will be given second or third-line treatment with ivonescimab 20mg/kg every 3 weeks. An estimated 38 patients will be enrolled in approximately 20 centres. Patients will be treated for a maximum of 2 years, until disease progression, unacceptable toxicity, withdrawal of consent or another discontinuation criterion is met. The null hypothesis is disease control rate (DCR) at 12 weeks ≤ 30%. The alternative hypothesis is DCR ≥ 55% at 12 weeks.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: PD-L1 (CD274) expression (testing required; no eligibility threshold specified)
Available pathological samples (at least 10 slides from the thoracoscopy biopsies) for centralized PD-L1, MTAP, immunohistochemistry, and NGS / transcriptome analyses
Required: MTAP expression (testing required; no eligibility threshold specified)
Available pathological samples (at least 10 slides from the thoracoscopy biopsies) for centralized PD-L1, MTAP, immunohistochemistry, and NGS / transcriptome analyses
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: immunotherapy (nivolumab, ipilimumab, pembrolizumab)
after maximum 2 lines including immunotherapy by nivolumab ± ipilimumab, and standard P/P chemotherapy [with (maximum 40% total of patients) or without bevacizumab], sequentially (regardless of treatment order), or first-line combining standard chemotherapy + IO (pembrolizumab or other IO investigational drug but no anti-angiogenic drug)
Must have received: platinum-based chemotherapy
after maximum 2 lines including immunotherapy by nivolumab ± ipilimumab, and standard P/P chemotherapy [with (maximum 40% total of patients) or without bevacizumab], sequentially (regardless of treatment order), or first-line combining standard chemotherapy + IO (pembrolizumab or other IO investigational drug but no anti-angiogenic drug)
Cannot have received: anti-angiogenic / anti-VEGF pathway drug (bevacizumab)
Exception: except if combined with P/P chemotherapy [scheme validated by ASCO, NCCN, and ESMO guidelines] in maximum 40% of the total of recruited patients (n=15)
Previous treatment for PM by more than 2 lines of systemic treatment, or by bevacizumab (or another anti-angiogenic / anti-VEGF pathway drug) except if combined with P/P chemotherapy [scheme validated by ASCO, NCCN, and ESMO guidelines] in maximum 40% of the total of recruited patients (n=15)
Lab requirements
Blood counts
neutrophils ≥1500/mm3; platelets ≥100 000/mm3; haemoglobin ≥9 g/dL
Kidney function
Creatinine Clearance ≥45 mL/min (Cockroft or MDRD or CKD-epi)
Liver function
AST and ALT <3 x ULN, total bilirubin <2 x ULN (patients with hepatic metastases or Gilbert's syndrome must have AST and ALT ≤5 x ULN and a baseline total bilirubin ≤2 x ULN)
Adequate biological functions: Creatinine Clearance ≥45 mL/min (Cockroft or MDRD or CKD-epi); neutrophils ≥1500/mm3; platelets ≥100 000/mm3; haemoglobin ≥9 g/dL; AST and ALT <3 x ULN, total bilirubin <2 x ULN (patients with hepatic metastases or Gilbert's syndrome must have AST and ALT ≤5 x ULN and a baseline total bilirubin ≤2 x ULN), urine protein <2+ or 24 hours urine protein quantification <1.0 g, prothrombin time (PT) or international normalized ratio (INR) ≤1.5 x ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤1.5 × ULN (unless abnormalities are unrelated to coagulopathy or are secondary to prophylactic coagulation).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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