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NECIM: Neoadjuvant Chemo-Immunotherapy for Inoperable Pleural Mesothelioma
NCT07121374Phase 2
Key facts
- Status
- Recruiting
- Start
- Jul 2025
- Primary completion
- Jun 2028
- Countries
- 1
- Modality
- Monoclonal Antibodies
- Drugs
- nivolumabipilimumab
- Conditions
- pleural mesothelioma
01
Overview
Phase 2, open-label, single-arm trial of nivolumab and ipilimumab in pleural mesothelioma. Primary endpoint: Percentage of successful completion of neoadjuvant regimen followed by surgery at 17 weeks. Started Jul 2025; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Neoadjuvant Chemo-IO + Surgery
Neoadjuvant chemotherapy and dual immunotherapy followed by surgery if operable
03
Who it enrols
Adult patients with pathologically confirmed epithelioid pleural mesothelioma (cT2-3 N0-1 M0) considered inoperable, WHO PS 0-1, and fit for systemic therapy and surgery.
04
Endpoints
Primary
Percentage of successful completion of neoadjuvant regimen followed by surgery
Secondary
Toxicity of neoadjuvant regimen and surgery
Efficacy of neoadjuvant regimen in inoperable patients
Quality of life during treatment
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