Actively Recruiting
Evaluating Ivonescimab as a Potential Treatment for Pleural Mesothelioma Patients Whose Cancer Has Returned After Previous Immunotherapy and Chemotherapy
Led by Intergroupe Francophone de Cancerologie Thoracique · Updated on 2026-03-16
38
Participants Needed
20
Research Sites
143 weeks
Total Duration
On this page
Sponsors
I
Intergroupe Francophone de Cancerologie Thoracique
Lead Sponsor
S
Summit Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluating Ivonescimab as a Potential Treatment for Pleural Mesothelioma Patients Whose Cancer Has Returned After Previous Immunotherapy and Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Histologically confirmed pleural mesothelioma diagnosis
- Disease progression documented by CT scan after up to 2 prior treatments including immunotherapy and chemotherapy
- Measurable disease by modified RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Weight loss less than 10% in last 3 months
- Age 18 years or older
- Life expectancy greater than 3 months
- Available pathological samples for centralized analysis
- Adequate kidney, blood, liver function and coagulation parameters
- Use of effective contraception for women of childbearing potential and sexually active men during and six months after treatment
- Covered by national health insurance
You will not qualify if you...
- ECOG performance status greater than 1
- More than 2 prior systemic treatments or prior use of bevacizumab except in limited cases
- Rapid tumor progression during prior immunotherapy
- Pleural effusion without measurable pleural thickness
- Non-pleural mesothelioma without pleural involvement
- Recent diagnosis of other cancers or active cancers within past 3 years except certain treated cases
- Uncontrolled pleural effusion requiring frequent drainage
- Symptomatic untreated brain metastases
- Need for radiotherapy at treatment start except palliative bone radiotherapy
- History of primary immunodeficiency, organ transplantation requiring immunosuppression, or recent immunosuppressive drugs
- Use of systemic corticosteroids above 10 mg prednisone equivalent within 14 days before treatment
- Active autoimmune diseases requiring systemic immunosuppression
- Active inflammatory intestinal or serious chronic intestinal diseases
- Moderate or severe interstitial lung disease
- Recent major surgery or trauma
- History of significant bleeding or clotting disorders
- Uncontrolled hypertension
- Significant heart, gastrointestinal, thromboembolic, pulmonary, or vascular conditions within specified recent periods
- Radiologic evidence of major lung blood vessel invasion or tumor cavitation
- Active uncontrolled infections including active viral hepatitis or untreated HIV
- Recent live vaccinations within 30 days
- Inability to comply with study procedures
- Known allergy to study treatment or excipients
- Participation in another clinical trial or experimental treatment
- Legal protection status or inability to give informed consent
AI-Screening
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Trial Site Locations
Total: 20 locations
1
Besançon - CHU
Besançon, France
Actively Recruiting
2
Brest - CHU
Brest, France
Actively Recruiting
3
Caen - CHU
Caen, France
Actively Recruiting
4
Clermont-Ferrand - Centre Jean Perrin
Clermont-Ferrand, France
Actively Recruiting
5
Créteil - CHI
Créteil, France
Actively Recruiting
6
Grenoble - CHU
Grenoble, France
Actively Recruiting
7
Le Mans - CHG
Le Mans, France
Actively Recruiting
8
Lille - CHU
Lille, France
Actively Recruiting
9
Marseille - APHM
Marseille, France
Actively Recruiting
10
Montpellier - CHU
Montpellier, France
Actively Recruiting
11
Mulhouse - GHRMSA
Mulhouse, France
Actively Recruiting
12
Nantes - Hôpital Laennec
Nantes, France
Actively Recruiting
13
Paris - Bichat
Paris, France
Actively Recruiting
14
Bordeaux - CHU
Pessac, France
Actively Recruiting
15
Lyon - HCL
Pierre-Bénite, France
Actively Recruiting
16
Strasbourg - Nouvel Hôpital Civil
Strasbourg, France
Actively Recruiting
17
Toulon - CHI
Toulon, France
Actively Recruiting
18
Toulouse - CHU
Toulouse, France
Actively Recruiting
19
Tours - CHU
Tours, France
Actively Recruiting
20
Metz - Hôpital Robert Schuman
Vantoux, France
Actively Recruiting
Research Team
I
IFCT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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