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New treatment option for Pleural Mesotheliomas
Official title Evaluating Ivonescimab as a Potential Treatment for Pleural Mesothelioma Patients Whose Cancer Has Returned After Previous Immunotherapy and Chemotherapy
ClinicalTrials.gov ID: NCT06840834
What this study is testing
What is Ivonescimab?
Ivonescimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pleural mesotheliomas.
Also referred to as SMT112.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed Informed consent. people must have signed and dated an IEC approved written informed consent form in accordance with regulatory and...
- Histologically-proven Pleural Mesothelioma (no cytology allowed, biopsies by thoracoscopy recommended). Note: pathology certification by national...
- Documented progression by CT with iodine injection according to modified RECIST 1.1 for mesothelioma (mRECIST 1.1; pleural thickness perpendicular to...
- Measurable disease according to mRECIST 1.1.
- ECOG PS 0 or 1.
You likely can't join if
- ECOG PS\>1.
- Previous treatment for PM by more than 2 lines of systemic treatment, or by bevacizumab (or another anti-angiogenic / anti-VEGF pathway drug) except...
- Suspicion of hyperprogressive disease or rapid tumour progression when treated by previous IO (i.e. progressive disease within 9 weeks of treatment...
- Pleural effusion as the only radiological abnormality without measurable pleural thickness or mediastinal node enlargement.
- Peritoneal, pericardial or tunica vaginalis testis mesothelioma, without any pleural involvement at the time of diagnosis.
- Previous diagnosis of adenocarcinoma from any anatomic site within the previous 3 years, with the exception of prostate adenocarcinoma history in...
See the full eligibility criteria
Who can join
- Signed Informed consent. people must have signed and dated an IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any...
- Histologically-proven Pleural Mesothelioma (no cytology allowed, biopsies by thoracoscopy recommended). Note: pathology certification by national expert network NETMESO/MESOPATH should be checked as already done in...
- Documented progression by CT with iodine injection according to modified RECIST 1.1 for mesothelioma (mRECIST 1.1; pleural thickness perpendicular to the chest wall or mediastinum of 7mm or more, on 2 positions, at 3...
- Measurable disease according to mRECIST 1.1.
- ECOG PS 0 or 1.
- Weight loss \<10% within 3 months of study entry.
- Age ≥18 years.
- Life expectancy \>3 months.
- Available pathological samples (at least 10 slides from the thoracoscopy biopsies) for centralized PD-L1, MTAP, immunohistochemistry, and NGS / transcriptome analyses, all slides being centrally reviewed by the French...
- 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...
- Women of childbearing potential and sexually active should use a highly effective contraception method within the 28 days preceding the first dose and during the 6 months following the last dose of treatment. Women must...
- For male people who are sexually active with women of childbearing potential, an efficacious contraception method should be used during the treatment and during the 6 months following the last dose.
- Patient covered by a national health insurance.
What rules you out
- ECOG PS\>1.
- 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...
- Suspicion of hyperprogressive disease or rapid tumour progression when treated by previous IO (i.e. progressive disease within 9 weeks of treatment by previous nivolumab ± ipilimumab or alternative immunotherapy...
- Pleural effusion as the only radiological abnormality without measurable pleural thickness or mediastinal node enlargement.
- Peritoneal, pericardial or tunica vaginalis testis mesothelioma, without any pleural involvement at the time of diagnosis.
- Previous diagnosis of adenocarcinoma from any anatomic site within the previous 3 years, with the exception of prostate adenocarcinoma history in case of localized prostate cancer with good prognostic factors according...
- Previous or active cancer within the previous 3 years (except for already treated in situ carcinoma of the cervix, or basal cell skin cancer, treated or not).
- Uncontrolled pleural effusion despite previous (talc or other) pleurodesis, requiring thoracocentesis (by pleural aspiration) more often than every 21 days. However, patients with efficient indwelling pleural catheter...
- 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...
- Radiotherapy needed at initiation of treatment, except bone palliative radiotherapy on a painful or compressive tumour site (in this case, target lesions should not be selected in the irradiated zone).
- History of previous primary immunodeficiency, organ transplantation needing an immunosuppressive treatment, any immunosuppressive drug within 28 days before registration date, or history of severe toxicity (grade 3/4)...
- Systemic treatment with corticosteroids with a dose \>10 mg prednisone equivalent daily, within 14 days before initiation of the treatment. Inhaled, nasal or topical corticosteroids are allowed.
- History of active autoimmune disease, needing systemic immunosuppressive drug, including but not limited to rheumatoid polyarthritis, myasthenia, autoimmune hepatitis, systemic Lupus, Wegener's granulomatosis, vascular...
- Active inflammatory intestinal disease (diverticulosis, Crohn's disease, haemorrhagic recto-colitis, coeliac disease) or any serious chronic intestinal disease with uncontrolled diarrhoea.
- Pre-existing moderate or severe ILD as assessed by the diagnostic CT-scan and decrease of TLCO higher than 35% from theoretical normal values linked to such ILD.
- Major surgical procedures or serious trauma within 4 weeks prior to inclusion or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures...
- History of bleeding tendencies or coagulopathy, or clinically significant bleeding symptoms or risk within 4 weeks prior to inclusion, including but not limited to: gastrointestinal bleeding; haemoptysis (defined as...
- Current hypertension with systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after oral antihypertensive therapy.
- History of major diseases before registration, specifically:
- Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association [NYHA] classification ≥ grade 2) or vascular disease (e.g. aortic aneurysm at risk of rupture) that required hospitalization...
- History of oesophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses or acute gastrointestinal bleeding within 6 months before inclusion.
- History of arterial thromboembolic event, venous thromboembolic event of Grade 3 and above as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic...
- Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks prior to inclusion.
- History of perforation of the gastrointestinal tract or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial...
- Imaging during the screening period shows that the patient has:
- Radiologically documented evidence of major lung blood vessel invasion or encasement by cancer.
- Radiographic evidence of lung intratumor cavitation.
- Active uncontrolled infection including active tuberculosis, known acute viral hepatitis B and C according to serological tests. Patients with serological sequelae of cured viral hepatitis are allowed to be included...
- Patients with a known history of a positive test for HIV or known AIDS who have not received effective antiretroviral therapy (ART) for the last 4 weeks and who have an HIV viral load \>200 copies/mL, regardless of CD4+...
- Living attenuated vaccine received within the 30 previous days; mRNA and adenovirus vector anti-SARS-CoV2 vaccine are allowed.
- Inability to comply with study or follow-up procedures as estimated by the referent investigator.
- Known allergy or hypersensitivity to study treatment or any excipient.
- Concomitant treatment with another experimental treatment or participation in another clinical trial.
- Patient who is subject to legal protection or who is unable to express his will.
The study team makes the final eligibility decision.
Where it's taking place
- Besançon, France
- Brest, France
- Caen, France
- Clermont-Ferrand, France
- Créteil, France
- Grenoble, France
- Le Mans, France
- Lille, France
- Marseille, France
- Montpellier, France
- Mulhouse, France
- Nantes, France
- Paris, France
- Pessac, France
- Pierre-Bénite, France
- Strasbourg, France
- Toulon, France
- Toulouse, France
- Tours, France
- Vantoux, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Besançon, France; Brest, France; Caen, France; Clermont-Ferrand, France; Créteil, France; Grenoble, France and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.