[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pleural-mesotheliomas\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pleural-mesotheliomas":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100580710","phase-2-evaluating-ivonescimab-as-a-potential-treatment-for-pleural-mesothelioma-patients-whose-cancer-has-returned-after-previous-immunotherapy-and-chemotherapy-100580710",false,"NCT06840834","Evaluating Ivonescimab as a Potential Treatment for Pleural Mesothelioma Patients Whose Cancer Has Returned After Previous Immunotherapy and Chemotherapy","Assessment of Ivonescimab as Salvage Treatment in Relapsing Pleural Mesothelioma Patients, Previously Treated by Immunotherapy and Standard Chemotherapy","Bi-MAPS","Inclusion Criteria:\n\n1. Signed Informed consent. Subjects 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 protocol-related procedures that are not part of normal subject care.\n\n   Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.\n2. Histologically-proven Pleural Mesothelioma (no cytology allowed, biopsies by thoracoscopy recommended).\n\n   Note: pathology certification by national expert network NETMESO\u002FMESOPATH should be checked as already done in routine in France by NETMESO regional expert MTB for PM (or similar national certification if the patient had his\u002Fher PM diagnosis obtained outside France, e.g. Belgium).\n3. 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 separate levels on transverse cuts of CT-scan, at least 1cm apart, the sum of 6 measurements defining a pleural unidimensional measure), or according to RECIST 1.1 for mediastinal nodes or metastatic lesion, after maximum 2 lines including immunotherapy by nivolumab ± ipilimumab, and standard P\u002FP 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).\n4. Measurable disease according to mRECIST 1.1.\n5. ECOG PS 0 or 1.\n6. Weight loss \\\u003C10% within 3 months of study entry.\n7. Age ≥18 years.\n8. Life expectancy \\>3 months.\n9. Available pathological samples (at least 10 slides from the thoracoscopy biopsies) for centralized PD-L1, MTAP, immunohistochemistry, and NGS \u002F transcriptome analyses, all slides being centrally reviewed by the French panel MESOPATH for mesothelioma histological certification. If archival tissue is either insufficient or unavailable, the patient may still be eligible upon discussion with IFCT.\n10. Adequate biological functions:\n\n    Creatinine Clearance ≥45 mL\u002Fmin (Cockroft or MDRD or CKD-epi); neutrophils\n\n    ≥1500\u002Fmm3; platelets ≥100 000\u002Fmm3; haemoglobin ≥9 g\u002FdL; AST and ALT \\\u003C3 x ULN, total bilirubin \\\u003C2 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 \\\u003C2+ or 24 hours urine protein quantification \\\u003C1.0 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).\n11. 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 have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 24 hours prior to the start of study drug.\n12. For male subjects 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.\n13. Patient covered by a national health insurance.\n\nExclusion Criteria:\n\n1. ECOG PS\\>1.\n2. Previous treatment for PM by more than 2 lines of systemic treatment, or by bevacizumab (or another anti-angiogenic \u002F anti-VEGF pathway drug) except if combined with P\u002FP chemotherapy \\[scheme validated by ASCO, NCCN, and ESMO guidelines\\] in maximum 40% of the total of recruited patients (n=15).\n3. 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, starting from C1D1 or from randomization if previous experimental immunotherapy).\n4. Pleural effusion as the only radiological abnormality without measurable pleural thickness or mediastinal node enlargement.\n5. Peritoneal, pericardial or tunica vaginalis testis mesothelioma, without any pleural involvement at the time of diagnosis.\n6. 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 to d'Amico classification (\\\u003CT2a, Gleason score ≤6 and PSA ≤10 ng\u002Fml), provided they were treated in a curative modality (surgery or radiotherapy, without any chemotherapy).\n7. 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).\n8. 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 (IPC) are eligible.\n9. 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 the treatment should be respected. Asymptomatic brain metastasis, not needing corticosteroids (\\>10 mg prednisone equivalent daily) or mannitol infusions, are allowed.\n10. 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).\n11. 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\u002F4) by immune mechanism linked to another immunotherapy treatment for any kind of disease.\n12. 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.\n13. 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 thrombosis associated with anti-phospholipid syndrome, Sjogren's syndrome with interstitial pulmonary disease, Guillain-Barré syndrome within previous 15 years, multiple sclerosis, vasculitis, or glomerulonephritis.\n\n    Patients with type I diabetes, or hypothyroidism, or immune cutaneous disease (vitiligo, psoriasis, alopecia) or benign rheumatoid polyarthritis not needing any immunosuppressive systemic treatment or \\>10 mg daily oral steroids, or benign sicca syndrome (Sjogren) without interstitial lung disease (ILD), or history of past Guillain-Barre syndrome beyond 15 previous years, totally reversible with no sequelae, no systemic immunosuppressive treatment during the last 20 years, are allowed to be included. Patients with Grave's disease or psoriasis not requiring systemic therapy within the previous two years from are allowed to be included.\n14. Active inflammatory intestinal disease (diverticulosis, Crohn's disease, haemorrhagic recto-colitis, coeliac disease) or any serious chronic intestinal disease with uncontrolled diarrhoea.\n15. 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.\n16. 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 (excluding central venous catheterization and port implantation) within 3 days prior to registration.\n17. 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 coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots), note: transient haemoptysis associated with diagnostic bronchoscopy is allowed; nasal bleeding \u002F epistaxis (bloody nasal discharge is allowed); need for therapeutic anticoagulant therapy within 14 days prior to inclusion. Note: prophylactic anticoagulation for deep vein thrombosis \u002F pulmonary embolism or to maintain venous patency is allowed.\n18. Current hypertension with systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after oral antihypertensive therapy.\n19. History of major diseases before registration, specifically:\n\n    1. 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 within 12 months prior to inclusion, or other cardiac impairment that may affect the safety evaluation of the study drug (e.g. poorly controlled arrhythmias, myocardial ischemia). Patients with a significant cardiac history, even if controlled, should have a LVEF \\>45%.\n    2. 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.\n    3. 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 attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to inclusion.\n    4. Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks prior to inclusion.\n    5. History of perforation of the gastrointestinal tract or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to inclusion.\n20. Imaging during the screening period shows that the patient has:\n\n    1. Radiologically documented evidence of major lung blood vessel invasion or encasement by cancer.\n    2. Radiographic evidence of lung intratumor cavitation.\n21. 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. Past primary pulmonary tuberculosis in youth does not consist of a contra-indication. Past tuberculosis disease history does not represent a contraindication provided the patient was treated for at least 6 months by anti-tuberculosis antibiotic treatment.\n22. 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\u002FmL, regardless of CD4+ T-cell count.\n23. Living attenuated vaccine received within the 30 previous days; mRNA and adenovirus vector anti-SARS-CoV2 vaccine are allowed.\n24. Inability to comply with study or follow-up procedures as estimated by the referent investigator.\n25. Known allergy or hypersensitivity to study treatment or any excipient.\n26. Concomitant treatment with another experimental treatment or participation in another clinical trial.\n27. Patient who is subject to legal protection or who is unable to express his will.","ALL","18 Years",{"count":20,"type":21},38,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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\u002Fkg every 3 weeks.\n\nAn 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.\n\nThe null hypothesis is disease control rate (DCR) at 12 weeks ≤ 30%. The alternative hypothesis is DCR ≥ 55% at 12 weeks.",[27],"Pleural Mesotheliomas",[29,30,31,32,33],"pleural mesothelioma","ivonescimab","bispecific antibody","anti-VEGF","anti-PD-1","RECRUITING","2026-03-13",{"date":37,"type":38},"2026-03-16","ACTUAL",{"date":40,"type":38},"2025-06-30",{"date":42,"type":21},"2028-03-31",{"name":44,"class":45},"Intergroupe Francophone de Cancerologie Thoracique","OTHER",20,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100610936","phase-2-trial-assessing-fianlimab-plus-cemiplimab-plus-chemotherapy-or-cemiplimab-plus-chemotherapy-in-patients-with-pleural-mesothelioma-100610936","NCT07234058","Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma","A Non-Comparative Phase IIR Trial Assessing Fianlimab Plus Cemiplimab Plus Pemetrexed-Platinum Chemotherapy or Cemiplimab Plus Pemetrexed-Platinum Chemotherapy for Treatment-Naive Pleural Mesothelioma (PM) Patients","LAG-MAPS","Inclusion Criteria:\n\n1. Signed written Informed Consent.\n\n   * Subjects 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 protocol-related procedures that are not part of normal subject care.\n   * Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.\n2. Histological diagnosis (no cytology allowed, thoracoscopy biopsy recommended).\n3. Non resectable PM as evaluated by a specialist MTB comprising a specialized thoracic surgeon.\n4. 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.\n5. ECOG PS 0 and 1.\n6. Weight loss \\\u003C10% within 3 months of study entry.\n7. Chemo-naive and immuno-naive.\n8. Age ≥18 years, \\\u003C76 years.\n9. Life expectancy \\>3 months.\n10. Available pathological samples (at least 10 slides from the thoracoscopy pleural biopsy sample).\n11. Adequate biological functions: creatinine clearance ≥45 mL\u002Fmin (Cockroft or MDRD or CKD-epi); neutrophils ≥1500\u002Fmm3; platelets ≥100 000\u002Fmm3; haemoglobin ≥9g\u002FdL; AST and ALT \\\u003C3 x ULN, total bilirubin \\\u003C2 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).\n12. WOCBP\\* must have a negative serum (beta-hCG) at screening.\n\n    \\*WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to the CTFG guidance. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.\n13. Male study participants with WOCBP partners are required to use condoms during the study and until 6 months after the last dose of study treatment unless they are vasectomised or practice sexual abstinence.\n14. Vasectomised partner or vasectomised study participant must have received medical assessment of the surgical success.\n\n    NB: Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.\n15. WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial and until 6 months after last treatment.\n16. All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose.\n17. As recommended in current French guidelines, a firm recommendation of radiation therapy for thoracocentesis tracts (3 x 7Gy) is made for patients with thoracocentesis or thoracoscopy within 2 months before accrual, with a firmly recommended interval between thoracoscopic procedure (removal of drains) and radiation of no more than 42 days. A 7-day interval between the end of radiotherapy and the initiation of treatment should be respected.\n\nExclusion Criteria:\n\n1. ECOG PS\\>2.\n2. Previous cancer treatment including chemotherapy or immunotherapy with anti-PD-1, anti-PD-L1, Anti-CTLA4 or any ICI antibody.\n3. Pleural effusion as the only radiological abnormality without measurable pleural thickness or mediastinal node enlargement.\n4. Peritoneal, pericardial or tunica vaginalis testis mesothelioma.\n5. 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 (\\\u003CT2a, score de Gleason ≤6 and PSA ≤10 ng\u002Fml) 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).\n6. Uncontrolled pleural effusion requiring frequent thoracocentesis (needing thoracoscopic pleural pleurodesis before possible accrual).\n7. 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.\n8. 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.\n9. History of previous primary immunodeficiency, organ transplantation needing an immunosuppressive treatment, any immunosuppressive drug within 28 days before randomisation date, or history of severe toxicity (grade 3\u002F4) by immune mechanism linked to another immunotherapy treatment for any kind of disease.\n10. Systemic treatment with corticosteroids with greater dose than 10 mg prednisone equivalent daily, within 14 days before initiation of the treatment. Inhaled, nasal or topic corticosteroids are allowed.\n11. 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 thrombosis associated with anti-phospholipid syndrome, Sjogren's syndrome with interstitial pulmonary disease, recent Guillain-Barré syndrome within previous 15 years, multiple sclerosis, vasculitis, or glomerulonephritis.\n\n    Patients with type I diabetes, or hypothyroidy, or immune cutaneous disease (vitiligo, psoriasis, alopecia) or benign rheumatoid polyarthritis not needing any immunosuppressive systemic treatment or over 10 mg daily oral steroids, or benign sicca syndrome (Sjogren) without interstitial pulmonary disease, or history of past Guillain-Barré syndrome beyond 15 previous years, totally reversible with no sequalae, no systemic immunosuppressive treatment during the last 20 years, can be included. Patients with Grave's disease or psoriasis not requiring systemic therapy within the last two years from randomisation can be included.\n12. Active inflammatory intestinal disease (diverticulosis, Crohn disease, haemorrhagic recto-colitis, coeliac disease) requiring systemic treatment, or any serious chronic intestinal disease with uncontrolled diarrhoea.\n13. History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (e.g. cellulitis, pneumonia, septicaemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.\n14. Active uncontrolled infection requiring therapy including active tuberculosis. Past primary pulmonary tuberculosis in youth does not consist of a contra-indication. Past tuberculosis disease history does not consist of a contra-indication provided the patient was treated during at least 6 months by anti-tuberculosis antibiotic treatment.\n15. Uncontrolled infection with HIV, HBV, or HCV infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.\n\n    Notes:\n    1. Patients with known HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.\n    2. Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.\n    3. Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.\n    4. Patients with HIV or hepatitis must be reviewed by a qualified specialist (e.g. infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial.\n16. Received a live vaccine within 30 days of planned start of study medication. Live or live attenuated vaccination with replicating potential. If a patient intends to receive a COVID-19 vaccine before the start of study drug, participation in the study should be delayed at least 1 week after any COVID-19 vaccination. During the treatment period, it is recommended to delay COVID-19 vaccination until patients are receiving and tolerating a steady dose of study drug. A vaccine dose should not be less than 48 hours before or after study drug dosing. mRNA and adenovirus vector anti-SARS-CoV2 vaccine are allowed.\n17. General serious condition such as congestive uncontrolled cardiac failure, uncontrolled cardiac arrythmia, uncontrolled ischemic cardiac disease (unstable angina or history of myocardial infarction within the previous 6 months), history of stroke within the 6 previous months, history of myocarditis. Patients with a significant cardiac history, even if controlled, should have a LVEF \\>45%.\n18. TnT or troponin I TnI \\> 2x institutional ULN at baseline. Patients with TnT or TnI levels between \\>1 to 2xULN are permitted if repeat levels within 24 hours are ≤ 1x ULN. If TnT or TnI levels are \\>1 to 2xULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on cardiological medical judgement in the patient's best interest.\n19. Known hypersensitivity to the active substances or to any of the excipients.\n20. Pre-existing moderate or severe lung interstitial disease as assessed by the diagnosis CT-scan and decrease of TLCO higher than 35% from theoretical normal values linked to such interstitial disease.\n21. Inability to comply with study or follow-up procedures as estimated by the referent investigator.\n22. Pregnant or breastfeeding women.\n23. Women of childbearing potential (WOCBP)\\* who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:\n\n    1. Stable use of combined (oestrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening;\n    2. Intrauterine device; intrauterine hormone-releasing system;\n    3. Bilateral tubal occlusion\u002Fligation;\n    4. Vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); or\n    5. Sexual abstinence†. \\*Pregnancy testing and contraception are required for WOCBP. †Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.\n24. For patients receiving cisplatin: patients with hearing problems; creatinine clearance \\\u003C60 ml\u002Fmin; patients concomitantly receiving phenytoin with prophylactic aim.","75 Years",{"count":57,"type":21},126,[24],"This is a multicentre, phase IIR, double non-comparative arm trial, with an initial safety run for the anti-LAG3 arm.\n\nApproximately 40 sites will participate in the study and will enroll 126 patients with treatment-naive, unresectable malignant PM.\n\nTreatment will be administered in 21-day cycles and will continue until disease progression, unacceptable toxicity, withdrawal of consent or for 2 years immunotherapy maximum.\n\nOnce 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.",[27],[29,62,63,64,33],"cemiplimab","fianlimab","anti-LAG3","NOT_YET_RECRUITING","2026-02-09",{"date":68,"type":38},"2026-02-11",{"date":70,"type":21},"2026-02",{"date":72,"type":21},"2029-09",{"name":44,"class":45},37]