Malignant pleural mesothelioma
Conditions
Interventions
In induction treatment, study interventions include oral lenvatinib, 8 mg QD, and pembrolizumab, 200 mg, carboplatin (AUC 5 mg/mL/min) or cisplatin (75 mg/m2), and pemetrexed, 500 mg/m2 all given by i
Sponsors
Kuribayashi Kozo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with unresectable advanced or metastatic malignant pleural mesothelioma without prior treatment for malignant pleural mesothelioma 2.Patients expected to survive more than 90 days 3.Patients with a transcutaneous oxygen saturation of 94% or greater measured with a pulse oximeter at rest without oxygen inhalation within 7 days prior to enrollment 4.Patients who have given written consent to participate in this clinical trial (consent by a surrogate is also acceptable, if applicable). 5.Patients who are judged by the principal investigator or subinvestigator to have one or more measurable lesions as defined in mRECIST by CT or MRI imaging within 28 days prior to enrollment. However, if the measurable lesion is a pleural lesion only and there is a history of pleurodesis (patients who underwent pleurodesis within 14 days prior to enrollment or pleurodesis with Picibanil within 28 days prior to enrollment are excluded), only patients whose measurable lesion was confirmed on imaging after pleurodesis are eligible. 6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention. 7. Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of [insert disease under study and any defining characteristics of the disease population] will be enrolled in this study. 8. Have adequate organ function as defined in the following table. All clinical laboratory tests in the screening period should be performed within 10 days prior to the start of study intervention.
Exclusion criteria
Exclusion criteria: 1. Patients with concomitant or pre-existing severe hypersensitivity reactions to other drugs, including antibody preparations 2. A WOCBP who has a positive urine pregnancy test within 72 hours prior to trial registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note. in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication. 3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or antiPDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (for example, CTLA4, OX40, CD137). 4. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to trial registration. 5. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. 6. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. 7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. 8. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. 9. Has known active CNS metastases and or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, in other words. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention. 10. Has severe hypersensitivity (more than Grade 3) to pembrolizumab and or any of its excipients. 11. Has active autoimmune disease that has required systemic treatment in the past 2 years (in other words, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (for example, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed. 12. Has a history of (non-infectious) pneumonitis interstitial lung disease that required steroids or has current pneumonitis interstitial lung disease. 13. Has an active infection requiring systemic therapy. 14. Has a known history of Human Immunodeficiency Virus (HIV) infection. 15. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen (HBsAg) reactive or HBV-DNA detected) or known active Hepatitis C virus (defined as HCV RNA (qualitative) detected or HCV antibody reactive, if HCV-RNA is not the local SOC) infection. 16. Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that migh
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor shrinkage (response rate) (Physician Judgment by Medical Institution, Modified RECIST criteria) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression-Free survival (Physician Judgment by Medical Institution, Modified RECIST criteria) 2. Overall survival time 3. Tumor shrinkage (disease control rate) (Physician Judgment by Medical Institution, Modified RECIST criteria) 4. Duration of response (Physician Judgment by Medical Institution, Modified RECIST criteria) 5. Best overall response (Physician Judgment by Medical Institution, Modified RECIST criteria) 6. Safety endpoints (adverse events, laboratory tests, vital signs, 12-lead ECG, chest X-ray, ECOG Performance Status) | — |
Contacts
Public ContactTetsuya Takagawa
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan
Outcome results
None listed