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Clinical Trial Summary

This is a multicentric, open-label, single arm phase II study to evaluate the efficacy and safety of the combination of pembrolizumab and lenvatinib in pre-treated thymic carcinoma patients who have progressed after at least one line of platinum-based chemotherapy for advanced disease without having received any previous immunotherapy (previous bevacizumab allowed, but not sunitinib), and not amenable to curative-intent radical surgery and/or radiotherapy, regardless of PD-L1 status.


Clinical Trial Description

Men and women aged ≥ 18 years old diagnosed with B3-thymoma or metastatic thymic carcinoma who have progressed after at least one line of platinum-based chemotherapy for advanced disease without having received any previous immunotherapy (previous bevacizumab allowed, but not sunitinib), and not amenable to curative-intent radical surgery and/or radiotherapy, regardless of PD- L1 status. Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1 criteria. Patients are not eligible if they are candidates for a local treatment with a curative intention. Patients must present Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 and with adequate organ function. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04710628
Study type Interventional
Source MedSIR
Contact
Status Active, not recruiting
Phase Phase 2
Start date September 21, 2021
Completion date January 31, 2026

See also
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Active, not recruiting NCT03134118 - Nivolumab in Patients With Type B3 Thymoma and Thymic Carcinoma (NIVOTHYM) Phase 2