RELEVENT Trial: Phase II Trial of Ramucirumab, Carboplatin, and Paclitaxel in Previously Untreated Thymic Carcinoma/B3 Thymoma With Area of Carcinoma

Thymic epithelial tumors are rare malignancies. Thymic carcinoma represents about 20% of all thymic epithelial tumors and has aggressive behavior, with a greater tendency to metastatic spread. Thymic carcinoma is often diagnosed in advanced stages for which systemic treatment is the main therapeutic...

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Bibliographic Details
Published in:Clinical lung cancer 2018-09, Vol.19 (5), p.e811-e814
Main Authors: Imbimbo, Martina, Vitali, Milena, Fabbri, Alessandra, Ottaviano, Margaret, Pasello, Giulia, Petrini, Iacopo, Palmieri, Giovannella, Berardi, Rossana, Zucali, Paolo, Ganzinelli, Monica, Marabese, Mirko, Broggini, Massimo, Marino, Mirella, Trama, Annalisa, Rulli, Eliana, Hollander, Lital, Pruneri, Giancarlo, Torri, Valter, Garassino, Marina Chiara
Format: Article
Language:English
Subjects:
Adolescent
Adult
Advanced
Aged
Aged, 80 and over
Antibodies, Monoclonal - administration & dosage
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Biologic therapy
Carboplatin - administration & dosage
Female
First line
Follow-Up Studies
Humans
Male
Middle Aged
Paclitaxel - administration & dosage
Prognosis
Ramucirumab
Research Design
TET
Thymoma - drug therapy
Thymoma - pathology
Thymus Neoplasms - drug therapy
Thymus Neoplasms - pathology
Young Adult
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Summary:Thymic epithelial tumors are rare malignancies. Thymic carcinoma represents about 20% of all thymic epithelial tumors and has aggressive behavior, with a greater tendency to metastatic spread. Thymic carcinoma is often diagnosed in advanced stages for which systemic treatment is the main therapeutic option. The association of chemotherapy and antiangiogenic agents in the first-line setting has never been investigated in this very rare cancer. However, preclinical and clinical evidence has suggested that inhibition of angiogenesis could be beneficial. The RELEVENT trial is a multicenter, open-label, single-arm, phase II study aimed at investigating the activity and safety of ramucirumab combined with paclitaxel and carboplatin in chemotherapy-naive patients affected by thymic carcinoma or B3 thymoma with area of carcinoma. The primary endpoint of the trial is the overall response rate. Progression-free survival, overall survival, and safety are secondary endpoints. Patient-reported outcomes will be collected at each visit. The mutational status of a subset of genes, polymorphisms, and selected micro-RNA expression will be evaluated.
ISSN:1525-7304
1938-0690
DOI:10.1016/j.cllc.2018.06.005