PECATI: A Multicentric, Open-Label, Single-Arm Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab and Lenvatinib in Pretreated B3-Thymoma and Thymic Carcinoma Patients

Clin Lung Cancer. 2022 May;23(3):e243-e246. doi: 10.1016/j.cllc.2021.07.008. Epub 2021 Jul 20.

Abstract

Thymic epithelial tumors are rare neoplastic proliferations of thymic epithelial cells. The aggressiveness of these malignancies increases as higher is the histologic subtype, being thymic carcinoma the most aggressive subtype, with a greater tendency to metastatic spread. In metastatic setting, there is no standard treatment after progression on platinum-based chemotherapy. In this scenario, monotherapy treatment either with lenvatinib, a multi-tyrosine kinase inhibitor with antiangiogenic properties, or pembrolizumab, an immune-checkpoint inhibitor, has reported clinical activity. Potential combination of both agents may have synergistic activity as reported in other cancer types. PECATI trial is a single-arm, investigator-initiated phase II study aiming to assess the activity and safety of the combination of lenvatinib and pembrolizumab in 43 patients with advanced B3-thymoma or thymic carcinoma who progressed on or after at least one previous line of platinum-based chemotherapy. The primary endpoint of the trial is 5-month progression-free survival rate and the secondary endpoints include overall response rate, duration of response, and overall survival.

Trial registration: ClinicalTrials.gov NCT03076554 NCT04321330 NCT04469725 NCT04417660 NCT03134118 NCT03463460.

Keywords: Immunotherapy; Lenvatinib; Pembrolizumab; Second-line; Thymic epithelial tumors.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Humans
  • Lung Neoplasms* / drug therapy
  • Phenylurea Compounds
  • Quinolines
  • Thymoma* / pathology
  • Thymus Neoplasms* / pathology

Substances

  • Antibodies, Monoclonal, Humanized
  • Phenylurea Compounds
  • Quinolines
  • pembrolizumab
  • lenvatinib

Associated data

  • ClinicalTrials.gov/NCT03076554
  • ClinicalTrials.gov/NCT04321330
  • ClinicalTrials.gov/NCT04469725
  • ClinicalTrials.gov/NCT04417660
  • ClinicalTrials.gov/NCT03134118
  • ClinicalTrials.gov/NCT03463460