Neoplasms

All Conditions

Blood and Lymph Conditions

Carcinoma

Thymoma

Thymus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Thoracic Neoplasms

Lymphatic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Lenvatinib

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Pembrolizumab 200 mg will be administered to patients as 30-minute IV infusion every 3 weeks (a window of -5 minutes and +10 minutes is permitted).

Lenvatinib 20 mg (2 capsules of 10 mg) will be administered daily at the same time, with or without food. At the day 1 of each cycle, lenvatinib will be administered within 4 hours after finishing pembrolizumab (lenvatinib after pembrolizumab). Lenvatinib cannot be chewed

Pembrolizumab 200 mg will be administered to patients as 30-minute intravenous infusion (a window of -5 minutes and +10 minutes is permitted) every 3 weeks.

Lenvatinib 20 mg (2 capsules of 10 mg) will be administered daily at the same time, with or without food. At the day 1 of each cycle, lenvatinib will be administered within 4 hours after finishing pembrolizumab (lenvatinib after pembrolizumab)

Lenvatinib 10 mg

Jordi Remon, MD, PhD

Benjamin Besse, MD, PhD

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.

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.

Combination of Pembrolizumab and Lenvatinib, in Pre-treated Thymic CArcinoma paTIents

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. PECATI.

PFS rate at 5 months, defined as the percentage of patients with B3-Thymoma and Thymic Carcinoma without disease progression at 5 months after starting the treatment combination.

Grade 3 and 4 AEs and serious adverse events (SAEs) will be assessed, according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v.5.0), to determine the safety and tolerability of the combination.

Spots Global Cancer Trial Database for lenvatinib 10 mg