Spots Global Cancer Trial Database for Combination of Pembrolizumab and Lenvatinib, in Pre-treated Thymic CArcinoma paTIents
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Trial Identification
Brief Title: Combination of Pembrolizumab and Lenvatinib, in Pre-treated Thymic CArcinoma paTIents
Official Title: 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.
Study ID: NCT04710628
Study Description
Brief 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.
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Institut Bergonié, Bordeaux, , France
Centre Oscar Lambert, Lille, , France
Hôpitaux Universitaires de Marseille - Hôpital Nord, Marseille, , France
Institut Curie, Paris, , France
Centre Hospitalier Universitaire de Toulouse, Toulouse, , France
IGR Gustave Roussy, Villejuif, , France
A.O.U. San Luigi Gonzaga, Orbassano, , Italy
Hospital Clinic i Provincial de Barcelona, Barcelona, , Spain
Hospital Sant Creu i Sant Pau, Barcelona, , Spain
Complejo Hospitalario Universitario A Coruña (CHUAC), La Coruña, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain
Contact Details
Name: Jordi Remon, MD, PhD
Affiliation: HM-CIOCC, Hospital HM Delfos, HM Hospitales, Barcelona (Spain)
Role: PRINCIPAL_INVESTIGATOR
Name: Benjamin Besse, MD, PhD
Affiliation: Medical Oncology Department Gustave Roussy, Villejuif (France)
Role: PRINCIPAL_INVESTIGATOR
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