This is a multicentric study. All patients with TET (thymic epithelial tumors) of any
histological type will participate in the study. This is an open-label phase 2 study that
will follow a Green-Dahlberg 2-stage design whose objective is to evaluate the activity and
safety of the combination of ramucirumab (10 mg / kg) + carboplatin (AUC 5) and paclitaxel
(200 mg / m2) in patients with relapsed and / or metastatic thymic carcinoma/ thymoma B3, in
the first line (RELEVENT trial).
Clinical and quality of life data will be collected for all treated patient. Based on the
histological evaluation performed by each participating center, patients will be screened for
inclusion in one of the four studies, based on the following criteria:
TOPS study only: all patients with A, AB, B1, B2, B3 without areas of carcinoma
histology, diagnosed during or after 2018, that do not have a fresh tissue sample and
screen failures of the RELEVENT and BIOTET study;
TRY registry: all patients with TETs diagnosed, treated or followed from 2010 to 2017
included (retrospective data collection);
BIOTET only: all patients with A, AB, B1, B2, B3 without areas of histology of the
carcinoma that have a fresh tissue sample;
RELEVENT only: all patients with thymoma B3 and areas of carcinoma and pa-tients with
thymic carcinoma who do not have a fresh tissue sample.
Patients with thymic carcinoma or thymoma B3 with areas of carcinoma will receive a
centralized pathological review of the tumour block or slides and will be screened to
participate in the Phase II RELEVENT pharmacological study.Histological diagnosis will be
confirmed before screening.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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