NCT03921671

Ramucirumab and Carbo-Paclitaxel for Untreated Thymic Carcinoma / B3 Thymoma With Carcinoma (RELEVENT)

Improving Treatment Strategies in Thymic Epithelial Tumors: a TYME Collaborative Effort

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Claudia Proto · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Thymic Carcinoma
• Thymoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Ramucirumab	Combination of ramucirumab (10 mg / kg) + carboplatin (AUC 5) and paclitaxel (200 mg / m2) in patients with carcinoma thymic (or thymoma B3 with areas of carcinoma), relapsed and / or metastatic, in the first line.

Timeline

• Start date: 2018-11-01
• Primary completion: 2021-10-09
• Completion: 2024-07-16
• First posted: 2019-04-19
• Last updated: 2024-05-29

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study