A phase IIb study of ramucirumab in combination with TAS102 versus TAS102 monotherapy in metastatic, chemotherapy refractory colorectal cancer patients: The RAMTAS trial of the German AIO (KRK-0316)

• Published in: Journal of clinical oncology Vol. 37; no. 15_suppl; p. TPS3617
• Main Authors: Kasper, Stefan, zur Hausen, Gerrit, Stein, Alexander, Stintzing, Sebastian, Berger, Andreas, Loges, Sonja, Hofheinz, Ralf, Trarbach, Tanja, Graeven, Ullrich, Fischer von Weikersthal, Ludwig, Goetze, Thorsten Oliver, Hagen, Volker A., Burock, Susen, Hoffmeister, Albrecht, Dechow, Tobias Nicolaas, Pauligk, Claudia, Virchow, Isabel, Siveke, Jens T, Al-Batran, Salah-Eddin, Schuler, Martin H.
• Format: Journal Article
• Language: English
• Published: 20-05-2019
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.2019.37.15_suppl.TPS3617

Abstract only TPS3617 Background: Patients with metastatic colorectal cancer (mCRC) with progressive disease on/after or who are intolerant to fluoropyrimidines, oxaliplatin, irinotecan, anti-angiogenic and anti-EGFR therapies have limited therapeutic options and a dismal prognosis, with a median survival below 6 months. Recently, Trifluridin/Tipiracil (TAS102) significantly improved survival in patients with refractory mCRC and ramucirumab has been approved in combination with FOLFIRI for the treatment of patients with mCRC after prior FOLFOX/bevacizumab first line therapy. Previous studies on both components provide a strong rationale to conduct a randomized study evaluating the efficacy and safety of ramucirumab in combination with TAS102 in patients with refractory mCRC to improve efficacy and prevent resistance. Methods: This is an interventional, randomized, open label, multicenter, phase IIb study in patients with advanced mCRC. Eligible patients will be randomized 1:1 and receive either ramucirumab and TAS102 (ramucirumab 8 mg/kg on d1+15, q4w and TAS102 35 mg/m² on d1-5 and d8-12, q4w) or TAS102 alone. Primary endpoint is overall survival as assessed by the Kaplan-Meier method, assuming a 6 months survival probability of 70% with ramucirumab in combination with TAS102 and 58% with TAS102 alone. Treatment groups are compared using the log-rank test. A total of 144 patients will be enrolled at 30 sites (1-sided alpha 0.10, power 0.80). Main secondary endpoints are overall response rate, disease control rate, progression free survival and quality of life. In addition, a large comprehensive translational research program will be conducted to identify novel predictive and prognostic biomarkers. The study started in December 2018. By February 2019, a total of 3 patients have been enrolled. Clinical trial information: NCT03520946.