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10107 Phase 1 Safety Run-In and Phase 2 Randomized Clinical Trial of Anetumab Ravtansine and MK-3475 (Pembrolizumab) Compared to MK-3475 (Pembrolizumab) Alone for Mesothelin-Positive Malignant Pleural Mesothelioma (ETCTN)
Protocol Number:
Phase I/II
Patrick Forde
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of this study is to test the safety of anetumab ravtansine given with MK- 3475 (pembrolizumab) at different doses to find out what effects, if any, it has on people.
Patients who have malignant pleural mesothelioma which has grown or has returned after initial treatment with chemotherapies may be eligible.
All study participants will receive both anetumab ravtansine and MK-3475 (pembrolizumab); the dose of the anetumab ravtansine may differ between groups of patients. The first group of study patients will receive the most commonly used doses of both drugs. If the study drugs cause serious side effects, the second group of study patients will receive a lower dose of anetumab ravtansine. If the study drugs do not cause serious side effects, these doses will be used for the second part of the study and at that time, the phase 1 part of the study will be stopped. The study will follow a schedule of 21-day periods and each 21-day period is known as a cycle. Both anetumab ravtansine and MK-3475 (pembrolizumab) will be given intravenously (IV, through a vein) once per cycle on day 1, anetumab ravtansine for 1 hour followed by MK-3475 (pembrolizumab) for 30 minutes. The study drugs may interact with certain foods and other medications; you will be given a drug interaction handout and wallet card as a resource for yourself, caregivers and other health care providers.You will receive the study drugs for up to a maximum of two years. After you finish treatment with (MK-3475) pembrolizumab and anetumab ravtansine, your doctor will continue to watch you for side effects and follow your condition every three months by telephone for up to one year.
Last Update
05/07/2021 05:02 AM