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UM1 10107 Anetumab ravtansine + Pembrolizumab in Pleural Mesothelioma - Clinical Trial

What is the Purpose of this Study?

We are doing this study to test the safety of the study drug Anetumab ravtansine when it is given with MK-3475 (pembrolizumab) at different doses to find out what effect, if any, it has on people.

What is the Condition Being Studied?

Mesothelioma which has grown or has returned after initial treatment with chemotherapies

Who Can Participate in the Study?

Adults with malignant pleural mesothelioma who have received platinum based chemotherapy

Age Group
Adults

What is Involved?

The study is divided into two parts.
-- Part 1 is looking for the best dose of Anetumab ravtansine
-- Part 2 will look at the activity and safety of Pemrolizumab with and without Anetumab ravtansine

If you join this study:
In part 1, 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 first part of the study will be stopped.

In part 2: you will be randomly (like flipping a coin) assigned by a computer to be in either Group 1 or 2.
Group 1 will receive anetumab ravtansine and MK-3475 (pembrolizumab)
Group 2 will receive only MK-3475 (pembrolizumab).

Study Details

Full Title
Phase 1 Safety run-in and Phase 2 Randomized Clinical Trial of Anetumab Ravtansine and MK-3475 (Pembrolizumab) Compare to MK-3475 (Pembrolizumab) Alone for Mesothelin-Positive Malignant Pleural Mesothelioma
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00092358
NCT:NCT03126630
Phase
Phase I
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698