Last updated on June 2020

Pembrolizumab With or Without Anetumab Ravtansine in Treating Patients With Mesothelin-Positive Pleural Mesothelioma


Brief description of study

This randomized phase I/II trial studies the side effects and how well pembrolizumab with or without anetumab ravtansine work in treating patients with mesothelin-positive pleural mesothelioma. Monoclonal antibodies, such as anetumab ravtansine and pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

Detailed Study Description

PRIMARY OBJECTIVES:

I. Determine the dose of anetumab ravtansine that is safe in combination with MK-3475 (pembrolizumab) to be used in the randomized phase 2 study. (Phase I safety lead-in) II. Determine if the overall response rate of the combination of anetumab ravtansine and MK-3475 (pembrolizumab) is superior to MK-3475 (pembrolizumab) alone. (Phase II)

SECONDARY OBJECTIVE:

I. To determine the progression free survival of anetumab ravtansine and MK-3475 (pembrolizumab) compared to MK-3475 (pembrolizumab) alone.

II. To evaluate the pharmacodynamic effects of anetumab ravtansine and MK-3475 (pembrolizumab) on soluble megakaryocyte potentiating factor (MPF).

III. To evaluate the pharmacokinetics of anetumab ravtansine and MK-3475 (pembrolizumab).

IV. To evaluate mononuclear phagocyte system (MPS) function, FcgammaRs, hormone and chemokine mediators as methods to evaluate factors affecting the pharmacokinetics and pharmacodynamics of these agents.

V. To determine the incidence of antibodies directed against anetumab ravtansine.

TERTIARY OBJECTIVE:

I. To determine whether elevations in Bim in TTR predict responses to treatment and whether its detection is dynamic with treatment.

II. To determine whether soluble PD-L1 predicts responses to treatment and whether its detection is dynamic with treatment.

III. To evaluate PD-L1 expression in archival tissue as a predictive marker of response to MK-3475 (pembrolizumab)-based therapy.

IV. To explore the symptomatic adverse events (AE) for tolerability of each treatment group using patient reported outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE).

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Upon radiologic documentation of disease progression, patients may cross over to Group II.

GROUP II: Patients receive anetumab ravtansine IV over 1 hour and pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 12 months.

Clinical Study Identifier: NCT03126630

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Recruitment Status: Open


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