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Monoclonal Antibodies

Pembrolizumab +/− Anetumab Ravtansine for Mesothelioma

Phase 1 & 2

Waitlist Available

Led By Aaron S Mansfield

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tissue submitted for testing at pre-registration shows moderate or stronger mesothelin expression in >= 30% of the tumor cells

Patients must have received platinum-based therapy with or without bevacizumab

Must not have

Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4

Patients who have received any monoclonal antibody therapy within 4 weeks prior to entering the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing pembrolizumab with or without anetumab ravtansine to treat mesothelin-positive pleural mesothelioma. Anetumab ravtansine is a monoclonal antibody that is linked to a chemotherapy drug. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer.

Who is the study for?

This trial is for patients with mesothelin-positive pleural mesothelioma who've had platinum-based chemotherapy. They must have measurable disease, normal organ function, and agree to contraception. Exclusions include HIV, hepatitis B/C, recent monoclonal antibody therapy or transfusions, active secondary cancers, certain drug interactions, and history of severe lung conditions.

What is being tested?

The study tests pembrolizumab (an immunotherapy) alone or combined with anetumab ravtansine (a targeted therapy that delivers chemo directly to cancer cells). It aims to see if this combination is more effective in treating pleural mesothelioma than pembrolizumab alone.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal organs (like inflammation), infusion-related reactions from the drugs being administered into the bloodstream, fatigue, liver issues due to elevated enzymes and bilirubin levels in blood tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor shows high levels of mesothelin in more than 30% of its cells.

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I have been treated with platinum-based therapy, with or without bevacizumab.

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I am mostly self-sufficient and can carry out daily activities.

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My cancer diagnosis of mesothelioma has been confirmed by lab tests.

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I have received platinum-based chemotherapy.

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My kidney function, measured by creatinine levels or clearance, is within the normal range.

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I am willing to provide a tissue sample for mesothelin testing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any strong medication that affects liver enzymes.

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I haven't had monoclonal antibody therapy in the last 4 weeks.

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I am allergic to medications similar to anetumab ravtansine or pembrolizumab.

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I have a history of hepatitis B or an active hepatitis C infection.

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I am not pregnant or breastfeeding.

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I have been treated with a PD-1, PD-L1, or PD-L2 inhibitor before.

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I do not have worsening brain cancer symptoms or need steroids for them.

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I have another cancer that is getting worse or needs treatment.

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I do not have a history of corneal epitheliopathy.

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I have no lasting side effects from previous cancer treatments above mild.

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I have or had lung inflammation treated with steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 2 Confirmed Tumor Response Rate (Phase II)

Phase I - Recommended Phase 2 Dose of Ametumab Ravtansine With Combination of Pembrolizumab

Secondary study objectives

Change in Megakaryocyte Potentiating Factor Levels Assessed in Tumor

Incidence of Adverse Events

Mononuclear Phagocyte System -FcgammaRs and Chemokine Mediators of Mononuclear Phagocyte System

+4 more

Other study objectives

Neoplasms

Measurements of soluble PD-L1

PD-L1 expression in archival tissue

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group II (anetumab ravtansine, pembrolizumab)Experimental Treatment4 Interventions

Patients receive anetumab ravtansine IV over 1 hour and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 12 months for anetumab ravtansine and up to 24 months for pembrolizumab in the absence of disease progression or unacceptable toxicity.

Group II: Group I (pembrolizumab)Active Control3 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Upon radiologic documentation of disease progression, patients may cross over to Group II.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

0 / 18Eligibility criteria met