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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 belowSelect...
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.
Select...
I am mostly self-sufficient and can carry out daily activities.
Select...
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:Select...
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
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 moreOther 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
~3150
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,018,090 Total Patients Enrolled
94 Trials studying Mesothelioma
8,582 Patients Enrolled for Mesothelioma
Aaron S MansfieldPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
3 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Mesothelioma
66 Patients Enrolled for Mesothelioma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any strong medication that affects liver enzymes.I haven't had monoclonal antibody therapy in the last 4 weeks.My tumor shows high levels of mesothelin in more than 30% of its cells.You are currently taking any other experimental medications.I am allergic to medications similar to anetumab ravtansine or pembrolizumab.I have a history of hepatitis B or an active hepatitis C infection.You have a low white blood cell count.Your total bilirubin levels are within the normal range for the hospital where you are being treated.I can understand and am willing to sign the consent form, or I have someone who can do it for me.My blood clotting tests are within normal limits or I am on a stable blood thinner dose.Women who could become pregnant must have a negative pregnancy test.I am not taking any excluded medications during this trial.I am not pregnant or breastfeeding.I have been treated with a PD-1, PD-L1, or PD-L2 inhibitor before.I do not have worsening brain cancer symptoms or need steroids for them.I haven't received blood products or colony stimulating factors in the last 4 weeks.My cancer diagnosis of mesothelioma has been confirmed by lab tests.I have been treated with platinum-based therapy, with or without bevacizumab.I am mostly self-sufficient and can carry out daily activities.You have HIV and do not meet certain requirements.I have received platinum-based chemotherapy.My kidney function, measured by creatinine levels or clearance, is within the normal range.You have a platelet count of at least 100,000 per microliter.I am willing to provide a tissue sample for mesothelin testing.Your AST and ALT levels in the blood are not more than 2.5 times the upper limit of normal.I have another cancer that is getting worse or needs treatment.I do not have a history of corneal epitheliopathy.Your body has enough infection-fighting white blood cells.I have no lasting side effects from previous cancer treatments above mild.My cancer can be measured using specific criteria.I have or had lung inflammation treated with steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (pembrolizumab)
- Group 2: Group II (anetumab ravtansine, pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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