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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
Ability to understand and the willingness to sign a written informed consent document, unless patient is of impaired decision making capacity in which case patient may be eligible if they have a legal authorized representative or caretaker available
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 can understand and am willing to sign the consent form, or I have someone who can do it for me.
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My blood clotting tests are within normal limits or I am on a stable blood thinner dose.
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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.
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My cancer can be measured using specific criteria.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Confirmed tumor response rate (Phase II)
Recommended phase 2 dose of anetumab ravtansine with combination of pembrolizumab
Secondary outcome measures
Change in megakaryocyte potentiating factor levels assessed in tumor
Duration of response
Incidence of adverse events
+4 more
Other outcome measures
Neoplasms
Measurements of soluble PD-L1
PD-L1 expression in archival tissue
+1 more

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 2
~1950

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,600 Total Patients Enrolled
93 Trials studying Mesothelioma
8,609 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

Anetumab Ravtansine (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03126630 — Phase 1 & 2
Mesothelioma Research Study Groups: Group I (pembrolizumab), Group II (anetumab ravtansine, pembrolizumab)
Mesothelioma Clinical Trial 2023: Anetumab Ravtansine Highlights & Side Effects. Trial Name: NCT03126630 — Phase 1 & 2
Anetumab Ravtansine (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03126630 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many study participants are being monitored in this research?

"This clinical trial is not currently searching for patients at this time. The trial was initially posted on 2/8/2018 and was last edited on 10/18/2022. If you are searching for other studies, there are presently 158 studies actively looking for patients with mesothelioma, malignant and 1002 trials for Pharmacological Study actively recruiting participants."

Answered by AI

How many locations are conducting this experiment?

"Currently, this study is operational in 27 locations. While some sites are in Phoenix, Creve Coeur and Saint Louis, there are also other centres located throughout the country. To limit travel burden, patients should aim to select the site that is geographically closest to them."

Answered by AI

Are people still being signed up to participate in this clinical trial?

"This study is not recruiting at this time, as reflected by the trial's last update on October 18th, 2022. If you are seeking other trials to participate in, there are 1002 pharmacological studies and 158 clinical trials for patients with mesothelioma that are still admitting patients."

Answered by AI

Could you name a few other research projects that have used this same drug in their tests?

"There are currently one thousand and two ongoing clinical trials for Pharmacological Study. Out of these, 122 have reached Phase 3. Many of theHouston-based trials are nearing their completion; however, there are still 36,098 sites around the world investigating this topic."

Answered by AI

Why do doctors most often prescribe this medication?

"Pharmacological Study is an effective treatment for malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI
~7 spots leftby Mar 2025