What side effects are associated with this type of intervention?

Common treatments for Pleural Mesothelioma, particularly those involving immune checkpoint inhibitors like nivolumab and ipilimumab, can cause a range of side effects. These include fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, and abdominal pain. More severe toxicities such as pneumonitis and myocarditis have also been observed.

What prior FDA approvals exist?

The FDA has approved several treatments for Pleural Mesothelioma, including immune checkpoint inhibitors and chemotherapy combinations. Notably, nivolumab and ipilimumab, both immune checkpoint inhibitors, have been approved for use in this condition. These drugs target PD-1 and CTLA-4 pathways, respectively, to enhance the immune system's ability to fight cancer. Additionally, the combination of pemetrexed and cisplatin has been a standard chemotherapy regimen. While bispecific antibodies like Volrustomig (MEDI5752) are still under investigation, they represent a promising new approach by simultaneously targeting multiple immune checkpoints.

What other types of research exist?

Promising alternatives to Volrustomig (MEDI5752) for Pleural Mesothelioma patients include: 1) Nivolumab plus Ipilimumab, which has shown efficacy in various cancers including mesothelioma. 2) Pembrolizumab, another PD-1 inhibitor, which has been effective in multiple cancer types. 3) Combination therapies involving immune checkpoint inhibitors and chemotherapy, such as Nivolumab plus platinum-based chemotherapy. These alternatives have demonstrated potential in clinical trials and may offer viable options for treatment in 2024.

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Alkylating agents

MEDI5752 + Chemotherapy for Pleural Mesothelioma (eVOLVE-Meso Trial)

Phase 3

Recruiting

Led By Marjorie G Zauderer, MD

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Histologically proven diagnosis of pleural mesothelioma with known histology (epithelioid vs. non-epithelioid)

Participant must be ≥ 18 years at the time of screening

Must not have

Active or prior documented autoimmune or inflammatory disorders

Tuberculosis, hepatitis B (HBV) or hepatitis C (HCV), human immunodeficiency virus (HIV) infection that is not well controlled

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12, 18, 24, 36 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a new drug called Volrustomig combined with two chemotherapy drugs, Carboplatin and Pemetrexed. It targets adult patients with advanced pleural mesothelioma that cannot be removed by surgery. The treatment aims to help the immune system fight the cancer while also killing cancer cells directly.

Who is the study for?

This trial is for adults over 18 with advanced, inoperable pleural mesothelioma. They must have stable health without significant deterioration in the past two weeks and measurable disease per specific criteria. Excluded are those with certain infections (TB, HBV, HCV, HIV), autoimmune or inflammatory disorders, another primary cancer (with exceptions), uncontrolled illnesses, or untreated brain metastases.

What is being tested?

The study compares the effectiveness of Volrustomig combined with Carboplatin and Pemetrexed against either platinum plus Pemetrexed or Nivolumab plus Ipilimumab. It's a phase III trial where participants are randomly assigned to receive one of these treatments to see which works best for unresectable pleural mesothelioma.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from the drugs being administered intravenously, fatigue from treatment burden on the body's resources, possible blood cell count changes affecting immunity and oxygen transport.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is confirmed as pleural mesothelioma and its type is known.

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I am 18 years old or older.

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My condition cannot be cured with surgery.

Exclusion Criteria

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

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I have or had an autoimmune or inflammatory disorder.

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I do not have uncontrolled TB, HBV, HCV, or HIV.

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I do not have any unmanaged ongoing illnesses.

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I am not currently receiving any cancer treatments like chemotherapy or radiotherapy.

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My cancer has spread to my brain and hasn't been treated or is getting worse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12, 18, 24, 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12, 18, 24, 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12, 18, 24, 36 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall Survival (OS) in experimental arm relative to comparator arm

Secondary study objectives

Area under the curve (AUC)

Disease-related symptoms using EORTC IL305 (Q1)

Disease-related symptoms using PRO-CTCAE (Q1, 5, 6, 9)

+14 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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: Volrustomig + Carboplatin + pemetrexedExperimental Treatment3 Interventions

Volrustomig in combination with carboplatin plus pemetrexed

Group II: Investigator's choice of standard careActive Control5 Interventions

The investigator's choice of nivolumab plus ipilimumab or platinum plus pemetrexed chemotherapy for participants with epithelioid histology, and nivolumab plus ipilumab for participants with non-epithelioid histology.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Pemetrexed

2014

Completed Phase 3

~5550

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Pleural Mesothelioma include chemotherapy, immunotherapy, and investigational therapies such as bispecific antibodies. Chemotherapy, often using drugs like pemetrexed and cisplatin, works by targeting rapidly dividing cancer cells, thereby slowing disease progression. Immunotherapy, including agents like nivolumab and ipilimumab, enhances the body's immune response against cancer cells by inhibiting immune checkpoints that cancer cells exploit to evade detection. Bispecific antibodies, such as Volrustomig (MEDI5752), target multiple immune checkpoints simultaneously, potentially offering a more robust anti-tumor response. These treatments are crucial for Pleural Mesothelioma patients as they can improve survival rates and quality of life by effectively managing the disease and alleviating symptoms.

Novel and Future Treatment Options in Mesothelioma: A Systematic Review.