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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12, 18, 24, 36 months

Awards & highlights

eVOLVE-Meso Trial Summary

This trial investigates the effectiveness and safety of a new drug combo to treat an aggressive cancer.

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.Check my eligibility

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.See study design

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.

eVOLVE-Meso Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

I am 18 years old or older.

Select...

My condition cannot be cured with surgery.

eVOLVE-Meso Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Area under the curve (AUC)

Disease-related symptoms using EORTC IL305 (Q1)

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

+14 more

eVOLVE-Meso 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

~6670

Pemetrexed

2014

Completed Phase 3

~5250

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,612,000 Total Patients Enrolled

Marjorie G Zauderer, MDPrincipal InvestigatorMemorial Slone Kettering (MSK) Cancer Centre, NY

Arnaud Scherpereel, MDPrincipal InvestigatorLille University

Frequently Asked Questions

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

What potentially deleterious effects could result from the administration of Volrustomig + Carboplatin + pemetrexed?

"We at Power have rated the safety of Volrustomig + Carboplatin + pemetrexed to be a 3, as we possess evidence for its efficacy and numerous reports indicating that it is safe."

Answered by AI

Are there still vacancies available for volunteers in this experiment?

"Clinicaltrials.gov indicates that the recruitment for this clinical trial concluded on October 18th 2023, as it was last edited by researchers then. This medical study first posted on November 30th of 2023 is no longer recruiting; however, there are 147 other studies actively searching for participants at present."

Answered by AI

How widely is the trial being implemented across varying locales?

"The ongoing trial has 125 sites across the United States, with notable locations in Santa Rosa, Aurora and Chicago. To reduce any necessary travel for participants, it is helpful to select a clinic close by when enrolling in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

2023. "MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06097728.

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