A Phase III, Randomized, Open-Label, Multicenter, Global Study of Volrustomig (MEDI5752) in Combination With Carboplatin Plus Pemetrexed Versus Platinum Plus Pemetrexed or Nivolumab Plus Ipilimumab in Participants With Unresectable Pleural Mesothelioma (eVOLVE-Meso)
Study of Volrustomig for Pleural Mesothelioma
Plain English Summary
MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma is a Phase 3 clinical trial sponsored by AstraZeneca studying Unresectable Pleural Mesothelioma. Tests Volrustomig combined with chemotherapy to see if it works better than other treatments for pleural mesothelioma. For patients with advanced, unresectable pleural mesothelioma who cannot have surgery. Participation involves receiving IV infusions of Volrustomig, carboplatin, and pemetrexed or other standard treatments. Alternative treatments include platinum plus pemetrexed or nivolumab plus ipilimumab. The trial aims to enroll 825 participants.
Official Summary
This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of Volrustomig (MEDI5752) + Carboplatin + Pemetrexed vs the investigator's choice of platinum + Pemetrexed or Nivolumab + Ipilimumab in participants with unresectable pleural mesothelioma.
Who Can Participate
Here is what you need to know about eligibility for this trial. Eligible if at least 18 years old, diagnosed with pleural mesothelioma, and cannot have surgery. Not eligible if have active autoimmune disorders, other cancers, or are receiving other cancer treatments. Age: 18 years and older. Health: Good overall health, no major illnesses. This trial is studying Unresectable Pleural Mesothelioma, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures overall survival, which means it looks at how long patients live with the treatment. The specific primary outcome measures are: Overall Survival (OS) in experimental arm relative to comparator arm (up to approximately 61 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial aims to fill a treatment gap by evaluating a new combination therapy for advanced pleural mesothelioma. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Unresectable Pleural Mesothelioma, where improved treatment options are needed.
Investor Insight
The large market size and competitive landscape suggest a high probability of approval for this innovative treatment. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 825 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if you meet the criteria for this study. Participation involves receiving IV infusions of Volrustomig, carboplatin, and pemetrexed. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: SINGLE
- Enrollment: 825 participants
Interventions
- DRUG: Volrustomig — MEDI5752: Administered as IV infusion
- DRUG: Pemetrexed — Alimta: Administered as IV infusion
- DRUG: Carboplatin — Paraplatin: Administered as IV infusion
- DRUG: Cisplatin — Platinol: Administered as IV infusion
- DRUG: Nivolumab — Opdivo: Administered as IV infusion
Primary Outcomes
- Overall Survival (OS) in experimental arm relative to comparator arm (up to approximately 61 months)
Secondary Outcomes
- Overall Survival (OS) (up to approximately 61 months)
- Progression Free Survival (PFS) (up to approximately 61 months)
- Landmark OS (12, 18, 24, 36 months)
- Landmark PFS (6, 12, 18, 24 months)
- Overall Response Rate (ORR) (up to approximately 61 months)
Full Eligibility Criteria
Key Inclusion Criteria: * Participant must be ≥ 18 years at the time of screening * Histologically proven diagnosis of pleural mesothelioma with known histology (epithelioid vs. non-epithelioid) * Advanced unresectable disease that cannot be treated with curative surgery (with or without chemotherapy) * WHO/ECOG performance status of 0 or 1 with no deterioration (that is, ECOG PS\>1) over the previous 2 weeks prior to day of first dosing * Has measurable disease per modified RECIST1.1 * Has adequate bone marrow reserve and organ function at baseline Key Exclusion Criteria: * As judged by the investigator, any condition that would interfere with evaluation of the investigational product or interpretation of participant safety or study results. * Active or prior documented autoimmune or inflammatory disorders * History of another primary malignancy with exceptions. * Uncontrolled intercurrent illness * Tuberculosis, hepatitis B (HBV) or hepatitis C (HCV), human immunodeficiency virus (HIV) infection that is not well controlled * Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment * Untreated or progressive CNS metastatic disease
Trial Locations
- Research Site, Phoenix, Arizona, United States
- Research Site, Duarte, California, United States
- Research Site, Santa Rosa, California, United States
- Research Site, Aurora, Colorado, United States
- Research Site, Jacksonville, Florida, United States
- Research Site, Atlanta, Georgia, United States
- Research Site, Chicago, Illinois, United States
- Research Site, Baltimore, Maryland, United States
- Research Site, Rochester, Minnesota, United States
- Research Site, St Louis, Missouri, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06097728?
NCT06097728 is a Phase 3 INTERVENTIONAL study titled "MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma." It is currently recruiting and is sponsored by AstraZeneca. The trial targets enrollment of 825 participants.
What conditions does NCT06097728 study?
This trial investigates treatments for Unresectable Pleural Mesothelioma. The primary condition under study is Unresectable Pleural Mesothelioma.
What treatments are being tested in NCT06097728?
The interventions being studied include: Volrustomig (DRUG), Pemetrexed (DRUG), Carboplatin (DRUG), Cisplatin (DRUG), Nivolumab (DRUG). MEDI5752: Administered as IV infusion
What does Phase 3 mean for NCT06097728?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT06097728?
This trial is currently "Recruiting." It started on 2023-11-09. The estimated completion date is 2028-11-16.
Who is sponsoring NCT06097728?
NCT06097728 is sponsored by AstraZeneca. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06097728?
The trial aims to enroll 825 participants. The trial is currently recruiting and accepting new participants.
How is NCT06097728 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06097728?
The primary outcome measures are: Overall Survival (OS) in experimental arm relative to comparator arm (up to approximately 61 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06097728 being conducted?
This trial is being conducted at 20 sites, including Phoenix, Arizona; Duarte, California; Santa Rosa, California; Aurora, Colorado and 16 more sites (United States).
Where can I find official information about NCT06097728?
The official record for NCT06097728 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06097728. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06097728 testing in simple terms?
Tests Volrustomig combined with chemotherapy to see if it works better than other treatments for pleural mesothelioma. For patients with advanced, unresectable pleural mesothelioma who cannot have surgery.
Why is this trial significant?
This trial aims to fill a treatment gap by evaluating a new combination therapy for advanced pleural mesothelioma. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT06097728?
Potential side effects include nausea, fatigue, and low blood cell counts. Monitor closely for any signs of allergic reactions or worsening of existing conditions. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06097728?
Ask your doctor if you meet the criteria for this study. Participation involves receiving IV infusions of Volrustomig, carboplatin, and pemetrexed. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06097728 signal from an investment perspective?
The large market size and competitive landscape suggest a high probability of approval for this innovative treatment. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves receiving IV infusions of Volrustomig, carboplatin, and pemetrexed or other standard treatments. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Unresectable Pleural Mesothelioma Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.