BridgeMD
Phase III Trial of Volrustomig (MEDI5752) in Combination with Carboplatin plus Pemetrexed vs. Investigator’s Choice of the Standard of Care in Unresectable Pleural Mesothelioma
EU CTIS ID: 2023-503231-17-00
What this study is testing
The primary objective is to demonstrate the superiority of volrustomig in combination with carboplatin plus pemetrexed relative to investigator’s choice of nivolumab in combination with ipilimumab or platinum plus pemetrexed by assessment of OS in participants with pleural mesothelioma.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant must be ≥ 18 years at the time of screening
- Histologically proven diagnosis of pleural mesothelioma with known histology (epithelioid or 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
You likely can't join if
- 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
See the full eligibility criteria
- Participant must be ≥ 18 years at the time of screening
- Histologically proven diagnosis of pleural mesothelioma with known histology (epithelioid or 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- South Africa
- Canada
- United States
- United Kingdom
- Australia
- China
- Brazil
- Turkey
- Japan
- Korea, Republic of
- Switzerland
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include South Africa; Canada; United States; United Kingdom; Australia; China and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.