CompletedPhase 2

Phase II MEDI4736 in Combination With Chemotherapy for First-Line Treatment of Unresectable Mesothelioma

United States55 participantsStarted 2017-06-13

Plain-language summary

Patients with pleural mesothelioma that can not be surgically removed will receive durvalumab, in combination with standard chemotherapy of pemetrexed and cisplatin as first-line treatment. Durvalumab is a type of drug called a monoclonal antibody (a type of protein). Laboratory tests show that it works by allowing the immune system to detect your cancer and reactivates the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die. The purpose of this study is to see whether adding durvalumab to standard chemotherapy will improve overall survival (OS).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Criteria: * Histologically and/or cytologically confirmed malignant pleural mesothelioma. * Unresectable disease (defined as the participant not being a candidate for curative surgery). * Measurable disease, defined as at least 1 lesion (measurable) that can be accurately assessed at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for repeated assessment (modified RECIST for pleural mesothelioma). * Available unstained archived tumor tissue sample in sufficient quantity to allow for analyses. At least fifteen unstained slides or a tumor block (preferred). NOTE: A fine needle aspiration sample is not sufficient to make the patient eligible for enrollment. Given the complexity of mesothelioma pathological diagnosis and that these will be newly diagnosed patients it is expected that they will have a core needle biopsy or surgical tumor biopsy as part of their initial diagnostic work up. * Age ≥ 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Ability to understand and willingness to sign Institutional Review Board (IRB)-approved informed consent. * Willing to provide archived tumor tissue and blood samples for research. * Adequate organ function as measured by the following criteria, obtained ≤ 2 weeks prior to registration: * Absolute Neutrophil Count (ANC) ≥ 1500/mm³ * Hemoglobin ˃9.0 g/dL * Platelets ˃100,000/mm³ * Serum creatinine clearance (CL)\>60 mL/min by the Cockcroft-Gault formula or b…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall Survival (OS)

Timeframe: From randomization until death, up to 32 months

Trial details

NCT IDNCT02899195

SponsorPrECOG, LLC.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-16

Results submitted2021-02-16

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