Phase II MEDI4736 in Combination With Chemotherapy for First-Line Treatment of Unresectable Mesot… (NCT02899195) | Clinical Trial Compass
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 range18 Years
SexALL
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…
What they're measuring
1
Overall Survival (OS)
Timeframe: From randomization until death, up to 32 months