A PHASE II/III RANDOMIZED STUDY OF PEMBROLIZUMAB IN PATIENTS WITH ADVANCED MALIGNANT PLEURAL MESOTHELIOMA - A phase II/III trial of pembrolizumab in mesothelioma (IND227)

Canadian Cancer Trials Group0 个研究点目标入组 390 人开始时间: 2019年7月15日最近更新: 2019年12月10日

适应症

试验速览

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•1. Diagnosis and histological confirmation of malignant pleural mesothelioma. Patients must be eligible to receive standard chemotherapy with pemetrexed and cisplatin. Patients must have measurable disease
•2. Patients must have unresectable advanced and/or metastatic disease, incurable by standard therapies.
•3. A sample of the patients tumour block must be available for central analysis
•4. ECOG 0-1
•5. Patients must not have had prior chemotherapy for metatastatic disease. Neo-adjuvant cisplatin based treatment must have been more than 12 months prior to registration.
•6. Prior surgery and radiation therapy must be at least 28 days prior to registration.
•7. Women and men of child bearing potential must agree to using appropriate contraception.
•8. Patients must provide written informed consent. Patients competent but physically unable to sign the consent form may have the document signed by their nearest relative or legal guardian.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 90

•1. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (at doses more than 10 mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
•2. Has active autoimmune disease that has required systemic treatment in the past 3 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
•3. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
•4. Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction.
•5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab or any of the other chemotherapy agents.
•6. Patients with evidence of interstitial lung disease.

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