A Phase III, Randomized, Open Label Trial of Nivolumab in combination with Ipilimumab versus Pemetrexed with Cisplatin or Carboplatin as First Line Therapy in unresectable Pleural Mesothelioma - CA209-743

Bristol-Myers Squibb0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年2月28日

试验速览

暂无简介。

•-Male and female subjects (18 years of age and over).
•-Histologically proven diagnosis of (MPM), thoracoscopy is highly recommended.
•-Advanced unresectable disease that is not amenable to therapy with curative intent (surgery with or without chemotherapy). Subjects that refuse potentially curative surgery are ineligible.
•-Available (archival and/or fresh) pathological samples for centralized PD-L1 IHC testing during the screening period. Subjects cannot be randomized until the tumor tissue for PD-L1 testing has been received at the Central Lab, however, the result of the testing is not required prior to randomization. Subjects can initiate therapy before the result of PD-L1 testing is available.
•-Prior palliative radiotherapy is acceptable, but at least 14 days must have passed since the administration of the radiotherapy and all signs of toxicity must have remitted.
•-ECOG Performance Status of 0-1
•-Weight loss < 10% during last 3 months
•-Measurable disease, defined as at least 1 lesion measured in up to two positions at three separate levels on transverse cuts of CT scan that is suitable for repeated assessment using adapted modified Response Evaluation Criteria in Solid Tumors [m-RECIST] for pleural mesothelioma
•-Adequate hematological, renal and hepatic functions

•-Primitive peritoneal, pericardial and tunica vaginalis testis mesotheliomas
•-Brain metastasis, except if surgically resected or treated with stereotaxic radiotherapy with no evolution within the 3 months before inclusion, and asymptomatic. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of <=10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization
•-Prior treatment with adjuvant or neoadjuvant chemotherapy, radical pleuropneumonectomy with or without intensity modulated radiotherapy or non-palliative RT
•-Prior intraoperative or intracavity chemotherapy for pleural mesothelioma
•-Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
•-History of chronic inflammatory or autoimmune disease,
•-Concurrent or prior malignancy requiring or anticipated to require concurrent intervention
•-Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.

发起方

Bristol-Myers Squibb