A Phase IIIb/IV Safety Trial of Flat Dose Nivolumab in Combination with Ipilimumab in Participants with Non-Small Cell Lung Cancer - CA209-817

Bristol-Myers Squibb0 个研究点目标入组 22 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•D4. Main inclusion criteria
•- Male and female patients over the age of 18 with ECOG status of 0-2 -
•Participants with histologically confirmed Stage IV (1st line NCSLC) or IIIB/IV
•(2nd line NSCLC) or recurrent, progressive NSCLC squamous or non-squamous
•histology, with no prior systemic anticancer therapy (including EGFR and ALK
•inhibitors) given as primary therapy for advanced or metastatic disease (1st
•line NSCLC) or with recurrent or progressive disease following multimodal
•therapy or platinum-doublet chemotherapy (2nd line NSCLC).
•Patients with untreated brain metastases, a controlled HIV infection, hepatic
•or renal impairment, or with a ECOG PS 2- Measurable disease by CT or MRI per
•RECIST 1.1.
•Participants must have tissue submitted for PD-L1 IHC testing prior to the
•treatment assignment. If PD-L1 IHC testing has already been conducted during
•screening for another BMS study, it does not need to be repeated for CA209-817.
•Women of childbearing potential must not be breastfeeding and must have a
•negative serum or urine pregnancy test within 24 hours prior to start of study
•treatment. This test will be repeated every 6 weeks during the study. Patients
•must follow the contraception requirements while enrolled in the study.

•-Patients previously treated with drugs targeting T-cell co-stimulation or
•checkpoint pathways.
•Patients with known EGFR mutations or ALK translocations sensitive to available
•targeted inhibitor therapy.
•Patients with an active, known or suspected autoimmune disease.
•Patients with type I diabetes mellitus, hypothyroidism only requiring hormone
•replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not
•requiring systemic treatment, or conditions not expected to recur in the
•absence of an external trigger are permitted to enrol.
•Patients with a condition requiring systemic treatment with either
•corticosteroids (> 10mg daily prednisone equivalent) or other immunosuppressive
•medications within 14 days of treatment assignment.. Patients with interstitial
•lung disease or, who are incarcerated or temporarily detained for psychiatric
•or physical illness.

发起方

Bristol-Myers Squibb