CHECKMATE 817 A Phase IIIb/IV Safety Trial of Flat Dose Nivolumab in Combination with Ipilimumab in Participants with Non-Small Cell Lung Cancer
A study to evaluate the safety of Nivolumab administered in combination with Ipilimumab in patients with advanced cancers. The initial cohort will enroll patients with newly diagnosed Stage 4 or recurrent non-small cell lung cancer.
Key Inclusion Criteria:
Participants with histologically confirmed Stage IV or recurrent NSCLC (per the 7th
International Association for the Study of Lung Cancer classification (IASLC)38) 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.
Subjects with histologically- or cytologically-documented squamous or non-squamous cell NSCLC who present with Stage IIIB/ Stage IV disease (per IASLC), or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiation therapy for locally advanced disease).
Evaluable disease by computed tomography (CT) or magnetic resonance imaging (MRI); radiographic tumor assessment performed within 28 days of start of study treatment.
Ajay Kundra, M.D.
BMS (Bristol-Myers Squibb)
- Providence Regional Cancer Partnership - Everett