A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab plus Ipilimumab or Nivolumab in Combination with Oxaliplatin plus Fluoropyrimidine versus Oxaliplatin plus Fluoropyrimidine in Subjects with Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer(CheckMate 649: CHECKpoint pathway and nivoluMab clinical Trial Evaluation 649) - CheckMate 649

Bristol-Myers Squibb International Corporation0 个研究点目标入组 3,200 人开始时间: 2016年11月7日最近更新: 2024年7月29日

研究概览

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•a) All subjects must have inoperable, advanced, locally advanced or metastatic GC or GEJ or distal esophageal carcinoma and have histologically confirmed predominant adenocarcinoma.
•b) Subject must be previously untreated with systemic treatment including HER 2 inhibitors given as primary therapy for advanced or metastatic disease.
•c) Allowed Prior Therapies: Prior adjuvant or neoadjuvant chemotherapy, radiotherapy and/or chemoradiotherapy for GC or GEJ cancer are permitted as long as the last administration of the prior
•regimen (whichever was given last) occurred at least 6 months prior to randomization. Palliative
•radiotherapy is allowed and must be completed 2 weeks prior to randomization.
•d) Subject must have at least one measurable lesion or evaluable disease by CT or MRI per RECIST 1.1 criteria.
•e) ECOG performance status score of 0 or 1.
•f) Tumor tissue must be provided for PD-L1 biomarker analyses prior to randomization.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 2240
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 960

•a) Known Her2 positive status
•b) Subjects with untreated CNS metastases.
•c) Subjects with ascites which cannot be controlled with appropriate interventions.
•d) Subjects with > Grade 1 peripheral neuropathy.
•e) Treatment with botanical preparations (eg herbal supplements or traditional Chinese medicines) intended to treat the disease under study within 2 weeks prior to randomization/treatment.
•f) Participants who have received a live/attenuated vaccine within 30 days of first treatment

发起方