A Randomized, Active-Controlled, Blinded, Phase III Clinical Trial of BMS-986213 (Fixed Dose Combination of Relatlimab [anti-LAG-3] and Nivolumab) in Combination with Chemotherapy versus Placebo in Combination with Chemotherapy as First-Line Treatment in Participants with Unresectable, Locally Advanced or Metastatic LAG-3 Postive Gastric or Gastroesophageal Junction Adenocarcinoma - CA224-051

Bristol-Myers Squibb0 个研究点目标入组 8 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•1) Males and Females, * 18 years of age
•2) All subjects must have a confirmed diagnosis (using tumour tissue) of unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma. The documentation of GEJ involvement can include biopsy, endoscopy, or imaging.
•3) Subject must be previously untreated with systemic treatment including HER 2 inhibitors given as primary therapy for unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma
•4) 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 last 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. Chinese traditional medicines with an approved indication of cancer treatment are permitted as long as the last administration occurred at least 2 weeks prior to randomization.
•5) Subject must have at least one measurable lesion or evaluable disease by CT or MRI per RECIST 1.1 criteria; radiographic tumor assessment should be performed within 28 days prior to randomization.
•6) HER2/neu protein negative LAG3 positive
•7) Adequate organ function
•8) ECOG performance status score of 0 or 1
•9) Tumor tissue must be provided for LAG-3, PD-L1, MSI, TMB biomarker analyses prior to randomization.

•1) LAG3 negative
•2) HER2 positive
•Medical Conditions
•3) Subjects with untreated known brains metastases.
•4) Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
•5) Subjects with active, known, or suspected autoimmune disease.
•6) Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
•7) All toxicities attributed to prior anti-cancer therapy other than hearing loss, alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE version 4) or baseline before administration of study drug.
•8) Subjects with > Grade 1 peripheral neuropathy.
•9) Subjects with ascites which cannot be controlled with appropriate interventions
•10) Uncontrolled or significant cardiovascular disease

发起方

Bristol-Myers Squibb