A Phase 1/2, Randomized Study Evaluating Multiple Nivolumab Combination Therapies in Patients with Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) after Failure of Platinum-Based Chemotherapy and Anti-PD-[L]1 Immunotherapy - CheckMate 79X: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 79X

Bristol-Myers Squibb International Corporation0 个研究点目标入组 550 人开始时间: 2020年5月8日最近更新: 2020年11月16日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Bristol-Myers Squibb International Corporation
入组人数: 550

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•- histologically or cytologically-documented Stage IV A/B non-small cell lung cancer, stage IIIB/C disease failed concurrent chemoRT
•- ECOG Performance Status of = 1
•- Radiographically documented disease progression on one anti-PD-1/anti-PD-L1 therapy and one platinum-based doublet regimen given either concurrently or sequentially within 90 days after the last dose of anti-LD-(L)1
•- All participants must have tumor tissue submitted prior to randomization, either a recent archival sample obtained on/after
•the date of disease progression of the last prior anticancer therapy and within 3 months prior to enrollment, or a fresh biopsy obtained
•during the screening period.
•- Prior toxicities must have resolved to grade =1
•- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test and must not be breastfeeding
•- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception. In addition, male participants must be willing to refrain from sperm donation during this time and must agree to follow instructions for method(s) of contraception. Azoospermic males are exempt from contraceptive requirements as well as WOCBP who are continuously not heterosexually active, however, a pregnancy test will still be required.
•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 275
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 275

排除标准

•- Prior treatment with Docetaxel
•- Untreated CNS metastases, carcinomatous meningitis or leptomeningeal metastases
•- Any tumor invading the Superior Vena Cava other blood vessel, GI Tract or Trachea
•- EGFR mutations, ALK translocations, ROS1 translocations which are sensitive to inhibitor therapy
•- History of cerebrovascular accident and coagulation disorders
•- Participants with interstital lung disease, history of cerebrovascular accident or history of abdominal fistula, gastrointestinal perforation, bowel obstruction, intra-abdominal abscess or grade 3-4 bleeding event within 6 months prior to randomization
•- Known toxicity on prior checkpoint inhibitor treatment
•- Participants who received more than one line of anti- PD-1/PD-L1 treatment
•- Participants who received previous CTLA-4 inhibitor treatment
•- Participants with known BRAF V600E mutation which are sensitive to available targeted inhibitor therapy are excluded

研究者

发起方

Bristol-Myers Squibb International Corporation

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