A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)

1/2期提前终止 NCT03281369

适应症	Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma
分期	1/2期
申办方	Hoffmann-La Roche
状态	提前终止
受试者人数	219 人
干预（药物）	5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin, Atezolizumab, Cobimetinib
开始日期	2017年10月13日
完成日期	2025年10月9日
结果公布日	2026年8月3日

摘要

A Phase Ib/II, open label, multi-center, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with locally advanced unresectable or metastatic G/GEJ cancer (hereafter referred to as gastric cancer) and esophageal cancer. Two cohorts of patients with gastric cancer have been enrolled in parallel in this study: the second-line (2L) Gastric Cancer Cohort consists of patients with gastric cancer who have progressed after receiving a platinum-containing or fluoropyrimide-containing chemotherapy regimen in the first-line setting, and the first-line (1L) Gastric Cancer Cohort consists of patients with gastric cancer who have not received prior chemotherapy in this setting. In each cohort, eligible patients will be assigned to one of several treatment arms. Additionally, a cohort of patients with esophageal cancer who have not received prior systemic treatment for their disease will be enrolled in this study. Eligible patients will be randomized to chemotherapy or the combination of chemotherapy with checkpoint inhibitor immunotherapy.

Stage 1: Percentage of Participants With Objective Response (OR), as Determined by Investigator According to RECIST v1.1

From randomization up to approximately 84.2 months · percentage of participants

Stage 1 Cohort 1: mFOLFOX6 + Atezolizumab + Cobimetinib	40.0 percentage of participants
Stage 1 Cohort 2: Ramucirumab + Paclitaxel (Control)	16.7 percentage of participants
Stage 1 Cohort 2: Atezolizumab + PEGPH20	0 percentage of participants
Stage 1 Cohort 2: Atezolizumab + BL-8040	15.4 percentage of participants
Stage 1 Cohort 2: Atezolizumab + Linagliptin	21.4 percentage of participants
Stage 1: Cisplatin + 5-FU (Control)	47.8 percentage of participants

Difference in Overall Response Rates	-16.67 (95% CI -45.77–12.43)

在 BENITIONS 中查看查看 ClinicalTrials.gov 原文

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Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poo — ECOG-ACRIN Cancer Research Group

全部试验

本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。

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