ArticleCancers2021
An Investigator-Initiated Phase 2 Study of Nivolumab Plus Low-Dose Ipilimumab as First-Line Therapy for Microsatellite Instability-High Advanced Gastric or Esophagogastric Junction Cancer (NO LIMIT, WJOG13320G/CA209-7W7).
Article in Cancers, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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Who cites it
17 citing papers in PubMed, 19 citations in OpenAlex.
- Development of combinatorial immunotherapy for patients with advanced gastric cancer from the perspective of immunosuppressive mechanisms in the tumor microenvironment.Fukushima journal of medical science · 2026Review
- Immune checkpoint inhibition inFrontiers in oncology · 2026Article
- Immune checkpoint inhibitors combined with chemotherapy in conversion therapy for stage IV gastric cancer: a multicenter retrospective cohort study.Cancer immunology, immunotherapy : CII · 2025Article
- Applications and challenges of immunotherapy in the management of gastric adenocarcinoma: current status and future perspectives.World journal of surgical oncology · 2025Review
- Prevalence and clinicopathological features of microsatellite instability-high metastatic or recurrent gastric and esophagogastric junction cancer: WJOG13320GPS.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2025Observational
- Current Landscape of Molecular Biomarkers in Gastroesophageal Tumors and Potential Strategies for Co-Expression Patterns.Cancers · 2025Review
- Management of HER2-positive and microsatellite instability-high advanced gastric cancer: a case report.International cancer conference journal · 2024Article
- Review
- Comparative efficacy of PD-1 blockade in patients with dMMR/MSI-H metastatic colorectal or gastric cancer: a global retrospective study.ESMO gastrointestinal oncology · 2024Article
- Concordance between microsatellite instability testing and immunohistochemistry for mismatch repair proteins and efficient screening of mismatch repair deficient gastric cancer.Oncology letters · 2023Article
- Immunotherapeutic strategy in the management of gastric cancer: molecular profiles, current practice, and ongoing trials.Journal of the Egyptian National Cancer Institute · 2023Review
- Review
- Current Strategy to Treat Immunogenic Gastrointestinal Cancers: Perspectives for a New Era.Cells · 2023Review
- Recent advances in immunotherapy and molecular targeted therapy for gastric cancer.Future science OA · 2023Review
- Article
- Comprehensive Analyses of Immune Subtypes of Stomach Adenocarcinoma for mRNA Vaccination.Frontiers in immunology · 2022Article
- Research Progress of Immunotherapy for Gastric Cancer.Technology in cancer research & treatmentReview
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Authors and funding
15 authors at 14 institutions in 1 country.
Funding
Abstract
Nivolumab (NIVO) plus low-dose ipilimumab (IPI) has shown a promising survival benefit in first-line treatment of microsatellite instability-high (MSI-H) colorectal cancer. We hypothesized that this regimen might also be beneficial for MSI-H gastric cancer (GC), which accounts for ~5% of all GC cases. NO LIMIT (WJOG13320G/CA209-7W7) is an investigator-initiated, single-arm, open-label, 14-center phase 2 trial of NIVO plus low-dose IPI for MSI-H GC in the first-line setting. Eligibility criteria include unresectable advanced, recurrent, or metastatic gastric or esophagogastric junction cancer with a histologically confirmed diagnosis of adenocarcinoma; confirmed MSI-H status with the MSI-IVD Kit (FALCO); no prior systemic anticancer therapy; an Eastern Cooperative Oncology Group performance status of 0 or 1; and a measurable lesion per RECIST 1.1. The primary objective of the study is to determine the overall response rate (ORR) for the NIVO+IPI regimen as assessed by blinded independent central review. Secondary end points include progression-free survival, overall survival, duration of response, safety, tolerability, and biomarkers. The number of patients was set at 28 on the basis of the threshold and expected ORR values of 35 and 65%, respectively, with a one-sided alpha error of 0.025 and power of 0.80. Subjects will receive treatment with nivolumab (240 mg) biweekly in combination with ipilimumab (1 mg/kg) every 6 weeks. The results of this study should clarify the therapeutic potential of NIVO+IPI for MSI-H GC in the first-line setting. Trial registration: JapicCTI-205400.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.