Trial reportJournal for immunotherapy of cancer2023
First-line nivolumab plus ipilimumab for metastatic non-small cell lung cancer, including patients with ECOG performance status 2 and other special populations: CheckMate 817.
Trial report in Journal for immunotherapy of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02869789 (A Phase 3b/4 Safety Trial of Flat Dose Nivolumab In Combination With Ipilimumab in Participants With Non-Small Cell Lung Cancer), which is not on this map. Cited by 44 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3b/4 Safety Trial of Flat Dose Nivolumab In Combination With Ipilimumab in Participants With Non-Small Cell Lung Cancer
Who cites it
44 citing papers in PubMed, 1 synthesis or guideline pooled it, 67 citations in OpenAlex.
- Impact of tumor immunotherapy on kidney injury and multi-organ outcomes: a mechanistic and clinical perspective.Frontiers in immunology · 2026Pooled it
- Multidimensional explanations and future perspectives on the limited efficacy of immunotherapy in prostate cancer.Asian journal of andrology · 2026Review
- NSCLC brain metastases exhibit reduced HLA-I antigen presentation machinery and immune evasion independent of IFNγ signaling defects.Molecular cancer · 2026Article
- International Consensus on Severe Lung Cancer-The Second Edition.Translational lung cancer research · 2026Review
- Immune Aging Within the Tumor Microenvironment Predicts Survival in Lung Adenocarcinoma.Cancers · 2026Article
- Progress in perioperative immunotherapy for lung cancer and analysis of therapy (Review).Oncology letters · 2026Review
- Clinicopathological characteristics and prognosis of brain metastasis in non-small cell lung cancer: A retrospective study.Medicine · 2026Article
- Treatment-free survival with first-line nivolumab plus ipilimumab in metastatic non-small cell lung cancer: a critical analysis beyond PD-L1 expression.Journal of thoracic disease · 2026Article
- Outcomes of Nivolumab-Plus-Ipilimumab in Metastatic Renal Cell Carcinoma: Second Interim Analysis of the J-ENCORE Study.International journal of urology : official journal of the Japanese Urological Association · 2026Observational
- Crosstalk in the brain tumor microenvironment: mechanisms, therapeutic strategies, and clinical advances.Military Medical Research · 2026Review
- Real-world outcomes of immune checkpoint inhibitors in people with HIV and skin cancer: a multicentre study.The oncologist · 2025Article
- Effective and safe use of immune checkpoint inhibitors for non-small cell lung cancer in people living with HIV.HIV medicine · 2025Review
- Advances in molecular pathology and therapy of non-small cell lung cancer.Signal transduction and targeted therapy · 2025Review
- Nephrotoxicity of Immune Checkpoint Inhibitors in Single and Combination Therapy-A Systematic and Critical Review.Biomedicines · 2025Review
- Progress in personalized immunotherapy for patients with brain metastasis.NPJ precision oncology · 2025Review
- Predictors of febrile neutropenia in small cell lung cancer patients receiving concurrent chemoradiotherapy with etoposide and cisplatin: a focus on nutritional status, inflammation, and performance status.American journal of cancer research · 2025Article
- An updated review on immune checkpoint inhibitor-induced colitis: epidemiology, pathogenesis, treatment strategies, and the role of traditional Chinese medicine.Frontiers in immunology · 2025Review
- Review
- Pathological complete response to conversion therapy for lung adenocarcinoma with brain metastasis: a case report.Frontiers in oncology · 2025Article
- Lung Cancer with Brain Metastasis-Treatment Strategies and Molecular Characteristics.Journal of clinical medicine · 2024Review
Corrections and comments
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Authors and funding
28 authors at 20 institutions in 10 countries.
Funding
Abstract
backgroundCheckMate 817, a phase 3B study, evaluated flat-dose nivolumab plus weight-based ipilimumab in patients with metastatic non-small cell lung cancer (NSCLC). Here, in this research, we report on first-line treatment in patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 (cohort A) and special populations (cohort A1: ECOG PS 2; or ECOG PS 0-1 with untreated brain metastases, renal impairment, hepatic impairment, or controlled HIV infection).
methodsCohorts A and A1 received nivolumab 240 mg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks. The primary endpoint was the incidence of grade 3-4 and grade 5 immune-mediated adverse events (IMAEs; adverse events (AEs) deemed potentially immune-related, occurring <100 days of last dose, and treated with immune-modulating medication (except endocrine events)) and treatment-related select AEs (treatment-related AEs with potential immunological etiology requiring frequent monitoring/intervention, reported between first dose and 30 days after the last dose) in cohort A; efficacy endpoints were secondary/exploratory. In cohort A1, safety/efficacy assessment was exploratory.
resultsThe most common grade 3-4 IMAEs were pneumonitis (5.1%), diarrhea/colitis (4.9%), and hepatitis (4.6%) in cohort A (N=391) and diarrhea/colitis (3.5%), hepatitis (3.5%), and rash (3.0%) in cohort A1 (N=198). The most common grade 3-4 treatment-related select AEs were hepatic (5.9%), gastrointestinal (4.9%), and pulmonary (4.6%) events in cohort A and gastrointestinal (4.0%), skin (3.5%), and endocrine (3.0%) events in cohort A1. No grade 5 IMAEs or treatment-related select AEs occurred. Treatment-related deaths occurred in 4 (1.0%) and 3 (1.5%) patients in cohorts A and A1, respectively. Three-year overall survival (OS) rates were 33.7% and 20.5%, respectively.
conclusionsFlat-dose nivolumab plus weight-based ipilimumab was associated with manageable safety and durable efficacy in cohort A, consistent with data from phase 3 metastatic NSCLC studies. Special populations of cohort A1 including patients with ECOG PS 2 or ECOG PS 0-1 with untreated brain metastases had manageable treatment-related toxicity and clinically meaningful 3-year OS rate. TRIAL REGISTRATION NUMBER: NCT02869789.
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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.