Trial reportThe oncologist2019
A Phase I/II Open-Label Study of Nivolumab in Previously Treated Advanced or Recurrent Nasopharyngeal Carcinoma and Other Solid Tumors.
Trial report in The oncologist, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03984357 (Induction, Concurrent and Adjuvant Nivolumab Combined With Induction Chemotherapy Followed by Radiotherapy Alone in Locoregionally Advanced Nasopharyngeal Carcinoma), which is not on this map. Cited by 24 papers, 4 of them syntheses 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.
Induction, Concurrent and Adjuvant Nivolumab Combined With Induction Chemotherapy Followed by Radiotherapy Alone in Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase 2, Multi-center, Single-arm Clinical Trial
Who cites it
24 citing papers in PubMed, 4 syntheses or guidelines pooled it, 47 citations in OpenAlex.
- SEOM-TTCC clinical guideline for nasopharyngeal carcinoma (update 2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Guideline
- TMBserval: a statistical explainable learning model reveals weighted tumor mutation burden better categorizing therapeutic benefits.Frontiers in immunology · 2023Pooled it
- SEOM-TTCC clinical guideline in nasopharynx cancer (2021).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2022Guideline
- Efficacy and tolerability of immunotherapy in advanced nasopharyngeal carcinoma with or without chemotherapy: a meta-analysis.Brazilian journal of otorhinolaryngologyPooled it
- KEYNOTE-032: A Randomized Phase I Study of Pembrolizumab in Chinese Patients with Advanced Non-Small Cell Lung Cancer.The oncologist · 2020Trial
- Immunotherapy in Asia: current insights and prospects in Southeast Asia and Malaysia.Frontiers in oncology · 2026Review
- TMBclaw: tumor clone-aware graph learning improves immunotherapy response prediction across heterogeneous cohorts.Briefings in bioinformatics · 2025Article
- Toripalimab plus gemcitabine and cisplatin induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma: a retrospective study.Frontiers in oncology · 2025Article
- THOR: a TMB heterogeneity-adaptive optimization model predicts immunotherapy response using clonal genomic features in group-structured data.Briefings in bioinformatics · 2024Article
- Article
- Predictive progression outcomes and risk stratification in patients with recurrent or metastatic nasopharyngeal carcinoma who received first-line immunochemotherapy.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024Article
- Precision drugs for recurrent or metastatic nasopharyngeal carcinoma (Review).Experimental and therapeutic medicine · 2023Review
- Precision medicine in nasopharyngeal carcinoma: comprehensive review of past, present, and future prospect.Journal of translational medicine · 2023Review
- Immunotherapy for nasopharyngeal carcinoma: Current status and prospects (Review).International journal of oncology · 2023Review
- Phase Ib/II Study of a Liposomal Formulation of Eribulin (E7389-LF) plus Nivolumab in Patients with Advanced Solid Tumors: Results from Phase Ib.Cancer research communications · 2023Article
- Clinical efficacy and biomarker analysis of dual PD-1/CTLA-4 blockade in recurrent/metastatic EBV-associated nasopharyngeal carcinoma.Nature communications · 2023Article
- TMBcat: A multi-endpointFrontiers in immunology · 2022Article
- A Joint Model Considering Measurement Errors for Optimally Identifying Tumor Mutation Burden Threshold.Frontiers in genetics · 2022Article
- Copy number loss in granzyme genes confers resistance to immune checkpoint inhibitor in nasopharyngeal carcinoma.Journal for immunotherapy of cancer · 2021Article
- Effectiveness and safety of nivolumab in patients with head and neck cancer in Japanese real-world clinical practice: a multicenter retrospective clinical study.International journal of clinical oncology · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
lessons learnedNivolumab treatment at doses of 3 mg/kg once every 2 weeks (Q2W), 240 mg Q2W, and 360 mg once every 3 weeks was well tolerated in the Chinese population, with no new safety signals identified.Comparison of intensive pharmacokinetic profiles of nivolumab at 3 mg/kg Q2W in Chinese versus global populations revealed no ethnic differences of nivolumab treatment.Nivolumab shows promising preliminary antitumor activity in nasopharyngeal carcinoma.
backgroundThis phase I/II study investigated the safety and pharmacokinetics (PK) of nivolumab (anti-programmed cell death-1 monoclonal antibody) in Chinese patients with nasopharyngeal carcinoma (NPC) and other solid tumors.
methodsA dose evaluation phase (3 mg/kg once every 2 weeks [Q2W]) was followed by a cohort expansion phase (3 mg/kg Q2W or flat doses of 240 mg Q2W or 360 mg once every 3 weeks).
resultsIn the dose evaluation phase, 8/8 patients completed one cycle with no dose-limiting toxicities. At data cutoff, 46/51 patients were evaluable for safety (all cohorts). Treatment-related adverse events (TRAEs) occurred in 35 (76%) patients and were primarily grade 1-2; one patient (3 mg/kg Q2W) discontinued because of study drug toxicity. Intensive PK profiles at 3 mg/kg, 240 mg, and 360 mg were well characterized at single and multiple doses of nivolumab. An objective response was determined in six (6/46) patients, four (4/32) of whom had NPC tumors.
conclusionNivolumab monotherapy at 3 mg/kg and flat doses of 240 mg and 360 mg were well tolerated in this Chinese patient population, with PK profiles at 3 mg/kg being similar to those of global patients. Preliminary efficacy results showed promising antitumor activity of nivolumab in advanced NPC.
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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.