ArticleClinical cancer research : an official journal of the American Association for Cancer Research2023
A Phase II Clinical Trial of Nivolumab and Temozolomide for Neuroendocrine Neoplasms.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03728361 (A Phase II, Multi-Cohort Trial of Combination Nivolumab and Temozolomide in Recurrent/Refractory Small-Cell Lung Cancer and Advanced Neuroendocrine Tumors), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.
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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 II, Multi-Cohort Trial of Combination Nivolumab and Temozolomide in Recurrent/Refractory Small-Cell Lung Cancer and Advanced Neuroendocrine Tumors
Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.
- Global research trends in gastroenteropancreatic neuroendocrine tumors: a bibliometric analysis from 2000 to 2023.Frontiers in oncology · 2025Pooled it
- Phase II study of everolimus and temozolomide as first-line treatment in metastatic high-grade gastroenteropancreatic neuroendocrine neoplasms.British journal of cancer · 2023Trial
- Advanced pulmonary carcinoid managed with chemoimmunotherapy and antiangiogenic agent: A case report and literature review.Molecular and clinical oncology · 2026Article
- European Society of Neuroendocrine Tumors (ENETS) 2025 guidance paper for lung and thymic carcinoids.Journal of neuroendocrinology · 2026Article
- Immunosuppressive Environment of Pancreatic NENs-A Review.Biomedicines · 2026Review
- Review
- Integrated molecular and clinical characterization of pulmonary large cell neuroendocrine carcinoma.Nature communications · 2025Article
- Updates on Pulmonary Neuroendocrine Carcinoids: Progress and Perspectives.Journal of clinical medicine · 2025Review
- Basic science and translational implications of current knowledge on neuroendocrine tumors.The Journal of clinical investigation · 2025Review
- Management of typical and atypical metastatic lung carcinoids: present and future perspectives.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025Review
- Immune-Checkpoint Inhibitors in Lung Neuroendocrine Tumors - A Systematic Review and Meta-Analysis.OncoTargets and therapy · 2025Review
- Review
- The Effectiveness of Atezolizumab in Metastatic Large Cell Neuroendocrine Carcinoma of the Lungs: Insights from the LANCE Pilot Study.Biomedicines · 2024Article
- Review
- Multiregion WES of metastatic pancreatic neuroendocrine tumors revealed heterogeneity in genomic alterations, immune microenvironment and evolutionary patterns.Cell communication and signaling : CCS · 2024Article
- Narrative Review of Immunotherapy in Gastroentero-Pancreatic Neuroendocrine Neoplasms.Current oncology (Toronto, Ont.) · 2023Review
- Potent molecular-targeted therapies for gastro-entero-pancreatic neuroendocrine carcinoma.Cancer metastasis reviews · 2023Review
- Review
- Liver Transplantation for Non-hepatocellular Carcinoma: The Role of Immune Checkpoint Inhibitors.Journal of clinical and experimental hepatologyReview
Corrections and comments
- Comment on
Authors and funding
22 authors at 1 institution in 1 country.
Funding
Abstract
purposeTreatment options are limited in patients with metastatic neuroendocrine neoplasms (NEN). We present the results for a phase II trial of combination nivolumab and temozolomide in patients with advanced NEN along with results of immune changes in peripheral blood. PATIENTS AND
methodsNCT03728361 is a nonrandomized, phase II study of nivolumab and temozolomide in patients with NEN. The primary endpoint was response rate using RECIST 1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. Immune profiling was performed by mass cytometry to evaluate the effect on peripheral blood immune cell subsets.
resultsAmong all 28 patients with NEN, the confirmed response rate was 9/28 [32.1%, 95% confidence interval (CI): 15.9-52.4]. Of 11 patients with lung NEN, the response rate was 64% (n = 7); there was a significant difference in responses by primary tumor location (lung vs. others, P = 0.020). The median PFS was 8.8 months (95% CI: 3.9-11.1 months), and median OS was 32.3 months (95% CI: 20.7-not reached months). Exploratory blood immune cell profiling revealed an increase in circulating CD8+ T cells (27.9% ± 13.4% vs. 31.7% ± 14.6%, P = 0.03) and a decrease in CD4+ T cells (59.6% ± 13.1% vs. 56.5% ± 13.0%, P = 0.001) after 2 weeks of treatment. LAG-3-expressing total T cells were lower in patients experiencing a partial response (0.18% ± 0.24% vs. 0.83% ± 0.55%, P = 0.028). Myeloid-derived suppressor cell levels increased during the study and did not correlate with response.
conclusionsCombination nivolumab and temozolomide demonstrated promising activity in NEN. See related commentary by Velez and Garon, p. 691.
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Registered trials
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.