Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2024
A Phase II Trial of the CD40 Agonistic Antibody Sotigalimab (APX005M) in Combination with Nivolumab in Subjects with Metastatic Melanoma with Confirmed Disease Progression on Anti-PD-1 Therapy.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 63 papers, 2 of them syntheses 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
63 citing papers in PubMed, 2 syntheses or guidelines pooled it, 54 citations in OpenAlex.
- Safety of immune checkpoint modulators beyond PD-1/PD-L1 and CTLA-4 in solid tumors: a meta-analysis.JNCI cancer spectrum · 2026Pooled it
- Agonistic anti-CD40 antibodies in patients with solid tumors: a systematic review and evidence map of clinical safety, with exploratory proportional synthesis.Frontiers in immunology · 2026Pooled it
- Intratumoral Sotigalimab with Pembrolizumab Induces Rapid Activation of Antigen-Presenting Cells and Drives Antitumor Responses in Non-injected Tumors in Metastatic Melanoma: A Phase I/II Study.Cancer discovery · 2026Trial
- Phase I/II clinical trial of a melanoma vaccine targeting shared non-mutated antigens and a shared mutated BRAF neoantigen with an agonistic CD40 antibody (CDX-1140) plus TLR3 agonist (poly-ICLC).Journal for immunotherapy of cancer · 2026Trial
- CD40 agonist mitazalimab with mFOLFIRINOX in untreated metastatic pancreatic cancer: Biomarkers associated with outcomes from OPTIMIZE-1.Cell reports. Medicine · 2025Trial
- A Phase 2 Study of Sotigalimab, a CD40 Agonist Antibody, plus Concurrent Chemoradiation as Neoadjuvant Therapy for Esophageal and Gastroesophageal Junction Cancers.Cancer research communications · 2025Trial
- [Novel therapeutic strategies for liver metastases driven by the common microenvironment].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2026Review
- Neutrophils in cancer.Nature reviews. Cancer · 2026Review
- Realizing the potential of agonistic antibody immunotherapy.Nature reviews. Drug discovery · 2026Review
- Review
- Innate Immune Cells in Non-Small Cell Lung Cancer: Roles in Tumor Progression and Therapeutic Responses.Cancer innovation · 2026Review
- Unraveling the molecular evolution and immune functions of Lr-CD40 in Lethenteron reissneri.Fish physiology and biochemistry · 2026Article
- Chlorotoxin suppresses melanoma vasculogenic mimicry via LINC01235/miR-128-3p/YY1/ VEGFR2/NRP1 axis.iScience · 2026Article
- CD40 agonism in renal cell carcinoma enhances immune checkpoint activity through myeloid cells.iScience · 2026Article
- Dendritic cell diversity and dysfunction in cancer: implications for immunotherapy and therapeutic targeting.Acta pharmacologica Sinica · 2026Review
- Reduced Tumor Control in Males Can Result from Impaired CD4+ T-cell Help through the CD40L-CD40 Pathway.Cancer immunology research · 2026Article
- CD40 Agonist Therapy in Melanoma: Translating Preclinical Promise Into Clinical Practice.Pigment cell & melanoma research · 2026Review
- Overview of glutamine metabolism in stromal components of the tumor microenvironment and potential anti-tumor therapies.Genes & diseases · 2026Review
- Harnessing myeloid cell plasticity for cancer therapy.Nature cancer · 2026Review
- IL1R1 blockade augments CD40 agonist mediated immunity in pancreatic cancer.Scientific reports · 2026Article
3 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
17 authors at 16 institutions in 2 countries.
Funding
Abstract
purposeDisease progression during or after anti-PD-1-based treatment is common in advanced melanoma. Sotigalimab is a CD40 agonist antibody with a unique epitope specificity and Fc receptor binding profile optimized for activation of CD40-expressing antigen-presenting cells. Preclinical data indicated that CD40 agonists combined with anti-PD1 could overcome resistance to anti-PD-1. PATIENTS AND
methodsWe conducted a multicenter, open-label, phase II trial to evaluate the combination of sotigalimab 0.3 mg/kg and nivolumab 360 mg every 3 weeks in patients with advanced melanoma following confirmed disease progression on a PD-1 inhibitor. The primary objective was to determine the objective response rate (ORR).
resultsThirty-eight subjects were enrolled and evaluable for safety. Thirty-three were evaluable for activity. Five confirmed partial responses (PR) were observed for an ORR of 15%. Two PRs are ongoing at 45.9+ and 26+ months, whereas the other three responders relapsed at 41.1, 18.7, and 18.4 months. The median duration of response was at least 26 months. Two additional patients had stable disease for >6 months. Thirty-four patients (89%) experienced at least one adverse event (AE), and 13% experienced a grade 3 AE related to sotigalimab. The most common AEs were pyrexia, chills, nausea, fatigue, pruritus, elevated liver function, rash, vomiting, headache, arthralgia, asthenia, myalgia, and diarrhea. There were no treatment-related SAEs, deaths, or discontinuation of sotigalimab due to AEs.
conclusionsSotigalimab plus nivolumab had a favorable safety profile consistent with the toxicity profiles of each agent. The combination resulted in durable and prolonged responses in a subset of patients with anti-PD-1-resistant melanoma, warranting further evaluation in this setting. See related commentary by Wu and Luke, p. 9.
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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.