ArticleClinical cancer research : an official journal of the American Association for Cancer Research2021
A Phase I Study of APX005M and Cabiralizumab with or without Nivolumab in Patients with Melanoma, Kidney Cancer, or Non-Small Cell Lung Cancer Resistant to Anti-PD-1/PD-L1.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03502330 (A Phase I/Ib Study of APX005M in Combination With Nivolumab and Cabiralizumab in Patients With Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell Carcinoma Whose Disease Has Progressed on Anti-PD- 1/PD-L1 Therapy), which is not on this map. Cited by 82 papers, 2 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.
A Phase I/Ib Study of APX005M in Combination With Nivolumab and Cabiralizumab in Patients With Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell Carcinoma Whose Disease Has Progressed on Anti-PD- 1/PD-L1 Therapy
Who cites it
82 citing papers in PubMed, 2 syntheses or guidelines pooled it, 92 citations in OpenAlex.
- 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
- Efficacy and safety of anti-PD-1/PD-L1-based dual immunotherapies versus PD-1/PD-L1 inhibitor alone in patients with advanced solid tumor: a systematic review and meta-analysis.Cancer immunology, immunotherapy : CII · 2024Pooled it
- 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
- Reduced colony-stimulating factor 1 receptor expression in myeloid cells has limited impact on chronic lymphocytic leukaemia progression.British journal of haematology · 2026Article
- Development of [111In]In-CHX-A″-DTPA-αCD68 for ImmunoSPECT to Image Murine Macrophages.Molecular pharmaceutics · 2026Article
- CD40 agonism in renal cell carcinoma enhances immune checkpoint activity through myeloid cells.iScience · 2026Article
- CD40 Agonist Therapy in Melanoma: Translating Preclinical Promise Into Clinical Practice.Pigment cell & melanoma research · 2026Review
- Explainable machine learning identifies features and thresholds predictive of immunotherapy response.Scientific reports · 2026Article
- Combining PD-L1 blockade with a second-generation HSP110 inhibitor enhances antitumor immunity in colorectal cancer.Cell death & disease · 2026Article
- Harnessing myeloid cell plasticity for cancer therapy.Nature cancer · 2026Review
- Article
- Tumor-Associated Macrophages (TAMs) in Cancer: Functional Programs, Metastatic Mechanisms, and Therapeutic Targeting.Cancers · 2026Review
- Targeting inflammatory microenvironments: overcoming therapy resistance and immunosuppression.Molecular cancer · 2026Review
- Tumor-associated macrophages in the tumor immune microenvironment of non-small cell lung cancer.Frontiers in immunology · 2026Review
- Metabolic-immune crosstalk in osteosarcoma: mechanisms and therapeutic opportunities.Frontiers in immunology · 2026Review
- Unraveling the Role of Tumor-infiltrating Immune Cells in Modulating Cancer Drug Resistance.Anti-cancer agents in medicinal chemistry · 2026Review
- Integrated plasma proteomics identifies HLA-G and osteopontin as circulating biomarkers of resistance to PD-1 inhibitor plus chemotherapy in choriocarcinoma.Frontiers in immunology · 2026Article
- Targeting Myeloid Cells for Cancer Immunotherapy.Cancer immunology research · 2025Review
- IL-17A-secreting γδ T cells promote resistance to CDK4/CDK6 inhibitors in HRNature cancer · 2025Article
- Targeting tumor-associated macrophages to overcome immune checkpoint inhibitor resistance in hepatocellular carcinoma.Journal of experimental & clinical cancer research : CR · 2025Review
22 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 3 institutions in 1 country.
Funding
Abstract
purposePD-1/PD-L1 inhibitors are approved for multiple tumor types. However, resistance poses substantial clinical challenges. PATIENTS AND
methodsWe conducted a phase I trial of CD40 agonist APX005M (sotigalimab) and CSF1R inhibitor cabiralizumab with or without nivolumab using a 3+3 dose-escalation design (NCT03502330). Patients were enrolled from June 2018 to April 2019. Eligibility included patients with biopsy-proven advanced melanoma, non-small cell lung cancer (NSCLC), or renal cell carcinoma (RCC) who progressed on anti-PD-1/PD-L1. APX005M was dose escalated (0.03, 0.1, or 0.3 mg/kg i.v.) with a fixed dose of cabiralizumab with or without nivolumab every 2 weeks until disease progression or intolerable toxicity.
resultsTwenty-six patients (12 melanoma, 1 NSCLC, and 13 RCC) were enrolled in six cohorts, 17 on nivolumab-containing regimens. Median duration of follow-up was 21.3 months. The most common treatment-related adverse events were asymptomatic elevations of lactate dehydrogenase (
conclusionsThis first in-human study of patients with anti-PD-1/PD-L1-resistant tumors treated with dual macrophage-polarizing therapy, with or without nivolumab demonstrated safety and pharmacodynamic activity. Optimization of the dosing frequency and sequence of this combination is warranted.
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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.