Trial reportJournal for immunotherapy of cancer2025
Phase 1b/2 study evaluating safety, efficacy and immune effects of TLR9 agonist cavrotolimod with anti-PD-1 antibodies among patients with advanced solid tumors.
Trial report in Journal for immunotherapy of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03684785 (Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors), which is not on this map. Cited by 8 papers.
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.
Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors: A Phase 1b/2 Study of Cavrotolimod Combined With Pembrolizumab or Cemiplimab
Who cites it
8 citing papers in PubMed.
- Review
- Design Considerations for Potent DNA-Platform-Based Cancer Vaccines.Current opinion in biomedical engineering · 2026Article
- NNMT-associated metabolic-thromboinflammatory-immune co-activation in heterogeneous CTC clusters: a hypothesis-generating computational framework".BMC cancer · 2026Article
- Long-term survival benefit of neoadjuvant oncolytic virus plus PD-1 blockade in acral melanoma: implications of STING in resistance and potential therapy.Experimental hematology & oncology · 2026Article
- Spherical Nucleic Acids: Turning Synthetic Advances and Fundamental Discovery into Translational Breakthroughs in Chemistry, Materials Development, Biology, and Medicine.Accounts of chemical research · 2026Article
- Amphiphilic Polymeric Micelle Spherical Nucleic Acids (SNAs) as Drug Delivery Vehicles.Bioconjugate chemistry · 2026Article
- Engineering spherical nucleic acids for precision cancer therapy: design strategies and medical applications.Theranostics · 2026Review
- TLR9: A Double-Dealing Toll-Like Receptor.ImmunoTargets and therapy · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
26 authors.
Funding
Abstract
backgroundThere is an unmet need for novel immunotherapies to overcome immune evasion in patients with advanced skin cancers resistant to programmed death (PD)-1 / PD-ligand 1 (PD-L1) blockade. Cavrotolimod is a novel spherical nucleic acid configuration of a toll-like receptor 9 agonist oligonucleotide, designed to trigger innate and adaptive immune responses to tumors. PATIENTS AND
methodsThe safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of intratumoral cavrotolimod, first dosed alone and then in combination with anti-PD-1 antibodies (pembrolizumab or cemiplimab), were assessed in a combined Phase 1b/2 dose escalation/dose expansion study in patients with advanced skin cancers, including melanoma, Merkel cell carcinoma and cutaneous squamous cell carcinoma (www. CLINICALTRIALS: gov; NCT03684785).
resultsA total of 58 patients (20 in dose-escalation and 38 in expansion cohorts) were enrolled. 55 (95%) of the 58 patients experienced progressive disease on prior anti-PD-(L)1 therapy. Cavrotolimod, in combination with anti-PD-1 therapy, produced objective responses in 6 (12%) and stable disease (SD) in 8 (16%) of 51 evaluable patients on this study, leading to a disease control rate of 27% (14/51). 5 of 6 (83%) patients with an objective response and 13 of 14 (93%) patients with disease control had progressed on prior anti-PD-(L)1 therapy. Disease control was durable, with median duration of 54 (range 24-88+) weeks for responses and 24 (range 11-35+) weeks for SD. Regression of both injected and non-injected tumors was observed. Cavrotolimod, alone and in combination with anti-PD-1 therapy, had a manageable safety profile with mostly transient adverse events (AEs). The most frequent Grade 3/4 cavrotolimod-related AEs were fatigue and injection site reactions. Cavrotolimod dosing was associated with robust chemokine/cytokine induction and lymphocyte activation in peripheral blood. Serial tumor biopsies of injected tumors suggested upregulation of genes associated with the interferon pathway, antiviral proteins, immune checkpoints, chemokines, granzymes and costimulatory proteins, along with increases in certain immune cell populations.
conclusionsCavrotolimod had a manageable safety profile and showed clinical activity in anti-PD-(L)1 refractory cutaneous malignancies, suggesting potential for further development as an antitumor immunotherapy in combination with other agents. TRIAL REGISTRATION NUMBER: NCT03684785.
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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.