GEO series
Intratumoral CD40 agonist sotigalimab in combination with pembrolizumab induces rapid activation of antigen presenting cells and drives anti-tumor responses in non-injected tumors in metastatic melanoma: Results of a phase 1/2 study
GSE324815
Homo sapiens
Genome binding/occupancy profiling by high throughput sequencing; Expression profiling by high throughput sequencing
24 samples
Submitted 2026/04/10
Platform GPL24676
Summary
Checkpoint inhibitors (CPIs) benefit metastatic melanoma (MM) patients, but resistance remains a challenge. This phase 1/2 (NCT02706353) study evaluated intratumoral sotigalimab (an anti-CD40 agonistic antibody) with pembrolizumab in 32 CPI-naïve MM patients. Primary endpoints included determining safety and tolerability, the recommended phase 2 dose (RP2D) of sotigalimab, and the objective response rate (ORR). The most common adverse events (AEs) related to sotigalimab were injection-site reactions, pruritus, and fatigue. The ORR was 47% and the disease control rate (DCR) was 91% for all patients, and 50% and 92% at the RP2D, respectively. Multiomic biomarker analyses of tumor and blood samples collected before and during treatment demonstrated that sotigalimab effectively engaged the CD40 pathway, boosting the infiltration and activation of myeloid cells, including CD11c+DC-LAMP+ dendritic cells (DCs) and macrophages. The combination therapy activated both innate and adaptive immunity, in both injected and non-injected tumors. TCR sequencing analysis showed increased T-cell clonality with expanded new clones shared between injected and non-injected tumors. Clinical responses correlated with these immunologic changes, but not with baseline immunological features associated with response to anti-PD1 monotherapy. In the B16 melanoma mouse model, single- cell RNA sequencing analysis showed that the combination therapy enhanced antitumor immunity and reduced the immunosuppressive tumor environment. These findings suggest that intratumoral sotigalimab may enhance anti-PD1 therapy, supporting the need for further randomized phase 2 trials to better evaluate its therapeutic potential in the 'in situ' immunization approach.
This dataset
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Direct links to NCBI, no account and no request form: the whole study as GSE324815_RAW.tar, processed values as the series matrix, the supplementary file directory, and per-sample supplementary files for any of the 24 samples. Raw sequencing reads are also available from ENA.
Also filed as BioProject PRJNA1437101 and SRA study SRP683479. Searching any of these in the dataset finder brings you back here.
Study design
24 conditions, each sampled once — no replicated groups
Read from 24 sample titles: 24 distinct titles with little repetition. Check it against the sample list below before relying on it.
Samples in this study
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- GSM9586646 Pt28_BL scmultiome- scRNA
- GSM9586647 Pt28_C1D3 scmultiome- scRNA
- GSM9586648 Pt28_C1D8 scmultiome- scRNA
- GSM9586649 Pt28_C2D1 scmultiome- scRNA
- GSM9586650 Pt32_BL scmultiome- scRNA
- GSM9586651 Pt32_C1D3 scmultiome- scRNA
- GSM9586652 Pt32_C1D8 scmultiome- scRNA
- GSM9586653 Pt32_C2D1 scmultiome- scRNA
- GSM9586654 Pt37_BL scmultiome- scRNA
- GSM9586655 Pt37_C1D3 scmultiome- scRNA
- GSM9586656 Pt37_C1D8 scmultiome- scRNA
- GSM9586657 Pt37_C2D1 scmultiome- scRNA
- GSM9586658 Pt28_BL scmultiome- scATAC
- GSM9586659 Pt28_C1D3 scmultiome- scATAC
- GSM9586660 Pt28_C1D8 scmultiome- scATAC
- GSM9586661 Pt28_C2D1 scmultiome- scATAC
- GSM9586662 Pt32_BL scmultiome- scATAC
- GSM9586663 Pt32_C1D3 scmultiome- scATAC
- GSM9586664 Pt32_C1D8 scmultiome- scATAC
- GSM9586665 Pt32_C2D1 scmultiome- scATAC
- GSM9586666 Pt37_BL scmultiome- scATAC
- GSM9586667 Pt37_C1D3 scmultiome- scATAC
- GSM9586668 Pt37_C1D8 scmultiome- scATAC
- GSM9586669 Pt37_C2D1 scmultiome- scATAC
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