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Phase 1b2 study evaluating safety efficacy and immune effects of TLR9 agonist cavrotolimod with antiPD1 antibodies among patients with advanced solid tumors summary
{
"episode_description": "PACULit Daily Literature Update: Today we review a Phase 1b2 open-label multicenter trial evaluating cavrotolimod, a TLR9 agonist, in combination with anti-PD-1 antibodies (pembrolizumab or cemiplimab) for advanced cutaneous malignancies, including melanoma, Merkel cell carcinoma, and cutaneous squamous cell carcinoma. The study (NCT03684785) enrolled 58 adults with heavily pre-treated disease, beginning with cavrotolimod monotherapy dose escalation followed by combination therapy. Primary endpoints focused on safety and tolerability; secondary endpoints assessed objective response rate (ORR), disease control rate (DCR), and duration of response, along with pharmacokinetics, pharmacodynamics, and immune biomarkers. Among 51 evaluable patients, ORR was 12% (6/51) and DCR was 27% (14/51) with median duration of response of 54 weeks; regression occurred in both injected and distant lesions, indicating an abscopal effect. Safety was manageable, with fatigue and injection-site reactions being the most common grade 3/4 events. Immune profiling showed robust peripheral cytokine/chemokine induction and increased tumor immune cell infiltration, suggesting synergy between cavrotolimod and anti-PD-1 therapy. While promising in a refractory population, limitations include the single-arm design and small, heterogeneous cohort. Full study details are reported by Milhem et al., 2025 in the Journal for Immunotherapy of Cancer, and ongoing trials will clarify potential clinical benefit of this approach for resistant skin cancers.",
"keywords": [
"TLR9 agonist",
"cavrotolimod",
"intratumoral administration",
"anti-PD-1 therapy",
"pembrolizumab",
"cemiplimab",
"Phase 1b2",
"open-label",
"multicenter",
"cutaneous malignancies",
"melanoma",
"Merkel cell carcinoma",
"cutaneous squamous cell carcinoma",
"refractory to anti-PD-(L)1",
"safety and tolerability",
"
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By Pharmacy & Acute Care University{
"episode_description": "PACULit Daily Literature Update: Today we review a Phase 1b2 open-label multicenter trial evaluating cavrotolimod, a TLR9 agonist, in combination with anti-PD-1 antibodies (pembrolizumab or cemiplimab) for advanced cutaneous malignancies, including melanoma, Merkel cell carcinoma, and cutaneous squamous cell carcinoma. The study (NCT03684785) enrolled 58 adults with heavily pre-treated disease, beginning with cavrotolimod monotherapy dose escalation followed by combination therapy. Primary endpoints focused on safety and tolerability; secondary endpoints assessed objective response rate (ORR), disease control rate (DCR), and duration of response, along with pharmacokinetics, pharmacodynamics, and immune biomarkers. Among 51 evaluable patients, ORR was 12% (6/51) and DCR was 27% (14/51) with median duration of response of 54 weeks; regression occurred in both injected and distant lesions, indicating an abscopal effect. Safety was manageable, with fatigue and injection-site reactions being the most common grade 3/4 events. Immune profiling showed robust peripheral cytokine/chemokine induction and increased tumor immune cell infiltration, suggesting synergy between cavrotolimod and anti-PD-1 therapy. While promising in a refractory population, limitations include the single-arm design and small, heterogeneous cohort. Full study details are reported by Milhem et al., 2025 in the Journal for Immunotherapy of Cancer, and ongoing trials will clarify potential clinical benefit of this approach for resistant skin cancers.",
"keywords": [
"TLR9 agonist",
"cavrotolimod",
"intratumoral administration",
"anti-PD-1 therapy",
"pembrolizumab",
"cemiplimab",
"Phase 1b2",
"open-label",
"multicenter",
"cutaneous malignancies",
"melanoma",
"Merkel cell carcinoma",
"cutaneous squamous cell carcinoma",
"refractory to anti-PD-(L)1",
"safety and tolerability",
"