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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_title": "PACULit Daily Literature Update: Cavrotolimod + Anti-PD-1 in Advanced Skin Cancers (Phase 1b2)",
"episode_description": "Britany and Seth review a Phase 1b2 open-label trial evaluating intratumoral cavrotolimod, a TLR9 agonist, in combination with systemic anti-PD-1 antibodies (pembrolizumab or cemiplimab) in 58 patients with advanced or metastatic melanoma, Merkel cell carcinoma, or cutaneous squamous cell carcinoma who largely progressed on prior anti-PD-(L)1 therapy. The discussion covers trial design, safety and early efficacy signals (ORR 12%, DCR 27%), durable responses, and evidence of an abscopal effect. Immune profiling showed robust innate/adaptive activation, including interferon signaling and increased tumor-infiltrating cytotoxic T cells and dendritic cells. The episode also highlights safety, pharmacodynamics, and the need for larger trials to confirm efficacy and guide patient selection.",
"study_details": {
"trial_phase": "Phase 1b2",
"trial_nct": "NCT03684785",
"design": "open-label, multicenter, dose-escalation and expansion, single-arm",
"population": [
"advanced/metastatic melanoma",
"Merkel cell carcinoma",
"cutaneous squamous cell carcinoma"
],
"number_enrolled": 58,
"evaluable_for_response": 51
},
"outcomes": {
"objective_response_rate": "12%",
"disease_control_rate": "27%",
"median_duration_of_response_weeks": 54,
"median_duration_of_stable_disease_weeks": 24,
"abscopal_effect": true
},
"safety_and_tolerability": {
"common_grade_3_4_AEs": [
"fatigue",
"injection_site_reactions"
],
"overall_tolerability": "manageable"
},
"immune_correlates": [
"increased circulating chemokines/cytokines",
"lymphocyte activation in blood",
"upregulation of interferon pathway genes in tumor",
"enhanced tumor infiltration by cytotoxic T cells and dendritic cells"
],
"mechanism_and_rationale": "TLR9 activation by cavrotolimod primes innate and adaptive immunity to overcome PD-1 blockade resistance; after
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By Pharmacy & Acute Care University{
"episode_title": "PACULit Daily Literature Update: Cavrotolimod + Anti-PD-1 in Advanced Skin Cancers (Phase 1b2)",
"episode_description": "Britany and Seth review a Phase 1b2 open-label trial evaluating intratumoral cavrotolimod, a TLR9 agonist, in combination with systemic anti-PD-1 antibodies (pembrolizumab or cemiplimab) in 58 patients with advanced or metastatic melanoma, Merkel cell carcinoma, or cutaneous squamous cell carcinoma who largely progressed on prior anti-PD-(L)1 therapy. The discussion covers trial design, safety and early efficacy signals (ORR 12%, DCR 27%), durable responses, and evidence of an abscopal effect. Immune profiling showed robust innate/adaptive activation, including interferon signaling and increased tumor-infiltrating cytotoxic T cells and dendritic cells. The episode also highlights safety, pharmacodynamics, and the need for larger trials to confirm efficacy and guide patient selection.",
"study_details": {
"trial_phase": "Phase 1b2",
"trial_nct": "NCT03684785",
"design": "open-label, multicenter, dose-escalation and expansion, single-arm",
"population": [
"advanced/metastatic melanoma",
"Merkel cell carcinoma",
"cutaneous squamous cell carcinoma"
],
"number_enrolled": 58,
"evaluable_for_response": 51
},
"outcomes": {
"objective_response_rate": "12%",
"disease_control_rate": "27%",
"median_duration_of_response_weeks": 54,
"median_duration_of_stable_disease_weeks": 24,
"abscopal_effect": true
},
"safety_and_tolerability": {
"common_grade_3_4_AEs": [
"fatigue",
"injection_site_reactions"
],
"overall_tolerability": "manageable"
},
"immune_correlates": [
"increased circulating chemokines/cytokines",
"lymphocyte activation in blood",
"upregulation of interferon pathway genes in tumor",
"enhanced tumor infiltration by cytotoxic T cells and dendritic cells"
],
"mechanism_and_rationale": "TLR9 activation by cavrotolimod primes innate and adaptive immunity to overcome PD-1 blockade resistance; after