An open label, single arm trial evaluating the efficacy and safety of EVX-01 in combination with pembrolizumab in checkpoint inhibitor treatment naïve adults with unresectable or metastatic melanoma

Conditions

unresectable or metastatic melanoma

Brief summary

Composite of a BOR of CR or PR for patients with SD at the time of EVX-01 administration and a BOR of CR for patients with PR at the time of EVX-01 administration, during 24 months of treatment with pembrolizumab, as per RECIST 1.1 criteria.

Detailed description

Overall response rate, defined as the proportion of the patients in the analysis population who have best response as CR or PR assessed 24 months after initiation of treatment with pembrolizumab as per RECIST 1.1 criteria, PFS assessed 24 months after initiation of treatment with pembrolizumab and defined as the time from initiation of pembrolizumab treatment to the first documented disease progression per RECIST 1.1. criteria or death due to any causes, whichever occurs first, OS, assessed 24 months after initiation of treatment with pembrolizumab and defined as the time from initiation of treatment of pembrolizumab to death due to any cause, Number, type and severity of AEs and SAEs, Level of immunologic response toward EVX-01 measured by CD4+ and CD8+ neoepitope specific lymphocytes, assessed throughout dosing with EVX-01

Related papers

No related papers found yet.

Interventions

DRUGEVX-01

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Composite of a BOR of CR or PR for patients with SD at the time of EVX-01 administration and a BOR of CR for patients with PR at the time of EVX-01 administration, during 24 months of treatment with pembrolizumab, as per RECIST 1.1 criteria.	—

Secondary

Measure	Time frame
Overall response rate, defined as the proportion of the patients in the analysis population who have best response as CR or PR assessed 24 months after initiation of treatment with pembrolizumab as per RECIST 1.1 criteria, PFS assessed 24 months after initiation of treatment with pembrolizumab and defined as the time from initiation of pembrolizumab treatment to the first documented disease progression per RECIST 1.1. criteria or death due to any causes, whichever occurs first, OS, assessed 24 months after initiation of treatment with pembrolizumab and defined as the time from initiation of treatment of pembrolizumab to death due to any cause, Number, type and severity of AEs and SAEs, Level of immunologic response toward EVX-01 measured by CD4+ and CD8+ neoepitope specific lymphocytes, assessed throughout dosing with EVX-01	—

Measure

Time frame

Overall response rate, defined as the proportion of the patients in the analysis population who have best response as CR or PR assessed 24 months after initiation of treatment with pembrolizumab as per RECIST 1.1 criteria, PFS assessed 24 months after initiation of treatment with pembrolizumab and defined as the time from initiation of pembrolizumab treatment to the first documented disease progression per RECIST 1.1. criteria or death due to any causes, whichever occurs first, OS, assessed 24 months after initiation of treatment with pembrolizumab and defined as the time from initiation of treatment of pembrolizumab to death due to any cause, Number, type and severity of AEs and SAEs, Level of immunologic response toward EVX-01 measured by CD4+ and CD8+ neoepitope specific lymphocytes, assessed throughout dosing with EVX-01

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Countries

Italy

Outcome results

None listed