Neoadjuvant pembrolizumab in patients with stage IIb/c melanoma, a phase II double-blind placebo-controlled randomized trial NEOPRIME

Conditions

Stage IIb/c melanoma

Brief summary

Pathological response rate

Detailed description

Frequency and severity of adverse events (AEs) and serious adverse events (SAEs), Feasibility of neoadjuvant therapy in stage II melanoma, Sentinel lymph node positivity rate, Local recurrence rate, Regional recurrence rate, Recurrence-free survival (RFS), Distant-metastasis free survival, Melanoma-specific survival (MSS), Overall survival (OS), Change in dermoscopic features and correlation to histopathology, Change in tumor thickness as assessed with ultrasound and correlation to histopathology, Change in ctDNA levels during and after neoadjuvant treatment and surgery, Change in T-cell receptor repertoire before and after neoadjuvant treatment, Predictive and prognostic biomarker discovery

Related papers

No related papers found yet.

Interventions

DRUGNatriumklorid Fresenius Kabi 9 mg/ml infusionsvätska

DRUGlösning

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
Pathological response rate	—

Secondary

Measure	Time frame
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs), Feasibility of neoadjuvant therapy in stage II melanoma, Sentinel lymph node positivity rate, Local recurrence rate, Regional recurrence rate, Recurrence-free survival (RFS), Distant-metastasis free survival, Melanoma-specific survival (MSS), Overall survival (OS), Change in dermoscopic features and correlation to histopathology, Change in tumor thickness as assessed with ultrasound and correlation to histopathology, Change in ctDNA levels during and after neoadjuvant treatment and surgery, Change in T-cell receptor repertoire before and after neoadjuvant treatment, Predictive and prognostic biomarker discovery	—

Measure

Time frame

Frequency and severity of adverse events (AEs) and serious adverse events (SAEs), Feasibility of neoadjuvant therapy in stage II melanoma, Sentinel lymph node positivity rate, Local recurrence rate, Regional recurrence rate, Recurrence-free survival (RFS), Distant-metastasis free survival, Melanoma-specific survival (MSS), Overall survival (OS), Change in dermoscopic features and correlation to histopathology, Change in tumor thickness as assessed with ultrasound and correlation to histopathology, Change in ctDNA levels during and after neoadjuvant treatment and surgery, Change in T-cell receptor repertoire before and after neoadjuvant treatment, Predictive and prognostic biomarker discovery

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Countries

Sweden

Outcome results

None listed