A phase 2 clinical trial on neoadjuvant pembrolizumab in patients diagnosed with high-risk melanoma without clinical evidence of metastatic dissemination.

Conditions

Melanoma

Brief summary

The rate of negative sentinel node procedures (=absence of viable melanoma metastases found on histopathological examination of the sentinel node) following the neoadjuvant treatment.

Detailed description

RFS is defined as the time from study recruitment to the date of first recurrence (or death from any cause), DMFS from recruitment to the first diagnosis of a distant metastasis (or death from any cause) and OS is defined as the time of recruitment until the date of death from any cause., Safety as assessed by anamnesis, clinical examination, analysis of blood and any additional medical examination that is indicated. AE will be graded by the Common Terminology Criteria of Adverse events (CTCAE), version 5.0 (National Institutes of Health, National Cancer Institute)., Health-related quality of life through the following patient-reported outcomes measure (PROM): European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)., Describe markers of pathological response of melanoma micrometastasis in the sentinel node., Describe the relation between the gene expression signature in bulk RNA sequencing of the primary tumor and the result of the sentinel node biopsy.

Related papers

No related papers found yet.

Interventions

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
The rate of negative sentinel node procedures (=absence of viable melanoma metastases found on histopathological examination of the sentinel node) following the neoadjuvant treatment.	—

Secondary

Measure	Time frame
RFS is defined as the time from study recruitment to the date of first recurrence (or death from any cause), DMFS from recruitment to the first diagnosis of a distant metastasis (or death from any cause) and OS is defined as the time of recruitment until the date of death from any cause., Safety as assessed by anamnesis, clinical examination, analysis of blood and any additional medical examination that is indicated. AE will be graded by the Common Terminology Criteria of Adverse events (CTCAE), version 5.0 (National Institutes of Health, National Cancer Institute)., Health-related quality of life through the following patient-reported outcomes measure (PROM): European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)., Describe markers of pathological response of melanoma micrometastasis in the sentinel node., Describe the relation between the gene expression signature in bulk RNA sequencing of the primary tumor and the result of the s	—

Measure

Time frame

RFS is defined as the time from study recruitment to the date of first recurrence (or death from any cause), DMFS from recruitment to the first diagnosis of a distant metastasis (or death from any cause) and OS is defined as the time of recruitment until the date of death from any cause., Safety as assessed by anamnesis, clinical examination, analysis of blood and any additional medical examination that is indicated. AE will be graded by the Common Terminology Criteria of Adverse events (CTCAE), version 5.0 (National Institutes of Health, National Cancer Institute)., Health-related quality of life through the following patient-reported outcomes measure (PROM): European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)., Describe markers of pathological response of melanoma micrometastasis in the sentinel node., Describe the relation between the gene expression signature in bulk RNA sequencing of the primary tumor and the result of the s

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Countries

Belgium

Outcome results

None listed