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This study is a retrospective cohort study. A database will be created from the data available of all patients that have participate in the named patient program for pembrolizumab in the Netherlands. This database will be used for analysis of response markers and for an evaluation of adverse events.
This study is a retrospective cohort study. A database will be created from the data available of all patients that have participate in the named patient program for pembrolizumab in the Netherlands. This database will be used for analysis of response markers and for an evaluation of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with pemprolizumab | All patients in this study have received treatment with pembrolizumab for the indication of an advanced melanoma. Patients will be included from all 14 WIN-O (Werkgroep Immunologie Nederland voor Oncologie) centers in the Netherlands. Patients are at least 18 years of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemprolizumab | Drug | All patients in this study have received treatment with pembrolizumab for the indication of an advanced melanoma. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early serum response markers | Serum markers: S100B, LDH, white blood count differential neutrophils, monocytes, lymphocytes, eosinophils, basophils. Markers will be correlated to early response as measured by RECIST 1.1 criteria at week 12 and 18 of treatment with pembrolizumab. | up to day 126 |
| Predicitve patient characteristics | Patient characteristics: age, gender, WHO performance status | baseline |
| Predictive tumor characteristics | Tumor characteristics: M-stage, presence of CNS metastases, mutation status, PD-L1 status. | baseline |
| Adverse events of clinical interest will be collected and graded according to the CTCAE version 4.0 criteria | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Overall survival will be evaluated for all patients treated with pembrolizumab. | 2 years |
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All patients that were eligible for treatment with pembrolizumab in the Named Patient Program in the Netherlands.
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All patients in this study have received treatment with pembrolizumab for the indication of an advanced melanoma.
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| Name | Affiliation | Role |
|---|---|---|
| G.A.P. Hospers, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | 9713 GZ | Netherlands |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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|
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |