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The study examines the development of fever after administration of Actemra (tocilizumab) in patients who have fever and other cytokine release symptoms (headache, nausea, palpitations, low blood pressure) due to cancer therapy (Tafinlar (dabrafenib) / Mekinist (trametinib) +/- immunotherapy) . The goal of the study is to better understand the side effects and to find an effective therapy against them.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Other | The patients will be administered Tocilizmab (Actemra) at the following dosage :
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actemra | Drug | Dosage: 8mg/kg (max. 800mg) Actemra administered intravenously as an infusion over 60 min. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pyrexia management | The primary outcome represents the proportion of patients that reduce to at least <38°C after tocilizumab infusion in BRAF+ melanoma patients under treatment with dabrafenib/trametinib +/- immunotherapy - pyrexia status will be assessed at screening visit and on every other defined visit until remission, by assessing body temperature. | 1 hour to up to 72 hours. |
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Inclusion Criteria:
Informed Consent as documented by signature
Subjects (males and females) age ≥ 18 years
ECOG < 3
Subjects with pyrexia grade 1*- 4 and elevated CRP with persistent fever after one day of antipyretic therapy with or without at least one other additional symptom of cytokine release syndrome such as nausea, headache, tachycardia, hypotension, maculopapular rash, shortness of breath, transaminitis, renal failure, dehydration
Elevated CRP serum levels further than normal baseline levels (> 3.0 mg/L)
Subjects with resected, non-resectable, adjuvant or metastatic BRAF+ melanoma treated with :
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Clinic of Dermatology | Zurich | Canton of Zurich | 8058 | Switzerland |
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| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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