Pyrexia Management Using an IL-6 Antibody in BRAF+ Melanoma Patients Treated With Dabrafenib/ Trametinib +/- Immunotherapy (Nov IIT- Pyrex)
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|ClinicalTrials.gov Identifier: NCT04652258|
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : October 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pyrexia||Drug: Actemra||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open Label, Single Arm, Single Center Study to Evaluate Pyrexia Management (With or Without Any Other Cytokine Release Symptoms) Using Tocilizumab, an Humanized Monoclonal Antibody Against the Interleukin - 6 Receptor in BRAF+ Melanoma Patients Treated With Dabrafenib/ Trametinib +/- Immunotherapy|
|Actual Study Start Date :||December 1, 2020|
|Estimated Primary Completion Date :||June 1, 2022|
|Estimated Study Completion Date :||October 1, 2022|
The patients will be administered Tocilizmab (Actemra) at the following dosage :
Dosage: 8mg/kg (max. 800mg) Actemra administered intravenously as an infusion over 60 min.
- Pyrexia management [ Time Frame: 1 hour to up to 72 hours. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652258
|University Hospital Zurich, Clinic of Dermatology||Recruiting|
|Zürich, Switzerland, 8058|
|Contact: Reinhard Dummer, Prof. +41442552507 firstname.lastname@example.org|