Clinical Trials Directory

Trials / Terminated

TerminatedNCT04652258

Pyrexia Management Using an IL-6 Antibody in BRAF+ Melanoma Patients Treated with Dabrafenib/ Trametinib +/- Immunotherapy

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

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
20 (actual)
Sponsor
University of Zurich · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGActemraDosage: 8mg/kg (max. 800mg) Actemra administered intravenously as an infusion over 60 min.

Timeline

Start date
2021-02-01
Primary completion
2021-10-31
Completion
2021-10-31
First posted
2020-12-03
Last updated
2024-11-01

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT04652258. Inclusion in this directory is not an endorsement.