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

Pyrexia Clinical Trial

— Nov IIT- Pyrex  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04652258
• Other study ID #: NovartisIIT/ 2020-01929
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: September 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Informed Consent as documented by signature

2. Subjects (males and females) age = 18 years

3. ECOG < 3

4. 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

5. Elevated CRP serum levels further than normal baseline levels (> 3.0 mg/L)

6. Subjects with resected, non-resectable, adjuvant or metastatic BRAF+ melanoma treated with :

• BRAF inhibitor (dabrafenib) in combination with MEK inhibitor (trametinib)

• BRAF inhibitor (dabrafenib) in combination with MEK inhibitor (trametinib) preceded by therapy with anti-PD-1/PD-L1 and/or anti CTLA-4 inhibitor

• BRAF inhibitor (dabrafenib) in combination with MEK inhibitor (trametinib) plus anti-PD- 1/PD-L1 inhibitor

Related Conditions & MeSH terms

• Fever
• Hyperthermia
• Pyrexia

Intervention

Drug:
• Actemra
Dosage: 8mg/kg (max. 800mg) Actemra administered intravenously as an infusion over 60 min.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Clinic of Dermatology	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.