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

Phase 2

Terminated

• Conditions: Pyrexia
• Interventions: Drug: Actemra

• Registration Number: NCT04652258
• Lead Sponsor: University of Zurich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2020-11-26
• Study First Posted: 2020-12-03
• Study Start: 2021-02-01
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	Actemra	The patients will be administered Tocilizmab (Actemra) at the following dosage : * First dose: 8mg/kg, max. 800mg iv. during 60min * If necessary second dose: 8mg/kg, max. 800mg iv. during 60min after 20-36 hours from first dose

Primary Outcome Measures

Name	Time	Method
Pyrexia management	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.

Trial Locations

Locations (1)

University Hospital Zurich, Clinic of Dermatology; 🇨🇭 Zürich, Switzerland