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

NCT04652258 | Terminated Phase 2

• 1 other identifier: NovartisIIT/ 2020-01929
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pyrexia

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Treatment arm

OTHER

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

Drug: Actemra

Interventions

Actemra DRUG

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

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 :
• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Clinic of Dermatology

Zurich, Canton of Zurich, 8058, Switzerland

Location

MeSH Terms

Conditions

Fever

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 3, 2020
• Study Start: February 1, 2021
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

CH (1)