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

Rekrutierend

NCT-Nummer:
NCT04652258

Studienbeginn:
Dezember 2020

Letztes Update:
07.10.2021

Wirkstoff:
Actemra

Indikation (Clinical Trials):
Fever, Hyperthermia

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
University of Zurich

Collaborator:
-

Studienlocations
(1 von 1)

University Hospital Zurich, Clinic of Dermatology
8058 Zürich
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Reinhard Dummer, Prof.
Phone: +41442552507
E-Mail: reinhard.dummer@usz.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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.

Geprüfte Regime

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

Quelle: ClinicalTrials.gov