Pyrexia Management Using an IL-6 Antibody in BRAF+ Melanoma Patients Treated with Dabrafenib/ Trametinib +/- Immunotherapy (Nov IIT- Pyrex)

University of Zurich (UZH)

Status and phase: Terminated; Phase 2

Conditions: Pyrexia

Treatments: Drug: Actemra

Study type: Interventional

Funder types: Other

Identifiers

NCT04652258

NovartisIIT/ 2020-01929

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Treatment arm

Other group

Description:

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

Treatment:

Drug: Actemra