TerminatedPhase 2

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

Stopped: too few patients could be included

Switzerland20 participantsStarted 2021-02-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 :

What they're measuring

Pyrexia management

Timeframe: 1 hour to up to 72 hours.

Trial details

NCT IDNCT04652258

SponsorUniversity of Zurich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-31

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