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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04652258
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : October 7, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pyrexia Drug: Actemra Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open Label, Single Arm, Single Center Study to Evaluate Pyrexia Management (With or Without Any Other Cytokine Release Symptoms) Using Tocilizumab, an Humanized Monoclonal Antibody Against the Interleukin - 6 Receptor in BRAF+ Melanoma Patients Treated With Dabrafenib/ Trametinib +/- Immunotherapy
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Fever Melanoma
Drug Information available for: Tocilizumab

Arm Intervention/treatment
Treatment arm

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




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652258


Locations
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Switzerland
University Hospital Zurich, Clinic of Dermatology Recruiting
Zürich, Switzerland, 8058
Contact: Reinhard Dummer, Prof.    +41442552507    reinhard.dummer@usz.ch   
Sponsors and Collaborators
University of Zurich
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04652258    
Other Study ID Numbers: NovartisIIT/ 2020-01929
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fever
Hyperthermia
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries