Back to resultsPyrexia Management Using an IL-6 Antibody in BRAF+ Melanoma Patients Treated With Dabrafenib/ Trametinib +/- Immunotherapy (Nov IIT- Pyrex)
Primary Purpose
Pyrexia
Status
Unknown status
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Actemra
Sponsored by
About this trial
This is an interventional treatment trial for Pyrexia
Eligibility Criteria
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 :
- 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
Sites / Locations
- University Hospital Zurich, Clinic of DermatologyRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treatment arm
Arm 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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04652258
First Posted
November 26, 2020
Last Updated
September 29, 2021
Sponsor
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT04652258
Brief Title
Pyrexia Management Using an IL-6 Antibody in BRAF+ Melanoma Patients Treated With Dabrafenib/ Trametinib +/- Immunotherapy
Acronym
Nov IIT- Pyrex
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pyrexia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment arm
Arm Type
Other
Arm 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
Intervention Type
Drug
Intervention Name(s)
Actemra
Intervention Description
Dosage: 8mg/kg (max. 800mg) Actemra administered intravenously as an infusion over 60 min.
Primary Outcome Measure Information:
Title
Pyrexia management
Description
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.
Time Frame
1 hour to up to 72 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 :
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
Facility Information:
Facility Name
University Hospital Zurich, Clinic of Dermatology
City
Zürich
ZIP/Postal Code
8058
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reinhard Dummer, Prof.
Phone
+41442552507
Email
reinhard.dummer@usz.ch
12. IPD Sharing Statement
Learn more about this trial
Pyrexia Management Using an IL-6 Antibody in BRAF+ Melanoma Patients Treated With Dabrafenib/ Trametinib +/- Immunotherapy
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