Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT04652258
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04652258
Study Brief:
Protocol Section:
NCT04652258