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:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-24 @ 12:56 PM
NCT ID:
NCT01933061
Eligibility Criteria:
Inclusion Criteria:
* 1\. Histologically or cytologically confirmed cutaneous BRAF wild-type malignant melanoma with evidence of metastasis (Stage IV).
2\. No prior cytotoxic chemotherapy for metastatic malignant melanoma is permitted. No prior adjuvant cytotoxic chemotherapy is permitted.
* Up to one prior regimen with the following classes of agents is permitted:
o Targeted biologic agents (e.g. interleukin 2 \[IL-2\], granulocyte macrophage colony stimulating factor \[GM-CSF\], other cytokines or unarmed monoclonal antibodies)
o Targeted small molecule inhibitors (e.g., kinase inhibitors, heat shock protein \[HSP\] inhibitors, etc.).
* Immune checkpoint inhibitors (e.g. anti-CTLA4, anti-PD1, anti-PD-L1).
* Prior adjuvant therapy with interferon and/or vaccines is permitted.
* Prior treatments should be completed 4 weeks prior to enrollment in the study (ie, randomization).
3\. Male or non-pregnant and non-lactating female, and ≥ 18 years of age at the time of signing the informed consent document.
* If heterosexually active, the subject must agree to use medical doctor-approved contraception throughout the study, and for 6 months after last dose of study drug.
4\. History of malignancy in the last 5 years; subjects with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
* Subjects with other malignancies are eligible if they were cured by surgery (with or without radiotherapy) and have been continuously disease-free for at least 5 years.
5\. Radiographically-documented measurable disease (defined by the presence of at least one radiographically documented measurable lesion including measurable cutaneous metastasis).
6\. Adequate haemtological and biochemical parameters:
* ANC ≥ 1.5 x 109 cells/L.
* Platelets ≥ 100 x 109 cells/L.
* Hgb ≥ 9 g/dL.
* AST (SGOT) or ALT (SGPT) ≥ 2.5x upper limit of normal range (ULN);
o ≤ 5.0 x ULN if hepatic metastases present.
* Total bilirubin ≤ ULN. Creatinine ≤ 1.5 mg/dL. 8. ECOG performance status 0 to 1.
Exclusion Criteria:
* 1\. History of or current evidence of symptomatic brain metastases (brain Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) is needed to exclude brain metastasis), including leptomeningeal involvement.
2\. Subject has pre-existing peripheral neuropathy of National Cancer Institute NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Scale of Grade ≥ 2.
3\. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01933061
Study Brief:
Protocol Section:
NCT01933061