Ibrutinib in Treating Patients With Refractory Metastatic Cutaneous Melanoma (NCT02581930) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Ibrutinib in Treating Patients With Refractory Metastatic Cutaneous Melanoma
United States18 participantsStarted 2016-08-17
Plain-language summary
This phase II trial studies how well ibrutinib works in treating patients with stage IV melanoma of the skin that has not responded to previous treatment. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed melanoma of cutaneous primary; metastatic melanoma from unknown primary are allowed
* Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 10 mm (\>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
* Stage IV disease
* If BRAFV600-mutant, documented refractory disease to at least one BRAF inhibitor (dabrafenib or vemurafenib) and/or a MEK inhibitor (trametinib or cobimetinib), defined as progression of measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria while on treatment; subjects with MAPK inhibitor-intolerance are eligible if they meet criteria
* Documented disease refractory to at least one PD1/PD-L1 inhibitor, defined as disease progression following at least 2 infusions of the same drug; radiographic disease progression will be documented by the institutional radiologist based on any radiographic evidence (magnetic resonance imaging \[MRI\], computed tomography \[CT\], positron emission tomography \[PET\], or other modalities, etc.) of disease progression on two separate radiographic scans assessment obtained at least 4 weeks apart; this minimum 4-week interval is required to define PD-1 inhibitor resistance based on imaging; alternatively, clinical disease progression may b…
What they're measuring
1
Number of Subjects With Antitumor Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria 1.1