The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Ibrutinib in Treating Patients With Refractory Metastatic Cutaneous Melanoma
Official Title: A Phase 2 Study of Ibrutinib (PCI-32765) in Refractory Distant Metastatic Cutaneous Melanoma: Correlation of Biomarkers With Response and Resistance
Study ID: NCT02581930
Brief 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.
Detailed Description: PRIMARY OBJECTIVES: I. Estimate rate of objective response (OR: complete response \[CR\] + partial response \[PR\]) to ibrutinib administered as single agent in patients with immune checkpoint inhibitor-refractory, or immune checkpoint inhibitor ineligible and mitogen-activated protein kinase (MAPK) inhibitor-refractory (if B-Raf proto-oncogene, serine/threonine kinase \[BRAF\]V600-mutant) or MAPK inhibitor-intolerant distant metastatic cutaneous melanoma. SECONDARY OBJECTIVES: I. Estimate progression-free survival (PFS) rate at 6 months after initiation of ibrutinib in patients with immune checkpoint inhibitor-refractory or immune checkpoint ineligible and MAPK inhibitor-refractory (if BRAFV600-mutant) or MAPK inhibitor-intolerant distant metastatic cutaneous melanoma. II. Estimate overall survival (OS) after initiation of ibrutinib in patients with immune checkpoint inhibitor-refractory or immune checkpoint ineligible and MAPK inhibitor-refractory (if BRAFV600-mutant) or MAPK inhibitor-intolerant distant metastatic cutaneous melanoma. III. Explore the association of ITK protein expression with OR and PFS. TERTIARY OBJECTIVES: I. Explore association between other putative targets of ibrutinib (e.g. Tec, ErbB4, Hck, Yes, BTK) in melanoma cells, as assessed by 2-color immunofluorescence (IF) in representative tissue sections obtained from pretreatment archived formalin-fixed paraffin-embedded (FFPE) tumor blocks or FFPE blocks obtained from fresh tissue biopsy from enrolled patients, with overall response (OR) and PFS. II. Explore ibrutinib-mediated effect(s) on immune cell subsets associated with immunomodulation by performing multiparameter flow cytometric analysis in peripheral blood mononuclear cell (PBMC) obtained prior to treatment, on day 29 (i.e., predose day 1 of cycle 2) following initiation of treatment with ibrutinib, and at the time of disease progression (3 time points). III. Determine pharmacokinetics (PK) of ibrutinib following daily dosing at 840 mg on day 8 of cycle 1 (Css). OUTLINE: Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 2 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Los Angeles General Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
UCHealth University of Colorado Hospital, Aurora, Colorado, United States
Moffitt Cancer Center, Tampa, Florida, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Case Western Reserve University, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
University of Wisconsin Carbone Cancer Center - University Hospital, Madison, Wisconsin, United States
Name: Stergios J Moschos
Affiliation: Duke University - Duke Cancer Institute LAO
Role: PRINCIPAL_INVESTIGATOR