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Spots Global Cancer Trial Database for Ibrutinib in Treating Patients With Refractory Metastatic Cutaneous Melanoma

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Stergios J Moschos

Affiliation: Duke University - Duke Cancer Institute LAO

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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