Clinical Trials Search
Clinical Trial 18916
Cancer Type: Cutaneous
Interventions:748645 (Ibrutinib); Ibrutinib (Imbruvica); PCI-32765 (Ibrutinib)
Study Type: Treatment
Phase of Study: Phase II
A Phase 2 Study of Ibrutinib (PCI-32765) in Refractory Distant Metastatic Cutaneous Melanoma: Correlation of Biomarkers with Response and Resistance
The purpose of this study is to test any good and/or bad effects of the study drug call ibrutinib. Ibrutinib could shrink the participant's cancer but it could also cause side effects. Researchers hope to learn if the study drug will shrink the cancer by at least one-quarter compared to its present size. Ibrutinib has already been FDA-approved to treat three cancer types: mantle-cell lymphoma, chronic lymphocytic leukemia and Waldenstrom's Macroglobulinemia. However, it is considered investigational for the treatment of metastatic melanoma. Researchers also want to perform studies on participants' tumor tissue and blood samples to see how ibrutinib affects the immune system and how their genes may affect the response to ibrutinib. There will be up to 32 people taking part in this study.
Primary Objective: - 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 and MAPK inhibitor-refractory (if BRAFV600-mutant) distant metastatic cutaneous melanoma. Secondary Objectives: - Estimate progression-free survival (PFS) after initiation of ibrutinib in patients with immune checkpoint inhibitor-refractory and MAPK inhibitor-refractory (if BRAFV600-mutant) distant metastatic cutaneous melanoma. - Estimate overall survival (OS) after initiation of ibrutinib in patients with immune checkpoint inhibitor-refractory and MAPK inhibitor-refractory (if BRAFV600-mutant) distant metastatic cutaneous melanoma. - Explore the association of ITK protein expression with OR and PFS. The ITK protein expression in melanoma cells (pretreatment) is assessed by 2-color immunofluorescence (IF) in representative tissue sections obtained from archival formalin-fixed embedded blocks or in representative tissue sections/slides obtained from fresh biopsies from enrolled patients. Exploratory Objectives: - Explore association between other putative targets of ibrutinib (e.g., Tec, ErbB4, Hck, Yes, BTK) in melanoma cells, as assessed by 2-color IF in representative tissue sections obtained from pretreatment archived FFPE tumor blocks or FFPE blocks obtained from fresh tissue biopsy from enrolled patients, with OR and PFS. - Explore ibrutinib-mediated effect(s) on immune cell subsets associated with immunomodulation by performing multiparameter flow cytometric analysis in 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).