Ibrutinib in Treating Patients With Refractory Metastatic Cutaneous Melanoma

NCT02581930 ↗

Phase 2 Active not recruiting 18 enrolled National Cancer Institute (NCI)

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2016-08-17
Primary completion: 2018-02-10
Completion: 2027-03-04

Outcome

Missed primary endpoint

registry p = 1.00; Probability of response 0.00; Exact binomial test, 1-sided; note: Significant if p-value is less than 0.1 NCT02581930 ↗

paper No antitumor responses were seen. PMID 33661190 ↗

Publications

Moschos SJ, Eroglu Z, Khushalani NI, Kendra KL, Ansstas G, In GK, Wang P, Liu G, Collichio FA, Googe PB, Carson CC, McKinnon K, Wang HH, Nikolaishvilli-Feinberg N, Ivanova A, Arrowood CC, Garrett-Mead N, Conway KC, Edmiston SN, Ollila DW, Serody JS, Thomas NE, Ivy SP, Agrawal L, Dees EC, Abbruzzese JL. Targeting the IL-2 inducible kinase in melanoma; a phase 2 study of ibrutinib in systemic treatment-refractory distant metastatic cutaneous melanoma: preclinical rationale, biology, and clinical activity (NCI9922). Melanoma Res. 2021 Apr 1;31(2):162-172. doi: 10.1097/CMR.0000000000000726.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibrutinib	Small molecule	840 mg	Oral