ASCO 2021: Phase II Study of Domatinostat Plus Avelumab for Merkel Cell Carcinoma
Posted: Wednesday, June 30, 2021
Although in recent years, anti–PD-L1 antibody therapies have become the standard of care for patients with Merkel cell carcinoma, many patients fail to respond or relapse. Recent data have suggested that a selective class I histone deacetylase inhibitor, domatinostat, may overcome disease resistance to checkpoint inhibitors. Domatinostat treatment may favorably modulate the tumor environment and allow for the reintroduction of anti–PD-L1 therapy for sustained benefits. Alexander Christopher Jonathan Van Akkooi, MD, PhD, of the Netherlands Cancer Institute, and colleagues presented the study intent of the phase II MERKLIN trial during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract TPS9592).
In this multicenter, single-arm trial, 40 patients with advanced, unresectable stage III or metastatic stage IV Merkel cell carcinoma who have experienced disease progression on anti–PD-L1 therapy will be enrolled across 46 clinical study sites in Europe and the United States. The researchers will treat patients with orally administered domatinostat in combination with the anti–PD-L1 antibody avelumab.
To assess antitumor activity, the investigators will measure objective response rates, safety, quality of life, and pharmacokinetics of the combination therapy. Candidates with a history of adverse reactions to anti–PD-L1 therapy, more than one line of previous systemic antineoplastic therapy, or significant active or chronic diseases will be excluded.
On October 16, 2020, the first patient was enrolled. As of February 15, 2021, 4 of the 40 patients have been enrolled. Currently, 21 of the 46 clinical sites are active. The study team will evaluate biomarkers for associated clinical benefit. For more details on this currently recruiting study, visit ClinicalTrials.gov.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
