A Study to Investigate Domatinostat in Combination with Avelumab in Patients With Advanced Unresectable/Metastatic Merkel Cell Carcinoma

Overview

About this study

The purpose of this study is to investigate the anti-tumor effectiveness of domatinostat in combination with avelumab in advanced unresectable/metastatic MCC patients progressing on anti-PD-(L)1 antibody monotherapy. It also aims to investigate safety, tolerability, pharmacokinetics, avelumab anti-drug antibodies (ADA) and health-related quality of life (HrQoL).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Histologically confirmed Merkel Cell Carcinoma (MCC).
  • ECOG performance status ≤ 1.
  • MCC in an advanced, unresectable stage III or metastatic stage IV (includes patients who refused surgical resection or are not eligible for such surgical resection).
  • Progressing on previous anti-PD-(L)1 antibody monotherapy within the last 12 weeks before planned first administration of study medication.

Exclusion Criteria:

  • History of serious anti-PD-(L)1 therapy-related adverse reactions prohibiting further avelumab treatment.
  • More than one line of previous systemic anti-neoplastic therapy other than anti-PD-(L)1 antibody monotherapy.
  • Palliative radiation therapy of single lesions within 2 weeks before planned administration of study medication.
  • Presence of significant active or chronic disease (infections, immunodeficiencies, cardiovascular, psychiatric disorders).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Yiyi Yan, M.D., Ph.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20517034

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