Domatinostat in Combination With Avelumab in Patients With Advanced Merkel Cell Carcinoma Progressing on Anti-PD-(L)1 (MERKLIN2)

4SC

Status and phase

Completed

Phase 2

Conditions

Merkel Cell Carcinoma

Treatments

Drug: domatinostat in combination with avelumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04393753

2018-004788-30 (EudraCT Number)

4SC-202-3-2018

Details and patient eligibility

About

This phase II trial studies how well domatinostat (4SC-202) works in combination with avelumab in adult patients with advanced unresectable and/or metastatic Merkel Cell Carcinoma that have progressed on a previous therapy with an anti-PD-(L)1 antibody

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)