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

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 4SC AG
• Treatments: Avelumab

Criteria

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)