Status:
COMPLETED
Domatinostat in Combination With Avelumab in Patients With Advanced Merkel Cell Carcinoma Progressing on Anti-PD-(L)1
Lead Sponsor:
4SC AG
Conditions:
Merkel Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2024
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04393753
Start Date
October 13 2020
End Date
February 26 2024
Last Update
May 8 2024
Active Locations (22)
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1
UZ Leuven
Leuven, Belgium
2
Bordeaux Hôpital Saint Andre
Bordeaux, France
3
Hôpital Ambroise Paré - Boulogne-Billancourt
Boulogne-Billancourt, France
4
CHU Nantes - Hotel Dieu
Nantes, France