Clinical trial · Interventional
Domatinostat in Combination With Avelumab in Patients With Advanced Merkel Cell Carcinoma Progressing on Anti-PD-(L)1
A Phase II, Open Label Study to Investigate the Efficacy and Safety of Domatinostat in Combination With Avelumab in Patients With Advanced Unresectable/Metastatic Merkel Cell Carcinoma Progressing on Anti-PD-(L)1 Antibody Therapy
NCT04393753CI-TRIAL-00076864MERKLIN2completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Merkel Cell Carcinoma | Merkel Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| domatinostat in combination with avelumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- domatinostat and avelumab
- description
- Single arm study of Domatinostat tablets in combination with avelumab infusion
- interventionNames
- Drug: domatinostat in combination with avelumab
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- up to 24 months
- description
- Objective Response Rate (ORR) defined as the percentage of patients having a confirmed CR or PR according to RECIST v1.1
Secondary outcomes (13)
- measure
- Durable Response Rate (DRR)
- timeFrame
- up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.