A Phase 2 interventional study of domatinostat in combination with avelumab in Merkel Cell Carcinoma, sponsored by 4SC AG. Completed at 22 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by 4SC AG · Phase 2, Interventional, and Treatment
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
138 studies on the registry are indexed under Carcinoma, Merkel Cell; 39 are open to participants now.
This study's enrollment of 19 is below the median of 40 across 119 interventional studies indexed under Carcinoma, Merkel Cell.
Browse Carcinoma, Merkel Cell studies →4SC AG is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Single arm study of Domatinostat tablets in combination with avelumab infusion
Drug: domatinostat in combination with avelumab
domatinostat tablets and avelumab infusion
Objective Response Rate (ORR)
Objective Response Rate (ORR) defined as the percentage of patients having a confirmed CR or PR according to RECIST v1.1
Time frame: up to 24 months
Durable Response Rate (DRR)
Durable Response Rate (DRR), defined as the percentage of patients having a RECIST v1.1 response lasting ≥ 6 months
Time frame: up to 24 months
Duration of Response (DoR)
Duration of Response (DoR), defined as the time from an initial objective response (CR or PR) according to RECIST v1.1 until disease progression or death due to any cause
Time frame: up to 24 months
Disease Control Rate (DCR)
Disease Control Rate (DCR), defined as the proportion of patients with either an objective response (CR, PR) or stable disease (SD) according to RECIST v1.1.
Time frame: up to 24 months
Durable Disease Control Rate (dDCR)
Durable Disease Control Rate (dDCR), defined as the percentage of patients having a RECIST v1.1 disease control lasting ≥ 6 months
Time frame: up to 24 months
Best Overall response (BOR)
Best Overall response (BOR), defined as the best response (PD, SD, PR, CR) according to RECIST v1.1 over the course of a patient's participation in the study, assessed up to 2 years
Time frame: up to 24 months
Progression Free Survival (PFS)
Progression Free Survival (PFS), defined as the time from first dosing (Day +1) to the date of PD or death from any cause (whichever comes first)
Time frame: up to 24 months
PFS Rate
PFS Rate, defined as the percentage of patients without PD at 6 and 12 months after first administration of study drug
Time frame: up to 24 months
Overall Survival (OS)
Overall Survival (OS), defined as the time from the first administration of study medication until death due to any cause
Time frame: up to 36 months
OS Rate
OS Rate, defined as the percentage of patients alive at 6 and at 12 months after first administration of study drug
Time frame: up to 12 months
Safety and Tolerability
Safety and Tolerability of the study medication (determined by number, frequency, duration and severity of AEs using CTCAE v5.0, physical examination, laboratory tests, vital signs, and ECGs)
Time frame: up to 24 months
Health related Quality of Life (HrQoL)
The impact of treatment on the patient's QoLwill be assessed with the questionnaires "Functional Assessment of Cancer Therapy - Melanoma (FACT-M)" where QoL is assessed on a scale 0-240 (higher score means better status of health), with "EQ-5D-5L" which is a multi attribute utility instrument for measuring health-related QoL as EQ5D index with a score 0-1 (higher score means better status of health) and with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) with a score 0-100 per subscale (n=9 per item (n=6), higher score means better QoL.
Time frame: up to 24 months
Plasma concentration of domatinostat and avelumab
Single trough values of domatinostat and avelumab at pre-defined time points
Time frame: up to 48 weeks
Avelumab anti-drug antibodies (ADA)
Avelumab anti-drug antibodies (ADA)
Time frame: up to 48 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2020 to primary completion in Feb 2024, 40 months.
Of 32 phase 2 interventional studies under Carcinoma, Merkel Cell, half reached primary completion within 92 months of starting (the median), counting those still running; a quarter within 47 and three quarters within 138. This study's 40 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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4SC AG