Domatinostat in Combination With Avelumab in Patients With Advanced Merkel Cell Carcinoma Progressing on Anti-PD-(L)1 (MERKLIN2)
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ClinicalTrials.gov Identifier: NCT04393753 |
Recruitment Status :
Active, not recruiting
First Posted : May 19, 2020
Last Update Posted : March 17, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Merkel Cell Carcinoma | Drug: domatinostat in combination with avelumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | September 1, 2020 |
Estimated Primary Completion Date : | July 2022 |
Estimated Study Completion Date : | July 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: domatinostat and avelumab
Single arm study of Domatinostat tablets in combination with avelumab infusion
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Drug: domatinostat in combination with avelumab
domatinostat tablets and avelumab infusion |
- Objective Response Rate (ORR) [ Time Frame: up to 24 months ]Objective Response Rate (ORR) defined as the percentage of patients having a confirmed CR or PR according to RECIST v1.1
- Durable Response Rate (DRR) [ Time Frame: up to 24 months ]Durable Response Rate (DRR), defined as the percentage of patients having a RECIST v1.1 response lasting ≥ 6 months
- Duration of Response (DoR) [ Time Frame: up to 24 months ]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
- Disease Control Rate (DCR) [ Time Frame: up to 24 months ]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.
- Durable Disease Control Rate (dDCR) [ Time Frame: up to 24 months ]Durable Disease Control Rate (dDCR), defined as the percentage of patients having a RECIST v1.1 disease control lasting ≥ 6 months
- Best Overall response (BOR) [ Time Frame: up to 24 months ]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
- Progression Free Survival (PFS) [ Time Frame: up to 24 months ]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)
- PFS Rate [ Time Frame: up to 24 months ]PFS Rate, defined as the percentage of patients without PD at 6 and 12 months after first administration of study drug
- Overall Survival (OS) [ Time Frame: up to 36 months ]Overall Survival (OS), defined as the time from the first administration of study medication until death due to any cause
- OS Rate [ Time Frame: up to 12 months ]OS Rate, defined as the percentage of patients alive at 6 and at 12 months after first administration of study drug
- Safety and Tolerability [ Time Frame: up to 24 months ]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)
- Health related Quality of Life (HrQoL) [ Time Frame: up to 24 months ]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.
- Plasma concentration of domatinostat and avelumab [ Time Frame: up to 48 weeks ]Single trough values of domatinostat and avelumab at pre-defined time points
- Avelumab anti-drug antibodies (ADA) [ Time Frame: up to 48 weeks ]Avelumab anti-drug antibodies (ADA)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393753

Responsible Party: | 4SC AG |
ClinicalTrials.gov Identifier: | NCT04393753 |
Other Study ID Numbers: |
4SC-202-3-2018 2018-004788-30 ( EudraCT Number ) |
First Posted: | May 19, 2020 Key Record Dates |
Last Update Posted: | March 17, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma, Merkel Cell Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Polyomavirus Infections DNA Virus Infections Virus Diseases Infections Tumor Virus Infections |
Carcinoma, Neuroendocrine Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Adenocarcinoma Neoplasms, Nerve Tissue Avelumab Antineoplastic Agents, Immunological Antineoplastic Agents |