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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04393753
Other study ID # 4SC-202-3-2018
Secondary ID 2018-004788-30
Status Completed
Phase Phase 2
First received
Last updated
Start date October 13, 2020
Est. completion date February 26, 2024

Study information

Verified date April 2024
Source 4SC AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date February 26, 2024
Est. primary completion date February 26, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
domatinostat in combination with avelumab
domatinostat tablets and avelumab infusion

Locations

Country Name City State
Belgium UZ Leuven Leuven
France Bordeaux Hôpital Saint Andre Bordeaux
France Hôpital Ambroise Paré - Boulogne-Billancourt Boulogne-Billancourt
France CHU Nantes - Hotel Dieu Nantes
France Hôpital Saint-Louis Paris
Germany Universitätsklinikum Dresden Dresden
Germany Helios Klinikum Erfurt Erfurt
Germany Universitätsklinikum Essen Essen
Germany Universitätsklinikum Heidelberg Heidelberg
Germany Universitätsklinikum Schleswig-Holstein Kiel Kiel
Germany Universitätsklinikum Köln Köln
Germany Universitätsklinikum Leipzig Leipzig
Germany Universitätsklinikum Schleswig-Holstein, Campus Lübeck Lübeck
Germany Technische Universität München München
Germany Universitätsklinikum Tübingen Tübingen
Italy Instituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari Bari
Italy Istituto Nazionale Tumori Fondazione G.Pascale Naples
Italy IOV - Istituto Oncologico Veneto IRCCS Padova
Italy Fondazione del Piemonte per l'Oncologia Torino
Netherlands Netherlands Cancer Institute Amsterdam Amsterdam
Netherlands Academic Hospital Maastricht Maastricht
Spain Hospital Universitari Vall d'Hebron Barcelona

Sponsors (1)

Lead Sponsor Collaborator
4SC AG

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Netherlands,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 up to 24 months
Secondary Durable Response Rate (DRR) Durable Response Rate (DRR), defined as the percentage of patients having a RECIST v1.1 response lasting = 6 months up to 24 months
Secondary 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 up to 24 months
Secondary 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. up to 24 months
Secondary 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 up to 24 months
Secondary 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 up to 24 months
Secondary 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) up to 24 months
Secondary PFS Rate PFS Rate, defined as the percentage of patients without PD at 6 and 12 months after first administration of study drug up to 24 months
Secondary Overall Survival (OS) Overall Survival (OS), defined as the time from the first administration of study medication until death due to any cause up to 36 months
Secondary OS Rate OS Rate, defined as the percentage of patients alive at 6 and at 12 months after first administration of study drug up to 12 months
Secondary 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) up to 24 months
Secondary 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. up to 24 months
Secondary Plasma concentration of domatinostat and avelumab Single trough values of domatinostat and avelumab at pre-defined time points up to 48 weeks
Secondary Avelumab anti-drug antibodies (ADA) Avelumab anti-drug antibodies (ADA) up to 48 weeks
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