Clinical trial NCT04393753: Domatinostat in Combination With Avelumab in Patients With Advanced Merkel Cell Carcinoma Progressing on Anti-PD-(L)1
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Merkel Cell Carcinoma
Lead sponsor: 4SC AG
Sponsor class: INDUSTRY
First posted: 2020-05-19
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 on a previous therapy with an anti-PD-(L)1 antibody


Eligibility criteria: 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)

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to 24 months
Secondary outcomes:
measure: Durable Response Rate (DRR)
timeFrame: up to 24 months
measure: Duration of Response (DoR)
timeFrame: up to 24 months
measure: Disease Control Rate (DCR)
timeFrame: up to 24 months
measure: Durable Disease Control Rate (dDCR)
timeFrame: up to 24 months
measure: Best Overall response (BOR)
timeFrame: up to 24 months
measure: Progression Free Survival (PFS)
timeFrame: up to 24 months
measure: PFS Rate
timeFrame: up to 24 months
measure: Overall Survival (OS)
timeFrame: up to 36 months
measure: OS Rate
timeFrame: up to 12 months
measure: Safety and Tolerability
timeFrame: up to 24 months
measure: Health related Quality of Life (HrQoL)
timeFrame: up to 24 months
measure: Plasma concentration of domatinostat and avelumab
timeFrame: up to 48 weeks
measure: Avelumab anti-drug antibodies (ADA)
timeFrame: up to 48 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: Bordeaux
country: France
facility: Bordeaux Hôpital Saint Andre
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré - Boulogne-Billancourt
city: Nantes
country: France
facility: CHU Nantes - Hotel Dieu
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Kiel
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck
city: München
country: Germany
facility: Technische Universität München
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Bari
country: Italy
facility: Instituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
city: Naples
country: Italy
facility: Istituto Nazionale Tumori Fondazione G.Pascale
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto IRCCS
city: Torino
country: Italy
facility: Fondazione del Piemonte per l'Oncologia
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute Amsterdam
city: Maastricht
country: Netherlands
facility: Academic Hospital Maastricht
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
References: