Domatinostat in Combination With Avelumab in Patients With Advanced Merkel Cell Carcinoma Progressing on Anti-PD-(L)1
NCT ID: NCT04393753
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
19 participants
INTERVENTIONAL
2020-10-13
2024-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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domatinostat and avelumab
Single arm study of Domatinostat tablets in combination with avelumab infusion
domatinostat in combination with avelumab
domatinostat tablets and avelumab infusion
Interventions
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domatinostat in combination with avelumab
domatinostat tablets and avelumab infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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4SC AG
INDUSTRY
Responsible Party
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Locations
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UZ Leuven
Leuven, , Belgium
Bordeaux Hôpital Saint Andre
Bordeaux, , France
Hôpital Ambroise Paré - Boulogne-Billancourt
Boulogne-Billancourt, , France
CHU Nantes - Hotel Dieu
Nantes, , France
Hôpital Saint-Louis
Paris, , France
Universitätsklinikum Köln
Cologne, , 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 Leipzig
Leipzig, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, , Germany
Technische Universität München
München, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Instituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari, , Italy
Istituto Nazionale Tumori Fondazione G.Pascale
Naples, , Italy
IOV - Istituto Oncologico Veneto IRCCS
Padua, , Italy
Fondazione del Piemonte per l'Oncologia
Torino, , Italy
Netherlands Cancer Institute Amsterdam
Amsterdam, , Netherlands
Academic Hospital Maastricht
Maastricht, , Netherlands
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Countries
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Other Identifiers
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2018-004788-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
4SC-202-3-2018
Identifier Type: -
Identifier Source: org_study_id
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