Domatinostat in Combination With Avelumab in Patients With Advanced Merkel Cell Carcinoma Progressing on Anti-PD-(L)1

NCT04393753 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: 4SC-202-3-20182018-004788-30
• Study Type: interventional
• Target: 19
• Locations: 6 countries
• Sites: 22

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

Conditions

Merkel Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Durable Response Rate (DRR)

  up to 24 months

• Duration of Response (DoR)

  up to 24 months

• Disease Control Rate (DCR)

  up to 24 months

• Durable Disease Control Rate (dDCR)

  up to 24 months

• Best Overall response (BOR)

  up to 24 months

Study Arms (1)

domatinostat and avelumab

EXPERIMENTAL

Single arm study of Domatinostat tablets in combination with avelumab infusion

Drug: domatinostat in combination with avelumab

Interventions

domatinostat in combination with avelumab DRUG

domatinostat tablets and avelumab infusion

domatinostat and avelumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• 4SC AG: lead

Study Sites (22)

UZ Leuven

Leuven, Belgium

Location

Bordeaux Hôpital Saint Andre

Bordeaux, France

Location

Hôpital Ambroise Paré - Boulogne-Billancourt

Boulogne-Billancourt, France

Location

CHU Nantes - Hotel Dieu

Nantes, France

Location

Hôpital Saint-Louis

Paris, France

Location

Universitätsklinikum Köln

Cologne, Germany

Location

Universitätsklinikum Dresden

Dresden, Germany

Location

Helios Klinikum Erfurt

Erfurt, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Universitätsklinikum Schleswig-Holstein Kiel

Kiel, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, Germany

Location

Technische Universität München

München, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Germany

Location

Instituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

Bari, Italy

Location

Istituto Nazionale Tumori Fondazione G.Pascale

Naples, Italy

Location

IOV - Istituto Oncologico Veneto IRCCS

Padua, Italy

Location

Fondazione del Piemonte per l'Oncologia

Torino, Italy

Location

Netherlands Cancer Institute Amsterdam

Amsterdam, Netherlands

Location

Academic Hospital Maastricht

Maastricht, Netherlands

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

MeSH Terms

Conditions

Carcinoma, Merkel Cell

Interventions

domatinostat; avelumab

Condition Hierarchy (Ancestors)

Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 19, 2020
• Study Start: October 13, 2020
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); BE (1); FR (4); IT (4); DE (10); ES (1)