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Merkel Cell CarcinomaPhase 2MERKLIN2NCT04393753

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

A Phase 2 study testing domatinostat in combination with avelumab in people with Merkel Cell Carcinoma, run by 4SC AG at 22 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Merkel Cell Carcinoma
What is being tested?
domatinostat in combination with avelumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
22 sitesin 6 countries
Study dates
13 Oct 2020to 26 Feb 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

22 sites in 6 countries.

22 sites in 6 countries

Germany10 sites

  • Universitätsklinikum Köln

    Cologne

  • Universitätsklinikum Dresden

    Dresden

  • Helios Klinikum Erfurt

    Erfurt

  • Universitätsklinikum Essen

    Essen

  • Universitätsklinikum Heidelberg

    Heidelberg

  • Universitätsklinikum Schleswig-Holstein Kiel

    Kiel

  • Universitätsklinikum Leipzig

    Leipzig

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck

  • Technische Universität München

    München

  • Universitätsklinikum Tübingen

    Tübingen

Other trials in Germany

France4 sites

  • Bordeaux Hôpital Saint Andre

    Bordeaux

  • Hôpital Ambroise Paré - Boulogne-Billancourt

    Boulogne-Billancourt

  • CHU Nantes - Hotel Dieu

    Nantes

  • Hôpital Saint-Louis

    Paris

Other trials in France

Italy4 sites

  • Instituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

    Bari

  • Istituto Nazionale Tumori Fondazione G.Pascale

    Naples

  • IOV - Istituto Oncologico Veneto IRCCS

    Padova

  • Fondazione del Piemonte per l'Oncologia

    Torino

Other trials in Italy

Netherlands2 sites

  • Netherlands Cancer Institute Amsterdam

    Amsterdam

  • Academic Hospital Maastricht

    Maastricht

Other trials in Netherlands

Belgium1 site

  • UZ Leuven

    Leuven

Other trials in Belgium

Spain1 site

  • Hospital Universitari Vall d'Hebron

    Barcelona

Other trials in Spain

About this study

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

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

Being tested
domatinostat in combination with avelumab
Medical subject headings
Carcinoma, Merkel Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • domatinostat in combination with avelumabDrug

    domatinostat tablets and avelumab infusion

Study groups in NCT04393753
Study groupRoleWhat they receive
domatinostat and avelumabExperimentalSingle arm study of Domatinostat tablets in combination with avelumab infusion
Receives: Drug: domatinostat in combination with avelumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 24 months

Secondary outcomes (13)

  1. Durable Response Rate (DRR)

    Durable Response Rate (DRR), defined as the percentage of patients having a RECIST v1.1 response lasting ≥ 6 months

    Measured: up to 24 months

  2. 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

    Measured: up to 24 months

  3. 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.

    Measured: up to 24 months

  4. 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

    Measured: up to 24 months

  5. 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

    Measured: up to 24 months

  6. 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)

    Measured: up to 24 months

  7. PFS Rate

    PFS Rate, defined as the percentage of patients without PD at 6 and 12 months after first administration of study drug

    Measured: up to 24 months

  8. Overall Survival (OS)

    Overall Survival (OS), defined as the time from the first administration of study medication until death due to any cause

    Measured: up to 36 months

  9. OS Rate

    OS Rate, defined as the percentage of patients alive at 6 and at 12 months after first administration of study drug

    Measured: up to 12 months

  10. 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)

    Measured: up to 24 months

  11. 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.

    Measured: up to 24 months

  12. Plasma concentration of domatinostat and avelumab

    Single trough values of domatinostat and avelumab at pre-defined time points

    Measured: up to 48 weeks

  13. Avelumab anti-drug antibodies (ADA)

    Avelumab anti-drug antibodies (ADA)

    Measured: up to 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2020
  2. Study start13 Oct 2020
  3. Primary completion26 Feb 2024
  4. Study completion26 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04393753
Sponsor's protocol ID
4SC-202-3-2018
Other IDs
2018-004788-30, 2018
Acronym
MERKLIN2
Status last verified
Apr 2024
First submitted
12 May 2020
Last updated
8 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing domatinostat in combination with avelumab in people with Merkel Cell Carcinoma, run by 4SC AG at 22 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Germany, France, Italy, Netherlands, Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04393753.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.

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