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Completed

NCT Number: NCT04393753

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UZ Leuven, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

domatinostat in combination with avelumab

Drug

domatinostat tablets and avelumab infusion

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: up to 24 months

    Objective Response Rate (ORR) defined as the percentage of patients having a confirmed CR or PR according to RECIST v1.1

Secondary outcomes

  1. Durable Response Rate (DRR)

    Time frame: up to 24 months

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

  2. Duration of Response (DoR)

    Time frame: up to 24 months

    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

  3. Disease Control Rate (DCR)

    Time frame: up to 24 months

    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.

  4. Durable Disease Control Rate (dDCR)

    Time frame: up to 24 months

    Durable Disease Control Rate (dDCR), defined as the percentage of patients having a RECIST v1.1 disease control lasting ≥ 6 months

  5. Best Overall response (BOR)

    Time frame: up to 24 months

    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

  6. Progression Free Survival (PFS)

    Time frame: up to 24 months

    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)

  7. PFS Rate

    Time frame: up to 24 months

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

  8. Overall Survival (OS)

    Time frame: up to 36 months

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

  9. OS Rate

    Time frame: up to 12 months

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

  10. Safety and Tolerability

    Time frame: up to 24 months

    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)

  11. Health related Quality of Life (HrQoL)

    Time frame: up to 24 months

    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.

  12. Plasma concentration of domatinostat and avelumab

    Time frame: up to 48 weeks

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

  13. Avelumab anti-drug antibodies (ADA)

    Time frame: up to 48 weeks

    Avelumab anti-drug antibodies (ADA)

Sponsors and collaborators

Lead sponsor

4SC AG

Industry

Registry information

Official study 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

Acronym: MERKLIN2

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 19, 2020
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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