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

4SC AG19 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Merkel Cell Carcinoma

Interventions

domatinostat in combination with avelumabDRUG

domatinostat tablets and avelumab infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (22)

UZ Leuven

Leuven, Belgium

Bordeaux Hôpital Saint Andre

Bordeaux, France

Outcomes

Primary Outcomes

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

Time frame: up to 24 months

Secondary Outcomes

Durable Response Rate (DRR)

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

Time frame: up to 24 months

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

Time frame: up to 24 months

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.

Time frame: up to 24 months

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

Time frame: up to 24 months

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

Time frame: up to 24 months

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)

Data from ClinicalTrials.gov

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