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PD-L1 Inhibitor

Domatinostat + Avelumab for Advanced Merkel Cell Carcinoma (MERKLIN2 Trial)

Phase 2

Waitlist Available

Research Sponsored by 4SC AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed Merkel Cell Carcinoma (MCC)

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

MERKLIN2 Trial Summary

This trial looks at how well domatinostat and avelumab work together to treat adults with advanced Merkel Cell Carcinoma that has gotten worse after previous treatment with an anti-PD-(L)1 antibody.

Who is the study for?

This trial is for adults with advanced Merkel Cell Carcinoma (MCC) that can't be surgically removed or has spread, and who have seen their cancer progress after treatment with anti-PD-(L)1 therapy. Participants should be relatively healthy otherwise, with a good performance status and no serious chronic diseases.Check my eligibility

What is being tested?

The study is testing the effectiveness of domatinostat in combination with avelumab in patients whose MCC has worsened despite previous anti-PD-(L)1 treatments. It's to see if this new combo can help control the cancer better than current options.See study design

What are the potential side effects?

Potential side effects may include immune-related reactions due to avelumab, as well as any common side effects from cancer therapies like fatigue, nausea, skin reactions, and an increased risk of infections.

MERKLIN2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer is confirmed as Merkel Cell Carcinoma.

Select...

My MCC cannot be removed by surgery and is in an advanced stage.

Select...

I am fully active and can carry on all my pre-disease activities without restriction.

MERKLIN2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR)

Secondary outcome measures

Avelumab anti-drug antibodies (ADA)

Best Overall response (BOR)

Disease Control Rate (DCR)

+10 more

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848

17%

Musculoskeletal and connective tissue disorders

11%

Injury, poisoning and procedural complications

Cardiac disorders

Immune system disorders

Gastrointestinal disorders

General disorders and administration site conditions

Metabolism and nutrition disorders

Investigations

Infections and infestations

Nervous system disorders

Endocrine disorders

Blood and lymphatic system disorders

Neoplasms benign, malignant and unspecified

Respiratory, thoracic and mediastinal disorders

Renal and urinary disorders

Skin and subcutaneous tissue disorders

100%

80%

60%

40%

20%

Study treatment Arm

Avelumab

MERKLIN2 Trial Design

1Treatment groups

Experimental Treatment

Group I: domatinostat and avelumabExperimental Treatment1 Intervention

Single arm study of Domatinostat tablets in combination with avelumab infusion

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

4SC AGLead Sponsor

14 Previous Clinical Trials

903 Total Patients Enrolled

Media Library

Avelumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04393753 — Phase 2

Neuroendocrine Carcinoma Research Study Groups: domatinostat and avelumab

Neuroendocrine Carcinoma Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT04393753 — Phase 2

Avelumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04393753 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled positions in this clinical trial?

"The data found on clinicaltrials.gov indicates that, despite having been initially listed on September 1st 2020 and updated lastly on March 16th 2022, this particular trial is not currently accepting patient enrolment. However, there are over 2500 other studies presently recruiting candidates for participation."

Answered by AI

How many venues are participating in the experiment?

"This research initiative is presently being conducted in Houston, Rochester and New york as well as 4 other cities. To reduce the need for travel, prospective participants should select a nearby medical centre to take part in the trial."

Answered by AI

Is the pairing of domatinostat and avelumab likely to cause any adverse effects?

"With reference to domatinostat and avelumab, our team has graded their safety as 2. This evaluation is based on the fact that this study is in Phase 2, meaning there are some affirming data points regarding safety yet no evidence of efficacy."

Answered by AI

Has there ever been a similar investigation previously conducted?

"Since 2014, domatinostat in combination with avelumab has been the subject of extensive research. The first trial was conducted by EMD Serono Research & Development Institute, Inc., and after 204 patients had completed this study it gained Phase 2 drug approval. Currently there are 112 active trials taking place across 1024 cities and 52 countries that involve this medicinal compound."

Answered by AI

Has prior research explored the potential synergy between domatinostat and avelumab?

"Domatinostat and avelumab were first tested together at Port Macquarie Base Hospital in 2014. Since then, 48 studies have reached completion while 112 trials remain active, with many of them taking place in the Houston area of Texas."

Answered by AI

What is the peak capacity of individuals participating in this medical research?

"At present, no further candidates are being sought for this specific trial which was initially uploaded on September 1st 2020 and last modified on March 16th 2022. However, there are multiple other studies in the fields of carcinoma and domatinostat combined with avelumab that have openings; 2478 trials related to cancer recruitment can be found while 112 such opportunities exist for the latter pair of treatments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Domatinostat in Combination With Avelumab in Patients With Advanced Merkel Cell Carcinoma Progressing on Anti-PD-(L)1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04393753.

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