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Monoclonal Antibodies

Avelumab for Merkel Cell Carcinoma

Phase 2
Waitlist Available
Research Sponsored by EMD Serono Research & Development Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at month 6 and 12
Awards & highlights

Study Summary

This trial is testing a new drug for people with MCC that has spread to other parts of their body. The drug is given to see if it is effective and safe.

Eligible Conditions
  • Merkel Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at month 6 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 6 and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
Part B: Durable Response Rate (DRR)
Secondary outcome measures
Part A: Duration of Response According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
Part A: Final Analysis: Overall Survival (OS) Time
Part A: Interim Analysis: Overall Survival (OS) Time
+19 more

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848
17%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Immune system disorders
6%
Endocrine disorders
6%
Cardiac disorders
6%
General disorders and administration site conditions
6%
Nervous system disorders
6%
Infections and infestations
6%
Investigations
6%
Gastrointestinal disorders
6%
Metabolism and nutrition disorders
6%
Blood and lymphatic system disorders
6%
Respiratory, thoracic and mediastinal disorders
6%
Neoplasms benign, malignant and unspecified
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B: AvelumabExperimental Treatment1 Intervention
Participants received Avelumab as first-line treatment for metastatic or distally recurrent MCC at a dose of 10 mg/kg as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
Group II: Part A: AvelumabExperimental Treatment1 Intervention
Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2018
Completed Phase 2
~2450

Find a Location

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Lead Sponsor
76 Previous Clinical Trials
30,656 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck KGaA, Darmstadt, Germany
288 Previous Clinical Trials
68,771 Total Patients Enrolled

Frequently Asked Questions

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

How many participants can join this medical experiment?

"This trial is no longer recruiting participants; the first posting was July 3rd 2014 and the most recent update being April 21st 2022. If you are searching for a different study, there are 2474 clinical trials actively enrolling patients with carcinoma or Merkel cell cancer as well as 112 studies utilizing Avelumab that need volunteers."

Answered by AI

Could you provide an overview of all the prior experiments that utilized Avelumab?

"At present, 112 trials are being conducted to assess the effectiveness of Avelumab. Of these studies, 10 have progressed into Phase 3 and are taking place in Barcelona and South dakota. Additionally there are numerous other locations participating with this research effort at a total of 3685 sites across the world."

Answered by AI

What is the proposed outcome of this trial?

"The primary aim of this extensive study, which is projected to last up to 161 weeks, will be the evaluation of Best Overall Response (BOR) as per RECIST 1.1 in participants. Secondary objectives include establishing Minimum Serum Post-dose Concentration of Aveluamb, analysing Overall Survival Time with the Kaplan-Meier method, and determining participant's response status according to RECIST 1.1 at 6 and 12 months. CR: Elimination of all manifestations of target and non-target lesions; PR: Reduction by no less than 30% from baseline in sum diameter length for all lesions are used as qualifying parameters"

Answered by AI

Are there any available spots remaining in this clinical investigation?

"According to clinicaltrials.gov, this medical trial is not currently open for recruitment as it was last updated on April 21st 2022 after being posted in July 2014. However, along with other 2586 active studies there are still plenty of opportunities for potential participants to get involved today."

Answered by AI

Could you provide insight into the potential risks associated with Avelumab treatment?

"Avelumab's safety has been assessed as a 2 because this is an ongoing Phase 2 trial and there are some reports on its safety but none regarding its efficacy."

Answered by AI

Is this clinical trial a pioneering endeavor?

"Avelumab first entered clinical research in 2014, with its sponsor being EMD Serono Research & Development Institute, Inc. After the success of its Phase 1 trial involving 204 participants, this drug was granted approval for further development. Currently there are 112 active studies running across 1024 cities and 52 countries that make use of Avelumab to treat a variety of medical conditions."

Answered by AI

How many North American hubs are currently conducting this research?

"Currently, 14 clinical sites are administering this trial. These locations include Tampa, Boston and Aurora as well as 11 others - it is beneficial for patients to pick the nearest site in order to limit travel expenses."

Answered by AI
Recent research and studies
~19 spots leftby Apr 2025