Completed
Temporary Authorization for Use (ATU) to Avelumab for Treatment of Adult Patients With Metastatic Merkel Cell Carcinoma (mMCC)
What is being tested
Data Collection
Who is eligible
Adenocarcinoma+13
+ Carcinoma
+ DNA Virus Infections
Over 18 Years
+14 Eligibility Criteria
How is it accessible
Completed
Available upon a request by a licensed MDExpanded Access
Summary
Principal SponsorMerck KGaA, Darmstadt, Germany
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Expanded access to Avelumab solution for infusion will be made available for adult patients with mMCC whose disease has progressed after receiving at least one prior chemotherapy.
Official TitleTemporary Authorization for Use (ATU) to Avelumab for Treatment of Adult Patients With Metastatic Merkel Cell Carcinoma (mMCC)
Principal SponsorMerck KGaA, Darmstadt, Germany
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Conditions
Pathology
AdenocarcinomaCarcinomaDNA Virus InfectionsInfectionsNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueTumor Virus InfectionsVirus DiseasesCarcinoma, Merkel CellNeuroectodermal TumorsCarcinoma, NeuroendocrineNeuroendocrine TumorsPolyomavirus Infections
Criteria
3 inclusion criteria required to participate
Measurable metastatic Merkel cell carcinoma according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1), has failed at least one line of adequately dosed chemotherapy in the metastatic setting and has subsequently progressed (where adequate dosing is defined as a minimum of 2 cycles)
Not eligible for participation in any ongoing clinical trial for Merkel cell carcinoma including the Javelin Merkel 200 study (NCT02155647)
Adequate hematological, hepatic and renal function as defined in the protocol
11 exclusion criteria prevent from participating
Brain metastases
Prior organ transplantation, including allogeneic stem cell transplantation
History of testing positive for human immunodeficiency virus (HIV) or known AIDS or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Concurrent, active, malignant disease (other than Merkel cell carcinoma) with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ as defined in protocol
Show More Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center