Expanded Access to Avelumab for Treatment of Metastatic Merkel Cell Carcinoma (mMCC)

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ClinicalTrials.gov Identifier: NCT03089658

Expanded Access Status : Approved for marketing

First Posted : March 24, 2017

Last Update Posted : October 9, 2019

Sponsor:

Collaborator:

Pfizer

Information provided by (Responsible Party):

Merck KGaA, Darmstadt, Germany

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Metastatic Merkel Cell Carcinoma	Drug: Avelumab

Study Design

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Study Type :	Expanded Access
Official Title:	Temporary Authorization for Use (ATU) to Avelumab for Treatment of Adult Patients With Metastatic Merkel Cell Carcinoma (mMCC)

Resource links provided by the National Library of Medicine

Drug Information available for: Avelumab

Genetic and Rare Diseases Information Center resources: Merkel Cell Carcinoma Neuroendocrine Tumor Neuroepithelioma

U.S. FDA: Expanded Access (Compassionate Use)

U.S. FDA Resources

Interventions

Intervention Details:

Drug: Avelumab
Avelumab should be administered intravenously as per the recommended dose. Administration of Avelumab should continue according to the recommended schedule until disease progression or unacceptable toxicity.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Previous or active autoimmune disease requiring systemic immunosuppressive therapy
Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma
Clinically significant (that is, active) cardiovascular disease: cerebral vascular accident / stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment) unstable angina, congestive heart failure (New York Heart Association Classification Class ≥ II), or serious cardiac arrhythmia requiring medication
Persisting toxicity related to prior therapy of Grade >1 NCI-CTCAE v 4.03 (alopecia and sensory neuropathy Grade ≤ 2 is acceptable)
Being treated with chronic systemic corticosteroids or other chronic therapeutic immunosuppression
Pregnant or lactating (for women of childbearing potential)
Not using a highly effective contraception if the risk of conception exists

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089658

Locations

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France
Avelumab ATU Unit
Lyon, France

Sponsors and Collaborators

Merck KGaA, Darmstadt, Germany

Pfizer

More Information

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Responsible Party:	Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier:	NCT03089658 History of Changes
Other Study ID Numbers:	MS100070_0308
First Posted:	March 24, 2017 Key Record Dates
Last Update Posted:	October 9, 2019
Last Verified:	October 2019

Keywords provided by Merck KGaA, Darmstadt, Germany:


Metastatic Merkel Cell Carcinoma Expanded Access Program Temporary Authorisation for Use Avelumab

Additional relevant MeSH terms:

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Carcinoma, Merkel Cell Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Polyomavirus Infections DNA Virus Infections Virus Diseases Tumor Virus Infections	Carcinoma, Neuroendocrine Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Adenocarcinoma Neoplasms, Nerve Tissue Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs

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