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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

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

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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)



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.

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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

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

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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