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Trial record 21 of 432 for:    Expanded Access Studies

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

Expanded access is currently available for this treatment.
Verified March 2017 by Merck KGaA
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT03089658
First received: March 20, 2017
Last updated: May 8, 2017
Last verified: March 2017
  Purpose
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 Intervention
Metastatic Merkel Cell Carcinoma
Drug: Avelumab

Study Type: Expanded Access     What is 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 NLM:


Further study details as provided by Merck KGaA:

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03089658

Contacts
Contact: Avelumab ATU Unit +33 1 44 90 39 09 atu-avelumab@parexel.com

Locations
France
Avelumab ATU Unit
Lyon, France
Sponsors and Collaborators
Merck KGaA
Pfizer
  More Information

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT03089658     History of Changes
Other Study ID Numbers: MS100070_0308
Study First Received: March 20, 2017
Last Updated: May 8, 2017

Keywords provided by Merck KGaA:
Metastatic Merkel Cell Carcinoma
Expanded Access Program
Temporary Authorisation for Use
Avelumab

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Merkel Cell
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

ClinicalTrials.gov processed this record on May 25, 2017