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

NCT03089658

Last updated date
Study Location
Avelumab ATU Unit
Lyon, , , France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Merkel Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Metastatic Merkel Cell CarcinomaExpanded Access to Avelumab for Treatment of Metastatic Merkel Cell Carcinoma (mMCC)
NCT03089658
  1. Lyon,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Expanded Access to Avelumab for Treatment of Metastatic Merkel Cell Carcinoma (mMCC)
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.
Detailed Description Not Provided
Study Type Expanded Access
Intervention 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Approved for marketing
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03089658
Responsible Party Merck KGaA, Darmstadt, Germany
Study Sponsor Merck KGaA, Darmstadt, Germany
Collaborators Pfizer
Investigators Not Provided
PRS Account Merck KGaA, Darmstadt, Germany
Verification Date October 2019