Expanded Access to Avelumab for Treatment of Metastatic Merkel Cell Carcinoma (mMCC)
NCT03089658
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Adult Trials: 18+ Years
- 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
- 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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| 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 |