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
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Condition or disease | Intervention/treatment |
---|---|
Metastatic Merkel Cell Carcinoma | Drug: Avelumab |
Study Type : | Expanded Access |
Official Title: | Temporary Authorization for Use (ATU) to Avelumab for Treatment of Adult Patients With Metastatic Merkel Cell Carcinoma (mMCC) |

- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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

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
France | |
Avelumab ATU Unit | |
Lyon, France |
Responsible Party: | Merck KGaA, Darmstadt, Germany |
ClinicalTrials.gov Identifier: | NCT03089658 |
Other Study ID Numbers: |
MS100070_0308 |
First Posted: | March 24, 2017 Key Record Dates |
Last Update Posted: | October 9, 2019 |
Last Verified: | October 2019 |
Metastatic Merkel Cell Carcinoma Expanded Access Program Temporary Authorisation for Use Avelumab |
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 |