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

Metastatic Merkel Cell Carcinoma Clinical Trial

Official title:

Temporary Authorization for Use (ATU) to Avelumab for Treatment of Adult Patients With Metastatic Merkel Cell Carcinoma (mMCC)

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT03089658
• Other study ID #: MS100070_0308
• Status: Approved for marketing

Study information

• Verified date: October 2019
• Source: Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Merkel Cell
• Metastatic Merkel Cell Carcinoma

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.

Locations

Country	Name	City	State
France	Avelumab ATU Unit	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA, Darmstadt, Germany	Pfizer

Country where clinical trial is conducted

France,