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

Conditions

Metastatic Merkel Cell Carcinoma

Keywords

Metastatic Merkel Cell Carcinoma, Expanded Access Program, Temporary Authorisation for Use, Avelumab

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.

Munhoz RR, Cayol F, Corrales L, Gerson R, Tilli M, Barreto EO, Sánchez Castillo JO, Schmerling RA, Cinat G.

2020-10-265 citations

10.1007/s00262-020-02756-9

Avelumab in European patients (pts) with metastatic Merkel cell carcinoma (mMCC): Experience from an ad hoc expanded access program (EAP)

Paolo A. Ascierto, Paul Nathan, V. Kasturi, Luc Dirix, Eyal Fenig et al. (10 authors)

Annals of Oncology2018-12-011 citations

10.1093/annonc/mdy487.010

Avelumab in European patients (pts) with metastatic Merkel cell carcinoma (mMCC): Experience from an ad-hoc expanded access program (EAP)

Paul Nathan, Vijay Kasturi, Luc Dirix, Eyal Fenig, P.A. Ascierto et al. (10 authors)

Annals of Oncology2018-10-013 citations

10.1093/annonc/mdy289.046

Second-line avelumab treatment of patients (pts) with metastatic Merkel cell carcinoma (mMCC): Experience from a global expanded access program (EAP).

John Walker, Vijay Kasturi, Célèste Lebbé, Shahneen Sandhu, Giovanni Grignani et al. (9 authors)

Journal of Clinical Oncology2018-05-205 citations

10.1200/jco.2018.36.15_suppl.9537

Interventions

DRUGAvelumab

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

Sex/Gender

ALL

Age

18 Years to No maximum

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

Countries

France

Outcome results

None listed