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

Primary Purpose

Metastatic Merkel Cell Carcinoma

Status

Approved for marketing

Phase

Locations

France

Study Type

Expanded Access

Intervention

Avelumab

About this trial

This is an expanded access trial for Metastatic Merkel Cell Carcinoma focused on measuring Metastatic Merkel Cell Carcinoma, Expanded Access Program, Temporary Authorisation for Use, Avelumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

Avelumab ATU Unit

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT03089658

First Posted

March 20, 2017

Last Updated

October 7, 2019

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT03089658

Brief Title

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

Official Title

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

Study Type

Expanded Access

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Approved for marketing

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Merkel Cell Carcinoma

Keywords

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

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Avelumab

Intervention Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Eligibility Criteria

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

Facility Information:

Facility Name

Avelumab ATU Unit

City

Lyon

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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