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Expanded Access to Avelumab for Treatment of Metastatic Merkel Cell Carcinoma (mMCC) | Clinical Trials | Clareo Health

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

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

NCT03089658•Merck KGaA, Darmstadt, Germany

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)

Exclusion Criteria

•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
+2 more criteria

Locations (1)

Avelumab ATU Unit

Lyon, France

Key Dates

Last Updated

October 9, 2019

Conditions

Metastatic Merkel Cell Carcinoma

Interventions

Avelumab

DRUG

Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma

NCT06947928

Advanced Or Metastatic Merkel Cell Carcinoma

View study

RECRUITINGPHASE1/PHASE2

Targeted Therapy and Avelumab in Merkel Cell Carcinoma

NCT04261855

Metastatic Merkel Cell Carcinoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 9, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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