Last updated on February 2020

A Phase Ib Study to Evaluate the Safety Tolerability and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12)

Brief description of study

The study consists of 2 parts: Dose Escalation phase (Part A) and Expansion phase (Part B). The dose escalation phase will evaluate the safety, tolerability, and PK of avelumab in combination with M9241 in subjects with locally advanced, unresectable, or metastatic solid tumors. Expansion phase will assess the safety and clinical activity of the combination regimen in selected tumor types. In Expansion phase subjects who have completed the combination treatment of avelumab at a given dose level of M9241, a safety review will be performed by the Safety monitoring committee in order to make a decision on the next dose level. Successive cohorts of 3 to 6 subjects will be treated with escalating doses of M9241 with avelumab intravenous (IV).

Clinical Study Identifier: NCT02994953

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Sharp Memorial Hospital

San Diego, CA United States
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St Joseph Heritage Healthcare

Santa Rosa, CA United States
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Holy Cross Hospital Inc.

Fort Lauderdale, FL United States
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Metairie Oncologists, LLC

Metairie, LA United States
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National Cancer Institute

Bethesda, MD United States
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Virginia Piper Cancer Institute

Minneapolis, MN United States
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Washington University

Saint Louis, MO United States
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UC Health, LLC.

Cincinnati, OH United States
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Cedar Sinai Medical Center

Ashland, OR United States
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Centre Hospitalier Lyon Sud

Pierre Benite cedex, France
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Centre Paul Strauss

Strasbourg Cedex, France
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