NCT03439501

Avelumab in Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma[AVENT STUDY]

A Phase II Study of Avelumab in Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study was conducted to evaluate the complete response rate of avelumab in patients with NK / T-cell lymphoma besides relapsed or refractory stage lymphoma.

Detailed description

Extranodal natural killer/T-cell lymphoma (ENKTL) generally has poorer prognosis than other lymphomas because the majority of patients are present as advanced disease and show poor response to treatment. In particular, treatment of relapsed or refractory stage ENKTL is very poor and there is no standard treatment. ENKTL is entirely infected with Epstein-Barr virus (EBV) and the prevalence of this disease is closely related to EBV. Therefore, the biological properties of ENKTL may be affected by EBV-related protein and LMP1 may induce activation of molecules in various sub-channels, such as PI3K/Akt and NF-kB, and affect the aggressiveness of lymphoma. As an increase in PDL1 has been reported recently among the major roles of LMP1, the role of Immuno-oncology drug targeting PDL1 among ENKTL is expected. Therefore, Avelumab that inhibits PDL1 may effectively treat NK/T-cell lymphoma besides relapsed or refractory stage lymphoma.

Conditions

• Lymphoma, Extranodal NK-T-Cell

Interventions

Type	Name	Description
DRUG	avelumab	* Study drug: Avelumab (PD-L1 inhibitor; MSB0010718C) * Dosage: 10 mg per body weight (kg) of a subject every two weeks * One cycle consists of two injection of avelumab (28 days). * The treatment cycle will be repeated until progression of disease or unacceptable toxicity and dose adjustments are permitted for patients who are unable to tolerate the side effects of drugs within each cycle.

Timeline

• Start date: 2018-01-16
• Primary completion: 2022-01-30
• Completion: 2022-03-30
• First posted: 2018-02-20
• Last updated: 2021-09-24

Locations

1 site across 1 country: South Korea