NCT02520791

Anti-ICOS Monoclonal Antibody MEDI-570 in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Follicular Variant or Angioimmunoblastic T-cell Lymphoma

A Phase I Trial of MEDI-570 in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) Follicular Variant and Angioimmunoblastic T-Cell Lymphoma (AITL)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of anti-inducible T-cell co-stimulator (ICOS) monoclonal antibody MEDI-570 in treating patients with peripheral T-cell lymphoma follicular variant or angioimmunoblastic T-cell lymphoma that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as anti-ICOS monoclonal antibody MEDI-570, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.

Detailed description

PRIMARY OBJECTIVE: I. To determine the safety, maximum tolerated dose and recommended phase II dose (RP2D) of anti-ICOS monoclonal antibody MEDI-570 (MEDI-570) in patients with refractory/relapsed peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), follicular lymphoma, mycosis fungoides (MF) and cutaneous T-cell lymphomas (CTCL). SECONDARY OBJECTIVES: I. To evaluate the pharmacokinetic profile of MEDI-570. II. To evaluate the overall response rate (ORR) and progression free survival (PFS) of MEDI-570 at all dose levels and in a 10-patient expansion cohort at the maximum tolerated dose (MTD). III. To determine short and long term effects of MEDI-570 at all dose levels on the immune system and on T-cell lymphocyte subsets. IV. To determine the relationship between ICOS expression on tumor cells and response to MEDI-570. EXPLORATORY OBJECTIVE: I. To evaluate biomarkers of response and resistance to MEDI-570 in the study population. OUTLINE: This is a dose-escalation study. Patients receive anti-ICOS monoclonal antibody MEDI-570 intravenously (IV) over 1-4 hours on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 6 weeks for 12 weeks.

Conditions

• Advanced Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
• Recurrent Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type
• Recurrent Grade 1 Follicular Lymphoma
• Recurrent Grade 2 Follicular Lymphoma
• Recurrent Grade 3a Follicular Lymphoma
• Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
• Recurrent Mycosis Fungoides
• Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
• Refractory Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type
• Refractory Grade 1 Follicular Lymphoma
• Refractory Grade 2 Follicular Lymphoma
• Refractory Grade 3a Follicular Lymphoma
• Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
• Stage IB Mycosis Fungoides AJCC v7
• Stage II Mycosis Fungoides AJCC v7
• Stage III Cutaneous T-Cell Non-Hodgkin Lymphoma
• Stage III Mycosis Fungoides AJCC v7
• Stage IV Cutaneous T-Cell Non-Hodgkin Lymphoma
• Stage IV Mycosis Fungoides AJCC v7

Interventions

Type	Name	Description
BIOLOGICAL	Anti-ICOS Monoclonal Antibody MEDI-570	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2016-09-13
• Primary completion: 2024-12-18
• Completion: 2026-12-24
• First posted: 2015-08-13
• Last updated: 2026-04-13

Locations

23 sites across 2 countries: United States, Canada