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Mogamulizumab and Pembrolizumab in Treating Patients With Relapsed or Refractory Lymphomas

2017-10-19 18:41:10 | BioPortfolio

Summary

This randomized phase I/II trial studies the best dose and side effects of mogamulizumab in combination with pembrolizumab and to see how well they work in treating patients with lymphomas that have come back after a period of improvement or does not respond to treatment. Monoclonal antibodies, such as mogamulizumab and pembrolizumab, may interfere with the ability of cancer cells to grow and spread.

Description

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of mogamulizumab when administered in combination with pembrolizumab in patients with relapsed, refractory lymphomas. (Phase I) II. To assess the safety and tolerability of mogamulizumab when administered in combination with pembrolizumab in patients with relapsed, refractory lymphomas. (Phase I) III. To assess the 12-month progression-free survival of mogamulizumab when administered in combination with pembrolizumab compared to pembrolizumab alone in patients with relapsed and refractory diffuse large B-cell lymphomas. (Phase II)

SECONDARY OBJECTIVES:

I. To observe and record anti-tumor activity. (Phase I) II. To assess the overall response rate, complete response rate, partial response rate, duration of response of mogamulizumab and pembrolizumab compared to pembrolizumab alone in patients with relapsed and refractory diffuse large B-cell lymphomas. (Phase II)

TERTIARY OBJECTIVES:

I. To determine whether 12-month progression-free survival of mogamulizumab and pembrolizumab when administered to patients with relapsed and refractory diffuse large B-cell lymphomas differs based on the presence or absence of mutations in B2M or CD58 or amplifications in PD-L1.

II. To determine whether 12-month progression-free survival of mogamulizumab and pembrolizumab when administered to patients with relapsed and refractory diffuse large B-cell lymphomas differs based on changes in CD8 T-cell, natural killer (NK) cell, and FoxP3+ regulatory T cell (Treg) prevalence in response to therapy as measured by immunohistochemistry.

III. To determine whether mogamulizumab and pembrolizumab alters the prevalence, immunophenotype and function of peripheral blood regulatory T-cells as well as effector CD4 and CD8 T-cells by multi-parametric flow cytometry.

IV. To determine whether differences in tumor metabolism as measured by liquid chromatography-mass spectrometry (LC-MS) correlate with differences in baseline immune infiltration as measured by ribonucleic acid sequencing (RNA-seq) or with 12-month progression-free survival of mogamulizumab and pembrolizumab when administered to patients with relapsed and refractory diffuse large B-cell lymphomas.

OUTLINE: This is a phase I, dose-escalation study of mogamulizumab followed by a phase II study. Patients are randomized to 1 of 2 arms.

ARM I: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and mogamulizumab IV over 60 minutes on days 1, 8 and 15 of course 1, then day 1 of subsequent courses.

ARM II: Patients receive pembrolizumab IV over 30 minutes on day 1.

In both arms, courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Study Design

Conditions

Diffuse Large B-Cell Lymphoma

Intervention

Laboratory Biomarker Analysis, Mogamulizumab, Pembrolizumab

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-10-19T18:41:10-0400

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Medical and Biotech [MESH] Definitions

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