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A Phase 1 / 2a Study to Evaluate the Safety and Preliminary Efficacy of Ibrutinib and Pembrolizumab in Patients with Mantle Cell Lymphoma (MCL)

Status
Active
Cancer Type
Lymphoma
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03153202
Protocol IDs
17-0554 (primary)
NCI-2017-01538
Study Sponsor
Icahn School of Medicine at Mount Sinai

Summary

This phase I / IIa trial studies the side effects of ibrutinib and pembrolizumab and how well they work in treating patients with mantle cell lymphoma that has come back or does not respond to treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ibrutinib and pembrolizumab may work better in treating patients with mantle cell lymphoma.

Objectives

PRIMARY OBJECTIVES:
I. Assess the safety of fixed dose or, as needed, de-escalated ibrutinib/pembrolizumab in patients with mantle cell lymphoma (MCL) to determine recommended phase 2 dosing of ibrutinib. (Phase I)
II. Assess complete response (CR) rate of combination ibrutinib/pembrolizumab therapy, in comparison to historical data of ibrutinib monotherapy, in patients with MCL. (Phase IIa)

SECONDARY OBJECTIVES:
I. Assess duration of response, overall response rate, and duration of stable disease, compared to historical data of single agent ibrutinib, in patients with MCL. (Phase IIa)

EXPLORATORY OBJECTIVES:
I. Assess progression-free survival rate at 1 year and overall survival at 1 year of combination ibrutinib/pembrolizumab therapy, in comparison to historical data of ibrutinib monotherapy, in patients with MCL.
II. Assess TH2:TH1 skewing and checkpoint/costimulatory molecule expression (e.g. PD-1, CTLA-4, ICOS, OX40, GITR, CD137, BTLA, LAG3, ICOS, TIM3, TIGIT) across the immune cell repertoire as well as checkpoint/costimulatory molecule ligands (e.g. PD-L1, PD-L2, CD80, CD86) of patients during the 4 week lead-in of ibrutinib and then during pembrolizumab therapy, using mass cytometry.

OUTLINE:
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-21 and pembrolizumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 3 months.
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