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Ibrutinib and Pembrolizumab in Treating Patients with Relapsed or Refractory Mantle Cell Lymphoma


Active: Yes
Cancer Type: Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
NCT ID: NCT03153202
Trial Phases: Phase I
Phase II
Protocol IDs: 17-0554 (primary)
NCI-2017-01538
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Icahn School of Medicine at Mount Sinai
NCI Full Details: http://clinicaltrials.gov/show/NCT03153202

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 (relapsed) or does not respond to treatment (refractory). 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 OBJECTIVE:
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. Cycles 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.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.