Last updated on November 2018

A Study to Evaluate Safety Pharmacokinetics Pharmacodynamics and Preliminary Efficacy of the Combination of Ibrutinib With Nivolumab in Participants With Hematologic Malignancies


Brief description of study

The purpose of this study is to determine the safety and to establish the recommended phase 2 dose (RP2D) for the combination of ibrutinib and nivolumab in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), follicular cell lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). Once the dose is optimized, the combination will be assessed for Pharmacokinetics, Pharmacodynamics, and preliminary efficacy, further safety in participants with CLL/SLL, FL or DLBCL and in participants with Richter syndrome.

Detailed Study Description

This is an open-label study, which consists of Part A (Dose Optimization Cohorts) and Part B (Expansion Cohorts). Part A consists of two dose optimization cohorts (cohort A1 and cohort A2) will determine the RP2D for the combination based on safety, pharmacokinetic, and pharmacodynamic assessments in participants with relapsed/refractory CLL/SLL or B-cell non-Hodgkin lymphoma (B-NHL). Part B consists 3 participant populations to further evaluate the safety and clinical activity of ibrutinib in combination with nivolumab: Cohort B1 (participants with CLL/SLL with del 17p or del 11q), Cohort B2 (participants with FL), Cohort B3 (participants with DLBCL) and Cohort B4 (participants with Richter syndrome). Part A and B will consist of Screening Period (28 days before enrollment), Treatment Period and Follow up Period (every 3 months until death or the end of study). Participants will receive nivolumab intravenously (Day 1 of every cycle) and ibrutinib orally once daily on a 14-day cycle. Efficacy will primarily be evaluated by International Workshop on Chronic Lymphocytic Leukemia (IWCLL) and International Working Group (IWG) for lymphoma guidelines. Participants' safety will be monitored throughout the study. Further exploration of pharmacokinetic/pharmacodynamic and biomarker information will be assessed throughout the trial.

Clinical Study Identifier: NCT02329847

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Winship Cancer Institute Emory University

Winship Cancer Institute Emory University
Atlanta, GA United States

Mt. Sinai School of Medicine

Mt. Sinai School of Medicine
New York, NY United States

Memorial Sloan Kettering Cancer Center

Memorial Sloan Kettering Cancer Center
New York, NY United States

University of Pittsburgh Medical Center

University of Pittsburgh Medical Center
Pittsburgh, PA United States

Flinders Medical Centre

Flinders Medical Centre
Bedford Park, Australia

St. Vincent's Hospital Sydney

St. Vincent's Hospital Sydney
Darlinghurst, Australia

Austin Hospital

Austin Hospital
Heidelberg, Australia

Princess Alexandra Hospital

Princess Alexandra Hospital
Woolloongabba, Australia

Rambam Medical Center

Rambam Medical Center
Haifa, Israel

Hadassah Medical Center

Hadassah Medical Center
Jeursalem, Israel

Sheba Medical Center

Sheba Medical Center
Ramat Gan, Israel

Sourasky (Ichilov) Medical Center

Sourasky (Ichilov) Medical Center
Tel Aviv, Israel

Zespol Szpitali Miejskich

Zespol Szpitali Miejskich
Chorzow, Poland

Klinika Hematologii i Transplantologii, UCK

Klinika Hematologii i Transplantologii, UCK
Gdansk, Poland

Malopolskie Centrum Medyczne

Malopolskie Centrum Medyczne
Krakow, Poland

Klinika Hematologii, Nowotworow Krwi i ...

Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku SPSK nr 1
Wroclaw, Poland

Hosp. Univ. Vall D Hebron

Hosp. Univ. Vall D Hebron
Barcelona, Spain

Hosp. Clinic I Provincial de ...

Hosp. Clinic I Provincial de Barcelona
Barcelona, Spain

Hosp. Gral. Univ. Gregorio Maranon

Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain

Hosp. Univ. Fund. Jimenez Diaz

Hosp. Univ. Fund. Jimenez Diaz
Madrid, Spain

Hosp. Clinico Univ. de Salamanca

Hosp. Clinico Univ. de Salamanca
Salamanca, Spain

Ankara University Medical Faculty

Ankara University Medical Faculty
Ankara, Turkey

Gazi University Medical Faculty

Gazi University Medical Faculty
Ankara, Turkey

American Hospital

American Hospital
Istanbul, Turkey

Recruitment Status: Closed


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