Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia

NCT03514017 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: MCC-19199
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the impact of sequential overlapping treatment with PD-1 monoclonal antibody (mAb), pembrolizumab/MK-1375, followed by ibrutinib on endogenous immune function in previously untreated, high-risk CLL patients. Immune function will be evaluated through various laboratory correlative tests.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Lymphocytic; Leukemia; CLL; Blood disease; White blood cells; Bone marrow disease; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate (ORR) to the Therapeutic Intervention

  Response categories according to The International Workshop on Chronic Lymphocytic Leukemia (IWCLL): Complete remission (CR); Complete remission with incomplete marrow recovery (CRi); Partial remission (PR); Progressive disease (PD); Stable disease (SD), defined as not meeting criteria for CR, CRi, PR or PD.

  Up to 2 years

• Time to Best Response

  Time to best response to chronic lymphocytic leukemia (CLL) to the therapeutic intervention.

  Up to 2 years

Secondary Outcomes (1)

• Progression-free Survival (PFS)

  Up to 2 years

Study Arms (1)

Pembrolizumab and Ibrutinib

EXPERIMENTAL

Treatment with pembrolizumab and ibrutinib and follow-up period of up to 24 months. Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib is a small-molecule inhibitor of BTK.

Drug: Pembrolizumab; Drug: Ibrutinib

Interventions

Pembrolizumab DRUG

Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years.

Also known as: Keytruda®

Pembrolizumab and Ibrutinib

Ibrutinib DRUG

Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily).

Also known as: Imbruvica®

Pembrolizumab and Ibrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have high risk CLL
• Have documented previously untreated CLL according to IWCLL criteria
• Willing and able to provide written informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Demonstrate adequate organ function
• Able to take oral medication and willing to adhere to the medication regimen

You may not qualify if:

• Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment
• Meets IWCLL criteria to start therapy
• Has had any treatment for CLL including any investigational agent, chemotherapy, mAb, anti-PD-1, anti-PDL-1, or anti-CTLA-4
• Transformation of CLL to aggressive NHL (Richter's transformation or pro-lymphocytic leukemia)
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 90 days after the last dose of trial treatment
• Major surgery or a wound that has not fully healed within 4 weeks of first dose
• Additional criteria may apply

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: collaborator
• Janssen Scientific Affairs, LLC: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia; Hematologic Diseases; Bone Marrow Diseases

Interventions

pembrolizumab; ibrutinib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Julio Chavez, MD, MS
• Organization: Moffitt Cancer Center

julio.c.chavez@moffitt.org

813-745-4294

Study Officials

• Julio Chavez, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 2, 2018
• Study Start: May 31, 2019
• Primary Completion: May 16, 2023
• Study Completion: May 16, 2023
• Last Updated: March 2, 2026
• Results First Posted: September 25, 2023

Record last verified: 2026-02

Locations

US (1)