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Clinical Trial 19199

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT03514017

Phase: Phase II
Prinicipal Investigator:

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Overview

Study Title

Phase II Trial of Ibrutinib and PD-1 Blockade in High Risk Chronic Lymphocytic Leukemia to Improve Immune Function.

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.

Objective

Primary: 1. Assessment of the overall response rate (ORR) of CLL to therapeutic intervention (defined per current iWCLL 2008 response criteria). 2. Time to response of CLL to therapeutic intervention (defined as time to achievement of response according to iWCLL 2008 criteria). Secondary Objectives: 1. Restoration of immune response as measured by: a. Decreased markers of T-cell exhaustion. b. Increased of quantitative immunoglobulin levels and subtype. 2. Safety and toxicity of the combination. 3. Progression free survival (PFS). 4. Incidence of Richter's transformation.

Treatments

Therapies

Medications

748645 (Ibrutinib); Ibrutinib (Imbruvica); PCI-32765 (Ibrutinib); Pembrolizumab (Keytruda)

Inclusion Criteria

  • 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

  • Exclusion Criteria

  • 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

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