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Kinase Inhibitor

Pembrolizumab for Chronic Lymphocytic Leukemia

Phase 2
Waitlist Available
Led By Julio Chavez, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have high risk CLL
Have documented previously untreated CLL according to IWCLL criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial will study the effect of combining two drugs, pembrolizumab/MK-1375 and ibrutinib, on patients with high-risk chronic lymphocytic leukemia who have not been treated before. Researchers will look at how well the drugs work and how they affect the patients' immune system.

Eligible Conditions
  • Chronic Lymphocytic Leukemia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR) to the Therapeutic Intervention
Time to Best Response
Secondary outcome measures
Progression-free Survival (PFS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab and IbrutinibExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950
Ibrutinib
2014
Completed Phase 3
~1880

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
537 Previous Clinical Trials
134,986 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,695 Total Patients Enrolled
Janssen Scientific Affairs, LLCIndustry Sponsor
157 Previous Clinical Trials
579,667 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby Mar 2025