NCT03153202

Study to Evaluate the Safety and Preliminary Efficacy of Ibrutinib and Pembrolizumab in Patients With Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)

StatusActive, Not Recruiting

PhasePhase 1/2

SponsorJoshua Brody

Primary completionApr 2027 (estimated)

At risk: Primary completion moved at least 1 year 4 months later.

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Record History

All 11 versions: 10 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

Notable Oct 27, 2026 Primary completion pushed from Nov 2025 to Apr 2027 Show 5 more changesShow less
- Study completion pushed from Nov 2026 to Apr 2028
- Eligibility criteria expanded, about 32 words
- Secondary endpoints: details revised at 1 of 3 entries
- Collaborators: details revised at 1 of 1 entry
- Study description expanded, about 2 words
Minor Nov 16, 2024 Trial status: Recruiting to Active, Not Recruitingv10 Show 4 more changesShow less
- Enrollment target: 21 to 23
- Primary completion date: Dec 2025 to Nov 2025
- Study completion date: Dec 2025 to Nov 2026
- Site details revised
Notable Dec 20, 2023 Enrollment target: 40 to 21v9
Notable Sep 1, 2023 Primary and study completion dates pushed to Dec 2025v8
Notable Mar 2, 2021 Primary completion date: Apr 10, 2021 to Dec 2023
- Study completion date: Apr 10, 2021 to Dec 2024
v6

Show 4 earlier versionsHide 4 earlier versions

Notable May 20, 2020 Primary and study completion dates: Apr 10, 2020 to Apr 10, 2021
- Site contact updated
v5
Notable Apr 22, 2019 Primary and study completion dates: Apr 2019 to Apr 10, 2020v4
Minor Nov 16, 2018 Primary and study completion dates moved earlier to Apr 2019
- Site contact updated
v3
Notable Jul 19, 2017 Trial status: Not Yet Recruiting to Recruiting
- Start date changed from estimate of May 2017 to Jul 14, 2017
- Site details revised
v2

May 11, 2017 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Dose Limiting Toxicity (DLT)

Timeframe: up to 3 months

Secondary (3)

Complete Response (CR) rate

Progression-free Survival Rate

Overall Survival Rate

Arms and interventions

Participants with CLLExperimental

Participants with relapsed/ refractory Chronic Lymphocytic Leukemia (CLL) or 17p- CLL

Participants with MCLExperimental

Participants with relapsed/ refractory Mantle Cell Lymphoma (MCL)

Drugs: Ibrutinib, Pembrolizumab

Sites

1 site in 1 country

Icahn School of Medicine at Mount SinaiNew York, New York, United States

About this trial

The purpose of this study is to determine the most appropriate dose for the combination of ibrutinib and pembrolizumab and to see if the combination is active for the disease. The study will monitor for any side effects and if the combination of ibrutinib and pembrolizumab works in the cancers being studied. There will be 2 experimental drugs given to the subject in this study. One experimental drug used in this study is called ibrutinib and the second is called pembrolizumab. This is the first time that ibrutinib will be used in combination with pembrolizumab. This combination is considered experimental. Experimental means that it is still being tested to see if it is safe and effective. Ibrutinib is a new drug known as a 'Bruton's Tyrosine Kinase (BTK) inhibitor'. Ibrutinib blocks an enzyme (protein) that affects how certain types of blood cancer cells grow and survive. Blocking this enzyme is a very important mechanism in killing blood cancer cells. Ibrutinib has been approved in the United States, Israel, and the European Union for use in adult patients with mantle cell lymphoma (MCL) and adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Pembrolizumab is an antibody (a type of human protein) that is being tested to see if it will allow the body's immune system to work against tumor cells. Pembrolizumab is approved for use by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with melanoma (skin cancer) who have received prior treatments. Pembrolizumab is not FDA approved to treat patients with chronic lymphocytic leukemia \[CLL\] and mantle cell lymphoma \[MCL\].

Trial details

Enrollment: 23 participants (estimated)
Started: Jul 14, 2017
Study completion: Apr 2028 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, non-randomized, open label, treatment
Oversight: Data monitoring committee, FDA-regulated drug
Conditions: Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, Chronic Lymphocytic Leukemia
Collaborators: Merck Sharp & Dohme LLC
First posted: May 15, 2017
Registry updated: Oct 29, 2026
Last verified: Oct 2026

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