Trials / Terminated
TerminatedNCT03514017
Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia
Phase II Trial of Ibrutinib and PD-1 Blockade in High Risk Chronic Lymphocytic Leukemia to Improve Immune Dysfunction
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pembrolizumab | Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years. |
| DRUG | Ibrutinib | 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). |
Timeline
- Start date
- 2019-05-31
- Primary completion
- 2023-05-16
- Completion
- 2023-05-16
- First posted
- 2018-05-02
- Last updated
- 2026-03-02
- Results posted
- 2023-09-25
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03514017. Inclusion in this directory is not an endorsement.