Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ibrutinib · 1 trial · 2 indications
Safety of fixed dose as determined by DLT to determine recommended phase 2 dosing
| Arm | Type | Description |
|---|---|---|
| Participants with CLL | EXPERIMENTAL | Participants with relapsed/ refractory Chronic Lymphocytic Leukemia (CLL) or 17p- CLL |
| Participants with MCL | EXPERIMENTAL | Participants with relapsed/ refractory Mantle Cell Lymphoma (MCL) |
| Name | Type | Description |
|---|---|---|
| Ibrutinib | DRUG | once daily oral intake ibrutinib |
| Pembrolizumab | DRUG | 200mg IV pembrolizumab on Day 1 of each cycle |
Inclusion Criteria: 1. Be willing and able to provide written informed consent/assent for the trial. 2. Be ³ 18 years of age on day of signing informed consent.c 3. Have measurable disease based on: 1. Lugano classification \[6\] (cohorts A,C) 2. International Workshop on CLL \[7\] (cohorts ...
Ibrutinib is an investigational small molecule being studied for the treatment of Chronic Lymphocytic Leukemia (CLL). It is currently in Phase 1 clinical development. The drug is being evaluated in combination with pembrolizumab in a clinical trial that also includes patients with Mantle Cell Lymphoma.
Ibrutinib is a kinase inhibitor, belonging to the -tinib class of drugs. It works by targeting kinases, which are enzymes involved in cell signaling and growth. This mechanism is being studied in the context of Chronic Lymphocytic Leukemia and other hematologic malignancies.
Ibrutinib is being developed by Merck & Company, Inc., a pharmaceutical company traded on the stock exchange under the ticker symbol MRK. The company is currently conducting clinical trials to evaluate the drug's safety and preliminary efficacy in patients with Chronic Lymphocytic Leukemia.
Ibrutinib is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants, and is designed to evaluate the safety and preliminary efficacy of the drug.
Ibrutinib is being studied in a Phase 1 clinical trial with the identifier NCT03153202. This trial evaluates the safety and preliminary efficacy of Ibrutinib in combination with pembrolizumab in patients with Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma. The trial is active but not recruiting, with an enrollment of 23 participants in the United States.