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Ibrutinib

Phase 1

Chronic Lymphocytic Leukemia | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Nov 19, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment23
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03153202Study to Evaluate the Safety and Preliminary Efficacy of Ibrutinib and Pembrolizumab in Patients With Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)PHASE1 ACTIVE NOT_RECRUITING 23Jul 14, 2017Nov 1, 2026Nov 19, 20241 United States
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Study Endpoints
Primary Endpoints
Dose Limiting Toxicity (DLT)
up to 3 months

Safety of fixed dose as determined by DLT to determine recommended phase 2 dosing

Secondary Endpoints
Complete Response (CR) rate
up to 1 year
Progression-free Survival Rate
up to 1 year
Overall Survival Rate
up to 1 year
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Participants with CLLEXPERIMENTALParticipants with relapsed/ refractory Chronic Lymphocytic Leukemia (CLL) or 17p- CLL
Participants with MCLEXPERIMENTALParticipants with relapsed/ refractory Mantle Cell Lymphoma (MCL)
Interventions
NameTypeDescription
IbrutinibDRUGonce daily oral intake ibrutinib
PembrolizumabDRUG200mg IV pembrolizumab on Day 1 of each cycle
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT03153202studyFirstPostDate: changed