Phase 2
Completed N=61
A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Lymphomas
Source: ClinicalTrials.gov NCT02401048 ↗Enrolled (actual)
61
Serious AEs
54.1%
Results posted
Jun 2019
Primary outcomePrimary: Phase 1b/2 : Overall Response Rate of Number of Participants — 7; 8 Participants
Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of the combination treatment of ibrutinib and MEDI4736 in subjects with relapsed or refractory lymphomas.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1b/2 : Overall Response Rate of Number of Participants |
7; 8 | — |
| SECONDARY Phase 1b/ 2: Duration of Response |
11.3; NA | — |
| SECONDARY Phase 1b/ 2: Progression-free Survival (PFS) |
10.2; 2.6 | — |
| SECONDARY Phase 1b/2: Overall Survival |
NA; 5.1 | — |
| SECONDARY Phamacokinetics: Mean Maximum Observed Plasma Concentration (Cmax) for Ibrutinib |
196; 140; 155; 183 | — |
| SECONDARY Pharmacokinetics: Mean Time to Maximum Observed Plasma Concentration (Tmax) for Ibrutinib |
1.95; 2.01; 2.00; 2.07 | — |
| SECONDARY Pharmacokinetics: Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC0-24h) for Ibrutinib |
1078; 936; 1096; 1606 | — |
| SECONDARY Pharmacokinetics: Mean Terminal Elimination Half-Life (t1/2,Term) for Ibrutinib |
5.35; 6.43; 6.14; 5.27 | — |
| SECONDARY Pharmacokinetics: Mean Peak Plasma Concentration (Cmax) for MEDI4736 |
388 | — |
| SECONDARY Pharmacokinetics: Mean Trough Plasma Concentration (Ctrough) for MEDI4736 |
207 | — |
| SECONDARY Pharmacokinetics: MEDI4736 Accumulation Ratio for Cmax |
1.90 | — |
| SECONDARY Pharmacokinetics: MEDI4736 Accumulation Ratio for Ctrough |
3.31 | — |
| SECONDARY Bruton Tyrosine Kinase (BTK) Occupancy |
77.6; 91.2 | — |
| SECONDARY Pharmacodynamics of Ibrutinib in Subjects With Relapsed or Refractory Lymphomas |
83.1; 94.4 | — |
| SECONDARY Pharmacodynamics of MEDI4736 in Subjects With Relapsed or Refractory Lymphomas |
18.4; NA | — |
Eligibility Criteria
Inclusion Criteria
- Pathologically documented relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL)
- Measurable disease sites on CT scan (>1.5 cm in longest dimension)
- Adequate hematologic function:
- Absolute Neutrophil Count >1500 cells/mm3
- Platelets >50000 cells/mm3
- Hemoglobin >8.0 g/dL
- Adequate hepatic and renal function:
- AST or ALT ≤2.5 x ULN
- Bilirubin ≤1.5 x ULN
- Estimated creatinine clearance (Cockcroft-Gault) >40 mL/min
- ECOG 0 or 1
Exclusion Criteria
- Received prior therapies: ibrutinib, or other BTK inhibitor and/or anti-PD1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody
- Requires treatment or prophylaxis with a strong cytochrome P450 (CYP) 3A inhibitor
- Primary CNS lymphoma or evidence of CNS involvement by lymphoma
Data sourced from ClinicalTrials.gov (NCT02401048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.