Overview

This trial is active, not recruiting.

Conditions diffuse large b-cell lymphoma, follicular lymphoma
Treatments ibrutinib, medi4736
Phase phase 1/phase 2
Targets BTK, PD-1
Sponsor Pharmacyclics
Collaborator AstraZeneca
Start date May 2015
End date April 2018
Trial size 109 participants
Trial identifier NCT02401048, PCYC-1136-CA

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of the combination treatment of ibrutinib and MEDI4736 in patients with relapsed or refractory lymphomas.

United States Alabama, California, Massachusetts, Michigan, Ohio, and Pennsylvania
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Dose determination safety cohort
ibrutinib
medi4736
(Experimental)
Will use the recommended Phase 2 doses determined in the Phase 1 portion
ibrutinib
medi4736
(Experimental)
Will use the recommended Phase 2 doses determined in the Phase 1 portion
ibrutinib
medi4736

Primary Outcomes

Measure
Phase 1b/2 (Number and type of adverse events)
time frame: Approximately 12 months

Secondary Outcomes

Measure
Phase Ib/2 (Overall response rate)
time frame: Approximately 12 months
Phase Ib/2 (Pharmacokinetics of ibrutinib) Cmax
time frame: Approximately 2 months
Phase Ib/2 (Pharmacokinetics of ibrutinib) AUC0-24
time frame: Approximately 2 months
Phase Ib/2 (Pharmacokinetics of MEDI4736) Cmax
time frame: Approximately 8 months
Phase Ib/2 (Pharmacokinetics of MEDI4736) Ctrough
time frame: Approximately 8 months
Phase Ib/2 (Pharmacodynamics of ibrutinib) Btk occupancy after ibrutinib administration
time frame: Approximately 1 month

Eligibility Criteria

Male or female participants at least 18 years old.

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: 1. Absolute Neutrophil Count >1500 cells/mm3 2. Platelets >50000 cells/mm3 3. Hemoglobin >8.0 g/dL - Adequate hepatic and renal function: 1. AST or ALT ≤2.5 x ULN 2. Bilirubin ≤1.5 x ULN 3. 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

Additional Information

Official title A Multi-Center Open-Label Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With MEDI4736, in Subjects With Relapsed or Refractory Lymphomas
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Pharmacyclics.