A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Lymphomas

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmacyclics LLC.
• Collaborators: AstraZeneca; Janssen Research & Development, LLC
• Treatments: Antibodies, Monoclonal; Durvalumab

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:

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