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

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

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.

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