A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Inclusion Criteria:

- Histologically documented diagnosis of DLBCL.

- Phase 1: any DLBCL subtype.

- Phase 2: activated B-cell or unclassifiable subtypes confirmed by
immunohistochemistry using the Hans algorithm

- Relapsed or refractory DLBCL, defined as having received at least 1 but no more than 3
prior treatment regimens and ineligible for high-dose chemotherapy/autologous stem
cell transplant.

- Fluorodeoxyglucose-avid disease (based on local evaluation) per the Lugano
Classification. Fluorodeoxyglucose-avid disease is defined as disease with a 5-point
scale score of 4 or 5.

- Archived tumor tissue (block or 15-20 unstained slides) available, or be willing to
undergo an incisional or excisional lymph node biopsy of accessible adenopathy (or, in
less accessible lymph nodes, 4 to 8 core biopsies).

- At least 1 measurable (≥ 2 cm in longest dimension) lesion on CT scan or magnetic
resonance imaging (MRI).

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Exclusion Criteria:

- Transformed DLBCL or DLBCL with coexistent histologies (eg, follicular or
mucosa-associated lymphoid tissue lymphoma).

- Primary mediastinal (thymic) large B-cell lymphoma.

- Known central nervous system lymphoma (either primary or metastatic).

- Allogeneic stem cell transplant within the previous 6 months, or active graft versus
host disease following allogeneic transplant.

- Use of immunosuppressive therapy within 28 days of starting study treatment.
Immunosuppressive therapy includes but is not limited to cyclosporine A, tacrolimus,
or high-dose corticosteroids. Subjects receiving corticosteroids must be at a dose
level ≤ 10 mg/day within 7 days of initiating study treatment.

- Prior or concurrent therapy with a Janus kinase inhibitor or Bruton's tyrosine kinase
inhibitor