INCB040093 and INCB040093 Combined With Itacitinib (INCB039110) in Relapsed/Refractory Hodgkin Lymphoma

A Phase 2, Open-Label Study of the Safety and Efficacy of INCB40093 and INCB40093 Combined With Itacitinib (INCB039110) in Subjects With Relapsed or Refractory Hodgkin Lymphoma

A Phase 2, open-label study to evaluate the safety and efficacy of INCB040093 as monotherapy and as combination therapy with itacitinib (INCB039110) in subjects with relapsed or refractory Hodgkin Lymphoma.

Inclusion Criteria:

• Men and women, aged 18 years or older
• Histologically confirmed diagnosis of classical HL
• Must be relapsed or refractory after autologous stem cell transplant (ASCT) and/or 2 or more prior chemotherapy regimens
• Must have had prior treatment with brentuximab vedotin or not a candidate for treatment with brentuximab vedotin
• Eastern Cooperative Oncology Group (ECOG) 0 to 2

Exclusion Criteria:

• Laboratory parameters not within the protocol-defined range
• Received an investigational study drug within 28 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug.
• Received any approved anticancer medications within 21 days or 5 half-lives (whichever is longer) prior to receiving their first dose of study drug EXCEPT steroids at ≤ 10 mg prednisone daily (or equivalent).
• Has any unresolved toxicity ≥ Grade 2 from previous anticancer therapy
• Received autologous stem cell transplant within 28 days or allogeneic transplant within 3 months prior to first dose of study drug
• History of lymphoma involving the central nervous system
• Evidence of active or prior hepatitis infection.