Phase I/II Study of Nivolumab in Combination With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma

NCT03681561 Phase 1/Phase 2 RECRUITING

This is a Phase I/II, multicenter, open-label, dose escalation/dose-expansion study to evaluate the tolerability, safety, and the maximum tolerated dose (MTD) of ruxolitinib when given with fixed dose nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

Details

Lead sponsor	Veronika Bachanova
Phase	Phase 1/Phase 2
Status	RECRUITING
Enrolment	54
Start date	2018-09-13
Completion	2027-07

Conditions

• Hodgkin Lymphoma

Interventions

• Ruxolitinib
• Nivolumab

Primary outcomes

• Maximum Tolerated Dose — 24 months
  To assess the maximum tolerated dose (MTD) of ruxolitinib in combination with nivolumab in patients with relapsed/refractory Hodgkin lymphoma. (Phase I Only)
• Overall Disease Control — 24 months
  To evaluate the best Overall Disease Control (CR+PR+SD) at 3 months of nivolumab in combination with ruxolitinib at MTD in patients with relapsed/refractory Hodgkin lymphoma using the modified Lugano Classification "lymphoma response criteria to immunomodulatory therapy criteria" (LYRIC)1 (Phase II Only)

Countries

United States