NCT03681561

Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Veronika Bachanova · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Ruxolitinib	Phase I: Ruxolitinib at assigned dose\* twice daily by mouth begin Day 1 and continuing daily until study treatment stop. * Dose Levels: 1. (starting) : 10mg twice daily 2: 15mg twice daily 3: 20mg: twice daily Phase II: Ruxolitinib 20mg twice daily by mouth begin Day 1 and continuing daily until study treatment stop.
DRUG	Nivolumab	Nivolumab 480 mg IV every 4 weeks (Day 1) Until disease progression, unacceptable toxicity, patient refusal or a maximum of 2 years

Timeline

• Start date: 2018-09-13
• Primary completion: 2026-03-01
• Completion: 2027-07-01
• First posted: 2018-09-24
• Last updated: 2026-03-09

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study