Treatment With Nivolumab at the Fixed Dose 40 mg (Nivo40) in Patients With Relapsed/Refractory Hodgkins Lymphoma

• Status: Completed
• Trial end date: 2019-12-20
• Target enrollment: 0
• Participant gender: All

Summary

A phase I/II trial to evaluate the safety and efficacy of nivolumab at the fixed dose 40 mg in patients with relapsed or refractory Hodgkins lymphoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Petersburg State Pavlov Medical University
• Treatments: Antibodies, Monoclonal; Nivolumab

Criteria

Inclusion Criteria:

• Diagnosis: Histologically confirmed Hodgkins lymphoma

• Relapsed or refractory disease after at least two prior lines of treatment

• Age 18-70 years old

• Signed informed consent

• No severe concurrent illness

Exclusion Criteria:

• Uncontrolled bacterial or fungal infection at the time of enrollment

• Requirement for vasopressor support at the time of enrollment

• Karnofsky index <30%

• Pregnancy

• Somatic or psychiatric disorder making the patient unable to sign informed consent

• Active or prior documented autoimmune disease requiring systemic treatment.