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

St. Petersburg State Pavlov Medical University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hodgkin Lymphoma

Treatments: Drug: Nivolumab 40 mg in 4 ml Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03343665

№30/17-н

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Nivolumab 40 mg

Experimental group

Description:

Experimental: Nivolumab Nivolumab 40 mg IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Treatment:

Drug: Nivolumab 40 mg in 4 ml Injection