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

Phase 1

Completed

• Conditions: Hodgkin Lymphoma
• Interventions: Drug: Nivolumab 40 mg in 4 ml Injection

• Registration Number: NCT03343665
• Lead Sponsor: St. Petersburg State Pavlov Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-11-12
• Study First Submitted QC: 2017-11-14
• Study First Posted: 2017-11-17
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nivolumab 40 mg	Nivolumab 40 mg in 4 ml Injection	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.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	12 months	Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by LYRIC criteria

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DOR)	12 months
Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03	12 months	Toxicity parameters based on NCI CTCAE 4.03 grades: hematological toxicity (CBC), hepatotoxicity (liver function tests), nephrotoxicity (creatinine), neurotoxicity (attending physician assessment), fatigue (attending physician assessment), rash (attending physician assessment), colitis (attending physician assessment), pneumonitis (attending physician assessment), autoimmune disorders (level of hormones, presence of autoimmune antibodies, attending physician assessment).
Progression-Free Survival (PFS)	12 months
Overall Survival (OS)	12 months

Trial Locations

Locations (1)

First Pavlov State Medical University of St. Petersburg; 🇷🇺 Saint-Petersburg, Russian Federation