A Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of Nivolumab at the Fixed Dose 40 mg (Nivo40) in Patients With Relapsed or Refractory Hodgkins Lymphoma.

St. Petersburg State Pavlov Medical University1 site in 1 country30 target enrollmentAugust 1, 2017

ConditionsHodgkin Lymphoma

InterventionsNivolumab 40 mg in 4 ml Injection

DrugsNivolumab 40 mg in 4 ml Injection

Overview

Phase: Phase 1
Intervention: Nivolumab 40 mg in 4 ml Injection
Conditions: Hodgkin Lymphoma
Sponsor: St. Petersburg State Pavlov Medical University
Enrollment: 30
Locations: 1
Primary Endpoint: Overall Response Rate (ORR)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2017

End Date

December 20, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

St. Petersburg State Pavlov Medical University

Responsible Party

Principal Investigator

Ivan S Moiseev

Vice-director for science of R.M. Gorbacheva Memorial Institute of Hematology, Oncology and Transplantation

St. Petersburg State Pavlov Medical University

Eligibility 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.

Arms & Interventions

Nivolumab 40 mg

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.

Intervention: Nivolumab 40 mg in 4 ml Injection

Outcomes

Primary Outcomes

Overall Response Rate (ORR)

Time Frame: 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 Outcomes

Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03(12 months)
Progression-Free Survival (PFS)(12 months)
Overall Survival (OS)(12 months)
Duration of Response (DOR)(12 months)