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

January 22, 2020 updated by: Ivan S Moiseev, St. Petersburg State Pavlov Medical University

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Saint-Petersburg, Russian Federation, 197089
        • First Pavlov State Medical University of St. Petersburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Nivolumab 40 mg in 4 ml Injection
40 mg by intravenous (IV) infusion on day 1 Duration of cycle 14 days
Other Names:
  • Opdivo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 12 months
12 months
Progression-Free Survival (PFS)
Time Frame: 12 months
12 months
Duration of Response (DOR)
Time Frame: 12 months
12 months
Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03
Time Frame: 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).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Petersburg State Pavlov Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

December 20, 2019

Study Completion (Actual)

December 20, 2019

Study Registration Dates

First Submitted

November 12, 2017

First Submitted That Met QC Criteria

November 14, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • №30/17-н

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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