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

Primary Purpose

Hodgkin Lymphoma

Status
Completed
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
Nivolumab 40 mg in 4 ml Injection
Sponsored by
St. Petersburg State Pavlov Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring Nivolumab

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • First Pavlov State Medical University of St. Petersburg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nivolumab 40 mg

Arm 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.

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
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

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

Full Information

First Posted
November 12, 2017
Last Updated
January 22, 2020
Sponsor
St. Petersburg State Pavlov Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03343665
Brief Title
Treatment With Nivolumab at the Fixed Dose 40 mg (Nivo40) in Patients With Relapsed/Refractory Hodgkins Lymphoma
Acronym
Nivo40
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Petersburg State Pavlov Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma
Keywords
Nivolumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab 40 mg
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Nivolumab 40 mg in 4 ml Injection
Other Intervention Name(s)
Opdivo
Intervention Description
40 mg by intravenous (IV) infusion on day 1 Duration of cycle 14 days
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03
Description
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).
Time Frame
12 months
Title
Duration of Response (DOR)
Time Frame
12 months
Title
Progression-Free Survival (PFS)
Time Frame
12 months
Title
Overall Survival (OS)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris V Afanasyev, Ph.D
Organizational Affiliation
St. Petersburg State Pavlov Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Pavlov State Medical University of St. Petersburg
City
Saint-Petersburg
ZIP/Postal Code
197089
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33062947
Citation
Lepik KV, Fedorova LV, Kondakova EV, Zalyalov YR, Babenko EV, Lepik EE, Kotselyabina PV, Beynarovich AV, Popova MO, Volkov NP, Stelmakh LV, Baykov VV, Moiseev IS, Mikhailova NB, Kulagin AD, Afanasyev BV. A Phase 2 Study of Nivolumab Using a Fixed Dose of 40 mg (Nivo40) in Patients With Relapsed/Refractory Hodgkin Lymphoma. Hemasphere. 2020 Sep 23;4(5):e480. doi: 10.1097/HS9.0000000000000480. eCollection 2020 Oct.
Results Reference
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Treatment With Nivolumab at the Fixed Dose 40 mg (Nivo40) in Patients With Relapsed/Refractory Hodgkins Lymphoma

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