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

Sponsor
St. Petersburg State Pavlov Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT03343665
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
28.6
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nivolumab 40 mg in 4 ml Injection
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Aug 1, 2017
Actual Primary Completion Date :
Dec 20, 2019
Actual Study Completion Date :
Dec 20, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    2. Duration of Response (DOR) [12 months]

    3. Progression-Free Survival (PFS) [12 months]

    4. Overall Survival (OS) [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 First Pavlov State Medical University of St. Petersburg Saint-Petersburg Russian Federation 197089

    Sponsors and Collaborators

    • St. Petersburg State Pavlov Medical University

    Investigators

    • Principal Investigator: Boris V Afanasyev, Ph.D, St. Petersburg State Pavlov Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ivan S Moiseev, Vice-director for science of R.M. Gorbacheva Memorial Institute of Hematology, Oncology and Transplantation, St. Petersburg State Pavlov Medical University
    ClinicalTrials.gov Identifier:
    NCT03343665
    Other Study ID Numbers:
    • №30/17-н
    First Posted:
    Nov 17, 2017
    Last Update Posted:
    Jan 23, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ivan S Moiseev, Vice-director for science of R.M. Gorbacheva Memorial Institute of Hematology, Oncology and Transplantation, St. Petersburg State Pavlov Medical University
    Nivolumab
    Additional relevant MeSH terms:
    Lymphoma
    Hodgkin Disease
    Nivolumab

    Study Results

    No Results Posted as of Jan 23, 2020