NCT03343665

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

2.4 years

First QC Date

November 12, 2017

Last Update Submit

January 22, 2020

Conditions

Hodgkin Lymphoma

Keywords

Nivolumab

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Secondary Outcomes (4)

  • Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03

    12 months

  • Duration of Response (DOR)

    12 months

  • Progression-Free Survival (PFS)

    12 months

  • Overall Survival (OS)

    12 months

Study Arms (1)

Nivolumab 40 mg

EXPERIMENTAL

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

Interventions

Nivolumab 40 mg in 4 ml InjectionDRUG

40 mg by intravenous (IV) infusion on day 1 Duration of cycle 14 days

Also known as: Opdivo
Nivolumab 40 mg

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Pavlov State Medical University of St. Petersburg

Saint Petersburg, 197089, Russia

Location

Related Publications (1)

  • 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.

    PMID: 33062947DERIVED

MeSH Terms

Conditions

Hodgkin Disease

Interventions

NivolumabInjections

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Boris V Afanasyev, Ph.D

    St. Petersburg State Pavlov Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-director for science of R.M. Gorbacheva Memorial Institute of Hematology, Oncology and Transplantation

Study Record Dates

First Submitted

November 12, 2017

First Posted

November 17, 2017

Study Start

August 1, 2017

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

January 23, 2020

Record last verified: 2020-01

Locations

RU(1)