NCT03343665CompletedPhase 1
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 enrollmentStarted: August 1, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Overall Response Rate (ORR)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
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.
Intervention: Nivolumab 40 mg in 4 ml Injection (Drug)
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)
Investigators
Ivan S Moiseev
Vice-director for science of R.M. Gorbacheva Memorial Institute of Hematology, Oncology and Transplantation
St. Petersburg State Pavlov Medical University
Study Sites (1)
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