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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03343665
Other study ID # ?30/17-?
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date August 1, 2017
Est. completion date December 20, 2019

Study information

Verified date January 2020
Source St. Petersburg State Pavlov Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 20, 2019
Est. primary completion date December 20, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Nivolumab 40 mg in 4 ml Injection
40 mg by intravenous (IV) infusion on day 1 Duration of cycle 14 days

Locations

Country Name City State
Russian Federation First Pavlov State Medical University of St. Petersburg Saint-Petersburg

Sponsors (1)

Lead Sponsor Collaborator
St. Petersburg State Pavlov Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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). 12 months
Secondary Duration of Response (DOR) 12 months
Secondary Progression-Free Survival (PFS) 12 months
Secondary Overall Survival (OS) 12 months
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