Clinical trial · Interventional
Treatment With Nivolumab at the Fixed Dose 40 mg (Nivo40) in Patients With Relapsed/Refractory Hodgkins Lymphoma
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.
NCT03343665CI-TRIAL-00042952Nivo40completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab 40 mg in 4 ml Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nivolumab 40 mg
- 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.
- interventionNames
- Drug: Nivolumab 40 mg in 4 ml Injection
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- 12 months
- 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
Secondary outcomes (4)
- measure
- Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLepik 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 33062947