NCT04981899CompletedPhase 2
PET-Adapted Low-Dose Nivolumab With NICE-40 for Relapsed/Refractory Classical Hodgkin Lymphoma
Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab at the Fixed Dose 40 mg, Ifosfamide, Carboplatin, Etoposide (NICE-40) in Patients With Relapsed/Refractory Hodgkin Lymphoma
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
Nivolumab is an anti-PD-1 antibody with high activity in patients with relapsed/refractory classical Hodgkin lymphoma (r/r cHL). A PET-adapted strategy using nivolumab with ICE added for patients without complete response has shown high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, while allowing omission of salvage chemotherapy in a substantial proportion of patients. This study evaluates the safety and efficacy of a PET-adapted strategy using fixed-dose nivolumab 40 mg, with ifosfamide, carboplatin, and etoposide (NICE-40) administered to patients without complete response to nivolumab monotherapy.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (actual)
- First submitted
- 19 Jul 2021
- Start date
- 1 Mar 2021
- Primary completion date
- 1 May 2026
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Diseases
- Hodgkin lymphoma
- NCT number
- NCT04981899
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 37
- From 1 Mar 2021 to the primary completion date, 1 May 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active or prior documented autoimmune disease requiring systemic treatment.
Other illness
- Uncontrolled bacterial or fungal infection at the time of enrollment
- Somatic or psychiatric disorder making the patient unable to sign an informed consent
Lab values
- Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms
Other
- Requirement for vasopressor support at the time of enrollment
- Karnofsky index \<30%
- Pregnancy
Who the study is looking for
- Diagnosis: Histologically confirmed Hodgkins lymphoma
- Relapsed or refractory disease after the first line of treatment
- Age 18-70 years old
- Ejection fraction greater than 50%
- ECOG 0-2 status
- Signed informed consent
- No severe concurrent illness
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Irkutsk State Regional Children's Clinical Hospital Coordinator of this site? Confirm its status | Irkutsk | Russia | Unknown status |
| Irkutsk Regional Cancer Center Coordinator of this site? Confirm its status | Irkutsk | Russia | Unknown status |
| Moscow Clinical Research Center Hospital 52 of the Moscow City Health Department Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| National Medicine Research Center of oncology named after N.N. Petrov Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| St. Petersburg State Pavlov Medical University Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.