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NCT Number: NCT04981899

A 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

Nivolumab is an anti-PD-1 antibody highly effective in patients with relapsed/refractory classical Hodgkin lymphoma. A PET-adapted regimen of Nivo combined with ICE as first salvage therapy was shown to induce high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, allowing to omit salvage chemotherapy in a substantial proportion of r\\r cHL patients. This study evaluates the safety and efficacy of PET-adapted treatment of nivolumab at the fixed dose of 40 mg in combination with ifosfamide, carboplatin, and etoposide (NICE-40) in patients with relapsed/refractory Hodgkin Lymphoma.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National Medicine Research Center of oncology named after N.N. Petrov, Saint Petersburg, Pesochny, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Uncontrolled bacterial or fungal infection at the time of enrollment
  • Requirement for vasopressor support at the time of enrollment
  • Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms
  • Karnofsky index <30%
  • Pregnancy
  • Somatic or psychiatric disorder making the patient unable to sign an informed consent
  • Active or prior documented autoimmune disease requiring systemic treatment.

Treatment and study plan

Nivolumab

Drug

6 infusions of nivolumab at a fixed dose of 40 mg, 14 days apart, and infusion of nivolumab on day 0 of the NICE-40.

ifosfamide

Drug

5000 mg / m2, 24-hour infusion on day 2 of the NICE-40.

carboplatin

Drug

Optimized to get AUC = 5 (max. 800 mg) on day 2 of the NICE-40.

etoposide

Drug

100 mg / m2 intravenously on 1-3 days of the NICE-40.

Primary outcomes

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

    Time frame: 12 months

    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).

  2. 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 and Lugano 2014 criteria

Secondary outcomes

  1. Duration of Response (DOR)

    Time frame: 24 months

  2. Overall Survival (OS)

    Time frame: 24 months

  3. Progression-Free Survival (PFS)

    Time frame: 24 months

  4. Progression-Free Survival Rate (Post Autologous Transplant)

    Time frame: 24 months

    PFS is defined as the duration of time from start of transplant to time of progression or death, whichever occurs first.

  5. Overall Survival (Post Autologous Transplant)

    Time frame: 24 months

    OS is defined as the duration of time from start of transplant to time of death (due to any cause).

Sponsors and collaborators

Lead sponsor

St. Petersburg State Pavlov Medical University

Other

Registry information

Official study title

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

Acronym: NICE-40

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 29, 2021
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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