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NCT Number: NCT06188676

Multicenter Study of Safety and Efficacy Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed PMBL

This compares the effects of nivolumab at a fixed dose of 40 mg with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.

Recruiting

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Key information

Conditions

Primary Mediastinal Lymphoma

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Research Center for Hematology

Moscow, 125167, Russia

Location status: Recruiting

Location contact

Yana Mangasarova, MD

CONTACT

[email protected]

+74956122361

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient must have histologically confirmed primary mediastinal B-cell lymphoma (PMBCL) as defined by World Health Organization (WHO) criteria Age 18-70 years old Ejection fraction greater than 50% ECOG 0-2 status Signed informed consent No severe concurrent illness measurable disease (at least one lesion that can be accurately measured in at least two dimensions on a CT scan, at least >15 mm in largest diameter

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

Cyclophosphamide

Drug

Ciclofosfamida

Doxorubicin hydrochloride

Drug

Adriamycin

Etoposide Phosphate

Drug

Etopophos

Prednisolone

Drug

Prednisolonum

Rituximab

Drug

Chimeric Anti-CD20 Antibody

vincristine sulfate

Drug

Oncovin

Filgrastim

Drug

G-CSF

pegfilgrastim

Drug

PEG-filgrastim

Nivolumab 40 mg in 4 ml Injection

Drug

Opdivo

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: From enrollment on the study to first occurrence of relapse/progression or death, assessed up to 5 years

    The primary analysis will be a one-sided Log-rank test stratified by choice of backbone and radiation therapy and whether the patient had a cycle of therapy prior to enrolling.

Secondary outcomes

  1. Efficacy-related event-free survival

    Time frame: Up to 5 years

    Will be analyzed using a one-sided stratified Log-rank test at alpha = 0.05 or 0.025, as appropriate, with events defined as progression, change in therapy due to a finding that led to concern about efficacy, biopsy + disease after 6 cycles of therapy, and death.

  2. Therapy-related event-free survival

    Time frame: Up to 5 years

    Will be analyzed using a one-sided stratified Log-rank test at alpha = 0.05 or 0.025, as appropriate, with events defined as progression, change in therapy due to a finding that led to concern about efficacy, biopsy + disease after 6 cycles of therapy, and death.

  3. Overall survival

    Time frame: Up to 5 years

    Will be analyzed using a one-sided stratified Log-rank test at alpha = 0.05 or 0.025, as appropriate, with events defined as only death.

Study contacts

Contact information is provided by the study sponsor or research team.

Euvgena Zvonkov, MD,PhD

CONTACT

[email protected]

+74956122361

Yana Mangasarova, MD

CONTACT

[email protected]

+74956122361

Sponsors and collaborators

Lead sponsor

National Research Center for Hematology, Russia

Network

Registry information

Official study title

Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Jan 3, 2024
Registry last updated
Jan 3, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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