Combining nivolumab with chemotherapy for newly diagnosed primary mediastinal lymphoma
Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma
PHASE3 · National Research Center for Hematology, Russia · NCT06188676
This study is testing if adding a new immune-boosting drug called nivolumab to standard chemotherapy can help people with newly diagnosed primary mediastinal lymphoma do better in their treatment.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | National Research Center for Hematology, Russia (network) |
| Drugs / interventions | nivolumab, rituximab, chemotherapy, immunotherapy |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06188676 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the safety and efficacy of nivolumab at a fixed dose of 40 mg combined with chemo-immunotherapy against chemo-immunotherapy alone in patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). The approach utilizes nivolumab, a monoclonal antibody that enhances the immune system's ability to target cancer cells, alongside traditional chemotherapy agents. The study aims to determine if this combination can improve treatment outcomes for patients with PMBCL. Participants will receive a regimen that includes chemotherapy drugs and rituximab, which targets CD20 on B cells.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with histologically confirmed primary mediastinal B-cell lymphoma and an ECOG performance status of 0-2.
Not a fit: Patients with uncontrolled infections, severe organ failure, or significant psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for patients with primary mediastinal lymphoma, potentially improving survival rates.
How similar studies have performed: While the combination of immunotherapy and chemotherapy has shown promise in other studies, this specific approach with nivolumab in PMBCL is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Moscow
- National Research Center for Hematology — Moscow, Russia (RECRUITING)
Study contacts
- Study coordinator: Yana Mangasarova, MD
- Email: v.k.jana@mail.ru
- Phone: +74956122361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Primary Mediastinal Lymphoma, PET-adapted Treatment, Nivolumab at the fixed dose 40 mg, R-DA-EPOCH