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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
Phase 3 trial testing Cyclophosphamide in Primary Mediastinal Lymphoma in 100 participants. Currently enrolling.
1 April 2029
Quick facts
| Lead sponsor | National Research Center for Hematology, Russia |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 April 2022 |
| Primary completion | 1 April 2029 |
| Estimated completion | 1 April 2029 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Doxorubicin Hydrochloride — full drug profile →
- Etoposide Phosphate
- Prednisolone — full drug profile →
- Rituximab
- Vincristine Sulfate (Vincristine Sulfate) — full drug profile →
- Filgrastim
- Pegfilgrastim
- Nivolumab 40 mg in 4 ml Injection — full drug profile →
Conditions studied
- Primary Mediastinal Lymphoma — all drugs for Primary Mediastinal Lymphoma →
Sponsor
National Research Center for Hematology, Russia — full company profile →
Who can join
Adults 18 to 70, any sex, with Primary Mediastinal Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Prognostic impact of biomarkers in PMBCL: rationale for early integration of immune checkpoint inhibitors.
Mangasarova YK, Abdurashidova RR, Risinskaya NV, Biderman BV, et al · · 2025 · PMID 40416849 · DOI 10.37349/etat.2025.1002318
Verify or expand the search:
- PubMed search for NCT06188676
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Primary Mediastinal Lymphoma
Currently open trials in the same condition.
- NCT05518383 — B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021 · Phase 4 · recruiting
Other National Research Center for Hematology, Russia trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06188676 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Research Center for Hematology, Russia
- Last refreshed: 3 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06188676.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing