Last reviewed · How we verify
NCT03343665: Nivo40
Treatment With Nivolumab at the Fixed Dose 40 mg (Nivo40) in Patients With Relapsed/Refractory Hodgkins Lymphoma
Completed
Phase 1, PHASE2
Last updated 23 January 2020
What this trial tests
Phase 1, PHASE2 trial testing Nivolumab 40 mg in 4 ml Injection in Hodgkin Lymphoma in 30 participants. Completed in 20 December 2019.
Timeline
1 August 2017
Primary endpoint
20 December 2019
20 December 2019
20 December 2019
Quick facts
| Lead sponsor | St. Petersburg State Pavlov Medical University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 August 2017 |
| Primary completion | 20 December 2019 |
| Estimated completion | 20 December 2019 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Nivolumab 40 mg in 4 ml Injection — full drug profile →
Conditions studied
- Hodgkin Lymphoma — all drugs for Hodgkin Lymphoma →
Sponsor
St. Petersburg State Pavlov Medical University
Who can join
Adults 18 to 80, any sex, with Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A phase I/II trial to evaluate the safety and efficacy of nivolumab at the fixed dose 40 mg in patients with relapsed or refractory Hodgkins lymphoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Dosing Regimens of Immune Checkpoint Inhibitors: Attempts at Lower Dose, Less Frequency, Shorter Course.
Jiang M, Hu Y, Lin G, Chen C. · · 2022 · cited 36× · PMID 35795044 · DOI 10.3389/fonc.2022.906251 -
A Phase 2 Study of Nivolumab Using a Fixed Dose of 40 mg (Nivo40) in Patients With Relapsed/Refractory Hodgkin Lymphoma.
Lepik KV, Fedorova LV, Kondakova EV, Zalyalov YR, et al · · 2020 · cited 28× · PMID 33062947 · DOI 10.1097/hs9.0000000000000480 -
Checkpoint inhibition in hematologic malignancies.
Tsumura A, Levis D, Tuscano JM. · · 2023 · cited 14× · PMID 37920162 · DOI 10.3389/fonc.2023.1288172 -
Five-Year Follow-Up of Patients With Relapsed and Refractory Classic Hodgkin Lymphoma Treated With Low-Dose Nivolumab (40 mg): A Matched Cohort Study With Standard-Dose Therapy.
Fedorova L, Lepik K, Kotselyabina P, Balaeva A, et al · · 2025 · PMID 41076560 · DOI 10.1002/hon.70146 -
P062: The efficacy and safety of nivolumab 40 mg therapy versus 3 mg/kg in patients with relapsed and refractory classic Hodgkin lymphoma
Fedorova L, Lepik K, Mikhailova N, Kondakova E, et al · · 2022 -
Abstract Book for the 27th Congress of the European Hematology Association
· 2022 -
P1080: COMPARISON OF NIVOLUMAB 40 MG EFFICACY VERSUS 3 MG/KG IN PATIENTS WITH RELAPSED AND REFRACTORY CLASSIC HODGKIN LYMPHOMA
Fedorova L, Lepik K, Mikhailova N, Kondakova E, et al · · 2022 -
Abstract Book: 25th Congress of the European Hematology Association Virtual Edition, 2020
· 2020
Verify or expand the search:
- PubMed search for NCT03343665
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Nivolumab 40 mg in 4 ml Injection
Trials testing the same drug.
- NCT05492123 — Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer · Phase 2 · recruiting
- NCT06188676 — Multicenter Study of Safety and Efficacy Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunother · Phase 3 · recruiting
Other recruiting trials for Hodgkin Lymphoma
Currently open trials in the same condition.
- NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
- NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
- NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
- NCT06176690 — Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas · Phase 1 · recruiting
- NCT07002216 — BrECADD Therapy in Stage 2 B-IV Hodgkin Lymphoma · Phase 2 · recruiting
Other St. Petersburg State Pavlov Medical University trials
Trials by the same sponsor.
- NCT07238712 — Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies · Phase 2 · recruiting
- NCT06871007 — Nivolumab and DA-EPOCH-R in Pediatric Primary Mediastinal (Thymic) Large B-cell Lymphoma · Phase 1, PHASE2 · enrolling by invitation
- NCT05757466 — Prolgolimab Monotherapy or in Combination With Bendamustine for r/r Classical Hodgkin Lymphoma · Phase 2 · unknown
- NCT06022952 — The Impact of the "Stone MD" Mobile App on the Prevention of Forgotten Ureteral Stents · NA · unknown
- NCT05591716 — Evaluation of the Efficacy and Safety of Unimodal Bilateral Flexible Ureteroscopy. · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03343665 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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 St. Petersburg State Pavlov Medical University
- Last refreshed: 23 January 2020
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/NCT03343665.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing