Clinical trial · Interventional
Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma
NCT03004833CI-TRIAL-00088052NIVAHLcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the trial is to improve first-line treatment for early unfavorable cHL by introduction of the anti-PD-1 antibody Nivolumab with a truncated standard chemotherapy (AVD). The primary objective is to show efficacy of the two experimental treatment strategies. Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Classical Hodgkin Lymphoma | Classic Hodgkin Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adriamycin | Drug | — | UNRESOLVED |
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- 4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy)
- interventionNames
- Drug: Nivolumab
- Drug: Adriamycin
- Drug: Vinblastine
- Drug: Dacarbazine
- type
- EXPERIMENTAL
- label
- Arm B
- description
- 4 Cycles of Nivolumab, followed by 2 cycles of Nivolumab plus AVD, followed by 2 Cycles of AVD followed by IF-RT (30 Gy)
- interventionNames
- Drug: Nivolumab
- Drug: Adriamycin
- Drug: Vinblastine
- Drug: Dacarbazine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven classical HL * First diagnosis, no previous treatment * Age: 18-60 years * Stage I, IIA with risk factors a-d, IIB with RF c-d: 1. large mediastinal mass 2. extranodal lesions 3. elevated ESR 4. ≥ 3 nodal areas confirmed by central review. Exclusion Criteria: * Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL) * History of other malignancy ≤ 5 years * Prior chemotherapy or radiation therapy * Concurrent disease precluding protocol treatment * Pregnancy, lactation * Non-compliance
References
Publications (4)
- DERIVEDRobertz AS, Buhnen I, Meissner J, Trautmann-Grill K, Herhaus P, Halbsguth TV, Schaub V, Kerkhoff A, Mathas S, Bormann M, Dickhut A, Jaworek CP, Fuchs M, Kobe C, Baues C, Borchmann P, von Tresckow B, Behringer K, Brockelmann PJ. Gonadal function and fertility after Hodgkin lymphoma treatment with nivolumab-AVD in the phase 2 GHSG NIVAHL trial. Blood. 2026 Jun 18;147(25):3118-3121. doi: 10.1182/blood.2025031809. PMID 41926569
- DERIVEDBrockelmann PJ, Buhnen I, Meissner J, Trautmann-Grill K, Herhaus P, Halbsguth TV, Schaub V, Kerkhoff A, Mathas S, Bormann M, Dickhut A, Kaul H, Fuchs M, Kobe C, Baues C, Borchmann P, Engert A, von Tresckow B. Nivolumab and Doxorubicin, Vinblastine, and Dacarbazine in Early-Stage Unfavorable Hodgkin Lymphoma: Final Analysis of the Randomized German Hodgkin Study Group Phase II NIVAHL Trial. J Clin Oncol. 2023 Feb 20;41(6):1193-1199. doi: 10.1200/JCO.22.02355. Epub 2022 Dec 12. PMID 36508302
- DERIVEDGerhard-Hartmann E, Goergen H, Brockelmann PJ, Mottok A, Steinmuller T, Grund J, Zamo A, Ben-Neriah S, Sasse S, Borchmann S, Fuchs M, Borchmann P, Reinke S, Engert A, Veldman J, Diepstra A, Klapper W, Rosenwald A. 9p24.1 alterations and programmed cell death 1 ligand 1 expression in early stage unfavourable classical Hodgkin lymphoma: an analysis from the German Hodgkin Study Group NIVAHL trial. Br J Haematol. 2022 Jan;196(1):116-126. doi: 10.1111/bjh.17793. Epub 2021 Sep 14. PMID 34520052
- DERIVEDBrockelmann PJ, Goergen H, Keller U, Meissner J, Ordemann R, Halbsguth TV, Sasse S, Sokler M, Kerkhoff A, Mathas S, Huttmann A, Bormann M, Zimmermann A, Mettler J, Fuchs M, von Tresckow B, Baues C, Rosenwald A, Klapper W, Kobe C, Borchmann P, Engert A. Efficacy of Nivolumab and AVD in Early-Stage Unfavorable Classic Hodgkin Lymphoma: The Randomized Phase 2 German Hodgkin Study Group NIVAHL Trial. JAMA Oncol. 2020 Jun 1;6(6):872-880. doi: 10.1001/jamaoncol.2020.0750. PMID 32352505