Classical Hodgkin LymphomaPhase 2NIVAHLNCT03004833
Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma
A Phase 2 study testing Nivolumab, Adriamycin and Vinblastine in people with Classical Hodgkin Lymphoma, run by University of Cologne at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Classical Hodgkin Lymphoma
- What is being tested?
- Nivolumab, Adriamycin and Vinblastine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- 21 Feb 2017to 22 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
- large mediastinal mass
- extranodal lesions
- elevated ESR
- ≥ 3 nodal areas confirmed by central review.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Classical Hodgkin Lymphoma
- Being tested
- Nivolumab, Adriamycin, Vinblastine, Dacarbazine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Infusion of Nivolumab
AdriamycinDrug
Infusion of Adriamycin
VinblastineDrug
Infusion of Vinblastine
DacarbazineDrug
Infusion of Dacarbazine
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | 4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy) Receives: Drug: Nivolumab; Drug: Adriamycin; Drug: Vinblastine; Drug: Dacarbazine |
| Arm B | Experimental | 4 Cycles of Nivolumab, followed by 2 cycles of Nivolumab plus AVD, followed by 2 Cycles of AVD followed by IF-RT (30 Gy) Receives: Drug: Nivolumab; Drug: Adriamycin; Drug: Vinblastine; Drug: Dacarbazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission Rate
Measured: 4 to 6 weeks after end of treatment
Secondary outcomes (3)
Treatment related Morbidity
Measured: 1 year after end of treatment
Progression Free Survival
Measured: 1 and 3 years after end of treatment
Overall Survival
Measured: 1 and 3 years after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start21 Feb 2017
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Classical Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Paul Broeckelmann, University of Cologne
- Investigators
- Andreas Engert, Prof., Principal investigator, University of Cologne, I. Dept. of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004833
- Sponsor's protocol ID
- Uni-Koeln-2854
- Acronym
- NIVAHL
- Status last verified
- Mar 2025
- First submitted
- 7 Nov 2016
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Robertz 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.
PubMed 41926569Brockelmann 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.
PubMed 36508302Gerhard-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.
PubMed 34520052Brockelmann 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.
PubMed 32352505
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT03004833
- Acronym / sponsor ID
- NIVAHL / Uni-Koeln-2854
- Conditions
- Classical Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Nivolumab, Drug: Adriamycin, Drug: Vinblastine, Drug: Dacarbazine4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy) |
| Arm B | Experimental | Drug: Nivolumab, Drug: Adriamycin, Drug: Vinblastine, Drug: Dacarbazine4 Cycles of Nivolumab, followed by 2 cycles of Nivolumab plus AVD, followed by 2 Cycles of AVD followed by IF-RT (30 Gy) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabInfusion of Nivolumab | Drug | Arm A, Arm B |
| AdriamycinInfusion of Adriamycin | Drug | Arm A, Arm B |
| VinblastineInfusion of Vinblastine | Drug | Arm A, Arm B |
| DacarbazineInfusion of Dacarbazine | Drug | Arm A, Arm B |
Primary outcome
Complete Remission Rate
Time frame: 4 to 6 weeks after end of treatment
3 secondary outcomes
Treatment related Morbidity
Time frame: 1 year after end of treatment
Progression Free Survival
Time frame: 1 and 3 years after end of treatment
Overall Survival
Time frame: 1 and 3 years after end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Derived from this study: PubMed 41926569Robertz 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.
- Derived from this study: PubMed 36508302Brockelmann 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.
- Derived from this study: PubMed 34520052Gerhard-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.
- Derived from this study: PubMed 32352505Brockelmann 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Engert, Prof. principal investigator
University of Cologne, I. Dept. of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab, Adriamycin and Vinblastine in people with Classical Hodgkin Lymphoma, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Remission Rate (time frame: 4 to 6 weeks after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03004833, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.