Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma

NCT03004833 | Completed Phase 2 DMC

• 1 other identifier: Uni-Koeln-2854
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.

Conditions

Classical Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete Remission Rate

  4 to 6 weeks after end of treatment

Secondary Outcomes (3)

• Treatment related Morbidity

  1 year after end of treatment

• Progression Free Survival

  1 and 3 years after end of treatment

• Overall Survival

  1 and 3 years after end of treatment

Study Arms (2)

Arm A

EXPERIMENTAL

4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy)

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)

Drug: Nivolumab; Drug: Adriamycin; Drug: Vinblastine; Drug: Dacarbazine

Interventions

Nivolumab DRUG

Infusion of Nivolumab

Arm A; Arm B

Adriamycin DRUG

Infusion of Adriamycin

Arm A; Arm B

Vinblastine DRUG

Infusion of Vinblastine

Arm A; Arm B

Dacarbazine DRUG

Infusion of Dacarbazine

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University Hospital of Cologne

Cologne, Germany

Location

Related Publications (3)

• Brockelmann 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 DERIVED

• Gerhard-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 DERIVED

• Brockelmann 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 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

Nivolumab; Doxorubicin; Vinblastine; Dacarbazine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Andreas Engert, Prof.

  University of Cologne, I. Dept. of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: December 29, 2016
• Study Start: February 21, 2017
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)