Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma

Phase 2

Completed

• Conditions: Classical Hodgkin Lymphoma
• Interventions: Drug: Nivolumab; Drug: Adriamycin; Drug: Vinblastine; Drug: Dacarbazine

• Registration Number: NCT03004833
• Lead Sponsor: University of Cologne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-12-28
• Study First Posted: 2016-12-29
• Study Start: 2017-02-21
• Primary Completion: 2022-08-22
• Study Completion: 2022-08-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Adriamycin	4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy)
Arm A	Vinblastine	4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy)
Arm A	Nivolumab	4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy)
Arm A	Dacarbazine	4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy)
Arm B	Nivolumab	4 Cycles of Nivolumab, followed by 2 cycles of Nivolumab plus AVD, followed by 2 Cycles of AVD followed by IF-RT (30 Gy)
Arm B	Adriamycin	4 Cycles of Nivolumab, followed by 2 cycles of Nivolumab plus AVD, followed by 2 Cycles of AVD followed by IF-RT (30 Gy)
Arm B	Dacarbazine	4 Cycles of Nivolumab, followed by 2 cycles of Nivolumab plus AVD, followed by 2 Cycles of AVD followed by IF-RT (30 Gy)
Arm B	Vinblastine	4 Cycles of Nivolumab, followed by 2 cycles of Nivolumab plus AVD, followed by 2 Cycles of AVD followed by IF-RT (30 Gy)

Primary Outcome Measures

Name	Time	Method
Complete Remission Rate	4 to 6 weeks after end of treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital of Cologne; 🇩🇪 Cologne, Germany