Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma

Sponsor
University of Cologne
Study ID
NCT03004833
Phase
PHASE2
Status
Completed

Conditions

  • Classical Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Infusion of Nivolumab
  • Adriamycin — DRUG
    Infusion of Adriamycin
  • Vinblastine — DRUG
    Infusion of Vinblastine
  • Dacarbazine — DRUG
    Infusion of Dacarbazine

Study Details

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.

Key Dates

Start date
Feb 21, 2017
Status verified
Mar 2025
Primary completion
Aug 22, 2022
Completion
Aug 22, 2022

Study Design

Enrollment
110 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy)
  • Experimental: Arm B
    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 Measure

Complete Remission Rate [ Time Frame: 4 to 6 weeks after end of treatment ]

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