Brentuximab Vedotin and Nivolumab in Treating Participants With Early Stage Classic Hodgkin Lymphoma

Titre officiel

A Phase 2 Front-Line PET/CT-2 Response-Adapted Brentuximab Vedotin and Nivolumab Incorporated and Radiation-Free Management of Early Stage Classical Hodgkin Lymphoma (cHL)

Sommaire:

This phase II trial studies how well brentuximab vedotin and nivolumab work in treating participants with stage I-II classic Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin and nivolumab, may interfere with the ability of tumour cells to grow and spread.

Description de l'essai

Primary Outcome:

  • 18-month Progression-free survival (PFS) for each arm of therapy

Secondary Outcome:

  • Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0
  • Scores from European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire C30, version 3 (EORTC-C30) for each arm of therapy
  • Positron emission tomography/computed tomography-2 negativity rate
  • 3-year PFS for each arm of treatment
  • Overall survival for each arm of treatment

Primary Objectives:

  • Determine the 18 month progression free survival (PFS) for each arm of therapy stratified by positron emission tomography (PET)/computed tomography (CT)-2 response.

Secondary Objectives:

  • Assess safety, tolerability, and quality of life (QOL) for each arm of therapy.
  • Measure PET/CT-2 negativity rate after 2 lead-in cycles of doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD).
  • Evaluate the 3-year PFS and overall survival (OS) for each arm of treatment.

Exploratory Objectives:

  • Evaluate if a baseline antitumour immune response, as assessed by a Nanostring gene panel, correlates with PFS.
  • Evaluate if minimal residual disease (MRD) status, as monitored by cancer personalized profiling by deep sequencing (CAPP-Seq) of circulating tumour (ct) deoxyribonucleic acid (DNA), can be correlated with PFS.

Outline: Participants are assigned to 1 of 2 groups based on their PET/CT-2 scans.

GROUP I (PET/CT-2 NEGATIVE): Participants without bulky disease are randomized to either Arm A or B and participants with bulky disease are assigned to Arm B. ARM A: Participants receive brentuximab vedotin intravenously (IV) over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. ARM B: Participants receive doxorubicin IV, bleomycin IV, vinblastine IV, dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Participants then receive nivolumab IV over 60 minutes on day 1. Treatment with nivolumab repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

GROUP II (PET/CT-2 POSITIVE): Participants receive doxorubicin IV, vinblastine IV, dacarbazine, IV and brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Participants that are PET/CT negative receive nivolumab IV over 60 minutes on day 1. Treatment with nivolumab repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up for 3 years.

Voir cet essai sur ClinicalTrials.gov

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