Clinical Trial 19323

Cancer Type:
Interventions:Adcetris (Brentuximab vedotin); BMS-936558 (Nivolumab); Brentuximab vedotin; Nivolumab; SGN-35 (Brentuximab vedotin)

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Celeste Bello

Overview

Study Title

Randomized, Open-label, Phase 3 Trial of Nivolumab plus Brentuximab vedotin versus Brentuximab vedotin alone in Participants with Relapsed Refractory or Ineligible for Autologous Stem Cell Transplant (ASCT) Advanced Stage Classical Hodgkin Lymphoma (CheckMate 812: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 812)

Summary

The purpose of this study is to determine whether an investigational immuno-therapy combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The participants of this trial will comprise of patients who have relapsed or did not respond to treatment and are not eligible for stem cell transplant.

Objective

Primary: To compare progression free survival of nivolumab + BV vs BV based on BICR assessments. Secondary: To compare the complete response rate of nivolumab + BV vs BV based on BICR assessments. To assess objective response rate and duration of response based on BICR. To assess duration of complete response based on BICR. To assess overall survival of participants treated with nivolumab + BV vs BV. To assess PFS based on investigator assessments. Tertiary/Exploratory: To assess the overall safety and tolerability of nivolumab in combination with chemotherapy, as measured by incidence and severity of adverse events (AEs), serious adverse events (SAEs), and specific laboratory abnormalities. To assess CRR, BOR, ORR, DOR and DOCR based on investigator assessments. To investigate the association between biomarkers in the peripheral blood and tumor tissue, such as PD-L1 expression, with safety and efficacy measures. To characterize pharmacokinetics of nivolumab + BV and explore exposure-response relationships. To characterize the immunogenicity of nivolumab and BV. To evaluate both generic health related quality of life as assessed by the EQ-5D and cancer specific quality of life as assessed by the QLQC30, FACT-Lymphoma and WPAI-GH. To evaluate the pharmacodynamic activity of nivolumab + BV combination therapy in the peripheral blood and tumor tissue as measured.by flow cytometry, immunohistochemistry, soluble factor analysis, and gene.expression (microarray technology, quantitative RT-PCR). To assess the indeterminate response (IR) as defined by LYRIC.

Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Participants must have a pathologic diagnosis of classical Hodgkin lymphoma (cHL) who are relapsed or refractory with one of the following: A.) Autologous stem cell transplant (ASCT) ineligible patients; B.) Patients after failure of ASCT.
  • Must have at least one lesion that is > 15 mm (1.5 cm) in the longest diameter and avid by Fluoro Deoxy Glucose (FDG) > Positron Emission Tomography (PET) scan
  • Other protocol defined inclusion/exclusion criteria could apply

  • Exclusion Criteria

  • Known central nervous system (CNS) lymphoma
  • Participants with nodular lymphocyte-predominant Hodgkin lymphoma (HL)
  • Participants with known history of pancreatitis or progressive multifocal leukoencephalopathy (PML)
  • Other protocol defined inclusion/exclusion criteria could apply