Clinical trial · Interventional
A Study of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed/ Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant,
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient enrollment.
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brentuximab vedotin | Biological | Brentuximab Vedotin | ALIAS |
| Nivolumab | Biological | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Module A
- description
- Nivolumab combined with Brentuximab
- interventionNames
- Biological: Nivolumab
- Biological: Brentuximab vedotin
- type
- EXPERIMENTAL
- label
- Module B
- description
- Brentuximab alone
- interventionNames
- Biological: Brentuximab vedotin
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- From randomization to date of death, or disease progression (up to approximately 45 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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:. i) Autologous stem cell transplant (ASCT) ineligible patients. ii) 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. Exclusion Criteria * Known central nervous system 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 apply.
References
Publications (0)
Data not yet available