Phase 2
Completed N=93
A Study of Brentuximab Vedotin Combined With Nivolumab for Relapsed or Refractory Hodgkin Lymphoma
Source: ClinicalTrials.gov NCT02572167 ↗Enrolled (actual)
93
Serious AEs
23.1%
Results posted
Mar 2019
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 6; 55; 30; 5 Participants
Summary
The purpose of this study is to assess the safety profile and antitumor activity of brentuximab vedotin administered in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma (HL)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
6; 55; 30; 5; 41; 15 | — |
| PRIMARY Complete Remission Rate |
4; 33; 24 | — |
| SECONDARY Objective Response Rate |
6; 43; 28 | — |
| SECONDARY Duration of Complete Response |
NA; NA; NA | — |
| SECONDARY Duration of Objective Response |
NA; NA; NA | — |
| SECONDARY Progression-free Survival Post-autologous Stem Cell Transplant |
NA; NA; NA | — |
Eligibility Criteria
Inclusion Criteria
- Relapsed or refractory Hodgkin lymphoma following failure of standard frontline chemotherapy for the treatment of classical Hodgkin lymphoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
- Previously treated with brentuximab vedotin, immune-oncology agents, or received an allogeneic or autologous stem cell transplant
- Documented history of a cerebral vascular event
- History of another invasive malignancy that has not been in remission for at least 3 years
- History of progressive multifocal leukoencephalopathy (PML)
Data sourced from ClinicalTrials.gov (NCT02572167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.