Nivolumab & Brentuximab Vedotin Consolidation After Autologous SCT in Patients With High-Risk Cla… (NCT03057795) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Nivolumab & Brentuximab Vedotin Consolidation After Autologous SCT in Patients With High-Risk Classical Hodgkin Lymphoma
United States62 participantsStarted 2017-04-03
Plain-language summary
This phase II trial studies how well nivolumab and brentuximab vedotin work after stem cell transplant in treating patients with high-risk classical Hodgkin lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as nivolumab and brentuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Documented informed consent
* Agreement to allow the use of archival tissue from pre-ASCT tumor biopsies
* If unavailable, exceptions may be granted with study principal investigator (PI) approval
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Histologically confirmed diagnosis of classical Hodgkin lymphoma (excluding nodular lymphocyte predominant Hodgkin lymphoma) according to the World Health Organization (WHO) classification, with hematopathology review at the participating institution
* Have high-risk relapsed or refractory Hodgkin lymphoma (HL), defined as at least one of the following:
* Primary refractory disease to front-line therapy
* Relapse within 1 year of completing front-line therapy
* Extranodal involvement at the time of pre-ASCT relapse
* B symptoms at pre-ASCT relapse
* More than one type of pre-ASCT salvage therapy required
* Planning to receive or have received autologous stem cell transplantation (ACST) per institutional standards as part of standard of care
* Pre-ASCT participants may consent but will not be eligible to begin treatment until after ASCT, and will have to fulfill all inclusion and exclusion criteria before starting protocol
* All participants must initiate day 1 of protocol therapy within 30-60 days post stem cell reinfusion; study PI can grant exception for a patient to start as late as 75 days post stem cell reinfusion with a reasonable justification for a delay (e.g. rec…
What they're measuring
1
Progression-free Survival at 18 Months
Timeframe: From the first dose of study treatment to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed at 18 months.