Study of Nivolumab in Subjects With Hodgkin's Lymphoma (Registrational) (CheckMate 205)

Status: Recruiting
Phase: Phase 2
Diagnosis: Lymphoma
NCT ID: NCT02181738 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 14-242

 

The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by objective response rate (ORR) based on independent radiologic review committee (IRRC) assessment, and defined as proportion of subjects achieving either a partial remission (PR) or complete remission (CR)

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
Philippe Armand, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Jeremy Abramson, MD, Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Kathleen McDermott, kmcdermott@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Must have received prior high-dose conditioning chemotherapy followed by autologous stem cell transplant (ASCT) as a part of salvage therapy for cHL - Subjects may be Brentuximab vedotin- naïve, or may have had prior Brentuximab vedotin treatment as a salvage therapy after failure of ASCT Exclusion Criteria: - Known central nervous system lymphoma - Subjects with nodular lymphocyte-predominant Hodgkin Lymphoma - Prior treatment history with Brentuximab vedotin before ASCT - Prior allogeneic stem cell transplantation (SCT) - Chest radiation ≤ 24 weeks prior to first dose - Carmustine ≥ 600 mg/m² received as part of the pre-transplant conditioning regimen
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