Dr. Lisa Roth Describes a Clinical Trial Testing Nivolumab in Patients with Hodgkin Lymphoma who Relapsed after an Autologous Stem Cell Transplant

In this video Dr. Lisa Roth explains the benefits of a phase II trial for men and women with Hodgkin lymphoma whose disease has relapsed after an autologous stem cell transplant. The purpose of this study is to evaluate the clinical benefits of nivolumab in people with relapsed Hodgkin lymphoma. This trial is sponsored by Bristol-Myers Squibb.

If you’re interested in participating in this trial please call 646-962-2074 for more information. A full listing of Hodgkin lymphoma trials at Weill Cornell Medical College can be found here.

New Clinical Trial: Phase 2 Study of Nivolumab in classical Hodgkin Lymphoma Subjects after Failure of Autologous Stem Cell Transplant

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with classical Hodgkin Lymphoma (cHL) subjects after failure of autologous stem cell transplant (ASCT). The study sponsor is Bristol-Myers Squibb, and the principal investigator at Weill Cornell is Dr. Lisa Roth. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Key Eligibility

  • Men and women age 18 and older
  • Cohort A: Subjects not exposed to brentuximab vedotin
    – Documented absence of complete response (CR) after 90 days from stem cell infusion for most recent ASCT; or
    – Documented relapsed disease (after CR) or disease progression (after Partial Response (PR) or Stable Disease (SD))
  • Cohort B: Subjects who failed treatment with brentuximab vedotin which was administered after failure of ASCT
    – Documented failure to achieve at least PR after the most recent treatment; or
    – Documented relapse disease (after CR) or disease progression (after PR or SD)
  • Detailed eligibility reviewed when you contact the study team

Study Details

This clinical trial is for men and women with classical Hodgkin Lymphoma who failed autologous stem cell transplant (ASCT).  Subjects never treated with brentuximab vedotin are in Cohort A, or may have had prior brentuximab vedotin treatment as a salvage therapy after failure of ASCT are in Cohort B. The study is evaluating an experimental drug called nivolumab.

Nivolumab is in clinical development for the treatment of subjects with solid tumors and hematological (blood) malignancies. Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body’s immune system to work against tumor cells.

The purposes of this research study is to assess treatment with nivolumab with hopes that treatment with nivolumab will lead to clinical benefit, as demonstrated by a clinically meaningful objective response rate, including durable responses with substantial magnitude of tumor burden reduction in the heavily treated cHL subjects.

New Clinical Trial: Nivolumab in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) that have Either Failed or are Not Eligible for Autologous Stem Cell Transplant

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with relapsed or refractory diffuse large B-cell lymphoma, that have either failed or are not eligible for Autologous Stem Cell Transplant. The study sponsor is Bristol-Myers Squibb, and the principal investigator at Weill Cornell is Dr. John Leonard. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Key Eligibility

  • Men and women equal to or greater than 18 years of age
  • A performance status of 0 or 1
  • Biopsy confirmation of relapsed, refractory DLBCL, or transformed lymphoma (TL) prior to the initiation of study drug
  • Prior treatment as defined below:
    – Subjects with relapsed or refractory DLBCL or TL after high-dose conditioning chemotherapy and ASCT, or
    – Subjects with relapsed or refractory DLBCL or TL after at least 2 prior multi-agent  chemotherapy regimens if ASCT ineligible. Ineligibility for ASCT will be determined  using local institutional criteria
  • Detailed eligibility reviewed when you contact the study team

Study Details

This clinical trial is testing a drug called Nivolumab (also known as BMS-936558, a monoclonal antibody) as therapy for subjects with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) after failure of autologous stem cell transplant (ASCT). The purpose of this study is to test the effectiveness, safety, and tolerability of the investigational drug Nivolumab.

Subjects enrolled on this study will receive Nivolumab 3 mg/kg intravenously on the start of every 2 week cycle.  The study medication may be interrupted, withheld or stopped for different reasons. However, subjects will be asked to follow up periodically for two years after ending treatment.

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