Tag: Hodgkin Lymphoma

New Clinical Trial: Phase 1 Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 in Relapsed or Refractory CLL and Lymphomas

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with mantle cell lymphoma. The study sponsor is Bristol-Myers Squibb Research & Development, and the principal investigator at Weill Cornell is John P. Leonard, M.D.. 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
  • Hodgkin’s lymphoma or B-cell malignancy
  • Relapsed after, or refractory to, prior therapy for Hodgkin’s lymphoma or B-cell malignancy
  • Detailed eligibility reviewed when you contact the study team

Study Details 

This clinical trial is for men and women with relapsed or refractory lymphomas including:

  • Hodgkin
  • Follicular
  • CLL
  • DLBCL
  • Mantle cell lymphoma

The study is evaluating the experimental drug BMS-986016 (Anti-Lag-3), to demonstrate adequate safety and tolerability, as well as a favorable risk/benefit profile, to support further clinical testing.

The study will be conducted in 2 parts. Part A consists of a dose escalation design and Part B consists of cohort expansion in 4 disease-restricted populations. Treatment in Part B will be initiated when the maximum tolerated dose (or maximum administered dose) for Part A has been determined.

Subjects will complete up to 3 periods of the study: Screening (up to 28 days), Treatment (up to a maximum of twelve 8-week cycles of therapy), and Clinical Follow-up (135 days following last dose of study drug). Women of child bearing potential will have additional follow-up assessments through Day 165 for home pregnancy tests. Each treatment cycle comprises 4 doses of BMS-986016 administered intravenously on Days 1, 15, 29, and 43. Subjects will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.

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.

A New Era of Immunotherapy in Lymphoma: Nivolumab and Pembrolizumab Give New Hope to People with Lymphoid Malignancies

Picture1By Peter Martin, MD

Nivolumab and pembrolizumab are members of a class of drugs known as immune checkpoint inhibitors. Both drugs are monoclonal antibodies that bind to and inhibit the programmed death 1 receptor (PD-1) on the surface of T-cells, thereby improving the ability of the immune system to fight against cancer. The concept is especially attractive because it capitalizes on the ability of the immune system to fight cancer rather than relying on drugs that are toxic to cancer cells. Both drugs (as well as other immune checkpoint inhibitors) have demonstrated significant promise in various solid tumors (e.g., melanoma) but are only now entering the world of lymphoma. On December 7, during a morning session at the 56th annual meeting of the American Society of Hematology, we saw some early evidence of the promise that this class of drugs represents.

In the first abstract, Dr. Philippe Armand presented preliminary results from a phase I trial of nivolumab in patients with previously treated Hodgkin lymphoma (HL). These results were simultaneously published in the New England Journal of Medicine and led the FDA to grant nivolumab the breakthrough therapy designation for patients with relapsed/refractory HL. A total of 23 patients with relapsed or refractory HL were enrolled on the trial and every patient experienced reduction of tumor burden, including 70% achieving a partial response and 17% experiencing a complete response. Of the 18 patients who had previously received brentuximab vedotin, the overall response rate was 89%. Longer follow up will be required to better estimate the duration of benefit.

In a second abstract, Dr. Alexander M. Lesokhin presented the results from the same phase I trial of nivolumab in patients with relapsed or refractory lymphoid malignancies, including B-cell and T-cell non-Hodgkin lymphoma (NHL) and multiple myeloma (MM). The overall response rate in patients with B-NHL was 28%, including 40% of patients with DLBCL. Nivolumab appeared less promising in patients with T-NHL and MM.

In a final abstract Dr. Craig H. Moskowitz presented preliminary results from a phase I trial with pembrolizumab in patients with Hodgkin lymphoma after failure of brentuximab vedotin. Almost 70% of patients had also previously received prior autologous stem cell transplantation and the median number of prior therapies was 4. The reported response rate was 53%, including a 20% complete response rate.

The results from these trials confirm the activity and safety of anti-PD-1 antibodies in patients with Hogkin and non-Hodgkin lymphomas. For information regarding ongoing trials at Weill Cornell Medical College with nivolumab for treatment of Hodgkin and non-Hodgkin lymphomas, follow the links for Hodgkin lymphoma, follicular lymphoma, and DLBCL, or contact us at (212) 746-1362. Look to this space for more news concerning nivolumab.