RELATIVITY-069

Combination of drugs already used to treat skin cancer may offer a new treatment option for Hodgkin's and non-Hodgkin's lymphomas

Gender
Women and men
Age
up to 30 years
Trial type
Interventional
Line of therapy
Relapsed / refractory
Phase
Phase I/II

What is this trial about?

Hodgkin’s and non-Hodgkin’s lymphomas are malignant diseases of the lymphatic system. New treatment options are being sought for cases in which the disease remains active or recurs despite therapy. The goal of the RELATIVITY-069 study is to investigate the safety, tolerability, and efficacy of the combination of the two drugs, relatlimab and nivolumab, which has not yet been studied for this purpose. Patients under the age of 31 with recurrent or uncontrollable Hodgkin lymphoma or non-Hodgkin lymphoma are eligible to participate in this study.

Detailed description

Hodgkin's and non-Hodgkin's lymphomas are malignant diseases of the lymphatic system. The affected lymphocytes are a subtype of white blood cells that are part of the body's immune system. The main difference between Hodgkin’s and non-Hodgkin’s lymphomas lies in the presence of specific cells (Hodgkin cells). The most common symptoms include swollen lymph nodes, fever, night sweats, weight loss, and fatigue. The causes of these diseases are usually unknown, but genetic factors and certain infections may play a role. If the disease returns (recurrence) after treatment or if it cannot be controlled (refractory), alternative treatment options and, in many cases, intensified therapy are required. Although several treatment options are now available for this, new drugs are constantly being developed and studied to further improve the chances of a cure even in these situations. Relatlimab is a new antibody that blocks the LAG-3 protein on T lymphocytes, thereby preventing their growth. Relatlimab is currently approved for the treatment of skin cancer. Nivolumab is a well-known checkpoint inhibitor that blocks the PD-1 protein, enabling the immune system to attack cancer cells. By combining these two drugs, researchers hope to increase the effectiveness of treatment. This has not yet been studied in Hodgkin’s and non-Hodgkin’s lymphomas.

The goal of this Phase 1 and Phase 2 study is to further investigate the efficacy and safety of the combination therapy of relatlimab and nivolumab in a selected group of patients. The study is divided into two phases: Phase 1 focuses on assessing safety and determining the optimal dose of the combination therapy. Phase 2 investigates the efficacy of the previously determined dose for treating the participants. All patients receive the same treatment, and the study is open-label, meaning that both the medical staff and the patients know which medications are being administered. The primary endpoint of the first phase is the maximum tolerated dose, the occurrence of side effects, and the survival rate for up to 135 days after the last dose. The primary endpoint of the second phase is [to be specified] and will be assessed for up to 96 weeks.

Patients under 31 years of age with recurrent or uncontrollable Hodgkin lymphoma or non-Hodgkin lymphoma are eligible to participate in this study.

Facts

  1. What disease: Hodgkin lymphoma and non-Hodgkin lymphoma
  2. Cancer characteristics: disease recurrence or uncontrollable (refractory)
  3. What the study investigates: safety and efficacy of the combination of the drugs relatlimab and nivolumab (not yet approved for this use)
  4. Study objective: To improve treatment options, response rates, and survival rates
  5. Study duration: Approximately 2 years
  6. Study characteristics: Two phases, open-label, one treatment group

Trial sites

We currently have no reliable information about trial sites in Germany for this study.

Medical editorial team

  • Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
  • PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine

This description is based on the public trial registry (NCT05255601) and was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.