The main goal of this study is to see how a new treatment (brentuximab vedotin and nivolumab, called Bv-NIVO) compares to the usual treatment for people who were just diagnosed with early-stage (Stage I or II) Hodgkin lymphoma (HL). We want to find out which treatment works better.
You are being asked to take part in this study because you have early-stage HL (Stage I or II). HL is a type of cancer that starts in the lymph system, which is part of your immune system. This study wants to see if adding a treatment called immunotherapy (Bv-NIVO) to the usual treatment works better for people with early HL. Immunotherapy helps your immune system fight cancer. Brentuximab vedotin is a medicine called antibody-drug conjugate. It finds cancer cells that have a marker called CD30, attaches to them, and delivers a drug (vedotin) to kill those cells. Nivolumab is a protein that attaches to certain molecules in the body to help trigger the immune system to fight cancer. If you join this study, you will first get 2 cycles of chemotherapy. The most common drug combination is called ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine). This part of treatment takes 2 months. After that, your doctors will check how your cancer responds. If it responds quickly, that is called rapid early response (RER). If it responds slowly, that is called slow early response (SER). We will also look at risk factors to help decide your next treatment. Favorable risk means your cancer is less likely to come back. Unfavorable risk means your cancer has a higher chance of coming back. If you have RER, you will get either the usual treatment or a new treatment using Bv-NIVO for another 2-4 months. If you have SER, you will get either the usual therapy or a new treatment using Bv-NIVO, plus radiation. This treatment will last about 3 to 5 months. Which treatment you get is chosen at random, like flipping a coin. You will not choose your treatment. You will also fill out surveys about your health and quality of life. We will also ask for copies of your scans and tests used to diagnose your cancer and check your cancer after therapy. If you have SER, you will need two extra scans to help plan your treatment. Your treatment may last up to 7 months and we will check in on your health for up to 13 years. You and your insurance will pay for medical treatments related to this study.
You may be able to join this study if you have been recently diagnosed with stage I or II classic Hodgkin lymphoma. Types include nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted. You must have at least one tumor that can be measured in two directions and is 1.5 cm or larger. You must have a whole body or limited whole body PET scan performed 42 days before joining the study. You cannot join if you have nodular lymphocyte predominant Hodgkin lymphoma, a history of lung problems like interstitial pneumonitis or interstitial lung disease, or an immune system problem that is not well controlled or needs ongoing treatment (such as certain genetic conditions or if you have had an organ transplant). More details are on ClinicalTrials.gov. Your study doctor or study team member will go over these requirements with you.
Protocol Number: 24-2065
More information available at ClinicalTrials.gov: NCT05675410
Principal Investigator