A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
About
A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-Oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma
This phase III trial compares the effects of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and stage II classical Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability for tumor cells to grow and spread. Brentuximab is a monoclonal antibody that causes the body to make an immune response. It binds to certain targets in the body, in this case lymphoma cells, and kills them by delivering vedotin. Chemotherapy works in different ways to help stop the growth of cancer cells, either by killing the cells, stopping them from dividing or stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or lessen short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.
Study Plan: This study wants to compare progression-free survival (PFS) of a standard chemotherapy approach vs an immunotherapy approach in patients with newly diagnosed early-stage classic Hodgkin lymphoma who have a rapid early response. Patients will be randomized between arms.
Arm A: ABVD for additional two cycles
Arm B: ABVD, brentuximab vedotin, nivolumab
Arm C: ABVD, eBEACOPP, ISRT
Arm D: ABVD, brentuximab vedotin, nivolumab, ISRT
Arm E: ABVD, AVD
Arm F: ABVD, brentuximab vedotin, nivolumab
Arm G: ABVD, eBEACOPP, ISRT
Arm H: ABVD, brentuximab vedotin, nivolumab, ISRT
COG # AHOD2131
Eligibility Criteria
Inclusion Criteria
- Diagnosis: Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic, based upon institutional pathologic classification are eligible to enroll based on stage, group and age, further described in the protocol
- Age: Patients must be ≤ 50 years of age at the time of enrollment
- Patients must have adequate renal and liver function as defined by the protocol
Exclusion Criteria
- Patients with RMS that is considered a second malignancy and previous cancer(s) that were treated with chemotherapy and/or radiation
- Patients with central nervous system involvement of RMS
- Pregnant or lactating female patients
Primary Investigator
Dr. Glenn Edwards is the section chief of Pediatric Hematology/Oncology, as well as the Children's Oncology Group's principal investigator for Carilion Clinic. With over 30 years of clinical experience, he is board certified by the American Board of Pediatrics in Pediatrics and Pediatric Hematology/Oncology. He completed his fellowship at Walter Reed Army Medical Center and completed his internship and residency at Tripler Army Medical Center.
Contact Information
Wendy McCarty, CCRP
Clinical Research Coordinator
Sydnee Moses, BS
Clinical Research Coordinator
