This study is investigating the effectiveness of brentuximab vedotin (Adcetris) and nivolumab (Opdivo) in early-stage Hodgkin lymphoma (HL). The main outcome that will be measured will be survival without cancer worsening after 18 months.
The details
There are many different treatments for HL. Each treatment or combination of treatments has different effects. Brentuximab vedotin and nivolumab are targeted therapies for the treatment of HL. This means that they kill tumor cells specifically. Doxorubicin (Adriamycin), bleomycin, vinblastine (Velbe) and dacarbazine (DTIC) is a combination of chemotherapies also known as ABVD. ABVD is often used to treat HL. It is important to investigate the effects of combinations of targeted treatments and chemotherapy for early-stage HL.
This study will evaluate the effectiveness of brentuximab vedotin and nivolumab in patients with HL. The main outcome will be survival without the disease worsening, 18 months after treatment.
Who are they looking for?
This study is looking to recruit 264 patients. Participants must have confirmed diagnosis of classical HL. Patients must not have kidney, liver or heart failure. Patients of childbearing age must agree to use contraception during the study and up to 6 months of the study drugs.
Patients who have received treatment for HL, other than up to two rounds of ABVD, may not participate in this study. Patients must not have received corticosteroids or other drugs to block the immune system for at least 2 weeks before participating in the study. Patients with any other active cancers, who have central or peripheral nerve diseases or uncontrolled heart and blood vessel diseases will not be recruited.
How will it work
Patients will be divided into two groups based on their PET/CT scans. Patients without bulky disease on PET/CT scan (group 1) will be randomly assigned to one of two subgroups. Group 1A will receive treatment with brentuximab vedotin and nivolumab. This will be given every 21 days for up to 3 courses. Group 1B will receive ABVD on days 1 and 15 every 28 days for up to 2 courses, followed by nivolumab every 14 days for up to 6 courses.
Group 2 will include patients with bulky disease on PET/CT. This group will receive ABVD without bleomycin (AVD) and brentuximab vedotin on days 1 and 15 every 28 days for up to 4 cycles. Patients who will respond to treatment will then receive nivolumab every 14 days for up to 6 courses.
Patients will be followed up to 3 years. The main outcomes to be measured will be survival without the disease worsening, overall survival, and side effects.
