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Home»Hodgkin's lymphoma» Looking for participants to test the safety and effectiveness of nivolumab and brentuximab vedotin in older patients with Hodgkin lymphoma
Clinical Trial
Looking for participants to test the safety and effectiveness of nivolumab and brentuximab vedotin in older patients with Hodgkin lymphoma
This phase 2 trial aims to test the effectiveness of a combined treatment with nivolumab (Opdivo) and brentuximab vedotin (Adcetris) in older patients with Hodgkin lymphoma. The main outcome to be measured will be the response of the tumor to the treatment. This trial is recruiting in California, Columbia, Illinois, Minnesota, Missouri, Ohio and Texas in the United States.
The details
Nivolumab is a treatment that stops tumor growth by blocking the division and growth of cancer cells. Brentuximabvedotin is a treatment that attaches to a protein on the cancer cell, allowing a chemotherapy to enter and kill the cell.
The combination of these two agents may increase the effectiveness of the treatment in older patients with Hodgkin lymphoma. The main outcomes to be measured will include tumor response to the combination and treatment toxicity.
Who are they looking for?
This trial will recruit 75 participants. Patients must be over the age of 60, or younger than 60 who are not able to undergo chemotherapy. Women must not be pregnant or breastfeeding. Both men and women must be willing to use contraception to prevent pregnancy. Patients must not have undergone prior lymphoma treatment. Participants must have normal blood levels.
Patients must not have any immune disease, infections, hepatitis, HIV, heart disease or brain metastasis (cancer spread).
How will it work
Patients will receive brentuximab vedotin over 30 minutes and nivolumab by IV (through a vein) over 60 minutes on day 1. Treatment repeats every 21 days for 7 courses and 6-8 weeks in course 8 in the absence of disease progression or unacceptable toxicity.
Patients will be followed up at 30, 60, 90, 150, 210, 270 days, every 90 days for 2 years, and then every 6 months for 5 years.
The tumor response to the treatment will be determined following the last treatment. Side effects will be reported.
