This study is investigating the effectiveness of a new combination of treatments, nivolumab (Opdivo) and varlilumab (CDX-1127), for non-responsive, aggressive B-cell lymphomas. The main outcome that will be measured is the proportion of patients that respond to treatment (overall response rate). This trial is recruiting in the US.
The details
Many patients with B-Cell lymphomas respond well to treatments. Some may lose response over time (relapsed). Others may not respond at all (refractory). Nivolumab is commonly used to treat relapsed and refractory B-cell lymphomas (RRBL).
This study aims to assess whether nivolumab is more, or less, effective for treating when used in combination with a new drug, varlilumab. The main outcome that will be measured is the overall response rate after 2 years.
Who are they looking for?
This study will recruit 106 participants. To be included, participants must have been non-responsive to at least 2 different treatments for B-Cell lymphoma. Participants must be expected to live for greater than 12 weeks after the trial begins. To participate, females must not be pregnant. Patients must have adequate blood cell count and liver and kidney function.
Patients treated with chemotherapy, radiation, immunotherapy or a targeted therapy within a month of the study start or those who have not recovered from side effects from previous treatments will not be included. Patients currently being treated with another trial medication cannot participate. Patients who have received a stem cell transplant with cells from a donor or an organ transplant will not be included. Patients will be excluded if they have autoimmune conditions except for vitiligo, type 1 diabetes or hypothyroidism or if they are treated with corticosteroids. Previous other cancer and bowel disease are also exclusion criteria.
How will it work
Participants will be divided into 2 groups. Those in group 1 will be treated with nivolumab every 2 weeks for 4 months. After this, participants will be treated every 4 weeks. This will continue for up to 2 years. If the cancer worsens or the participant cannot tolerate the side-effects treatment may stop or participants can switch to group 2.
Participants in group 2 will receive the same nivolumab treatment as those in group 1. In addition to this, participants will also be administered varlilumab every 4 weeks. This will continue for up to 2 years or until the cancer worsens or side-effects cannot be tolerated.
Patients will be followed up for response, survival and side effects for up to 2 years.
