This study will investigate the effects of nivolumab (Opdivo) and brentuximab vedotin (Adcetris) after stem cell transplant in patients with high risk relapsed or refractory Hodgkin lymphoma (RRHL). The main outcome that will be measured is progression-free survival. This trial is recruiting in multiple locations in the United States.
The details
Many patients are cured by treatments for Hodgkin lymphoma (HL). However some patients may lose response to treatment (relapse). Others may not respond at all (refractory). Stem cell transplant is commonly used to treat RRHL. This involves the transfer of stem cells to a patient. Anti-cancer drugs may be given following stem cell transplant. Different combinations may have different effects on RRHL.
This study will investigate the effectiveness of nivolumab and brentuximab vedotin after stem cell transplant in patients with RRHL. The main outcome that will be measured is progression-free survival in the 18 months after treatment. This is the length of time during and after the treatment of cancer that a patient lives with the disease without it worsening.
Who are they looking for?
This study will recruit 65 participants with RRHL. Participants must have never responded to a treatment, must have relapsed within 1 year of finishing a standard therapy, must have cancer in an area other than the lymph nodes or must have undergone more than one type of treatment before transplant. All participants must have received or be planning to receive a stem cell transplant. Patients must have recovered from side effects from previous treatments and must have adequate bone marrow, liver, and kidney function tests. All patients able to conceive must use adequate birth control during the study and up to 7 months of the last dose of study drugs.
Those who have undergone an allogeneic stem cell transplant with cells from another donor will not be included. Those who have previously been refractory to treatment with brentuximab vedotin or an anti-PD-1 therapy similar to nivolumab will not be included. Patients with brain lymphoma, those who had a live vaccine in the previous 30 days, with a history of another cancer, active infections, lung disease, autoimmune conditions, or blood vessel disease will not be included. Women must not be pregnant or breastfeeding.
How will it work
All participants will receive the same treatment. Patients will begin treatment in the 30-60 days following a stem cell transplant. Patients will be treated with brentuximab vedotin and nivolumab on day 1 of a 21-day cycle. Treatment will take place once every 21 days. This will continue for up to 8 rounds of treatment unless the participant experiences disease progression or severe side effects.
Patients will be followed up for survival for up to 18 months.
