ANIMATE
Research type
Research Study
Full title
A phase II study of nivolumab monotherapy in patients with relapsed/refractory Hodgkin lymphoma, fit for autologous stem cell transplant, who fail to reach complete metabolic remission after first or second line salvage therapy
IRAS ID
216147
Contact name
Graham Collins
Contact email
Sponsor organisation
University College London
Eudract number
2017-002544-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 6 months, 1 days
Research summary
The ANIMATE trial is testing a drug called Nivolumab in patients with Hodgkin lymphoma which has either relapsed after initial chemotherapy, or not responded well enough to initial chemotherapy. Usual treatment in this situation is 2-4 cycles of chemotherapy (‘salvage treatment’) followed by an autologous stem cell transplant (a transplant of the patient’s own cells). The cure rate after a transplant is high if there has been a very good response to salvage treatment.
Response is assessed using PET-CT scans, where a small amount of radioactive glucose is injected and highlights areas where there is still active disease (a ‘positive’ PET scan). If the PET-CT scan is positive after salvage, more treatment is needed before transplant.
Nivolumab is a drug which targets cancer cells and recruits the immune system to fight the cells. Nivolumab is approved for use in a number of cancers, including in Hodgkin lymphoma patients who have relapsed after stem cell transplant. This trial tests whether nivolumab is effective if used earlier, before stem cell transplantation.
Patients will be registered to the trial during initial salvage treatment. After 2 cycles of combination chemotherapy (or 4 cycles if treated with brentuximab vedotin), patients will have a PET-CT scan, which will be reviewed by experts at St Thomas’ Hospital, London. If the scan is negative, patients will not receive trial treatment and will be followed up only. If the scan is positive, patients who are fit for treatment will receive 4-8 cycles of nivolumab, given every 2 weeks. Response will be checked by PET-CT after 4 cycles. Patients with a negative scan or progressive disease will stop treatment. Patients with a positive scan will have 4 more cycles before a final PET-CT scan.
Patients on the trial will be followed up for at least 3 years.
REC name
London - South East Research Ethics Committee
REC reference
18/LO/0204
Date of REC Opinion
1 Mar 2018
REC opinion
Favourable Opinion