PAGE
MENU

SPiReL

SPiReL

Phase 2 Study of an Immunotherapeutic Vaccine, DPX-Survivac with Low Dose Cyclophosphamide administered with Pembrolizumab in Patients with persistent or Recurrent/refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Diffuse Large B-Cell Lymphoma (DLBCL) is the most common type of non-Hodgkin Lymphoma. Although standard therapies are often successful in curing DLBCL in 2 out of 3 patients, approximately 33% of patients will stop responding to their current treatments or their cancer will come back. New and effective treatments for these patients are urgently needed, as their survival rates are low.

The SPiReL study is a Canadian multi-centre clinical trial, being carried out at Sunnybrook as well as sites in Calgary, Ottawa and Montreal. The SPiReL study will examine the effects of using three immunotherapy treatments in combination, in patients with DLBCL that has come back (relapsed), or is not responding to current treatments (refractory). Patients may have also had a stem cell transplant that did not work, or they are not eligible to receive a stem cell transplant. DPX-Survivac is a vaccine which is made to recognize and attack specific antigens on the surface of DLBCL tumour cells when they express a protein called Survivin. This protein is expressed in a large percentage of relapsed or refractory DLBCL tumours. Pembrolizumab and low dose cyclophosphamide, which use the immune system to kill cancer cells, will be used together with the vaccine to treat patients in the SPiReL study. A strong anti-lymphoma immune response should be generated by the combination of these three immunotherapies.

The primary outcome of the Phase II SPiReL study is to examine patient response rate to the study treatment.
The secondary outcomes of the study are to determine if tumour size decreases with treatment, to determine the toxicity profile of the medications used in the study, and to document the length of time that patients responded to the study treatment.

In addition, the study will also explore the effects of the treatment on the immune system and gene expression, through the examination of biological samples prior to treatment and during treatment.

The SPiReL study will enroll 25 participants at its participating sites in Canada. The study began in March 2018 and is estimated to be completed by May of 2021

SPiReL is funded by Immunovaccine (IMV). IMV is providing the DPX-Survivac vaccine, and Merck Sharp and Dohme Corp. are providing the Pembrolizumab for the study.

For more information on the SPiReL study, please contact SPiReL@sunnybrook.ca

Team members and contact information

Location

Sunnybrook Health Sciences Centre
2075 Bayview Avenue, T2013, Toronto, ON Canada M4N 3M5

Related links

News & stories