NCT02323230

A Study of DPX-Survivac Vaccine Therapy in Patients With Recurrent Survivin-expressing DLBCL

Phase 2 Study of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide in Patients With Recurrent Survivin-Expressing Diffuse Large B-Cell Lymphoma (DLBCL)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 2 study was designed to assess the efficacy and safety of DPX-Survivac plus low dose cyclophosphamide in up to 24 subjects with recurrent diffuse large B-cell lymphoma (DLBCL) who are not eligible for transplant. However, with the evolving field of immunotherapy Immunovaccine has begun to focus on combination therapies, combining DPX-Survivac treatment with checkpoint inhibitors and other immune modulators. This phase 2 study was therefore terminated with fewer subjects than planned to allow the progress of other studies, such as NCT03349450.

Detailed description

A multi-center treatment study assessing the efficacy and safety of an immunotherapeutic vaccine (DPX-Survivac) combined with low dose cyclophosphamide. Subjects with measurable, histologically proven DLBCL expressing survivin will be treated in this open-label, single arm study. Survivin is a protein commonly over-expressed in many types of cancer, including DLBCL.

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	DPX-Survivac	Immunotherapeutic vaccine targeting survivin antigen will be administered subcutaneously
DRUG	Cyclophosphamide	Low dose cyclophosphamide will be taken by mouth

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-06-01
• Completion: 2018-02-01
• First posted: 2014-12-23
• Last updated: 2021-06-22

Locations

2 sites across 1 country: Canada