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

Diffuse Large B-Cell Lymphoma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02323230
• Other study ID #: ONC-DPX-Survivac-05
• Status: Terminated
• Phase: Phase 2
• Start date: January 2015
• Est. completion date: February 2018

Study information

• Verified date: February 2018
• Source: ImmunoVaccine Technologies, Inc. (IMV Inc.)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Main Inclusion Criteria:

• Subjects with histologically proven recurrent DLBCL. Subjects may have recurrence after primary or second treatment regimens for DLBCL. Subjects with recurrence at least 90 days post-autologous stem cell transplantation (ASCT) are eligible. Patients with partial response or measurable disease after first line therapy (who are not candidates for ASCT) or after second line therapy without disease progression may also be eligible.

• Previous localized surgery, radiotherapy, and chemotherapy more than 21 days prior to SD0.

• Subjects may have received previous courses of an investigational biologic therapy including active or passive immunotherapy (e.g. rituximab), other B cell depleting antibody therapy, or radioimmunotherapy (e.g. tositumomab or ibritumomab) if last administration is greater than 77 days prior to SD0.

• Subjects must have at least one measurable site of disease.

• Willing to undergo a pre-treatment and post-treatment tumor biopsy.

• Subjects must have evidence of survivin expression in pre-treatment tumor sample.

• A screening Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-1.

• A life expectancy > 6 months.

Main Exclusion Criteria:

• Patients eligible for possible curative therapies such as ASCT.

• Patients undergoing concurrent chemotherapy, radiation therapy, or immunotherapy or who are currently on an investigational product/trial are excluded. There must be at least 21 days since completion of prior chemotherapy/radiation and at least 77 days since completion of immunotherapy until study treatment begins (SD0). Subjects must have recovered from all acute toxicities from prior treatment; peripheral neuropathy must be < grade 2.

• Lactate dehydrogenase (LDH) greater than 2 times the upper limit of normal.

• Patients with refractory disease after their last treatment (i.e. progression within 90 days).

• Patients who have received prior survivin based vaccines.

• Progressive CNS lymphoma requiring treatment within 84 days prior to SD0.

• History of active autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis requiring treatment within the last two years.

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Biological:
• DPX-Survivac
Immunotherapeutic vaccine targeting survivin antigen will be administered subcutaneously

Drug:
• Cyclophosphamide
Low dose cyclophosphamide will be taken by mouth

Locations

Country	Name	City	State
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	Sunnybrook Health Sciences Centre, Odette Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
ImmunoVaccine Technologies, Inc. (IMV Inc.)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate		approximately 6 months
Secondary	Immune response	levels of cell mediated immunity targeting the survivin epitopes	1 year
Secondary	Frequency of adverse events		1 year