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

NCT02323230 | Terminated Phase 2

• 1 other identifier: ONC-DPX-Survivac-05
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  approximately 6 months

Secondary Outcomes (2)

• Immune response

  1 year

• Frequency of adverse events

  1 year

Study Arms (1)

DPX-Survivac + low dose cyclophosphamide

EXPERIMENTAL

Biological: DPX-Survivac; Drug: Cyclophosphamide

Interventions

DPX-Survivac BIOLOGICAL

Immunotherapeutic vaccine targeting survivin antigen will be administered subcutaneously

DPX-Survivac + low dose cyclophosphamide

Cyclophosphamide DRUG

Low dose cyclophosphamide will be taken by mouth

DPX-Survivac + low dose cyclophosphamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ImmunoVaccine Technologies, Inc. (IMV Inc.): lead

Study Sites (2)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Health Sciences Centre, Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: December 23, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: February 1, 2018
• Last Updated: June 22, 2021

Record last verified: 2018-02

Locations

CA (2)