NCT01416038

Phase 1 Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer

Phase 1-2 Study of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide in Patients With Surgically Operable or Advanced Stage Ovarian, Fallopian Tube or Peritoneal Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.) · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Immunotherapy is a novel way to treat cancer and does so by targeting the immune system to destroy tumor cells. Many different therapeutic vaccines have been evaluated in phase 1, 2, and even phase 3 trials. Much has been learned about the principles of applying immune-based therapies and specifically the types of patients that may be most likely to mount an effective immune response. When used alone, cancer vaccines may have their greatest impact earlier in the disease course or in situations with minimal residual disease. ImmunoVaccine Technologies Inc. (Immunovaccine) is an immuno-oncology company developing a novel adjuvanting technology platform termed DepoVax. DepoVax was created to enhance the speed, strength and duration of an immune response. The peptide antigens included in DPX-Survivac are designed to target Survivin, a protein which is over-expressed in many cancer types, including epithelial ovarian cancers. This study was designed be a phase 1-2 trial to determine the safety and immunogenicity profiles of DPX-Survivac, a therapeutic vaccine co-administered with a regimen of low dose oral cyclophosphamide. The dosing-finding phase 1 study of 15 subjects would move directly into a randomized phase 2 study. 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, such as in NCT02785250.

Detailed description

The standard treatment for all ovarian cancer is aggressive debulking surgery followed by chemotherapy. Ovarian carcinoma is one of the most chemosensitive solid tumors and early stage patients are most responsive to treatment. However, despite improvements to the standard treatment over the past three decades, almost all patients with advanced stage disease at presentation will relapse, with an average progression free survival of 16-18 months. When residual or recurrent disease manifests itself, resistance to chemotherapy often prohibits further curative therapy. Therefore, there are still significant unmet needs in treating ovarian cancer patients. Treatment with DPX-Survivac is for patients with late-stage ovarian, fallopian tube, or peritoneal cancer who have completed initial chemotherapy treatment and successful debulking surgery. The phase 1 dose finding study will administer 3 doses of DPX-Survivac with or without accompanying low dose oral cyclophosphamide.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Peritoneal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	DPX-Survivac	Vaccine targeting survivin antigen will be administered subcutaneously.
DRUG	low dose cyclophosphamide (oral)	Low dose cyclophosphamide will be taken by mouth.

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2011-08-12
• Last updated: 2017-04-21

Locations

7 sites across 2 countries: United States, Canada