Overview

This trial is active, not recruiting.

Conditions ovarian cancer, fallopian tube cancer, peritoneal cancer
Treatments dpx-survivac, low dose cyclophosphamide (oral)
Phase phase 1/phase 2
Sponsor ImmunoVaccine Technologies, Inc.
Start date December 2011
End date May 2013
Trial size 19 participants
Trial identifier NCT01416038, ONC-DPX-Survivac-01

Summary

This is a phase 1-2 study to determine the safety and immunogenicity profiles of DPX-Survivac, a therapeutic vaccine co-administered with a regimen of low dose oral cyclophosphamide. DPX-Survivac is for the treatment of ovarian, fallopian tube, and peritoneal cancers.

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. Cancer vaccines may have their greatest impact earlier in the disease course or in situations with minimal residual disease.

ImmunoVaccine Technologies Inc. (Immunovaccine) is developing therapeutic vaccines against various solid cancers based on a patented vaccine delivery and enhancement system. Immunovaccine's vaccine formulation, termed DepoVax, is a lipid-based formulation created to enhance the speed, strength and duration of the immune response. Immunovaccine's hypothesis is that the immune enhancement properties of its formulation are the result of the co-delivery of antigen and adjuvant and the created depot effect. 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 will begin with a phase 1 safety cohort study; at least 15 non-randomized patients will be enrolled into the open-label dose finding study. The study will then progress directly into the 2:1 randomized, double-blinded phase 2 portion of the study. The phase 2 will be a placebo controlled efficacy study, enrolling approximately 250 patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Phase 1, Cohort A: 0.5 mL of DPX-Survivac (injection)
dpx-survivac
Vaccine targeting survivin antigen will be administered subcutaneously.
(Experimental)
Phase 1, Cohort B: 0.1 mL DPX-Survivac (injection) with low dose cyclophosphamide (oral)
dpx-survivac
Vaccine targeting survivin antigen will be administered subcutaneously.
low dose cyclophosphamide (oral)
Low dose cyclophosphamide will be taken by mouth.
(Experimental)
Phase 1, Cohort C: 0.5 mL DPX-Survivac (injection) with low dose cyclophosphamide (oral)
dpx-survivac
Vaccine targeting survivin antigen will be administered subcutaneously.
low dose cyclophosphamide (oral)
Low dose cyclophosphamide will be taken by mouth.

Primary Outcomes

Measure
PHASE 1: Number of reported adverse events
time frame: Until 6 month follow up
PHASE 2: Progression free survival as per RECIST 1.1 criteria
time frame: Until last progression-free patient is 1.5 years beyond first vaccination

Secondary Outcomes

Measure
PHASE 1-2: Levels of cell mediated immunity targeting the survivin epitopes
time frame: Until 6 month follow up
PHASE 2: Repeated CA-125 measurements
time frame: Until last progression-free patient is 1.5 years beyond first vaccination
PHASE 2: Progression free survival as per immune response criteria (irRC)
time frame: Until last progression-free patient is 1.5 years beyond first vaccination

Eligibility Criteria

Female participants at least 18 years old.

Main Inclusion Criteria for Phase 1: - Subjects with stage IIc-IV epithelial ovarian, fallopian tube and peritoneal cancer who have completed adjuvant treatment consisting of up to 8 cycles of paclitaxel and carboplatin chemotherapy or other acceptable chemotherapy after initial debulking surgery with evidence of a complete or partial response by radiological imaging. These subjects may remain on hormonal therapy during the trial if such treatment has been prescribed by their treating physician. These subjects may have been in a clinical trial for an investigational carboplatin based adjuvant therapy. - Subjects with recurrent ovarian, fallopian tube or peritoneal cancer who have clinical or radiologic evidence of a complete or partial response or stable disease after completion of first-line chemotherapy for their recurrent disease and are not suitable for additional cytotoxic therapy are eligible. These subjects may have previously received a course of adjuvant chemotherapy earlier in their disease management as described in point one above. These subjects are eligible regardless of their CA-125 results. These subjects may have been in a clinical trial of an investigational therapy. - Subjects may have received previous courses of an investigational biologic therapy including active or passive immunotherapy greater than 60 days prior to receiving the first injection of DPX-Survivac - At least 30 days since localized surgery, radiotherapy or chemotherapy - Subjects may be on a biphosphonate provided it had not been initiated within 14 days prior to receiving the first injection of DPX-Survivac Main Exclusion Criteria for Phase 1: - Subjects undergoing concurrent chemotherapy, radiation therapy, immunotherapy are excluded - Subjects who participated in therapeutic adjuvant ovarian cancer studies are excluded except for platinum-based adjuvant studies - Subjects who have received more than one course of chemotherapy for recurrent disease - Subjects receiving bevacizumab for maintenance therapy are excluded (subjects who received bevacizumab as part of their adjuvant therapy will be permitted) - History of autoimmune disease - Subjects with recent history of thyroiditis - Presence of an acute infection requiring antibiotics within 4 weeks of study entry or a chronic infection including but not limited to: urinary tract infection, HIV, viral hepatitis - Subjects with brain metastases - Concurrent (within the last 5 years) second malignancy other than non melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer - Acute or chronic skin disorders that will interfere with subcutaneous injection of the vaccine or subsequent assessment of potential skin reactions - Serious intercurrent chronic or acute illness, such as cardiac disease, hepatic disease, or other illness considered by the investigator as an unwarranted high risk for an investigational product - Subjects on steroid therapy or other immunosuppressive, such as azathioprine or cyclosporin A - Allergies to any component of the vaccine - Pregnant or nursing mothers - Subjects with a medical or psychological impediment to probable compliance with the protocol

Additional Information

Official title 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
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. The phase 2, placebo controlled, study will administer DPX-Survivac or placebo with accompanying low dose cyclophosphamide or placebo. PHASE 1 - non-randomized, open-label, dose-finding study - at least 15 subjects - three safety cohorts (listed in the table above) - safety and immunogenicity findings will determine dosage for phase 2 PHASE 2 - 2:1 randomized, double-blinded, placebo controlled study - approximately 250 subjects - two arms (1) Experimental: DPX-Survivac (injection) and low dose cyclophosphamide (oral) and (2) Control: placebo injection and oral placebo
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by ImmunoVaccine Technologies, Inc..