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

Brief Title

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

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

Brief 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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Number of reported adverse events

Secondary Outcome

 Levels of cell mediated immunity targeting the survivin epitopes

Condition

Ovarian Cancer

Intervention

DPX-Survivac

Study Arms / Comparison Groups

 Vaccine

Description:  Cohort A: 0.5 mL of DPX-Survivac (injection)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

Start Date

December 2011

Completion Date

May 2013

Primary Completion Date

May 2013

Eligibility Criteria

        Main Inclusion Criteria:

          -  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:

          -  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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

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Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT01416038

Organization ID

ONC-DPX-Survivac-01

Responsible Party

Sponsor

Study Sponsor

ImmunoVaccine Technologies, Inc. (IMV Inc.)

Study Sponsor

, ,

Verification Date

April 2017