Ovarian Cancer Clinical Trial

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

Summary

As a follow-on study to NCT01416038, this study is designed to identify the optimal dosage of immunotherapeutic survivin vaccine DPX-Survivac and low dose oral cyclophosphamide. The combination treatment is being evaluated in a non-randomized, multi-cohort study as post-chemotherapy treatment for patients with late-stage ovarian, fallopian tube, or peritoneal cancer.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Histologically confirmed stage IIc-IV epithelial ovarian, fallopian tube or peritoneal cancer
Complete or partial response following standard of care surgery and first line chemotherapy
May have one disease recurrence with complete or partial response or stable disease following standard of care second line care treatment
Previous investigational biologic therapy allowed, must be more than 56 days prior to first injection
Previous treatment with bisphosphonate allowed, must be completed 14 days prior to first injection
Ambulatory with an ECOG 0-1
Life expectancy > 6 months
Meet protocol-specified lab requirements
Provide informed consent and have ability to comply with protocol requirements

Key Exclusion Criteria:

Concurrent chemotherapy, radiation therapy, immunotherapy are excluded (washout periods as specified in protocol)
Prior receipt of survivin based vaccines
Participation in prior therapeutic adjuvant ovarian cancer studies, except for platinum-based adjuvant studies
Progressive disease (rising CA-125 acceptable)
More than one course of chemotherapy for recurrent disease
Concurrent bevacizumab as maintenance therapy
Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer
History of autoimmune disease
Recent history of thyroiditis
Presence of a serious acute infection or chronic infection
Brain metastases
Other serious intercurrent chronic or acute illness
Ongoing treatment with steroid therapy or other immunosuppressive
Acute or chronic skin disorders

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

37

Study ID:

NCT03332576

Recruitment Status:

Completed

Sponsor:

ImmunoVaccine Technologies, Inc. (IMV Inc.)

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 3 Locations for this study

See Locations Near You

Winthrop University Hospital
Mineola New York, 11501, United States
Lenox Hill Hospital
New York New York, 10028, United States
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

37

Study ID:

NCT03332576

Recruitment Status:

Completed

Sponsor:


ImmunoVaccine Technologies, Inc. (IMV Inc.)

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider