Trial Search Results

Study of DPX-Survivac Vaccine Therapy and Epacadostat in Patients With Recurrent Ovarian Cancer

The purpose of this study is to test the safety and effectiveness of DPX-Survivac, an investigational vaccine, in combination with low dose cyclophosphamide and investigational drug epacadostat to stimulate the immune system to attack cancer cell in people with advanced stage ovarian cancer. DPX-Survivac plus low dose cyclophosphamide has previously been tested in women with ovarian cancer. This study hopes to determine if the combination with epacadostat improves immune response and anti-tumor effect. Participants will be screened for tumor expression of survivin (the target of DPX-Survivac) and enzyme IDO1 (the target of epacadostat).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

ImmunoVaccine Technologies, Inc.

Collaborator: Incyte Corporation

Stanford Investigator(s):

Intervention(s):

  • Biological: DPX-Survivac
  • Drug: Cyclophosphamide
  • Drug: Epacadostat (INCB024360)

Phase:

Phase 1

Eligibility


Key Inclusion Criteria:

   - Histologically confirmed stage IIc-IV epithelial ovarian, fallopian tube or peritoneal
   cancer

   - Platinum-resistant or -sensitive after completing first-line treatment (debulking
   surgery and adjuvant or neoadjuvant treatment with standard of care treatment such as
   carboplatin and paclitaxel). Subjects may have had any number of subsequent lines of
   chemotherapy.

   - Must have evidence of progressive disease with biochemical (i.e. rising CA-125) and/or
   radiologic progression

   - Must have measurable disease by RECIST v1.1, a successful pre-treatment tumor biopsy,
   and be willing to undergo tumor biopsy during treatment

   - Ambulatory with an ECOG 0-1

   - Life expectancy ≥ 6 months

   - Meet protocol-specified lab requirements

Key Exclusion Criteria:

   - Eligible for otherwise curative treatment or undergoing concurrent therapy

   - Prior receipt of survivin based vaccines or immune checkpoint inhibitors (e.g.
   anti-CTLA-4, anti-PD-1, anti-PD-L1, or any other antibody or drug specifically
   targeting T cell co-stimulation) or an IDO inhibitor

   - Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma
   in situ, or controlled bladder cancer

   - Clinical ascites or metastatic pleural fluid

   - Malignant bowel obstruction

   - History of autoimmune disease requiring treatment within the last two years (except
   vitiligo or diabetes)

   - Recent history of thyroiditis

   - Presence of a serious acute infection or chronic infection

   - Active central nervous system (CNS) or leptomeningeal metastasis (brain metastases)

   - GI condition that might limit absorption of oral agents

   - Other serious intercurrent chronic or acute illness, including myocardial infarction
   or cerebrovascular event within 6 months

   - Ongoing treatment with steroid therapy or other immunosuppressive

   - Receipt of monoamine oxidase inhibitors (MAOIs), UGT1A9 inhibitors, or melatonin
   supplements

   - Acute or chronic skin and/or microvascular disorders

   - Edema or lymphedema in the lower limbs > grade 2

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Dona Bahmani
650-724-3308
Recruiting