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Not Recruiting
Trial ID: NCT02785250
A Phase 1b/2 Study of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide and Epacadostat (INCB024360) in Patients With Recurrent Ovarian Cancer
Associate Professor of Obstetrics and Gynecology (Oncology)
Clinical Professor, Obstetrics & Gynecology - Gynecologic Oncology
Laurie Kraus Lacob Professor
Key Inclusion Criteria:
- Histologically confirmed, stage IIc-IV epithelial ovarian, fallopian tube or
peritoneal cancer
- Platinum-resistant or -sensitive subjects 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 either 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 laboratory 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
- Any single lesion greater than or equal to 4 cm (per RECIST v1.1)
- 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) or UGT1A9 inhibitors
- Receipt of live attenuated vaccines
- Acute or chronic skin and/or microvascular disorders
- Edema or lymphedema in the lower limbs > grade 2
drug: Cyclophosphamide
drug: Epacadostat (INCB024360)
other: DPX-Survivac
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Alma Gonzalez
650-498-0624