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

Not Recruiting

Trial ID: NCT02785250


T cell activating therapy DPX-Survivac, low dose oral cyclophosphamide, and IDO1 inhibitor epacadostat will be tested together for the first time in patients with recurrent ovarian, fallopian tube, or peritoneal cancer to determine the safety and potential immune-modulating activity of the combination of these agents.

Official Title

A Phase 1b/2 Study of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide and Epacadostat (INCB024360) in Patients With Recurrent Ovarian Cancer

Stanford Investigator(s)

Oliver Dorigo, M.D., Ph.D.
Oliver Dorigo, M.D., Ph.D.

Professor of Obstetrics and Gynecology (Oncology)

Amer Karam
Amer Karam

Clinical Professor, Obstetrics & Gynecology - Gynecologic Oncology

Jonathan S. Berek, MD, MMSc
Jonathan S. Berek, MD, MMSc

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

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Alma Gonzalez

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