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



Status:Recruiting
Conditions:Ovarian Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/2/2019
Start Date:April 2016
End Date:December 2020

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

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.

The Phase 1b component is a multicenter, non-randomized, open label, uncontrolled, safety and
effectiveness study to identify the recommended Phase 2 dose (R2PD) of epacadostat in
combination with DPX-Survivac and cyclophosphamide.

The Phase 2 component was initially a multicenter, randomized, open-label study to evaluate
the safety and effectiveness of DPX-Survivac + cyclophosphamide with or without the RP2D of
epacadostat. The design of the study has been amended to a single arm study in which up to 16
evaluable subjects will be enrolled to received DPX-Survivac plus intermittent low dose
cyclophosphamide (i.e. treatment arm 2).

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

- The sum of baseline target lesions, measured by RECIST v1.1, must be less than 5 cm.

- 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 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) 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
We found this trial at
7
sites
New York, New York 10021
Principal Investigator: Jeannine Villella, MD
Phone: 212-434-6626
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Augusta, Georgia 30912
Phone: 706-721-4430
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Augusta, GA
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Calgary, Alberta
Phone: 403-521-3149
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Calgary,
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Dallas, Texas 75246
Principal Investigator: James Strauss, MD
Phone: 972-566-3000
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Palo Alto, California 94304
Phone: 650-498-0624
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-662-2487
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Portland, Oregon 97239
Principal Investigator: Tanja Pejovic, MD
Phone: 503-494-1080
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Portland, OR
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