Brief Title
Study of DPX-Survivac Therapy in Patients With Recurrent Ovarian Cancer
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
Brief Summary
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.
Detailed Description
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).
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Safety as measured by adverse event reporting (CTCAE)
Secondary Outcome
Objective Response Rate (for each treatment group)
Condition
Recurrent Epithelial Ovarian Cancer
Intervention
DPX-Survivac
Study Arms / Comparison Groups
Arm 1
Description: DPX-Survivac, Cyclophosphamide, Epacadostat (Phase 1 and initially Phase 2)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
85
Start Date
April 2016
Completion Date
December 2020
Primary Completion Date
February 2020
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT02785250
Organization ID
ONC-DPX-Survivac-06
Secondary IDs
DeCidE1
Responsible Party
Sponsor
Study Sponsor
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Collaborators
Incyte Corporation
Study Sponsor
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Verification Date
January 2019