Study of DPX-Survivac Therapy in Patients With Recurrent Ovarian Cancer
A Phase 1b/2 Study of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide and Epacadostat (INCB024360) in Patients With Recurrent Ovarian Cancer
2 other identifiers
interventional
85
2 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2016
Longer than P75 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 18, 2016
CompletedFirst Posted
Study publicly available on registry
May 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedJune 18, 2021
June 1, 2021
4.5 years
May 18, 2016
June 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety as measured by adverse event reporting (CTCAE)
up to 13 months
Objective Response Rate (Phase 2 only)
Evaluated using modified RECIST v1.1
up to 13 months
Secondary Outcomes (6)
Objective Response Rate (for each treatment group)
up to 13 months
Duration of Response
up to 13 months
Cell mediated immunity as measured by the antigen specific response in peripheral blood
bimonthly for up to 13 months
Evaluation of treatment-induced changes in tumor infiltrating lymphocytes
at 8 to 10 weeks
Time to Progression
up to 13 months
- +1 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALDPX-Survivac, Cyclophosphamide, Epacadostat (Phase 1 and initially Phase 2)
Arm 2
EXPERIMENTALDPX-Survivac, Cyclophosphamide (in Phase 2 only)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ImmunoVaccine Technologies, Inc. (IMV Inc.)lead
- Incyte Corporationcollaborator
Study Sites (9)
Stanford University
Palo Alto, California, 94304, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912, United States
Lenox Hill Hospital
New York, New York, 10028, United States
Oregon Health & Sciences University, Knight Cancer Institute
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Mary Crowley Cancer Research Center
Dallas, Texas, 75230, United States
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2016
First Posted
May 27, 2016
Study Start
April 1, 2016
Primary Completion
October 1, 2020
Study Completion
May 1, 2025
Last Updated
June 18, 2021
Record last verified: 2021-06