Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT03029403
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed advanced epithelial ovarian, primary peritoneal or fallopian tube carcinomas.
* Patients must have radiologically documented disease progression from their prior line of therapy.
* Patients must have measurable disease based on RECIST 1.1.
* Have received a front line platinum-based regimen (administered via either IV or IP) following primary or interval debulking surgery with documented disease recurrence.
* Have fulfilled the following additional requirements regarding prior treatments depending on the cohort that the patient is to be enrolled in.
* Eastern Cooperative Group (ECOG) performance status \<=1.
* Life expectancy greater than 16 weeks.
* Availability of archival tumor tissue samples. Additional samples may be requested if tumor tissue provided is not adequate for quality and/or quantity as assessed by the laboratory.
* Be willing to provide tumor tissue from a newly obtained core or excisional biopsy prior to start treatment and on day 15 of cycle 1.
Exclusion Criteria:
* Patients who are receiving any other investigational agents.
* Diagnosis of immunodeficiency or therapy with systemic steroid or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
* History of autoimmune disease, such as but not restricted to, rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematous, ankylosing spondylitis, scleroderma, or multiple sclerosis requiring treatment within the last two years. Patients with vitiligo or diabetes are not excluded.
* Patients with history of thyroiditis within 5 years.
* Patients with known history of active TB (Bacillus Tuberculosis).
* Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Hypersensitivity to Pembrolizumab, DPX-Survivac immunovaccine, Cyclophosphamide or any of their excipients.
* Patients that have received a live vaccine within 30 days of planned start of study therapy.
* Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent or DPX-Survivac vaccine.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03029403
Study Brief:
Protocol Section:
NCT03029403