๐๏ธ Verified NIH Record โข Updated 2025-06-16
NeoVax With Nivolumab in Patients With Ovarian Cancer (NCT04024878)
๐ต Active, Not Recruiting Phase1 ๐ Investigational Drug / Biologic Sponsor: Dana-Farber Cancer Institute
๐ฉบ Plain-English Summary (8th-Grade Level)
This research study is evaluating a new type of vaccine called "Personalized NeoAntigen Cancer Vaccine" in combination with Nivolumab (Opdivoยฎ) for ovarian cancer.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (21 items) and avoid the listed exclusions (17 items).
Location: Dana Farber Cancer Institute โ Boston, Massachusetts
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Non-epithelial tumors or ovarian tumors with low malignant potential (i.e. borderline tumors)
- Mucinous or low grade histologies (i.e. low grade serous or low grade endometrioid)
- Cohort A and B patients who have signed prescreening consent form and then, in the opinion of the investigator, have progressed after 3 or 4 cycles of platinum-based chemotherapy, are ineligible for the treatment part of the study and no vaccine will be manufactured
- Prior immunotherapy with IL-2, IFN-ฮฑ, or anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte associated antigen 4 (anti-CTLA-4) antibody (including Ipilimumab), or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways
- Major surgery (other than debulking surgery for ovarian, primary peritoneal or fallopian tube cancer) for any reason within 4 weeks prior to initiation of vaccination and/or incomplete recovery from surgery
- Known brain metastases or leptomeningeal metastases because of their poor prognosis and because patients often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. A scan to confirm the absence of brain metastases is not required.
- Active or history of autoimmune disease (known or suspected). Exceptions are permitted for vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition requiring only hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
- Have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to the first dose of study drug (Nivolumab). Inhaled or topical steroids and adrenal replacement doses (โค 10 mg daily prednisone equivalents) are permitted in the absence of active autoimmune disease.
- Known human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, life-threatening illnesses unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, interfere with participation in this study.
- Known allergy to tetanus toxoid
- Have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (1 Sites)
- Dana Farber Cancer Institute โ Boston, Massachusetts
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.