A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Canc… (NCT05479045) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients
United States24 participantsStarted 2026-09
Plain-language summary
This is an open label, non-randomized, 2-stage phase II, single arm study to determine the efficacy of New York esophageal squamous cell carcinoma 1 (NY-ESO-1) peptide vaccine as a priming mechanism to prevent anti-PD1 resistance in patients with platinum-refractory stage III/IV ovarian cancer (OC).
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Be able and willing to provide written and signed informed consent prior to performing any protocol-related procedures, including screening evaluations.
✓. Women, 18 years or older, with stage III / IV platinum-refractory Ovarian Cancer (OC) (progressed on a platinum containing regimen within 6 months of therapy and adenocarcinoma histology) that can be evaluable by RECISTv1.1 criteria who progressed on standard treatment. Participants will be recruited irrespective of if they earlier received available FDA-approved therapies (including for participants with targetable mutations, such as BRCA mutations)
✓. Subjects will be eligible for study entry based on the following diagnostic workup:
✓. History/physical examination within 28 days prior to registration.
✓. Imaging of target lesion(s) within 28 days prior to registration.
✓. Study-specific assessments:
✓. Recovery from effects of recent surgery, radiotherapy or chemotherapy.
✓. Free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection).
Exclusion criteria
✕. Subjects who have received prior therapy with regimens containing nivolumab or CTLA-4, PD-L1, PD-L2 or PD-1 antagonists or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways.
✕. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
✕. History of severe allergic reactions (i.e., Grade 4 allergy, anaphylactic reaction from which the subject did not recover within 6 hours of institution of supportive care) to any unknown allergens or any components of the study drug formulations.
✕. Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener's granulomatosis) within the past 2 years. Subjects with childhood atopy or asthma, vitiligo, alopecia, Graves disease, Hashimoto disease, autoimmune diseases that will be consider stable by hormones /steroid replacement or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
✕. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study.
✕. Receipt of any conventional or investigational anticancer therapy not otherwise specified above within 28 days prior to the first dose of the combination treatment; in the case of monoclonal antibodies, 28 days or 5 half-lives, whichever is shorter, prior to the first dose of the combination treatment.
✕. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable.
✕. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE V5.0, Grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (e.g., hearing loss)