GYNORYLAQ™-VLINIVAL™: Ψ-Guided Personalized Neoantigen Peptide Vaccine for High-Risk Endometrial Cancer
Greece40 participantsStarted 2026-02-02
Plain-language summary
GYNORYLAQ-VLINIVAL is an Early Phase I, non-randomized, single-arm, open-label clinical trial enrolling 40 patients with high-risk or recurrent endometrial carcinoma. All participants receive GYNORYLAQ-TM, a personalized neoantigenic peptide vaccine generated by the GYNORYLAQ-EC™ quantum-classical engine, in combination with systemic and supportive drug regimens that are individually selected and prescribed by the treating medical oncologist, Dr Emmanouelides Christos, according to contemporary standards of care and the clinical status of each patient. Only the GYNORYLAQ-TM vaccine is considered investigational within this protocol; all concomitant drugs (including antineoplastic agents and supportive care medications) are non-investigational, chosen and adjusted at the discretion of Dr Emmanouelides Christos. The primary objectives are to evaluate the safety/tolerability of GYNORYLAQ-TM in this real-world therapeutic context and the feasibility of quantum-guided, GMP-grade personalized vaccine manufacture. Secondary and exploratory objectives characterize vaccine-induced T-cell immunity and explore correlations between quantum/physics-based scores and clinical/immunologic outcomes.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
.2. Willingness and ability (participant and/or guardian) to comply with scheduled visits, vaccination procedures, blood draws, imaging, and other study-related assessments.
.2. High-risk, recurrent, or metastatic disease, defined by at least one of: FIGO Stage III or IV at initial diagnosis, and/or Recurrent or progressive disease after prior surgery ± radiotherapy ± systemic therapy, not amenable to curative-intent surgery or radiotherapy.
.2. Disease status documented by CT/MRI (or PET/CT, if local standard) within 28 days before the first GYNORYLAQ-TM vaccination.
.2. Recovery from acute toxicity of prior therapies to Grade ≤1 or baseline (CTCAE v5.0), except for: Alopecia, Stable peripheral neuropathy (≤Grade 2), Other protocol-specified exceptions. 4.3. Prior immune checkpoint inhibitor therapy (e.g., anti-PD-1/PD-L1) is allowed, provided there is no history of Grade ≥3 immune-related adverse event that mandated permanent discontinuation.
.2. There is no absolute contraindication to all forms of systemic therapy that might reasonably be selected by Dr Emmanouelides Christos.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent AEs/SAEs and DLTs (CTCAE v5.0) With GYNORYLAQ™ Plus Oncologist-Selected Drug Regimens
Timeframe: From first vaccination through 30 days after last vaccination.
2
Feasibility of Quantum-Guided Vaccine Manufacturing
Timeframe: Up to 16 weeks from tumor tissue acquisition to vaccine release and first vaccination.
3
Vaccine Immunogenicity (Early Phase I Co-Primary)
Timeframe: Baseline to ~Week 24 and at end of treatment.
.3. The participant agrees that systemic and supportive drugs will be chosen, initiated, and adjusted by Dr Emmanouelides Christos and recorded as background therapy.
.2. Availability of matched normal sample (e.g., peripheral blood) for germline reference.
.3. Willingness, when clinically safe and feasible, to undergo additional tumour biopsy/biopsies for translational and correlative studies per protocol.
Exclusion criteria
.2. Disease requiring urgent, life-saving intervention that would preclude safe vaccine administration (e.g., impending organ failure requiring immediate surgery or high-dose radiotherapy).
.3. Disease burden or rate of progression such that, in the opinion of the investigator and/or Dr Emmanouelides Christos, any delay associated with vaccine manufacturing and initiation of protocol therapy would be unsafe.
.2. Participation in another interventional clinical trial with therapeutic intent or receipt of an investigational systemic agent within 4 weeks (or 5 half-lives, whichever is longer) before first GYNORYLAQ-TM dose, unless discussed with and approved by the sponsor/investigator.
.3. Prior allogeneic hematopoietic stem cell or solid organ transplantation. Autoimmune and Immune-mediated Conditions 3.1. Active, known, or suspected autoimmune disease requiring systemic immunosuppressive treatment (e.g., ≥10 mg/day prednisone equivalent) within the past 12 months, including but not limited to: Systemic lupus erythematosus Inflammatory bowel disease (Crohn's disease, ulcerative colitis) Multiple sclerosis Severe rheumatoid arthritis, systemic sclerosis, vasculitis Autoimmune hepatitis 3.2. Acceptable exceptions may include: Controlled autoimmune thyroiditis on stable hormone replacement Vitiligo, type 1 diabetes mellitus, or psoriasis not requiring systemic immunosuppression Other minor or stable autoimmune conditions deemed acceptable by the investigator.
.3. Primary or acquired immunodeficiency states (other than controlled HIV as per inclusion criteria) that, in the investigator's judgment, could significantly compromise vaccine-induced immune responses or increase risk.
.2. Short-term steroid use (e.g., antiemetic prophylaxis, contrast premedication, acute reaction management) is permitted as long as it is not chronic.
.2. History of venous thromboembolism (DVT/PE) that is not adequately anticoagulated, or acute events within 4 weeks prior to screening that pose high risk in the investigator's judgment.
.3. Severe, uncontrolled pulmonary disease, such as advanced COPD, interstitial lung disease with active symptoms, or chronic oxygen dependence that would substantially increase risk.