. 2024 Aug 19;20(35):2699–2708. doi: 10.1080/14796694.2024.2386922

Table 1.

Key inclusion and exclusion criteria in TEDOVA protocol.

Key inclusion criteria	Key exclusion criteria
1. Written informed consent 2. Histologically proven non-mucinous epithelial ovarian cancer 3. Positive HLA-A2 phenotype 4. Age ≥18 years 5. ECOG Performance Status 0–1 6. Platinum sensitive ovarian cancer regardless of the number of prior lines of platinum-based chemotherapy. Patient must have received at least four infusions of platinum during the last line of platinum-based chemotherapy 7. Previously treated with a PARP inhibitor or not eligible to PARPi 8. Previously treated with bevacizumab or contra-indication to bevacizumab 9. Patient may have received prior immune checkpoint inhibitor (ICI), and had a relapse after receiving the ICI without concomitant chemotherapy for at least 6 months 10. Randomization must be within 8 weeks of the last dose of chemotherapy 11. Adequate organ function: white blood cell ≥3000/mm³; neutrophils ≥1500/mm³; platelets ≥100 × 10³/mm³; hemoglobin ≥9 g/dl; ALT and AST ≤2.5 × ULN; total bilirubin ≤1.5 × ULN; serum creatinine ≤1.5 × ULN or creatinine clearance ≥40 mL/min (using Cockcroft–Gault formula) 12. Archival or fresh tumor tissue must be available for evaluating relevant biomarkers	1. Contra-indications or severe hypersensitivity (Grade 3 or higher) to immune therapies 2. Ongoing immunotherapy 3. Use of systemic corticosteroids (>10 mg/day equivalent prednisone), not stopped at least 7 days before study treatment start 4. Use of interferons, interleukins or live vaccine within 30 days prior to the first dose of study drug 5. Prior cancer vaccine therapy 6. Eligible for cytoreductive surgery at the time of inclusion 7. Clinical, radiological or biological progression (according Gynaecologic Cancer Intergroup criteria) at the end of last chemotherapy 8. Prior radiotherapy within 2 weeks of start of study intervention 9. Active autoimmune disease that has required systemic treatment in the past 2 years (corticosteroids or immunosuppressive drugs) 10. History of serious adverse reactions to any vaccine 13. History of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or other in situ cancer considered as cured) unless the patient has been free of the disease for at least 5 years. 11. Immune-deficient status 12. History of any chronic hepatitis 13. Uncontrolled or significant cardiovascular disease 14. Uncontrolled brain metastases 15. Life expectancy of less than 12 weeks 16. Pregnant or breastfeeding women

Key inclusion criteria

Key exclusion criteria

1. Written informed consent
2. Histologically proven non-mucinous epithelial ovarian cancer
3. Positive HLA-A2 phenotype
4. Age ≥18 years
5. ECOG Performance Status 0–1
6. Platinum sensitive ovarian cancer regardless of the number of prior lines of platinum-based chemotherapy. Patient must have received at least four infusions of platinum during the last line of platinum-based chemotherapy
7. Previously treated with a PARP inhibitor or not eligible to PARPi
8. Previously treated with bevacizumab or contra-indication to bevacizumab
9. Patient may have received prior immune checkpoint inhibitor (ICI), and had a relapse after receiving the ICI without concomitant chemotherapy for at least 6 months
10. Randomization must be within 8 weeks of the last dose of chemotherapy
11. Adequate organ function: white blood cell ≥3000/mm³; neutrophils ≥1500/mm³; platelets ≥100 × 10³/mm³; hemoglobin ≥9 g/dl; ALT and AST ≤2.5 × ULN; total bilirubin ≤1.5 × ULN; serum creatinine ≤1.5 × ULN or creatinine clearance ≥40 mL/min (using Cockcroft–Gault formula)
12. Archival or fresh tumor tissue must be available for evaluating relevant biomarkers

1. Contra-indications or severe hypersensitivity (Grade 3 or higher) to immune therapies
2. Ongoing immunotherapy
3. Use of systemic corticosteroids (>10 mg/day equivalent prednisone), not stopped at least 7 days before study treatment start
4. Use of interferons, interleukins or live vaccine within 30 days prior to the first dose of study drug
5. Prior cancer vaccine therapy
6. Eligible for cytoreductive surgery at the time of inclusion
7. Clinical, radiological or biological progression (according Gynaecologic Cancer Intergroup criteria) at the end of last chemotherapy
8. Prior radiotherapy within 2 weeks of start of study intervention
9. Active autoimmune disease that has required systemic treatment in the past 2 years (corticosteroids or immunosuppressive drugs)
10. History of serious adverse reactions to any vaccine
13. History of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or other in situ cancer considered as cured) unless the patient has been free of the disease for at least 5 years.
11. Immune-deficient status
12. History of any chronic hepatitis
13. Uncontrolled or significant cardiovascular disease
14. Uncontrolled brain metastases
15. Life expectancy of less than 12 weeks
16. Pregnant or breastfeeding women