OVACURE-2
Key facts
- Where
- Leiden, HollandiaSee the site
- Phase
- 1/2. fázis
Where in Hollandia
- Leids Universitair Medisch Centrum (LUMC)Leiden, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Leids Universitair Medisch Centrum (LUMC)
- Trial code
- EU 2025-522659-24-00
- Record updated
- 2025. december 3.
- Original description
TIL plus IL-2ld related toxicity assessment according to NCI CTCAE v5.0 grade > III and determine the recommended phase II dose based on dose-limiting toxicities (DLT)Read full original descriptionShow less
OVACURE-2: Adoptive T cell therapy plus low dose IL-2 (IL-2ld) as first line neoadjuvant therapy in patients with stage III/IV ovarian cancer
TIL plus IL-2ld related toxicity assessment according to NCI CTCAE v5.0 grade > III and determine the recommended phase II dose based on dose-limiting toxicities (DLT)
Inclusion: Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is >18 years old; Participants of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during trial intervention and for at least 7 months after the last dose of trial intervention; Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube, or primary peritoneal carcinoma (serous, endometrioid, clear cell, carcinosarcoma, or mucinous); Is newly diagnosed FIGO Stage III (extension cohort only) or IV; Is a deemed candidate/eligible to neoadjuvant carboplatin end paclitaxel per standard of care and Investigator discretion (not deemed candidates for upfront surgery/ PDS) are eligible; Possibility to upfront collect tumor tissue for TIL isolation and expansion; Presence of measurable progressive disease according to RECIST version 1.1 or elevated CA125>2 times the upper normal limit (UNL) within 3 months and confirmed; Has an ECOG PS of 0 or 1; Within the last 4 weeks prior to study day 0, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified: Hemoglobin ≥ 6,0 mmol/l , Granulocytes ≥ 1,500/μl, Lymphocytes ≥ 700/μl, Platelets ≥ 100,000/μl, Creatinine clearance ≥ 50 min/ml,Serum bilirubin ≤ 40 mol/l, ASAT and ALAT ≤ 5 x the normal upper limit, • Viral tests: - Negative for HIV type 1/2, HTLV and TPHA - No HBV (hepatitis B virus) antigen or antibodies against HBc in the serum - No antibodies against HCV (hepatitis C virus) in the serum; Able and willing to give valid written informed consent.
Exclusion: Serious acute or chronic illnesses, e.g. significant heart disease (NYHA Class III or IV), active infections requiring antibiotics, bleeding disorders, or other conditions requiring concurrent medications not allowed during this study; Other active malignancy within 2 years prior to entry into the study, except for treated non-melanoma skin cancer or curatively treated in-situ disease; Active immunodeficiency disease or autoimmune disease requiring immune suppressive drugs. Vitiligo is not an exclusion criterion; Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study; Patients with brain metastases; Lack of availability for follow-up assessments; Pregnancy or breastfeeding.