BridgeMD
OVACURE-2
EU CTIS ID: 2025-522659-24-00
What this study is testing
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)
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Patients with brain metastases
- 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.
- Active immunodeficiency disease or autoimmune disease requiring immune suppressive drugs. Vitiligo is not an exclusion criterion.
- 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.
- Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
- Lack of availability for follow-up assessments
See the full eligibility criteria
- 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.
- Patients with brain metastases
- 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.
- Active immunodeficiency disease or autoimmune disease requiring immune suppressive drugs. Vitiligo is not an exclusion criterion.
- 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.
- Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
- Lack of availability for follow-up assessments
- Pregnancy or breastfeeding
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.