OVACURE-2

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Leids Universitair Medisch Centrum (LUMC)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-12-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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)

Secondary objectives 2

1. Safety, according to NCI CTCAE v5.0 (all grades)
2. Immune monitoring, including TCR clonotypes

Conditions and MedDRA coding

Ovarian carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. 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.
2. Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube, or primary peritoneal carcinoma (serous, endometrioid, clear cell, carcinosarcoma, or mucinous)
3. Is newly diagnosed FIGO Stage III (extension cohort only) or IV.
4. 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.
5. Possibility to upfront collect tumor tissue for TIL isolation and expansion
6. 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
7. Has an ECOG PS of 0 or 1.
8. 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
9. Able and willing to give valid written informed consent.
10. 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

Exclusion criteria 7

1. Patients with brain metastases
2. 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.
3. Active immunodeficiency disease or autoimmune disease requiring immune suppressive drugs. Vitiligo is not an exclusion criterion.
4. 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.
5. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
6. Lack of availability for follow-up assessments
7. Pregnancy or breastfeeding

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. mmunotherapy related grade III/IV NCI-CTC toxicity

Secondary endpoints 2

1. All grade NCI CTC toxicity
2. CD8/CD4/MDSC, M1/2, Treg

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Leids Universitair Medisch Centrum (LUMC)

Sponsor organisation

Leids Universitair Medisch Centrum (LUMC)

Address

Albinusdreef 2

City

Leiden

Postcode

2333 ZA

Country

Netherlands

Scientific contact point

Organisation

Leids Universitair Medisch Centrum (LUMC)

Contact name

Judith Kroep

Public contact point

Organisation

Leids Universitair Medisch Centrum (LUMC)

Contact name

Judith Kroep

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications