Neoadjuvant Lymph Node Targeted Immunotherapy in Cervical Cancer: a Feasibility Study (NEOLYNC) (NCT07653503) | Clinical Trial Compass
RecruitingPhase 1
Neoadjuvant Lymph Node Targeted Immunotherapy in Cervical Cancer: a Feasibility Study (NEOLYNC)
Netherlands12 participantsStarted 2026-01-05
Plain-language summary
We aim to determine feasibility, safety and efficacy of TDLN-targeted immune checkpoint inhibition in different doses (nivolumab) in patients with cervical cancer.
Who can participate
Age range
18 Years
Sex
FEMALE
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:
* Female participants with uterus and cervix in situ who are at least 18 years of age on the day of signing informed consent with histologically confirmed primary diagnosis of cervical cancer and are intended to be treated with standard-of-care surgery (\< FIGO IB3). Only female participants with reproductive organs still in situ are eligible because this ensures the highest chance of the correct lymph(node) anatomy needed for the administration of the IMP;
* The participant is not pregnant, not breastfeeding, is not a woman of childbearing potential (WOCBP) or agrees to follow contraceptive guidance as described in 9.2.1. during the treatment period and at least until SoC surgery;
* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
Exclusion Criteria:
* WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks \[could consider shorter interval for kinase inhibitors or other short half-life drugs\] prior to allocation.
* Has received prior radiotherapy within 2 weeks of st…
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
Feasibility: Proportion of participants undergoing planned standard surgical treatment after 2 cycles of TDLN-targeted neoadjuvant ICI without treatment-related delay or cancellation.
Timeframe: Through study completion, an average of 2 months per patient
2
Pathologic response rate
Timeframe: Tumor tissue will be collected during standard-of-care surgery