Cervical CarcinomaPhase 1NEOLYNCNCT07653503
Neoadjuvant Lymph Node Targeted Immunotherapy in Cervical Cancer: a Feasibility Study (NEOLYNC)
A Phase 1 study testing Nivolumab in people with Cervical Carcinoma, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
We aim to determine feasibility, safety and efficacy of TDLN-targeted immune checkpoint inhibition in different doses (nivolumab) in patients with cervical cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Carcinoma
- What is being tested?
- Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Jan 2026to 1 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
Show all 21Show fewer
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (defined as >10 mg prednisone equivalent per day) or other systemic immunosuppressive therapy within 7 days prior to the first dose of study drug. The use of systemic corticosteroids and other immunosuppressants prior to initiation of study treatment should be avoided due to potential interference with the pharmacodynamic activity of nivolumab. Use of immunosuppressive agents after initiation of treatment is allowed when clinically indicated for the management of immune-related adverse events.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- Has known active CNS metastases and/or carcinomatous meningitis.
- Has severe hypersensitivity (≥Grade 3) to nivolumab and/or any of its excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy.
- Any contraindication to MRI, including but not limited to the presence of non-MRI-compatible implants (e.g., pacemakers, cochlear implants, neurostimulators), ferromagnetic metal fragments, or severe claustrophobia unmanageable with standard precautions.
- Prior surgical intervention in the inguinal region with potential disruption of lymphatic drainage.
- Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority.
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
- Any condition, as assessed by the research physician and/or medical oncologist, that in their clinical judgment makes the patient unsuitable for participation in the study. This may include, but is not limited to, poor physical condition, abnormal laboratory values, or other medical or psychosocial factors that could compromise patient safety or study integrity. Patients that are excluded based on this criterium will always be reported to the DSMB.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Centre Groningen
Groningen, 9700 RB
Willemiek Iwema, MD, +3150 361 61 61, w.m.iwema@umcg.nl
Hans W Nijman, Prof. dr.
About this study
We aim to determine feasibility, safety and efficacy of TDLN-targeted immune checkpoint inhibition in different doses (nivolumab) in patients with cervical cancer.
Read the detailed description
Objective: We aim to determine feasibility, safety and efficacy of TDLN-targeted immune checkpoint inhibition in different doses (nivolumab) in patients with cervical cancer.
Trial design: This is a single-arm, single-center phase 1 study to evaluate the feasibility and dose-finding of neoadjuvant nivolumab in newly diagnosed cervical cancer patients. Two 3-weekly subcutaneous administrations of nivolumab (5, 10, 15, or 30 mg) will be given in the inner-upper thigh, targeting the tumor-draining lymph nodes. Treatment will occur between diagnosis and standard-of-care surgery, followed by adjuvant therapy. The dose levels are based on the established bioavailability and previous reports of biological activity. Subjects participate in the study for 11 weeks with late follow-up visits after 3 and 6 months.
Trial population: The study will include female patients aged 18 and older with newly diagnosed cervical cancer (FIGO stage < IB3) who are eligible for standard-of-care surgery. Participants must not be pregnant or breastfeeding and must provide informed consent. Key exclusion criteria include prior systemic immunotherapy, recent systemic anti-cancer therapy, live vaccines, active infections, autoimmune diseases requiring treatment, known CNS metastases, and other malignancies within the last three years. Patients with hypersensitivity to nivolumab or severe comorbidities, including active pneumonitis or immunodeficiency, will be excluded.
Intervention: Nivolumab (5, 10, 15, or 30 mg), subcutaneous Q3W for a total of 2 administrations per patient, integrated into standard-of-care protocol prior to surgery. Based on the well-established timelines, the interval between diagnosis and standard-of-care (SoC) surgery is sufficient to treat patients with two administrations of nivolumab without interfering with standard treatment.
- Conditions
- Cervical Carcinoma
- Being tested
- Nivolumab
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Subcutaneous injection of nivolumab
| Study group | Role | What they receive |
|---|---|---|
| NEOLYNC study participants | Experimental | Not described Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Proportion of participants undergoing planned standard surgical treatment after 2 cycles of TDLN-targeted neoadjuvant ICI without treatment-related delay or cancellation.
Feasibility will be assessed as the proportion of participants who complete 2 cycles of neoadjuvant TDLN-targeted immune checkpoint inhibition and subsequently undergo planned standard surgical treatment without treatment-related delay or cancellation.
Measured: Through study completion, an average of 2 months per patient
Pathologic response rate
At least one partial pathologic response (pPR) must be observed, irrespective of dose level. All further pathologic responses will be reported on using descriptive statistics for the estimated percentage of viable remaining cancer cells at the end of the study period and defined based on work in other cancers such as melanoma, breast and colorectal cancer with:
- pPR - <90% vital tumor cells
- pNCR - <10% vital tumor cells in the tumor
- pCR - the complete absence of viable cancer cells in the tumor
Measured: Tumor tissue will be collected during standard-of-care surgery
Secondary outcomes (2)
Safety and toxicity
Adverse events be monitored in the current trial using GCP guidelines. All AEs will be followed until they have abated, or until a stable situation has been reached. The reporting period for all AEs begins with signing the ICF. Patients will visit the hospital in weeks 12, 21 and 33 to monitor potential long-term effects of the nivolumab.
Measured: Through study completion, an average of 2 months per patient
Radiologic responses
MRI will be performed at baseline (SoC diagnostic workup) and will be compared to MRI performed prior to surgery (week 11). Tumor response will be classified according to RECIST 1.1:
- Complete Response (CR): Disappearance of all target lesions.
- Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest-sum-on-study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
- Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: MRI is before start of study drug and 3 weeks after the second/last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start5 Jan 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653503
- Sponsor's protocol ID
- NEOLYNC-UMCG-001
- Acronym
- NEOLYNC
- Status last verified
- Apr 2026
- First submitted
- 11 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Lymph Node Targeted Immunotherapy in Cervical Cancer: a Feasibility Study (NEOLYNC)
- ClinicalTrials.gov ID
- NCT07653503
- Acronym / sponsor ID
- NEOLYNC / NEOLYNC-UMCG-001
- Conditions
- Cervical Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We aim to determine feasibility, safety and efficacy of TDLN-targeted immune checkpoint inhibition in different doses (nivolumab) in patients with cervical cancer.
Detailed description
Objective: We aim to determine feasibility, safety and efficacy of TDLN-targeted immune checkpoint inhibition in different doses (nivolumab) in patients with cervical cancer.
Trial design: This is a single-arm, single-center phase 1 study to evaluate the feasibility and dose-finding of neoadjuvant nivolumab in newly diagnosed cervical cancer patients. Two 3-weekly subcutaneous administrations of nivolumab (5, 10, 15, or 30 mg) will be given in the inner-upper thigh, targeting the tumor-draining lymph nodes. Treatment will occur between diagnosis and standard-of-care surgery, followed by adjuvant therapy. The dose levels are based on the established bioavailability and previous reports of biological activity. Subjects participate in the study for 11 weeks with late follow-up visits after 3 and 6 months.
Trial population: The study will include female patients aged 18 and older with newly diagnosed cervical cancer (FIGO stage < IB3) who are eligible for standard-of-care surgery. Participants must not be pregnant or breastfeeding and must provide informed consent. Key exclusion criteria include prior systemic immunotherapy, recent systemic anti-cancer therapy, live vaccines, active infections, autoimmune diseases requiring treatment, known CNS metastases, and other malignancies within the last three years. Patients with hypersensitivity to nivolumab or severe comorbidities, including active pneumonitis or immunodeficiency, will be excluded.
Intervention: Nivolumab (5, 10, 15, or 30 mg), subcutaneous Q3W for a total of 2 administrations per patient, integrated into standard-of-care protocol prior to surgery. Based on the well-established timelines, the interval between diagnosis and standard-of-care (SoC) surgery is sufficient to treat patients with two administrations of nivolumab without interfering with standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NEOLYNC study participants | Experimental | Drug: Nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (21 listed)
- 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 start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabSubcutaneous injection of nivolumab | Drug | NEOLYNC study participants |
Primary outcome
Feasibility: Proportion of participants undergoing planned standard surgical treatment after 2 cycles of TDLN-targeted neoadjuvant ICI without treatment-related delay or cancellation.
Time frame: Through study completion, an average of 2 months per patient
Feasibility will be assessed as the proportion of participants who complete 2 cycles of neoadjuvant TDLN-targeted immune checkpoint inhibition and subsequently undergo planned standard surgical treatment without treatment-related delay or cancellation.
Pathologic response rate
Time frame: Tumor tissue will be collected during standard-of-care surgery
At least one partial pathologic response (pPR) must be observed, irrespective of dose level. All further pathologic responses will be reported on using descriptive statistics for the estimated percentage of viable remaining cancer cells at the end of the study period and defined based on work in other cancers such as melanoma, breast and colorectal cancer with: * pPR - <90% vital tumor cells * pNCR - <10% vital tumor cells in the tumor * pCR - the complete absence of viable cancer cells in the tumor
2 secondary outcomes
Safety and toxicity
Time frame: Through study completion, an average of 2 months per patient
Radiologic responses
Time frame: MRI is before start of study drug and 3 weeks after the second/last dose of study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nivolumab in people with Cervical Carcinoma, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Proportion of participants undergoing planned standard surgical treatment after 2 cycles of TDLN-targeted neoadjuvant ICI without treatment-related delay or cancellation. (time frame: Through study completion, an average of 2 months per patient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.