Neoadjuvant Lymph Node Targeted Immunotherapy in Cervical Cancer: a Feasibility Study (NEOLYNC)

NCT07653503 | Recruiting Phase 1

• 1 other identifier: NEOLYNC-UMCG-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

We aim to determine feasibility, safety and efficacy of TDLN-targeted immune checkpoint inhibition in different doses (nivolumab) in patients with cervical cancer.

Conditions

Cervical Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Tumor tissue will be collected during standard-of-care surgery

Secondary Outcomes (2)

• Safety and toxicity

  Through study completion, an average of 2 months per patient

• Radiologic responses

  MRI is before start of study drug and 3 weeks after the second/last dose of study drug

Study Arms (1)

NEOLYNC study participants

EXPERIMENTAL

Drug: Nivolumab

Interventions

Nivolumab DRUG

Subcutaneous injection of nivolumab

NEOLYNC study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Centre Groningen

Groningen, 9700 RB, Netherlands

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 17, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-04

Locations

NL (1)