Clinical trial · Interventional
Evaluating PD-1/PD-L1 in Locally Advanced Rectal Cancer by Quantitative Fluorescence Molecular Endoscopy
Improving Detection and Treatment of Locally Advanced Rectal Cancer by Dual Wavelength Quantitative Fluorescence Molecular Endoscopy Using Nivolumab-800CW and Durvalumab-680LT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Colorectal cancer (CRC) claims 10% of global cancer-related deaths annually, with rising incidence. Locally advanced rectal cancer (LARC) requires improved diagnostic techniques. This study focuses on dual-wavelength quantitative fluorescence molecular endoscopy (qFME) using PD-1/PD-L1-targeted tracers for LARC patients undergoing neoadjuvant treatment. Eighteen patients will receive nivolumab-800CW and durvalumab-680LT before qFME procedures, assessing programmed death-1/programmed death ligand-1 (PD-1/PD-L1) expression. We want to test the feasibility of qFME and ex vivo fluorescence imaging after intravenous administration of nivolumab-800CW, targeting PD-1, and durvalumab-680LT, targeting PD-L1, to visualize PD-L1 and PD-1 expression before and after CRT in LARC patients. If successful, this method can potentially be used in the future to see which patients most likely benefit from additional immunotherapy beforehand. The non-randomized, prospective phase 1 intervention explores biomarkers' role in treatment response prediction. Tracer administration poses minimal risks. Patients will not directly benefit, but the study aims to establish the utility of nivolumab-800CW and durvalumab-680LT in determining PD-1/PD-L1 expression during endoscopy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Rectal Carcinoma | Rectal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imfinzi | Drug | Durvalumab | ALIAS |
| Opdivo | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Durvalumab-680LT and nivolumab-800CW
- description
- Study procedure 1: Combined intravenous tracer administration with 15mg IMFINZI and 15mg OPDIVO followed by fluorescence molecular endoscopy Study procedure 2: Combined intravenous tracer administration with 15mg IMFINZI and 15mg OPDIVO followed by fluorescence molecular endoscopy
- interventionNames
- Drug: Imfinzi
- Drug: Opdivo
Primary outcomes (5)
- measure
- Safety of nivolumab-800CW in combination with durvalumab-680LT
- timeFrame
- Until 24 hours after administration
- description
- To evaluate the safety of nivolumab-800CW in combination with durvalumab-680LT through monitoring vital signs, the injection site and evaluating possible tracer-related (severe) adverse events (SAE/AEs) and suspected unexpected serious adverse reactions (SUSARs).
- measure
- To investigate the feasibility of using fluorescence molecular endoscopy (FME) and ex vivo FMI to detect nivolumab-800CW and durvalumab-680LT signals indicating PD1 and PD-L1 expression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with LARC (cT3c-4, N1-2, M0); * Written informed consent is obtained; (We aim to include only patients who consent to both study procedures, however if some patients (n\<9) do not consent to the first or second procedure or withdraw their consent for the second procedure after the first procedure, they can still be included) * Be at least 18 years old; * Speak the Dutch language. Exclusion Criteria: * Concurrent uncontrolled medical conditions according to treating medical physician; * Pregnancy or breast feeding. A negative pregnancy test must be available for women of childbearing potential on the day of tracer administration (i.e. premenopausal women with intact reproductive organs and women less than two years after menopause); * Prior irradical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of the primary tumor. * Received an investigational drug within 30 days prior to administration of nivolumab-800CW and durvalumab-680LT according to the patient's medical history; * History of infusion reactions to nivolumab, durvalumab or other monoclonal antibodies according to the patient's medical history; * Active episode of inflammatory bowel disease; * Use of immunosuppressive agents; * Medical or psychiatric conditions that compromise the patient's ability to give informed consent according to treating medical physician.
References
Publications (0)
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