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Not yet recruiting NCT07196384

Optical PD-1 and PD-L1 Imaging in Locally Advanced Esophageal Cancer Using Durvalumab-680LT and Nivolumab-800CW

Phase I Interventional Esophageal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spectroscopy system, Nivolumab-800CW, Durvalumab-680LT.
Who it may be relevant to
Registry conditions: Esophageal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Optical PD-1 and PD-L1 Imaging Using Dual-wavelength Quantitative Fluorescence Endoscopy in Locally Advanced Esophageal Cancer Using Durvalumab-680LT and Nivolumab-800CW

Overview

Radiation and chemotherapy can shrink the tumor. For certain types of cancer, immunotherapy is added to further reduce the tumor size. Immunotherapy works for some patients and can sometimes keep the cancer under control for a long time. Unfortunately, immunotherapy does not work for every patient. That's why researchers around the world are looking for new ways to predict who will benefit from immunotherapy and who will not. It is likely that immunotherapy is more effective when the tumor or immune cells have specific targets, such as the proteins PD-L1 or PD-1. Unfortunately, clinicians cannot reliably detect these proteins through blood tests or tissue samples, because their presence can vary throughout the tumor. With this study, the investigators hope to use a new technique called 'fluorescence endoscopy' during an endoscopic ultrasound of the esophagus to visualize whether the PD-L1 or PD-1 proteins are present in esophageal cancer or immune cells. Additionally, the investigators aim to investigate whether the presence of these proteins changes before and after chemotherapy and/or radiation. This will help us determine the best timing for measuring these proteins in the future. What is fluorescence endoscopy? To determine whether the proteins are present, participants in this study will receive two 'tracers' via an IV beforehand. The first tracer is a fluorescent substance-a kind of 'glow-in-the-dark' compound-attached to a drug that binds to PD-L1 proteins in esophageal cancer. The second fluorescent tracer binds to PD-1 proteins on immune cells. During fluorescence endoscopy, the investigators use special equipment to detect these tracers in the esophagus. This information may help us better identify which patients are suitable for immunotherapy treatment and which are not.

Interventions

  • Device Spectroscopy system
    System that measures the fluorescence intensity in tissue in vivo.
  • Drug Nivolumab-800CW
    Fluorescent tracer
  • Drug Durvalumab-680LT
    Fluorescent tracer

Primary outcome measures

  • Feasiblity [Time frame: Up to 14 months]
  • Safety of dual tracer administratio [Time frame: Up to 14 months]
Secondary outcome measures (9)
  • Safety of dual tracer administration [Time frame: Up to 14 months]
  • Safety of dual tracer administration [Time frame: Up to 14 months]
  • Safety of dual tracer administration [Time frame: Up to 14 months]
  • Safety of dual tracer administration [Time frame: Up to 14 months]
  • Correlation between in vivo signal and ex vivo pathology [Time frame: Up to 14 months]
  • Correlation of fluorescence intensity before and after neoadjuvant therapy [Time frame: Up to 14 months]
  • Correlation between in vivo signal and ex vivo analysis [Time frame: Up to 14 months]
  • Investigate the sub-cellular location of the drugs. [Time frame: Up to 14 months]
  • Optimal dose determination of nivolumab-800CW [Time frame: up to 12 months]

Eligibility criteria

Inclusion criteria

  • Lesion suspected for locally advanced EC (cT1b-4a N0-3 M0);
  • Indication for neoadjuvant therapy or definitive chemo-radiation therapy;
  • Age ≥ 18 years;
  • Written informed consent.

Exclusion criteria

  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent according to treating medical physician;
  • Concurrent uncontrolled medical conditions according to treating medical physician;
  • Medical history of auto-immune disease and on active treatment;
  • Pregnancy or breast feeding. A negative pregnancy test must be available for women of childbearing potential (i.e. premenopausal women with intact reproductive organs and women less than two years after menopause);
  • Irradical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of the primary tumor prior to start of neoadjuvant therapy according to the patient's medical history;
  • Received an investigational drug within 30 days prior to the tracer administration according to the patient's medical history;
  • History of infusion reactions to durvalumab or nivolumab or other monoclonal antibodies according to the patient's medical history;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07196384 · UMCG 21164 · 2024-520090-12-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗