Esophageal CancerPhase 1GLOWNCT07196384
Optical PD-1 and PD-L1 Imaging in Locally Advanced Esophageal Cancer Using Durvalumab-680LT and Nivolumab-800CW
A Phase 1 study testing Spectroscopy system, Nivolumab-800CW and Durvalumab-680LT in people with Esophageal Cancer, run by University Medical Center Groningen.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Spectroscopy system, Nivolumab-800CW and Durvalumab-680LT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 30 Dec 2026
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
About this study
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
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.
Read more
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.
- Conditions
- Esophageal Cancer
- Being tested
- Spectroscopy system, Nivolumab-800CW, Durvalumab-680LT
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectroscopy systemDevice
System that measures the fluorescence intensity in tissue in vivo.
Nivolumab-800CWDrug
Fluorescent tracer
Durvalumab-680LTDrug
Fluorescent tracer
| Study group | Role | What they receive |
|---|---|---|
| 25 mg durvalumab-680LT + 15 mg nivolumab-800CW in esophageal cancer | Experimental | Not described Receives: Device: Spectroscopy system; Drug: Nivolumab-800CW; Drug: Durvalumab-680LT |
| 25 mg durvalumab-680LT + 25 mg nivolumab-800CW in esophageal cancer | Experimental | Not described Receives: Device: Spectroscopy system; Drug: Nivolumab-800CW; Drug: Durvalumab-680LT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasiblity
To determine the feasibility of our newly built dual-wavelength spectroscopy system in combination with the fluorescent tracers durvalumab-680LT and nivolumab-800CW. The spectroscopy system is considered feasible if at least 4 out of 10 patients demonstrate a higher tumor-to-healthy tissue ratio based on spectroscopy measurements. This ratio is calculated by dividing the spectroscopy value of the tumor region by that of the adjacent healthy tissue. The threshold of 4 out of 10 patients was selected based on literature data, which indicate that approximately 43.5% to 48.1% of patients exhibit high PD-1/PD-L1 expression in the tumor area. The investigators therefore expect a similar proportion of patients to show elevated spectroscopy values corresponding to increased target expression.
Measured: Up to 14 months
Safety of dual tracer administratio
- To assess the safety of dual tracer administration of nivolumab-800CW and durvalumab-680LT by evaluating heart rate in beats per minute.
Measured: Up to 14 months
Secondary outcomes (9)
Safety of dual tracer administration
- To assess the safety of dual tracer administration of nivolumab-800CW and durvalumab-680LT by evaluating blood pressure in mmHg
Measured: Up to 14 months
Safety of dual tracer administration
To assess the safety of dual tracer administration of nivolumab-800CW and durvalumab-680LT by evaluating number of AE's
Measured: Up to 14 months
Safety of dual tracer administration
To assess the safety of dual tracer administration of nivolumab-800CW and durvalumab-680LT by evaluating number of SAE'S
Measured: Up to 14 months
Safety of dual tracer administration
To assess the safety of dual tracer administration of nivolumab-800CW and durvalumab-680LT by evaluating number of SUSARS.
Measured: Up to 14 months
Correlation between in vivo signal and ex vivo pathology
- To investigate the correlation between fluorescence signals detected in vivo with ex vivo histopathology, immunohistochemistry; This correlation will be measured by comparing the percentage of staining on immunohistochemistry staining and the hight of the fluorescence signals detected in vivo (unit: Q • μfa,x).
Measured: Up to 14 months
Correlation of fluorescence intensity before and after neoadjuvant therapy
- To compare the fluorescence intensity of the fluorescent tracer durvalumab-680LT and nivolumab-800CW before and after neoadjuvant therapy. These measurements will be taken with a spectroscopy device at two different time points. The first before neoadjuvant treatment, the second after neoadjuvant treatment. The unit of the fluorescence intensity is Q • μfa,x. Both measurements will be compared with each other.
Measured: Up to 14 months
Correlation between in vivo signal and ex vivo analysis
- To compare fluorescence signals detected in vivo taken with a spectroscopy device during study-specific procedures with the percentage of fluorescence staining assessed by fluorescence microscopy
Measured: Up to 14 months
Investigate the sub-cellular location of the drugs.
- To assess the (sub)-cellular location and distribution of durvalumab-680LT and nivolumab-800CW by ex vivo fluorescence microscopy. The investigators image a slide of a biopsy block with the fluorescence microscope, after imaging the investigators introduce fluorescence markers targeting certain cell types on the same slide. These slides can be imaged with the fluorescence microscope again. Afterwards the two slides can be compared with each other to look for overlap.
Measured: Up to 14 months
Optimal dose determination of nivolumab-800CW
- To determine the most optimal dose of nivolumab-800CW for fluorescence molecular endoscopy.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start15 Dec 2025 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Martini Hospital Groningen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196384
- Sponsor's protocol ID
- UMCG 21164
- Other IDs
- 2024-520090-12-00
- Acronym
- GLOW
- Status last verified
- Dec 2024
- First submitted
- 22 Aug 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07196384
- Acronym / sponsor ID
- GLOW / UMCG 21164
- Conditions
- Esophageal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Martini Hospital Groningen
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Sep 2025 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25 mg durvalumab-680LT + 15 mg nivolumab-800CW in esophageal cancer | Experimental | Device: Spectroscopy system, Drug: Nivolumab-800CW, Drug: Durvalumab-680LT |
| 25 mg durvalumab-680LT + 25 mg nivolumab-800CW in esophageal cancer | Experimental | Device: Spectroscopy system, Drug: Nivolumab-800CW, Drug: Durvalumab-680LT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| Spectroscopy systemSystem that measures the fluorescence intensity in tissue in vivo. | Device | 25 mg durvalumab-680LT + 15 mg nivolumab-800CW in esophageal cancer, 25 mg durvalumab-680LT + 25 mg nivolumab-800CW in esophageal cancer |
| Nivolumab-800CWFluorescent tracer | Drug | 25 mg durvalumab-680LT + 15 mg nivolumab-800CW in esophageal cancer, 25 mg durvalumab-680LT + 25 mg nivolumab-800CW in esophageal cancer |
| Durvalumab-680LTFluorescent tracer | Drug | 25 mg durvalumab-680LT + 15 mg nivolumab-800CW in esophageal cancer, 25 mg durvalumab-680LT + 25 mg nivolumab-800CW in esophageal cancer |
Primary outcome
Feasiblity
Time frame: Up to 14 months
To determine the feasibility of our newly built dual-wavelength spectroscopy system in combination with the fluorescent tracers durvalumab-680LT and nivolumab-800CW. The spectroscopy system is considered feasible if at least 4 out of 10 patients demonstrate a higher tumor-to-healthy tissue ratio based on spectroscopy measurements. This ratio is calculated by dividing the spectroscopy value of the tumor region by that of the adjacent healthy tissue. The threshold of 4 out of 10 patients was selected based on literature data, which indicate that approximately 43.5% to 48.1% of patients exhibit high PD-1/PD-L1 expression in the tumor area. The investigators therefore expect a similar proportion of patients to show elevated spectroscopy values corresponding to increased target expression.
Safety of dual tracer administratio
Time frame: Up to 14 months
• To assess the safety of dual tracer administration of nivolumab-800CW and durvalumab-680LT by evaluating heart rate in beats per minute.
9 secondary outcomes
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
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 21 Nov 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Spectroscopy system, Nivolumab-800CW and Durvalumab-680LT in people with Esophageal Cancer, run by University Medical Center Groningen.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasiblity (time frame: Up to 14 months). 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 21 Nov 2025.