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Cancer biobank study aims to unlock secrets of immunotherapy resistance

NCT ID NCT06283238

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study collects blood and tumor tissue samples from people with gastroesophageal cancer to study genetic changes that may cause resistance to immunotherapy. It does not involve any treatment or experimental drugs. The goal is to identify new targets for future immunotherapies and better predict who will respond to treatment. The study was withdrawn before enrolling any participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Expected to start

Apr 2025

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study will be open to men and women of age 18 or above who meet the above patient selection criteria (section 4.0). Once a Cohort A patient is identified, a provider known to the patient will introduce the study, and if the patient is interested, a member of the study team will consent and enroll the patient. Cohort B subjects were already consented for this research under Pro00059349. Cohort C patients will be identified using DEDUCE as described in section 3.0. Patients will not be compensated for study participation.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Cohort A (GE Cohort) For this study, a maximum of 40 evaluable patients with gastroesophageal adenocarcinoma and 20 patients with squamous cell carcinoma who will receive anti-PD-1 treatment as standard of care treatment will be enrolled (combination therapy regimen with other agents are allowed). Evaluable patients are those that have received at least one dose of anti-PD-1 treatment. 10 patients who are ineligible for immunotherapy will also be enrolled to meet the exploratory objective. Inclusion Criteria: 1. Age \> 18 years 2. Ability to understand and the willingness to sign a written informed consent document 3. Diagnosis of gastric, esophageal, or gastroesophageal junction adenocarcinoma or squamous cell carcinoma. 4. Available archival tumor tissue or willingness to undergo research biopsy. Exclusion Criteria: 1. Patients unable to comply with the requirements of the study protocol 2. Patients known to be pregnant or nursing 3. Serious pre-existing medical condition, that in the opinion of the investigator, makes the patient unsuitable for the study Cohort B (Melanoma Cohort) 1\. All subjects that consented and enrolled to Pro00059349 will be rolled into this protocol for specimen analysis. See Pro00059349 for eligibility criteria for those subjects. Cohort C (Retrospective Cohort) Eligibility Criteria 1. GE subjects must have been treated with an immune checkpoint inhibitor for gastroesophageal adenocarcinoma or squamous cell carcinoma, or have been ineligible for immunotherapy due to low PD-L1 and received chemotherapy. 2. Melanoma subjects in cohort C must have stage II, III, or IV disease validated by histology or cytology 1. Primary cutaneous melanomas or melanomas of unknown primary site are eligible 2. Melanoma subjects must have been treated with immunotherapy (combination with other agents not allowed) 3. Patients with intra-cranial disease or disease involving the central nervous system are eligible.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Duke University

    Durham, North Carolina, 27710, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.