Cancer biobank study aims to unlock secrets of immunotherapy resistance
NCT ID NCT06283238
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 The study was withdrawn before enrolling any participants.
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Study facts
What this study's own registry entry says, in plain language.
- Expected to start
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Apr 2025
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Duke University
Durham, North Carolina, 27710, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New antibody GNR-051 tested for safety in Hard-to-Treat cancers
- New Antibody-Drug conjugate put to the test against Hard-to-Treat cancers
- Can a direct hit to tumors make immunotherapy work better?