Biobanking Upper Gastrointestinal Tumors to Evaluate Response (BURGER With BACON)

NCT06283238 | Withdrawn DMC FDA Drug

• 1 other identifier: Pro00115121
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to examine genetic changes that may contribute to immunotherapy resistance in gastroesophageal cancer. This information can potentially lead to the identification of new immunotherapeutic targets as well as improve the ability to identify those patients more likely to respond to immunotherapy. This study does not include any treatment or investigational drugs. Participants will be asked:

• to enroll before beginning standard care of treatment for their cancer
• for blood, archived tumor tissue, and fresh tumor tissue Researchers will compare participants who are not getting immunotherapy to identify potential differences in expression levels of a gene.

Conditions

GastroEsophageal Cancer

Outcome Measures

Primary Outcomes (4)

• Number of participants with Complete Response (CR)

  up to 3 years

• Number of participants with Partial Response (PR)

  up to 3 years

• Number of participants with Stable Disease

  up to 3 years

• Number of participants with Progressive Disease

  up to 3 years

Study Arms (3)

Cohort A

Participating subjects will be enrolled prior to initiating treatment with a regimen that includes an immune checkpoint inhibitor or chemotherapy alone in the case of the immunotherapy ineligible cohort. Archived formalin fixed paraffin embedded (FFPE) tumor tissue will be collected for all subjects if available. Patients will have an optional fresh research only biopsy if there is a lesion amenable to safe biopsy which will be frozen for further studies.

Drug: Immune checkpoint inhibitor (ICI) or chemotherapy alone

Cohort B (Melanoma Cohort)

Melanoma samples were previously collected and analyzed under Pro00059349, NCT02694965. Data will continue to be collected from participant's electronic medical records.

Drug: Immune checkpoint inhibitor (ICI) or chemotherapy alone

Cohort C

Retrospective portion that will allow for collection of data and archived tissue The Duke Enterprise Data Unified Content Explorer (DEDUCE) software tool will be utilized to identify patients with gastroesophageal adenocarcinoma or squamous cell or melanoma initiated on anti-PD-1 antibody immunotherapy at Duke University Medical Center and the Duke Cancer Institute between January 1, 2011 and August 31, 2023, and patients ineligible for immunotherapy that received chemotherapy during the same time period.

Drug: Immune checkpoint inhibitor (ICI) or chemotherapy alone

Interventions

Immune checkpoint inhibitor (ICI) or chemotherapy alone DRUG

Immune checkpoint inhibitor (i.e. pembrolizumab, nivolumab, or another checkpoint inhibitor) or chemotherapy alone

Cohort A; Cohort B (Melanoma Cohort); Cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age \> 18 years
• Ability to understand and the willingness to sign a written informed consent document
• Diagnosis of gastric, esophageal, or gastroesophageal junction adenocarcinoma or squamous cell carcinoma.
• Available archival tumor tissue or willingness to undergo research biopsy.

You may not qualify if:

• Patients unable to comply with the requirements of the study protocol
• Patients known to be pregnant or nursing
• Serious pre-existing medical condition, that in the opinion of the investigator, makes the patient unsuitable for the study
• Cohort B (Melanoma Cohort)
• \. 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
• 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.
• Melanoma subjects in cohort C must have stage II, III, or IV disease validated by histology or cytology
• Primary cutaneous melanomas or melanomas of unknown primary site are eligible
• Melanoma subjects must have been treated with immunotherapy (combination with other agents not allowed)
• Patients with intra-cranial disease or disease involving the central nervous system are eligible.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, PBMCs, and archived/fresh tissue

MeSH Terms

Interventions

Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 28, 2024
• Study Start: April 16, 2025
• Primary Completion: March 25, 2026
• Study Completion (Estimated): March 25, 2027
• Last Updated: January 29, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)