Biobanking Upper Gastrointestinal Tumors to Evaluate Response With Additional Banking of Cutaneous Neoplasms (BURGER With BACON)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Number of participants with Progressive Disease
研究概览
简要总结
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.
详细描述
The study will be divided into three cohorts: 1) Cohort A, which will enroll subjects prior to treatment with an immune checkpoint inhibitor or chemotherapy alone; 2) Cohort B, which will analyze samples collected from melanoma patients under Pro00059349; and 3) Cohort C, a retrospective portion that will allow for collection of data and archived tissue;
Cohort A: GE Subjects Treated with ICI
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. Additionally, excess tissue may be collected and flash frozen from standard of care biopsies that occur while patient is on study. Objective response assessments for these patients will be made by MD assessment, based on standard-of-care CT or MRI cross-sectional imaging. Blood and/or tissue specimens will be taken accordingly at the following time points:
Baseline (pre-treatment):
Patients will undergo a research blood draw. If subject receives a standard of care biopsy after consenting but before starting anti-PD-1 therapy, every attempt will be made to collect tissue from this biopsy for research purposes. If the patient is not scheduled for standard of care biopsy during this period, they will only undergo blood draw.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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.
排除标准
- •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)
- •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
- •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.
研究组 & 干预措施
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.
干预措施: Immune checkpoint inhibitor (ICI) or chemotherapy alone (Drug)
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.
干预措施: Immune checkpoint inhibitor (ICI) or chemotherapy alone (Drug)
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.
干预措施: Immune checkpoint inhibitor (ICI) or chemotherapy alone (Drug)
结局指标
主要结局
Number of participants with Progressive Disease
时间窗: up to 3 years
Number of participants with Stable Disease
时间窗: up to 3 years
Number of participants with Complete Response (CR)
时间窗: up to 3 years
Number of participants with Partial Response (PR)
时间窗: up to 3 years
次要结局
未报告次要终点