Studying How Live Tumor Biopsies Can Predict Response to Immunotherapy in Adults with Suspected or Confirmed Cancer
Led by Elephas · Updated on 2026-06-29
2000
Participants Needed
8
Research Sites
156 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the response to immunotherapy in patients with suspected or confirmed cancer by collecting tumor specimens during routine biopsy or similar procedures. The study focuses on analyzing live tumor biopsies to understand the tumor microenvironment and its immune cells intact. This research aims to compare the ex vivo tumor response to immunotherapy with the real-world clinical outcomes, helping to inform future treatment development.
Participants will provide tumor tissue samples obtained during their standard medical biopsy procedures. Additional biopsy samples may be collected if clinically appropriate. Alongside these specimens, clinical and genomic data from the patients standard care will be used to support the research. The study does not involve administering new treatments but observes responses through collected tissue and data.
Participants will undergo biopsies as part of their normal care, with no extra treatment required for the study. Information collected includes tumor tissue, clinical data, and genomic data. The main outcome measured is the ability to predict clinical response to immune checkpoint inhibitors. The study duration is about 36 months from enrollment to the studys end, allowing long-term data collection and analysis.
CONDITIONS
Brief Title
Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)
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Able and willing to provide informed consent for participation
Age 18 years or older at time of consent
Have a suspected or confirmed cancer diagnosis to be evaluated by biopsy
Newly diagnosed or suspected cancer patients must be treatment-naïve at biopsy
Other participants should have biopsy before starting next treatment line
You will not qualify if you...
Known autoimmune disease or prior condition (organ transplant, chronic kidney or liver disease) ineligible for immunotherapy
Severely immunocompromised individuals (e.g., on immunosuppressants, HIV positive on antiretrovirals, post transplantation)
Pregnant individuals
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Tissue sampling in the era of precision medicine: comparison of percutaneous biopsies performed for clinical trials or tumor genomics versus routine clinical care.