New test could predict immunotherapy success from live tumor samples
NCT ID NCT05520099
First seen Jun 25, 2026 · Last updated Jun 30, 2026 · Updated 3 times
Summary
This observational study collects extra tumor tissue from 416 people with various cancers (bladder, kidney, colorectal, head and neck, liver, lung, skin, endometrial) during routine biopsies. The goal is to develop and train a 'live tumor diagnostic platform' that can predict whether a patient will respond to immunotherapy. The platform's accuracy will be compared to standard tumor measurements and FDA-approved biomarkers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to a test that helps doctors predict which patients will benefit from immunotherapy, improving treatment decisions.
- What could go wrong
- This is an early-stage observational study, not a treatment trial. The platform may not prove accurate enough in larger, more diverse groups.
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.
- Participants
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About 416 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adults aged 18 years or older, able to provide informed consent, and have a suspected or confirmed cancer diagnosis that meets requirements outlined in the eligibility criteria above.
- 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.
Show the full entry requirements Hide 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.
Inclusion Criteria -- 1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. 2. Age ≥ 18 years at the time of consent. 3. Subjects must meet one of the following criteria: * Subjects suspected or diagnosed with recurrent, locally advanced or metastatic cancer: * Bladder: Urothelial Carcinoma (UC) * Kidney: Clear Cell Renal Cell Carcinoma (ccRCC) * Subjects suspected or diagnosed with recurrent or metastatic cancer: * Colon and Rectum: Microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) Colorectal Cancer (CRC) * Head and Neck: Squamous Cell Carcinoma (HNSCC), excluding nasopharyngeal and salivary gland cancers * Liver: Hepatocellular Carcinoma * Lung: Non-small cell lung cancer (NSCLC) * Skin: Cutaneous Melanoma, excluding Uveal Melanoma * Uterus: endometrial cancer * Subjects suspected or diagnosed with one of the following cancer types eligible for pure ICI neoadjuvant therapy: o Skin: Cutaneous Melanoma, Stage III * Subjects suspected or diagnosed with: * Any solid tumor type that is eligible for pure ICI therapy in the neoadjuvant or advanced/metastatic setting * Any metastatic solid tumor with high TMB, MSI-High or dMMR and are being considered for treatment with ICI therapy. * Any recurrent or metastatic patient with a solid tumor that the clinician plans to treat with ICI therapy. 4. Subjects must be clinically able, at investigator discretion, to undergo a biopsy procedure 5. Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment. Exclusion Criteria -- 1. Subjects who are pregnant 2. Subjects with a known auto-immune disease that would render them ineligible for immune-oncology treatment 3. Immunocompromised subjects, and subjects known to be HIV positive and currently receiving antiretroviral therapy 4. Subjects who are enrolled or plan to be enrolled in a blinded oncology treatment trial
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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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AdventHealth Orlando
Orlando, Florida, 32803, United States
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CARTI Cancer Center
Little Rock, Arkansas, 72205, United States
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Cleveland Clinic Florida
Stuart, Florida, 34994, United States
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John Theurer Cancer Center
Hackensack, New Jersey, 07601, United States
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Memorial Health System
Pembroke Pines, Florida, 33026, United States
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Meritus Center for Clinical Research
Hagerstown, Maryland, 21742, United States
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Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203, United States
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Salinas Valley Memorial Healthcare System
Salinas, California, 93901, United States
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University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
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University of South Florida (Tampa General Hospital)
Tampa, Florida, 33606, United States
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University of Wisconsin
Madison, Wisconsin, 53705, United States
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