Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform (NCT06349642) | Clinical Trial Compass
RecruitingNot Applicable
Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform
United States324 participantsStarted 2024-04-24
Plain-language summary
This study is being done to collect tissue samples to test how accurately a tumor response platform, Elephas, can predict clinical response across multiple types of immunotherapies, chemoimmunotherapy and tumor types.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Subjects must meet one of the following criteria:
* Subjects suspected of or diagnosed with the following Stage IV/metastatic or recurrent malignancies:
* Lung: Non-small Cell Lung Cancer (NSCLC)
* Skin: Cutaneous Malignancy, excluding Uveal Melanoma
* Esophageal Cancer
* Cervical Cancer
* Endometrial Cancer
* Colon Cancer: Mismatch repair deficient (dMMR) CRC only
* All solid tumors with high tumor mutation burden (TMB)
* All solid tumors that are microsatellite instability high (MSI-H)
* All mismatch repair deficient (dMMR) solid tumors
* Liver Cancer
* Any solid tumor with measurable disease that is eligible for pure ICI therapy or that the clinician plans to treat with immune checkpoint inhibitor (ICI) therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate laboratory developed tests (LDTs) that, per clinician, render the patient eligible for ICI therapy, either frontline or a later line.
OR
* Subjects suspected of or diagnosed with the following Stage III per provider discretion or IV/metastatic malignancies:
* Kidney: Clear Cell Renal Cell Carcinoma (ccRCC)
* Bladder: Urothelial Carcinoma (UC)
* Any solid tumor with measurable disease that is eligible for pure ICI therapy or that the clinician plans to treat with ICI therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate LDT tests that per clinician, render the patient eligible for…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Accuracy of the Elephas Score for predicting clinical response in neoadjuvant patients
Timeframe: Up to 3 years
2
Accuracy of the Elephas Score for predicting clinical response in locally advanced/metastatic patients