Predicting Immunotherapy Response from Live Tumor Biopsies
Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies
This project will try to see if analyzing live tumor biopsy samples kept in their 3D environment can predict whether people with advanced solid tumors will respond to immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Elephas Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 8 sites (Fort Smith, Arkansas and 7 other locations) |
| Trial ID | NCT07327489 on ClinicalTrials.gov |
What this trial studies
This observational effort collects tumor specimens and linked clinical and genomic data from adults who are having a biopsy as part of their normal care. The sponsor uses methods to cut, sort, and image tumor tissue while keeping the 3D tumor microenvironment, including immune cells, intact. Samples are exposed ex vivo to potential immunotherapy agents and the tissue's responses are characterized qualitatively and semi-quantitatively. Those ex vivo response data will be compared to real-world clinical outcomes to inform development of predictive tools.
Who should consider this trial
Good fit: Adults (≥18) with suspected or confirmed cancer who are undergoing a clinical biopsy—treatment-naïve if newly diagnosed or having the biopsy before their next line of therapy—and able to give informed consent.
Not a fit: Patients with known autoimmune disease or other conditions that preclude immunotherapy, severely immunocompromised individuals, and pregnant people are excluded and unlikely to benefit from the assay.
Why it matters
Potential benefit: If successful, this could help doctors predict who is likely to benefit from immunotherapy and avoid ineffective treatments.
How similar studies have performed: Some ex vivo tumor assays and organoid models have shown promise, but preserving an intact 3D tumor immune microenvironment for predicting immunotherapy response is relatively novel and not yet widely validated clinically.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Able and willing to provide informed consent for participation 2. Age ≥18 years at time of consent. 3. Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy. 4. 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. Have a known auto-immune disease or prior condition (prior organ transplant, chronic kidney or liver disease) that renders them ineligible for immunotherapy (IO) treatment. 2. Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients. 3. Pregnant person(s).
Where this trial is running
Fort Smith, Arkansas and 7 other locations
- Mercy Hospital - FTS — Fort Smith, Arkansas, United States (Recruiting)
- Frederick Health Hospital — Frederick, Maryland, United States (Recruiting)
- Mercy Hospital - SPG — Springfield, Missouri, United States (Recruiting)
- Mercy Hospital - South — St Louis, Missouri, United States (Recruiting)
- Mercy Hospital -STL — St Louis, Missouri, United States (Recruiting)
- Mercy Hospital - OKC — Oklahoma City, Oklahoma, United States (Recruiting)
- JPS Health Network — Forth Worth, Texas, United States (Recruiting)
- Baylor Scott and White Biorepository — Temple, Texas, United States (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.