Predicting Immunotherapy Response from Live Tumor Biopsies
Official title: Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies
Run by Elephas · NCT07327489 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Elephas Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 8 sites (Fort Smith, Arkansas and 7 other locations) |
| Status | Recruiting |
| Started | April 14, 2025 |
| Main results expected | April 2035 |
| Study ends | April 2038 |
| Registry record updated | June 29, 2026 |
| Trial ID | NCT07327489 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Show 2 more locations
-
JPS Health Network
Forth Worth, Texas, United States Recruiting -
Baylor Scott and White Biorepository
Temple, Texas, United States Not yet recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
SL-28 for Advanced Solid Tumours
A new allogeneic cell therapy called SL-28 is being tested in adults with advanced solid tumors to see if it is safe and can help shrink tumors.
-
A resource for collecting cancer data and biospecimens
This study is creating a resource to collect health information and samples from cancer patients and healthy individuals to help improve cancer prevention and treatment strategies.
-
EBNK-001 allogeneic NK cell therapy with low-dose IL-15, with or without pembrolizumab, for advanced solid tumors
This treatment tests an off-the-shelf NK cell product (EBNK-001) given with low-dose IL-15, either alone or with pembrolizumab, in adults with advanced or metastatic solid tumors who have exhausted standard options.
-
177Lu-BetaBart treatment for relapsed, inoperable, or metastatic solid tumors
This trial will test a radioactive antibody called 177Lu-BetaBart in adults whose solid tumors have progressed after prior treatment, including castration-resistant prostate, colorectal, lung, ovarian, or cervical cancer.
-
Testing trastuzumab deruxtecan (T‑DxD) for HER2‑positive advanced solid tumors
This will test whether trastuzumab deruxtecan (T‑DxD) helps adults in the US with HER2‑positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have had prior systemic treatment and have no satisfactory alternative options.
-
Virtual exercise program to preserve function and prevent disability during chemotherapy
This trial tests whether supervised resistance sessions by video plus short home aerobic workouts help adults 18–64 maintain strength and stay active while receiving curative-intent chemotherapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.