A live tumor fragment platform to assess immunotherapy response in core needle biopsies while addressing challenges of tumor heterogeneity.
T S Ramasubramanian, Pichet Adstamongkonkul, Christina M Scribano...
https://pubmed.ncbi.nlm.nih.gov/40791544Actively Recruiting
Age: 18Years +
All Genders
ID06349642
Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform
Led by Mayo Clinic ยท Updated on 2026-03-12
324
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
E
Elephas Biosciences Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how well a live tumor diagnostic platform called Elephas can predict how patients respond to various immunotherapies and chemoimmunotherapies across different types of tumors. This observational basket trial includes patients with several advanced or recurrent cancers who are receiving immune checkpoint inhibitor treatments. The study aims to improve understanding of tumor response to these therapies by collecting tissue samples and clinical data. Participants undergo tissue biopsies for research purposes, which may be done alongside their regular care biopsies or as separate procedures if needed. Blood samples may also be collected optionally. During the study, patients receive their usual checkpoint inhibitor treatments and standard tumor assessments as part of their care. This design allows researchers to analyze tissue and blood samples while monitoring treatment responses. Throughout the study period, participants will have their tumor status assessed regularly according to standard care. Researchers will evaluate the accuracy of the Elephas Score in predicting clinical response over up to three years for both neoadjuvant and locally advanced/metastatic patients. The study involves reviewing medical records and monitoring patient outcomes to validate this tumor diagnostic platform. Follow-up assessments will continue as participants receive their treatments and progress through their cancer care journey.
CONDITIONS
Brief Title
Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Suspected or diagnosed with Stage IV/metastatic or recurrent malignancies including non-small cell lung cancer, cutaneous malignancy (excluding uveal melanoma), esophageal cancer, cervical cancer, endometrial cancer, mismatch repair deficient colorectal cancer, liver cancer, clear cell renal cell carcinoma, urothelial carcinoma, triple negative breast cancer, or other solid tumors eligible for immune checkpoint inhibitor therapy
- Measurable disease as defined by protocol for locally advanced/metastatic patients
- Eligible for or planned to receive immune checkpoint inhibitor therapy either frontline or later line
- ECOG Performance Status of 0, 1, or 2
- Negative pregnancy test within 7 days prior to enrollment for persons of childbearing potential
- Female participants must not be pregnant or breastfeeding and must use contraception if applicable
- Willing and able to undergo additional research biopsies either during standard care biopsy or separately
- Patients with a known secondary cancer diagnosis may participate if it does not interfere with standard care treatment for the primary diagnosis
- Provide written informed consent
You will not qualify if you...
- Pregnant women
- Severe co-morbid systemic illnesses or other serious diseases that interfere with biopsy safety or study assessments
- Immunocompromised patients or HIV-positive patients currently on antiretroviral therapy
- Uncontrolled illnesses including active infections or psychiatric/social conditions limiting study compliance
- Enrollment in or planned enrollment in a blinded cancer therapeutic treatment trial that would interfere with this study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Diagnostic Evaluation
Duration - Occurs at standard care biopsy or scheduled separately
Participants undergo tissue biopsy and may optionally provide blood samples for research purposes alongside their standard care biopsies.
1 to 2 visits depending on biopsy scheduling
Long-term Monitoring
Duration - Up to 3 years
Participants receive standard treatment with immune checkpoint inhibitors and have their tumor assessments and medical records reviewed during the study.
Visits aligned with standard tumor assessments during treatment and follow-up
Trial Site Locations
Total: 3 locations
1
Mayo Clinic in Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
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Research Team
C
Clinical Trials Referral Office
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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