Observational Study to Collect Tissue Samples and Train a Live Tumor Diagnostic Platform for Predicting Response to Immune Checkpoint Inhibitors in Various Solid Tumors
Led by Mayo Clinic · Updated on 2026-03-12
324
Participants Needed
3
Research Sites
N/A
Total Duration
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 advancedmetastatic 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
Research Team
C
Clinical Trials Referral Office
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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
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
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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