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Observational Study of Elephas Platform for Cancer Treatment Prediction

This study is looking at how well a new platform called Elephas can predict if certain cancer treatments will work for you. Researchers want to see if Elephas can accurately tell if patients with specific solid tumors, like early-stage triple-negative breast cancer, metastatic bladder cancer, or metastatic colorectal cancer, will respond to immunotherapies or chemoimmunotherapy. You could be eligible if you are 18 or older and have certain advanced or recurrent cancers, including non-small cell lung cancer or colon cancer with specific biomarkers (dMMR). The study will measure the accuracy of the Elephas platform for up to 3 years. The current status of this study is unclear, but it plans to enroll 324 participants.

Study design
This is an observational study, meaning researchers will collect information without giving new treatments. It aims to enroll 324 participants.
What's involved
You may be asked to provide an optional research blood sample. Tissue samples will be collected during your scheduled standard-of-care biopsy or a separate research biopsy.
Compensation
Not stated in the trial record.
Follow-up
The study will track the accuracy of the Elephas platform for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06349642

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~324 participants
Updated 2026-03-12 on ClinicalTrials.gov
What's tested:Biospecimen CollectionTissue Collection

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Accuracy of the Elephas Score for predicting clinical response in neoadjuvant patients
Measured over Up to 3 years
+1 more outcome measured

Conditions

Early Stage Triple-Negative Breast Carcinoma
Metastatic Bladder Urothelial Carcinoma
Metastatic Cervical Carcinoma
Metastatic Clear Cell Renal Cell Carcinoma
Metastatic Colorectal Carcinoma
Metastatic Endometrial Carcinoma
Metastatic Esophageal Carcinoma
Metastatic Liver Carcinoma
Metastatic Lung Non-Small Cell Carcinoma
Metastatic Malignant Skin Neoplasm
Metastatic Malignant Solid Neoplasm
Resectable Lung Non-Small Cell Carcinoma
Early Stage Lung Non-Small Cell Carcinoma
Resectable Malignant Solid Neoplasm
Resectable Triple-Negative Breast Carcinoma
Stage III Renal Cell Cancer AJCC v8
Stage IV Cervical Cancer AJCC v8
Stage IV Renal Cell Cancer AJCC v8
Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Recurrent Cervical Carcinoma
Recurrent Colorectal Carcinoma
Recurrent Endometrial Carcinoma
Recurrent Esophageal Carcinoma
Recurrent Liver Carcinoma
Recurrent Lung Non-Small Cell Carcinoma
Recurrent Malignant Skin Neoplasm
Recurrent Malignant Solid Neoplasm

Explore related trials

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Where it's being run

3 sites across 3 states
Arizona1
Florida1
Minnesota1

Study leadership

  • Dev Mukhopadhyay, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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 ICI therapy, either frontline or a later line
Patients who will be receiving neoadjuvant CPI for the following resectable early-stage malignancies:
Breast Cancer: Triple negative breast cancer (TNBC)
Lung: Non-small cell lung cancer (NSCLC)
NOTE: Patients with suspected NSCLC who would be eligible for neoadjuvant checkpoint inhibitor (CPI) are eligible to enroll per provider discretion
Any solid tumor 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 ICI therapy, either frontline or a later line
LOCALLY ADVANCED/METASTATIC PATIENTS: Measurable disease as defined per protocol NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible.
NEOADJUVANT PATIENTS: Subjects must be eligible based on investigator discretion to receive approved CPI therapy.
Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy.
Subjects who are Stage I, II, or III and have progressed to metastatic cannot have received any anti-cancer treatment for at least 2 - 4 weeks (depending upon the washout period of prior anti-cancer treatment) prior to biopsy as per the agents used.
ECOG Performance Status (PS) 0, 1 or 2.
Negative pregnancy test done ≤7 days prior to enrollment, for persons of childbearing potential only
Female subjects must not be pregnant or breastfeeding and must use appropriate methods of contraception when applicable.
Subjects must be clinically able, at investigator discretion, and willing to undergo either:
additional biopsy passes during their standard of care biopsy, OR
a biopsy for research only, if applicable.
NOTE: These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to biopsies per the clinician.
Subjects with a known secondary cancer diagnosis are eligible to participate if participation does not interfere with systemic anti-cancer standard of care treatment for suspected primary diagnosis.
Provide written informed consent

Exclusion

Pregnant women because this study involves a greater than minimal risk procedure (biopsy)
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety for the biopsy
Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy
NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
Uncontrolled intercurrent illness including, but not limited to:
ongoing or active infection
psychiatric illness/social situations that would limit compliance with study requirements
Subjects who are enrolled or plan to be enrolled in a blinded cancer therapeutic treatment trial

What this trial measures

  • Accuracy of the Elephas Score for predicting clinical response in neoadjuvant patientsUp to 3 years

    Assessed based on pathologic complete response (pCR) during checkpoint inhibitor (CPI) treatment. Clinical non-response will be defined as non-pathological complete response. Patients who cannot have pathologic complete response determined will be excluded from the primary analysis.

  • Accuracy of the Elephas Score for predicting clinical response in locally advanced/metastatic patientsUp to 3 years

    Assessed based on Response Evaluation Criteria In Solid Tumors (RECIST) score for best overall response \[complete response (CR) or partial response (PR)\] during checkpoint inhibitor (CPI) treatment. Clinical non-response will be defined as either stable disease (SD) or disease progression (PD). Patients who cannot have best response determined will be excluded from the primary analysis.