Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform (ELEPHAS-04)

March 11, 2026 updated by: Mayo Clinic

Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform

This study is being done to collect tissue samples to test how accurately a tumor response platform, Elephas, can predict clinical response across multiple types of immunotherapies, chemoimmunotherapy and tumor types.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

324

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic in Arizona
        • Contact:
        • Principal Investigator:
          • Parminder Singh, MD
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic in Florida
        • Contact:
        • Principal Investigator:
          • Dev Mukhopadhyay, PhD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Principal Investigator:
          • Matthew Block, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients at Mayo Clinic in Rochester who are suspected of or diagnosed with Stage III or IV/metastatic cancer or receiving neoadjuvant (pre-operative) checkpoint inhibitors (CPI) for a resectable early stage of solid malignancies

Description

Inclusion Criteria:

Subjects must meet one of the following criteria:

  • 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.

OR

  • 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

OR

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Patients undergo tissue biopsy and may optionally undergo blood sample collection and have their medical records reviewed on study. Patients receive standard treatment with checkpoint inhibitors during the study and undergo standard tumor assessments during screening and follow-up.
Procedure: Biospecimen Collection
Undergo optional research blood sample.
Other Names:
  • Specimen Collection
  • Blood Draw
Procedure: Tissue Collection
Tissue specimen collection will be completed with your scheduled standard of care biopsy if possible. If standard of care biopsy is already completed or the research biopsy wasn't collected at the time as your standard of care biopsy, then the research biopsy will be scheduled for a different day for research purposes only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of the Elephas Score for predicting clinical response in neoadjuvant patients
Time Frame: Up 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.
Up to 3 years
Accuracy of the Elephas Score for predicting clinical response in locally advanced/metastatic patients
Time Frame: Up 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.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Elephas Biosciences Corporation

Investigators

  • Principal Investigator: Dev Mukhopadhyay, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC230901
  • 23-008413 (Other Identifier: Mayo Clinic Institutional Review Board)
  • NCI-2024-02979 (Registry Identifier: CTRP (Clinical Trials Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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