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Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform | Clinical Trials | Clareo Health

RECRUITING

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

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

NCT06349642•Mayo Clinic

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)
+14 more criteria

Exclusion Criteria

•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.
+10 more criteria

Locations (3)

Mayo Clinic in Arizona

Phoenix, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

April 24, 2024

Primary Completion Date

May 1, 2027

Completion Date

May 1, 2027

Last Updated

March 12, 2026

Enrollment

324

ESTIMATED participants

Conditions

Early Stage Triple-Negative Breast CarcinomaMetastatic Bladder Urothelial CarcinomaMetastatic Cervical CarcinomaMetastatic Clear Cell Renal Cell CarcinomaMetastatic Colorectal CarcinomaMetastatic Endometrial CarcinomaMetastatic Esophageal CarcinomaMetastatic Liver CarcinomaMetastatic Lung Non-Small Cell CarcinomaMetastatic Malignant Skin NeoplasmMetastatic Malignant Solid NeoplasmResectable Lung Non-Small Cell CarcinomaEarly Stage Lung Non-Small Cell CarcinomaResectable Malignant Solid NeoplasmResectable Triple-Negative Breast CarcinomaStage III Renal Cell Cancer AJCC v8Stage IV Cervical Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8Recurrent Cervical CarcinomaRecurrent Colorectal CarcinomaRecurrent Endometrial CarcinomaRecurrent Esophageal CarcinomaRecurrent Liver CarcinomaRecurrent Lung Non-Small Cell CarcinomaRecurrent Malignant Skin NeoplasmRecurrent Malignant Solid Neoplasm

Interventions

Biospecimen Collection

PROCEDURE

Tissue Collection

PROCEDURE

Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015 mayocliniccancerstudies@mayo.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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