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

NCT ID: NCT06349642

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 324 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-24
• Study Completion Date: 2027-05-31

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo optional research blood sample.

Tissue Collection

Intervention Type: PROCEDURE

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.

Interventions

Biospecimen Collection

Undergo optional research blood sample.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Blood Draw; Specimen Collection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elephas Biosciences Corporation

UNKNOWN

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dev Mukhopadhyay, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Arizona

Phoenix, Arizona, United States

Site Status: RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Trials Referral Office

Role: CONTACT

mayocliniccancerstudies@mayo.edu

855-776-0015

Facility Contacts

Clinical Trials Referral Office

Role: primary

mayocliniccancerstudies@mayo.edu

855-776-0015

Clinical Trials Referral Office

Role: primary

mayocliniccancerstudies@mayo.edu

855-776-0015

References

Ramasubramanian TS, Adstamongkonkul P, Scribano CM, Johnson C, Caenepeel S, Hrycyniak LCF, Vedder L, Dana N, Baltes C, Browning T, Chen YI, Dietz T, Flietner E, Kaplewski N, Kellner A, Korrer M, Liu C, Marhefke N, McDonnell P, Nasreen A, Pope V, Prasad A, Richardson J, Schneider S, Schultz M, Sood C, Sunil A, von Euw E, Wait E, Wargowski E, Advani P, Broome B, Bruckbauer A, Godwin A, Kokabi N, Martin R, Robaina M, Toia G, Routh J, Friedl A, Eliceiri K, Szulczewski M, Johnson S, Oliner J, Galon J, Capitini C, Mukhopadhyay D, Taube J, Braun D, Gierman HJ. A live tumor fragment platform to assess immunotherapy response in core needle biopsies while addressing challenges of tumor heterogeneity. bioRxiv [Preprint]. 2025 Jul 18:2025.07.18.663728. doi: 10.1101/2025.07.18.663728.

Reference Type: DERIVED

PMID: 40791544 (View on PubMed)

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2024-02979

Identifier Type: REGISTRY

Identifier Source: secondary_id

23-008413

Identifier Type: OTHER

Identifier Source: secondary_id

MC230901

Identifier Type: -

Identifier Source: org_study_id