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

NCT06349642 | Recruiting

• 3 other identifiers: MC230901NCI-2024-0297923-008413
• Study Type: observational
• Target: 324
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• Accuracy of the Elephas Score for predicting clinical response in neoadjuvant patients

  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

  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

Study Arms (1)

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; Procedure: Tissue Collection

Interventions

Biospecimen Collection PROCEDURE

Undergo optional research blood sample.

Also known as: Blood Draw, Specimen Collection

Observational

Tissue Collection 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.

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.
• Subjects suspected of or diagnosed with the following Stage III per provider discretion or IV/metastatic malignancies:
• Kidney: Clear Cell Renal Cell Carcinoma (ccRCC)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Elephas Biosciences Corporation: collaborator

Study Sites (3)

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40791544 DERIVED

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Specimens will only be retained for future research if participant grants permission. Research specimen collection kits for optional blood samples will be created and managed by the Mayo Clinic Biospecimen Accessioning and Processing lab. Research tissue samples will be collected at the time of the patient's standard of care biopsy, or if the standard of care biopsy has already occurred then a research only biopsy will be scheduled.

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Clear-cell metastatic renal cell carcinoma; Colorectal Neoplasms; Endometrial Neoplasms; Esophageal Neoplasms; Carcinoma, Hepatocellular; Carcinoma, Non-Small-Cell Lung; Skin Neoplasms; Neoplasm Metastasis; Carcinoma, Renal Cell; Carcinosarcoma

Interventions

Blood Specimen Collection; Specimen Handling; Tissue Banks

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Liver Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Neoplasms; Urologic Neoplasms; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplasms, Complex and Mixed; Sarcoma; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Biological Specimen Banks; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Dev Mukhopadhyay, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: April 24, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)