Predicting how tumors respond to immune therapies using a live diagnostic platform

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

This study is testing a new way to predict how well immune therapies will work for patients with different types of solid tumors, including early-stage and metastatic cancers.

Quick facts

• Study type: Observational
• Enrollment: 324 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mayo Clinic (Academic / other)
• Locations: 3 sites (Phoenix, Arizona and 2 other locations)
• Trial ID: NCT06349642 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect tissue samples from patients with various solid tumors to evaluate the accuracy of the Elephas tumor response platform in predicting clinical responses to immunotherapies and chemoimmunotherapy. The study focuses on patients with early-stage and metastatic cancers, including triple-negative breast carcinoma and several types of metastatic carcinomas. By analyzing these samples, researchers hope to improve treatment strategies for patients receiving immune checkpoint inhibitors. The study will involve biospecimen and tissue collection from eligible participants.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with Stage III or IV metastatic solid tumors who are being considered for immune checkpoint inhibitor therapy.

Not a fit: Patients with early-stage tumors or those not eligible for immune checkpoint inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the ability to predict patient responses to immune therapies, leading to more personalized and effective treatment plans.

How similar studies have performed: Other studies have shown promise in using diagnostic platforms to predict responses to immunotherapies, suggesting that this approach may be effective.

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

Where this trial is running

Phoenix, Arizona and 2 other locations

• Mayo Clinic in Arizona — Phoenix, Arizona, United States (Recruiting)
• Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
• Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Dev Mukhopadhyay, PhD — Mayo Clinic
• Study coordinator: Clinical Trials Referral Office

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