Clinical trial NCT06349642: Predicting Response to Immune Checkpoint Inhibitors Across Solid Tumors Using a Live Tumor Diagnostic Platform
Official title: Observational Basket Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform
Study type: OBSERVATIONAL
Overall status: RECRUITING
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 Cancer AJCC v8
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Elephas Biosciences Corporation
First posted: 2024-04-05
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: Inclusion Criteria:

* Subjects suspected of or diagnosed with the following Stage IV/metastatic 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 metastatic solid tumor that the clinician plans to treat with immune checkpoint inhibitor (ICI) therapy. NOTE: This can be either 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)

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 the clinician plans to treat with ICI therapy
* 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

Primary outcomes:
measure: Accuracy of the Elephas Score for predicting clinical response in neoadjuvant patients
timeFrame: Up to 3 years
measure: Accuracy of the Elephas Score for predicting clinical response in locally advanced/metastatic patients
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Dev Mukhopadhyay, PhD
role: PRINCIPAL_INVESTIGATOR
References: