RECRUITING

Predicting Response to Immune Checkpoint Inhibitors Across Solid Tumors Using a Live Tumor Diagnostic Platform

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-24

Study Completion:2027-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06349642

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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) * 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	* 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

Inclusion Criteria

Exclusion 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.
* 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)
* 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

* 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

Contacts and Locations

Study Contact

Clinical Trials Referral Office

CONTACT

855-776-0015

mayocliniccancerstudies@mayo.edu

Morgan Weidner

CONTACT

904-953-2000

Weidner.Morgan@mayo.edu

Principal Investigator

Dev Mukhopadhyay, PhD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Florida

Jacksonville, Florida, 32224

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Dev Mukhopadhyay, PhD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-24

Study Completion Date2027-05

Study Record Updates

Study Start Date2024-04-24

Study Completion Date2027-05

Terms related to this study

Additional Relevant MeSH Terms

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