[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06349642":3,"trial-entities:NCT06349642":185,"trial-summary:NCT06349642":202},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":46,"study_type":47,"primary_purpose":17,"phases":48,"enrollment_info":49,"interventions":52,"primary_outcomes":66,"secondary_outcomes":74,"sex":75,"minimum_age":76,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":77,"std_ages":123,"locations":126,"central_contacts":169,"overall_officials":171,"references":173,"see_also_links":181},"NCT06349642","MC230901","Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform","Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform","RECRUITING","2027-05","2026-03","2026-03-12","2024-04-24","Mayo Clinic","OTHER",false,"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.",null,[19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"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",[],"OBSERVATIONAL",[],{"count":50,"type":51},324,"ESTIMATED",[53,62],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":59},"PROCEDURE","Biospecimen Collection","Undergo optional research blood sample.",[58],"Observational",[60,61],"Blood Draw","Specimen Collection",{"type":54,"name":63,"description":64,"armGroupLabels":65},"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.",[58],[67,71],{"measure":68,"description":69,"timeFrame":70},"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",{"measure":72,"description":73,"timeFrame":70},"Accuracy of the Elephas Score for predicting clinical response in locally advanced\u002Fmetastatic 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.",[],"ALL","18 Years",{"inclusion":78,"exclusion":113,"raw_text":122},[79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112],"Subjects suspected of or diagnosed with the following Stage IV\u002Fmetastatic 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\u002Fmetastatic 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","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\u002FMETASTATIC 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",[114,115,116,117,118,119,120,121],"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\u002Fsocial 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:\n\nSubjects must meet one of the following criteria:\n\n* Subjects suspected of or diagnosed with the following Stage IV\u002Fmetastatic or recurrent malignancies:\n\n  * Lung: Non-small Cell Lung Cancer (NSCLC)\n  * Skin: Cutaneous Malignancy, excluding Uveal Melanoma\n  * Esophageal Cancer\n  * Cervical Cancer\n  * Endometrial Cancer\n  * Colon Cancer: Mismatch repair deficient (dMMR) CRC only\n  * All solid tumors with high tumor mutation burden (TMB)\n  * All solid tumors that are microsatellite instability high (MSI-H)\n  * All mismatch repair deficient (dMMR) solid tumors\n  * Liver Cancer\n  * 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.\n\nOR\n\n* Subjects suspected of or diagnosed with the following Stage III per provider discretion or IV\u002Fmetastatic malignancies:\n\n  * Kidney: Clear Cell Renal Cell Carcinoma (ccRCC)\n  * Bladder: Urothelial Carcinoma (UC)\n  * 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\n\nOR\n\n* Patients who will be receiving neoadjuvant CPI for the following resectable early-stage malignancies:\n\n  * Breast Cancer: Triple negative breast cancer (TNBC)\n  * Lung: Non-small cell lung cancer (NSCLC)\n\n    * NOTE: Patients with suspected NSCLC who would be eligible for neoadjuvant checkpoint inhibitor (CPI) are eligible to enroll per provider discretion\n  * 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\n* LOCALLY ADVANCED\u002FMETASTATIC 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.\n* NEOADJUVANT PATIENTS: Subjects must be eligible based on investigator discretion to receive approved CPI therapy.\n* Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy.\n* 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.\n* ECOG Performance Status (PS) 0, 1 or 2.\n* Negative pregnancy test done ≤7 days prior to enrollment, for persons of childbearing potential only\n* Female subjects must not be pregnant or breastfeeding and must use appropriate methods of contraception when applicable.\n* Subjects must be clinically able, at investigator discretion, and willing to undergo either:\n\n  * additional biopsy passes during their standard of care biopsy, OR\n  * a biopsy for research only, if applicable.\n  * NOTE: These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to biopsies per the clinician.\n* 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.\n* Provide written informed consent\n\nExclusion Criteria:\n\n* Pregnant women because this study involves a greater than minimal risk procedure (biopsy)\n* 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\n* Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * ongoing or active infection\n  * psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Subjects who are enrolled or plan to be enrolled in a blinded cancer therapeutic treatment trial",[124,125],"ADULT","OLDER_ADULT",[127,145,157],{"facility":128,"status":8,"city":129,"state":130,"zip":131,"country":132,"contacts":133,"geoPoint":142},"Mayo Clinic in Arizona","Phoenix","Arizona","85054","United States",[134,139],{"name":135,"role":136,"phone":137,"email":138},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",{"name":140,"role":141},"Parminder Singh, MD","PRINCIPAL_INVESTIGATOR",{"lat":143,"lon":144},33.44838,-112.07404,{"facility":146,"status":8,"city":147,"state":148,"zip":149,"country":132,"contacts":150,"geoPoint":154},"Mayo Clinic in Florida","Jacksonville","Florida","32224",[151,152],{"name":135,"role":136,"phone":137,"email":138},{"name":153,"role":141},"Dev Mukhopadhyay, PhD",{"lat":155,"lon":156},30.33218,-81.65565,{"facility":158,"status":8,"city":159,"state":160,"zip":161,"country":132,"contacts":162,"geoPoint":166},"Mayo Clinic in Rochester","Rochester","Minnesota","55905",[163,164],{"name":135,"role":136,"phone":137,"email":138},{"name":165,"role":141},"Matthew Block, MD, PhD",{"lat":167,"lon":168},44.02163,-92.4699,[170],{"name":135,"role":136,"phone":137,"email":138},[172],{"name":153,"affiliation":13,"role":141},[174,178],{"pmid":175,"type":176,"citation":177},"41484629","DERIVED","Ramasubramanian TS, Adstamongkonkul P, Scribano CM, Johnson C, Caenepeel S, Hrycyniak LCF, Vedder LC, Dana N, Baltes C, Browning V, 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 MM, Sood C, Sunil A, Euw EV, Wait E, Wargowski EE, Advani P, Broome B, Bruckbauer A, Godwin A, Kokabi N, Lou Y, Martin RCG 2nd, 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. J Transl Med. 2026 Jan 3;24(1):18. doi: 10.1186\u002Fs12967-025-07378-2.",{"pmid":179,"type":176,"citation":180},"40791544","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\u002F2025.07.18.663728.",[182],{"label":183,"url":184},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":186,"biomarkers":198},[187,188,189,190,191,192,193,194,195,196,197],"Breast Carcinoma","Cervical Carcinoma","Colorectal Carcinoma","Endometrial Carcinoma","Esophageal Carcinoma","Liver Carcinoma","Lung Non-Small Cell Carcinoma","Melanoma","Renal Cell Carcinoma","Solid Neoplasm","Urothelial Carcinoma",[199,200,201],"MRC1 wt Allele","MSI1 Gene","TPM2 wt Allele",{"nct_id":4,"found":203,"summary":204,"prompt_version":214},true,{"design":205,"status":206,"heading":207,"summary":208,"follow_up":209,"word_count":210,"commitments":211,"compensation":212,"drugs_mentioned":213},"This is an observational study, meaning researchers will collect information without giving new treatments. It aims to enroll 324 participants.","completed","Observational Study of Elephas Platform for Cancer Treatment Prediction","This study is looking at how well a new platform called Elephas can predict if certain cancer treatments will work for you. Researchers want to see if Elephas can accurately tell if patients with specific solid tumors, like early-stage triple-negative breast cancer, metastatic bladder cancer, or metastatic colorectal cancer, will respond to immunotherapies or chemoimmunotherapy. You could be eligible if you are 18 or older and have certain advanced or recurrent cancers, including non-small cell lung cancer or colon cancer with specific biomarkers (dMMR). The study will measure the accuracy of the Elephas platform for up to 3 years. The current status of this study is unclear, but it plans to enroll 324 participants.","The study will track the accuracy of the Elephas platform for up to 3 years.",114,"You may be asked to provide an optional research blood sample. Tissue samples will be collected during your scheduled standard-of-care biopsy or a separate research biopsy.","Not stated in the trial record.",[],"v2"]