Early Stage Triple-Negative Breast CarcinomaELEPHAS-04NCT06349642
Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform
An observational study of Early Stage Triple-Negative Breast Carcinoma and Metastatic Bladder Urothelial Carcinoma, run by Mayo Clinic at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Stage Triple-Negative Breast Carcinoma, Metastatic Bladder Urothelial Carcinoma, Metastatic Cervical Carcinoma
- What is being tested?
- Biospecimen Collection and Tissue Collection
- Type of treatment
- Surgery or procedure
- How many people
- 324 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Apr 2024to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Show all 37Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Dev Mukhopadhyay, PhD
- Recruiting
Mayo Clinic in Arizona
Phoenix, Arizona, 85054
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Parminder Singh, MD
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Matthew Block, MD, PhD
About this study
Official title: Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform
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
- Being tested
- Biospecimen Collection, Tissue Collection
- Medical subject headings
- Uterine Cervical Neoplasms, Clear-cell metastatic renal cell carcinoma, Colorectal Neoplasms, Endometrial Neoplasms, Esophageal Neoplasms, Carcinoma, Hepatocellular, Carcinoma, Non-Small-Cell Lung, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Blood Draw, Specimen Collection
Undergo optional research blood sample.
Tissue CollectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Procedure: Tissue Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start24 Apr 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Early Stage Triple-Negative Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Elephas Biosciences Corporation
- Responsible party
- Sponsor
- Investigators
- Dev Mukhopadhyay, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349642
- Sponsor's protocol ID
- MC230901
- Other IDs
- NCI-2024-02979, 23-008413
- Acronym
- ELEPHAS-04
- Status last verified
- Mar 2026
- First submitted
- 1 Apr 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Braun D, Dana N, Hernan HR, Sahni S, Scribano CM, Johnson C, Vedder L, von Euw E, Zweng J, Wargowski E, Sunil A, Sharma D, Routh J, Rexroad K, Nasreen A, McDonnell P, Jergens V, Costa C, Zuniga R, Toia GV, Patel PM, McGregor S, Martin RCG 2nd, Majeed U, Mukhopadhyay D, Lou Y, Kokabi N, Jakub JW, Hays D, Godwin AK, Giffi V, Gelbard A, Friedl A, Duimstra EK, Dronca RS, Chen R, Chalfin H, Bhattacharya S, Broome B, Babiker HM, Chandra T, Caenepeel S, Hrycyniak LCF, Sood C, Ramos H, Patel P, Advani P, Gierman HJ, Taube J. Prediction of immunotherapy response using live tumor fragments from routine clinical biopsies. Cell Rep Med. 2026 Oct 15:103114. doi: 10.1016/j.xcrm.2026.103114. Online ahead of print.
PubMed 42880280Ramasubramanian 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/s12967-025-07378-2.
PubMed 41484629Ramasubramanian 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.
PubMed 40791544
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform
- ClinicalTrials.gov ID
- NCT06349642
- Acronym / sponsor ID
- ELEPHAS-04 / MC230901
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Elephas Biosciences Corporation
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Procedure: Biospecimen Collection, Procedure: Tissue CollectionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (37 listed)
- Subjects suspected of or diagnosed with the following Stage IV/metastatic or recurrent malignancies:
- OR
- Subjects suspected of or diagnosed with the following Stage III per provider discretion or IV/metastatic malignancies:
- OR
- Patients who will be receiving neoadjuvant CPI for the following resectable early-stage malignancies:
Key exclusion criteria (8 listed)
- 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
- Uncontrolled intercurrent illness including, but not limited to:
- Subjects who are enrolled or plan to be enrolled in a blinded cancer therapeutic treatment trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Blood Draw, Specimen CollectionUndergo optional research blood sample. | Procedure or surgery | Observational |
| Tissue CollectionTissue 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. | Procedure or surgery | Observational |
Primary outcome
Accuracy of the Elephas Score for predicting clinical response in neoadjuvant patients
Time frame: Up to 3 years
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.
Accuracy of the Elephas Score for predicting clinical response in locally advanced/metastatic patients
Time frame: Up to 3 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Derived from this study: PubMed 42880280Braun D, Dana N, Hernan HR, Sahni S, Scribano CM, Johnson C, Vedder L, von Euw E, Zweng J, Wargowski E, Sunil A, Sharma D, Routh J, Rexroad K, Nasreen A, McDonnell P, Jergens V, Costa C, Zuniga R, Toia GV, Patel PM, McGregor S, Martin RCG 2nd, Majeed U, Mukhopadhyay D, Lou Y, Kokabi N, Jakub JW, Hays D, Godwin AK, Giffi V, Gelbard A, Friedl A, Duimstra EK, Dronca RS, Chen R, Chalfin H, Bhattacharya S, Broome B, Babiker HM, Chandra T, Caenepeel S, Hrycyniak LCF, Sood C, Ramos H, Patel P, Advani P, Gierman HJ, Taube J. Prediction of immunotherapy response using live tumor fragments from routine clinical biopsies. Cell Rep Med. 2026 Oct 15:103114. doi: 10.1016/j.xcrm.2026.103114. Online ahead of print.
- Derived from this study: PubMed 41484629Ramasubramanian 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/s12967-025-07378-2.
- Derived from this study: PubMed 40791544Ramasubramanian 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dev Mukhopadhyay, PhD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Stage Triple-Negative Breast Carcinoma and Metastatic Bladder Urothelial Carcinoma, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 37 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the Elephas Score for predicting clinical response in neoadjuvant patients (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06349642, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.