ImmunotherapyELEPHAS-02NCT05520099

Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform (ELEPHAS-02)

An observational study of Immunotherapy and Cancer, run by Elephas at 12 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

The primary objective of this study is to develop and train the Elephas live tumor diagnostic platform and determine the ex-vivo accuracy of the Elephas Score using in-vivo RECIST 1.1 as the reference method Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Immunotherapy, Cancer, Bladder Cancer
What is being tested?: Core Needle Biopsy, Forceps Biopsy, Punch Biopsy
Type of treatment: Surgery or procedure
How many people: 416 participants
Where: 12 sitesUnited States
Study dates: 26 Jun 2023to Jan 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: Adults aged 18 years or older, able to provide informed consent, and have a suspected or confirmed cancer diagnosis that meets requirements outlined in the eligibility criteria above.

Who may be able to join

Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent.
Subjects must meet one of the following criteria:
Subjects suspected or diagnosed with recurrent, locally advanced or metastatic cancer:
Bladder: Urothelial Carcinoma (UC)
Kidney: Clear Cell Renal Cell Carcinoma (ccRCC)

Show all 21Show fewer

Subjects suspected or diagnosed with recurrent or metastatic cancer:
Colon and Rectum: Microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) Colorectal Cancer (CRC)
Head and Neck: Squamous Cell Carcinoma (HNSCC), excluding nasopharyngeal and salivary gland cancers
Liver: Hepatocellular Carcinoma
Lung: Non-small cell lung cancer (NSCLC)
Skin: Cutaneous Melanoma, excluding Uveal Melanoma
Uterus: endometrial cancer
Subjects suspected or diagnosed with one of the following cancer types eligible for pure ICI neoadjuvant therapy:
o Skin: Cutaneous Melanoma, Stage III
Subjects suspected or diagnosed with:
Any solid tumor type that is eligible for pure ICI therapy in the neoadjuvant or advanced/metastatic setting
Any metastatic solid tumor with high TMB, MSI-High or dMMR and are being considered for treatment with ICI therapy.
Any recurrent or metastatic patient with a solid tumor that the clinician plans to treat with ICI therapy.
Subjects must be clinically able, at investigator discretion, to undergo a biopsy procedure
Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.

Who cannot join

Subjects who are pregnant
Subjects with a known auto-immune disease that would render them ineligible for immune-oncology treatment
Immunocompromised subjects, and subjects known to be HIV positive and currently receiving antiretroviral therapy
Subjects who are enrolled or plan to be enrolled in a blinded oncology treatment trial

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
John Theurer Cancer Center
Hackensack, New Jersey, 07601
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742
CARTI Cancer Center
Little Rock, Arkansas, 72205
University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, 40202
University of Wisconsin
Madison, Wisconsin, 53705
AdventHealth Orlando
Orlando, Florida, 32803
Memorial Health System
Pembroke Pines, Florida, 33026
Salinas Valley Memorial Healthcare System
Salinas, California, 93901
Cleveland Clinic Florida
Stuart, Florida, 34994
University of South Florida (Tampa General Hospital)
Tampa, Florida, 33606

Other trials in United States

About this study

Read the detailed description

Cancer is a leading cause of death and despite many new drugs, a major diagnostic challenge remains knowing which drug will work best for a patient. A new class of drugs called checkpoint inhibitors (CPIs) have revolutionized cancer treatment. However, current diagnostic methods (e.g. PDL1, MSI and TMB) do not accurately predict which patients will respond.

Elephas is developing a diagnostic platform using small 3D Live Tumor Fragments (LTFs) from participants for accurate prediction of drug response with a focus on CPIs such as Pembrolizumab (Keytruda). These LTFs contain both tumor cells and infiltrating immune cells, which are critical in determining response to CPIs and other immunotherapies.

In this observational clinical basket trial, participants will be recruited and their actual clinical response (using RECIST 1.1) to CPIs across five solid tumors (lung, head/neck, bladder, kidney, and skin) will be compared to the platform's predictive Artificial Intelligence (AI) score that is based on RNA, clinical data, and 3D microscopy images. The sensitivity and specificity of the platform's score will be determined and compared to current diagnostic methods for CPIs like PDL1, MSI, and TMB.

Conditions: Immunotherapy, Cancer, Bladder Cancer, Urothelial Carcinoma Bladder, Kidney Cancer, Clear Cell Renal Cell Cancer (ccRCC)
Being tested: Core Needle Biopsy, Forceps Biopsy, Punch Biopsy
Keywords: Immunotherapy, Live Tumor Fragment, Elephas, Elephas Score, Core Needle Biopsy, Forceps Biopsy, Punch Biopsy, Immune Checkpoint Inhibitors, Ex vivo Platform
Medical subject headings: Neoplasms, Urinary Bladder Neoplasms, Kidney Neoplasms, Carcinoma, Renal Cell, Colorectal Neoplasms, Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Core Needle Biopsy, Forceps Biopsy, Punch BiopsyProcedure or surgery
Subjects must be clinically able, at investigator discretion, to undergo additional core needle biopsy, forceps biopsy, or punch biopsy passes during their biopsy. These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to additional passes (e.g., liver or lymph nodes) per the clinician.

Study groups in NCT05520099
Study group	Role	What they receive
Patients with suspected or diagnosed cancer types as listed in the description		Subjects suspected or diagnosed with recurrent, locally advanced or metastatic cancer: bladder (urothelial carcinoma), kidney (ccRCC). Subjects suspected or diagnosed with recurrent or metastatic cancer: Colon and Rectum (MSI-H/dMMR Colorectal Cancer), Head and Neck (Squamous Cell Carcinoma), liver (Hepatocellular Carcinoma), Lung (NSCLC), Skin (Cutaneous Melanoma), Uterus (endometrial cancer). Subjects suspected or diagnosed with one of the following cancer types eligible for pure ICI neoadjuvant therapy: Skin (Cutaneous Melanoma, Stage III) Subjects suspected or diagnosed with: Any solid tumor type that is eligible for pure ICI therapy in the neoadjuvant or advanced/metastatic setting; Any metastatic solid tumor with high TMB, MSI-High or dMMR and are being considered for treatment with ICI therapy; Any recurrent or metastatic patient with a solid tumor that the clinician plans to treat with ICI therapy. Receives: Procedure: Core Needle Biopsy, Forceps Biopsy, Punch Biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

Determine Ex-Vivo Prognostic Accuracy of Elephas Platform
The ex-vivo prognostic accuracy of the Elephas live tumor diagnostic platform will be determined using in-vivo RECIST 1.1 as the reference method.
Measured: 3 years

Secondary outcomes (1)

Establish AUC of ELEPHAS Score and Compare with FDA Approved Biomarkers
The AUC of ELEPHAS Score will be established with a clinically meaningful confidence interval and compared to the AUCs of established FDA approved biomarkers for predicting clinical response to ICIs.
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 2023Jan 2027

First posted29 Aug 2022
Study start26 Jun 2023
Primary completionJan 2027 (estimated)
Study completionJan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for ImmunotherapyStudies of the same condition, open and under way.
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: 416 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05520099
Sponsor's protocol ID: ELEPHAS-02
Acronym: ELEPHAS-02
Status last verified: Jun 2026
First submitted: 26 Aug 2022
Last updated: 29 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chen S, Zhang Z, Zheng X, Tao H, Zhang S, Ma J, Liu Z, Wang J, Qian Y, Cui P, Huang D, Huang Z, Wu Z, Hu Y. Response Efficacy of PD-1 and PD-L1 Inhibitors in Clinical Trials: A Systematic Review and Meta-Analysis. Front Oncol. 2021 Apr 16;11:562315. doi: 10.3389/fonc.2021.562315. eCollection 2021.
PubMed 33937012
Cherukuri AR, Lubner MG, Zea R, Hinshaw JL, Lubner SJ, Matkowskyj KA, Foltz ML, Pickhardt PJ. Tissue sampling in the era of precision medicine: comparison of percutaneous biopsies performed for clinical trials or tumor genomics versus routine clinical care. Abdom Radiol (NY). 2019 Jun;44(6):2074-2080. doi: 10.1007/s00261-018-1702-1.
PubMed 30032384
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 42880280
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/s12967-025-07378-2.
PubMed 41484629
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: 10.1101/2025.07.18.663728.
PubMed 40791544

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 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 (ELEPHAS-02)
ClinicalTrials.gov ID: NCT05520099
Acronym / sponsor ID: ELEPHAS-02 / ELEPHAS-02
Conditions: Immunotherapy, Cancer, Bladder Cancer, Urothelial Carcinoma Bladder, Kidney Cancer, Clear Cell Renal Cell Cancer (ccRCC)
Keywords: Immunotherapy, Live Tumor Fragment, Elephas, Elephas Score, Core Needle Biopsy, Forceps Biopsy, Punch Biopsy, Immune Checkpoint Inhibitors
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 416 participants (estimated)
Lead sponsor: ElephasIndustry (pharma, biotech, devices)
Study start: 26 Jun 2023 (actual)
Primary completion: Jan 2027 (estimated)
Study completion: Jan 2027 (estimated)
First posted: 29 Aug 2022 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with suspected or diagnosed cancer types as listed in the description	–	Procedure: Core Needle Biopsy, Forceps Biopsy, Punch BiopsySubjects suspected or diagnosed with recurrent, locally advanced or metastatic cancer: bladder (urothelial carcinoma), kidney (ccRCC). Subjects suspected or diagnosed with recurrent or metastatic cancer: Colon and Rectum (MSI-H/dMMR Colorectal Cancer), Head and Neck (Squamous Cell Carcinoma), liver (Hepatocellular Carcinoma), Lung (NSCLC), Skin (Cutaneous Melanoma), Uterus (endometrial cancer). Subjects suspected or diagnosed with one of the following cancer types eligible for pure ICI neoadjuvant therapy: Skin (Cutaneous Melanoma, Stage III) Subjects suspected or diagnosed with: Any solid tumor type that is eligible for pure ICI therapy in the neoadjuvant or advanced/metastatic setting; Any metastatic solid tumor with high TMB, MSI-High or dMMR and are being considered for treatment with ICI therapy; Any recurrent or metastatic patient with a solid tumor that the clinician plans to treat with ICI therapy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adults aged 18 years or older, able to provide informed consent, and have a suspected or confirmed cancer diagnosis that meets requirements outlined in the eligibility criteria above.

Key inclusion criteria (21 listed)

Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent.
Subjects must meet one of the following criteria:
o Skin: Cutaneous Melanoma, Stage III
Subjects must be clinically able, at investigator discretion, to undergo a biopsy procedure

Key exclusion criteria (4 listed)

Subjects who are pregnant
Subjects with a known auto-immune disease that would render them ineligible for immune-oncology treatment
Immunocompromised subjects, and subjects known to be HIV positive and currently receiving antiretroviral therapy
Subjects who are enrolled or plan to be enrolled in a blinded oncology 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
Core Needle Biopsy, Forceps Biopsy, Punch BiopsySubjects must be clinically able, at investigator discretion, to undergo additional core needle biopsy, forceps biopsy, or punch biopsy passes during their biopsy. These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to additional passes (e.g., liver or lymph nodes) per the clinician.	Procedure or surgery	Patients with suspected or diagnosed cancer types as listed in the description

Primary outcome

Determine Ex-Vivo Prognostic Accuracy of Elephas Platform
Time frame: 3 years
The ex-vivo prognostic accuracy of the Elephas live tumor diagnostic platform will be determined using in-vivo RECIST 1.1 as the reference method.

1 secondary outcome

Establish AUC of ELEPHAS Score and Compare with FDA Approved Biomarkers
Time frame: 3 years

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 29 Jun 2026.
Background: PubMed 33937012Chen S, Zhang Z, Zheng X, Tao H, Zhang S, Ma J, Liu Z, Wang J, Qian Y, Cui P, Huang D, Huang Z, Wu Z, Hu Y. Response Efficacy of PD-1 and PD-L1 Inhibitors in Clinical Trials: A Systematic Review and Meta-Analysis. Front Oncol. 2021 Apr 16;11:562315. doi: 10.3389/fonc.2021.562315. eCollection 2021.
Background: PubMed 30032384Cherukuri AR, Lubner MG, Zea R, Hinshaw JL, Lubner SJ, Matkowskyj KA, Foltz ML, Pickhardt PJ. Tissue sampling in the era of precision medicine: comparison of percutaneous biopsies performed for clinical trials or tumor genomics versus routine clinical care. Abdom Radiol (NY). 2019 Jun;44(6):2074-2080. doi: 10.1007/s00261-018-1702-1.
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.
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. This study is not recruiting at the moment.

Fred Hausheer, MD, FACP study director

Elephas

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Immunotherapy and Cancer, run by Elephas at 12 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 21 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine Ex-Vivo Prognostic Accuracy of Elephas Platform (time frame: 3 years). 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 NCT05520099, which also lists 5 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 29 Jun 2026.