CancerELEPHAS-05NCT07327489
Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)
An observational study of Cancer and Immunotherapy, run by Elephas at 8 sites in United States.
Trial summary
This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Immunotherapy, Advanced Solid Tumors Cancer
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 8 sitesUnited States
- Study dates
- 14 Apr 2025to Apr 2038
- 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, who are able and willing to provide written informed consent, have a suspected or confirmed cancer diagnosis and will be undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up.
Who may be able to join
- Able and willing to provide informed consent for participation
- Age ≥18 years at time of consent.
- Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.
- 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
- Have a known auto-immune disease or prior condition (prior organ transplant, chronic kidney or liver disease) that renders them ineligible for immunotherapy (IO) treatment.
- Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.
- Pregnant person(s).
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Mercy Hospital - FTS
Fort Smith, Arkansas, 72903
Billy Cater, 479-314-5089, billy.cater@mercy.net
Aswanth Reddy, MD
- Recruiting
JPS Health Network
Forth Worth, Texas, 76104
April Bell, MS, CCRC, ACRP-PM, 817-702-8254, ABell01@jpshealth.org
Paras Patel
- Recruiting
Frederick Health Hospital
Frederick, Maryland, 21702
Ingrid Halvorson, 301-662-8477, ihalvorson@frederick.health
Heather Chalfin, MD
- Recruiting
Mercy Hospital - OKC
Oklahoma City, Oklahoma, 73120
Trisha Stubhar, 405-751-4343 ext. 4057523401, trisha.stubhar@mercy.net
Carla Kurkjian
- Recruiting
Mercy Hospital - SPG
Springfield, Missouri, 65804
Hanna Dulier, RN. BSN, 4178203891, hanna.dulier@mercy.net
Mohan Tummala, MD
- Recruiting
Mercy Hospital - South
St Louis, Missouri, 63128
Danielle Werle, RN, BSN, 3145256042, danielle.werle@mercy.net
Yifan Tu
- Recruiting
Mercy Hospital -STL
St Louis, Missouri, 63141
Alesia Bell, (314) 251-4400, alesia.bell@mercy.net
Nancy Umbeck, nancy.umbeck@mercy.net
- Not yet recruiting
Baylor Scott and White Biorepository
Temple, Texas, 76508
Vanessa Hoelscher, 254-724-6759, vanessa.hoelscher@bswhealth.org
Mathew Bower, MD
About this study
Official title: Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies
This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer.
Read the detailed description
Elephas is researching mechanisms of cutting, sorting and imaging tumors that leave the 3D tumor microenvironment (TME), including its immune cells, intact. This allows qualitative and semi-quantitative identification and characterization of the ex vivo response to exposure of potential immunotherapy. The ex vivo response data will then be compared to the clinical real world response data to inform development efforts.
This study will collect tumor specimens from patients with suspected or confirmed cancer. These specimens, along with clinical data and genomic data obtained as part of a patient's standard of care, will be used to perform this research.
- Conditions
- Cancer, Immunotherapy, Advanced Solid Tumors Cancer, Bladder Cancer, TNBC, Triple Negative Breast Cancer, Colorectal Cancer
- Being tested
- Biopsy
- Keywords
- Immunotherapy, Live Tumor Biopsy, Elephas, Cancer, Imaging, Tumor Cutting, Treatment Response, Core Needle Biopsy, Forceps Biopsy, Punch Biopsy
- Medical subject headings
- Neoplasms, Urinary Bladder Neoplasms, Triple Negative Breast Neoplasms, Colorectal Neoplasms, Endometrial Neoplasms, Head and Neck Neoplasms, Kidney Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Subjects must be clinically able, at investigator discretion, to undergo additional biopsy passes during their biopsy. Biopsy specimen(s) will be obtained during a standard of care (SOC) procedure. If a subject receives a subsequent SOC biopsy for clinical diagnosis purposes, additional sample(s) may be collected and sent to the Sponsor.
| Study group | Role | What they receive |
|---|---|---|
| Study Population | Adults aged 18 years or older, who are able and willing to provide written informed consent, have a suspected or confirmed cancer diagnosis and will be undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up. Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors & Researching Mechanisms of Tumor Cutting and Imaging
Collect human tumor specimens to research mechanisms of tumor cutting, imaging, and ex-vivo immunotherapy treatment response, while maintaining cell stability in a live tumor microenvironment.
Measured: Study duration is approximately 36 months from enrollment to end of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start14 Apr 2025
- Primary completionApr 2035 (estimated)
- Study completionApr 2038 (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 CancerStudies 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elephas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327489
- Sponsor's protocol ID
- ELEPHAS-05
- Acronym
- ELEPHAS-05
- Status last verified
- Jun 2026
- First submitted
- 19 Dec 2025
- 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 33937012Cherukuri 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 30032384Braun 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
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
- Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies
- ClinicalTrials.gov ID
- NCT07327489
- Acronym / sponsor ID
- ELEPHAS-05 / ELEPHAS-05
- Conditions
- Cancer, Immunotherapy, Advanced Solid Tumors Cancer, Bladder Cancer, TNBC, Triple Negative Breast Cancer, Colorectal Cancer
- Keywords
- Immunotherapy, Live Tumor Biopsy, Elephas, Cancer, Imaging, Tumor Cutting, Treatment Response, Core Needle Biopsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- ElephasIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- Apr 2035 (estimated)
- Study completion
- Apr 2038 (estimated)
- First posted
- 8 Jan 2026 (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 will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer.
Detailed description
Elephas is researching mechanisms of cutting, sorting and imaging tumors that leave the 3D tumor microenvironment (TME), including its immune cells, intact. This allows qualitative and semi-quantitative identification and characterization of the ex vivo response to exposure of potential immunotherapy. The ex vivo response data will then be compared to the clinical real world response data to inform development efforts.
This study will collect tumor specimens from patients with suspected or confirmed cancer. These specimens, along with clinical data and genomic data obtained as part of a patient's standard of care, will be used to perform this research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | Procedure: BiopsyAdults aged 18 years or older, who are able and willing to provide written informed consent, have a suspected or confirmed cancer diagnosis and will be undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up. |
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, who are able and willing to provide written informed consent, have a suspected or confirmed cancer diagnosis and will be undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up.
Key inclusion criteria (4 listed)
- Able and willing to provide informed consent for participation
- Age ≥18 years at time of consent.
- Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.
- 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.
Key exclusion criteria (3 listed)
- Have a known auto-immune disease or prior condition (prior organ transplant, chronic kidney or liver disease) that renders them ineligible for immunotherapy (IO) treatment.
- Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.
- Pregnant person(s).
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 |
|---|---|---|
| BiopsySubjects must be clinically able, at investigator discretion, to undergo additional biopsy passes during their biopsy. Biopsy specimen(s) will be obtained during a standard of care (SOC) procedure. If a subject receives a subsequent SOC biopsy for clinical diagnosis purposes, additional sample(s) may be collected and sent to the Sponsor. | Procedure or surgery | Study Population |
Primary outcome
Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors & Researching Mechanisms of Tumor Cutting and Imaging
Time frame: Study duration is approximately 36 months from enrollment to end of study.
Collect human tumor specimens to research mechanisms of tumor cutting, imaging, and ex-vivo immunotherapy treatment response, while maintaining cell stability in a live tumor microenvironment.
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.
- 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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Immunotherapy, run by Elephas at 8 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 4 inclusion and 3 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 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 8 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors & Researching Mechanisms of Tumor Cutting and Imaging (time frame: Study duration is approximately 36 months from enrollment to end of study.). 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 NCT07327489, 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 29 Jun 2026.