Clinical trial · Observational
Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)
Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies
NCT07327489CI-TRIAL-00116244ELEPHAS-05recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (15)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors Cancer | — | UNRESOLVED | — |
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| DMMR Colorectal Cancer | dMMR Colorectal Carcinoma | ALIAS | 0.90 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Immunotherapy | — | UNRESOLVED | — |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Liver Cancer |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Study Population
- description
- 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.
- interventionNames
- Procedure: Biopsy
Primary outcomes (1)
- measure
- Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors & Researching Mechanisms of Tumor Cutting and Imaging
- timeFrame
- Study duration is approximately 36 months from enrollment to end of study.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Able and willing to provide informed consent for participation 2. Age ≥18 years at time of consent. 3. Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy. 4. 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. Exclusion Criteria: 1. 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. 2. Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients. 3. Pregnant person(s).
References
Publications (2)
- BACKGROUNDChen 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. PMID 33937012
- BACKGROUNDCherukuri 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. PMID 30032384