Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform
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.
Arms & interventions
- ProcedureBiospecimen Collection
Undergo optional research blood sample.
- ProcedureTissue 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.
Outcome measures
Primary
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.
Time frame: 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.
Time frame: Up to 3 years
Eligibility criteria
Study locations (3)
Mayo Clinic in Arizona
Phoenix, Arizona, 85054
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
References
- 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)