Observational Basket Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform

Recruiting

• Conditions: Cutaneous Melanoma; Endometrial Cancer; Clear Cell Renal Cell Carcinoma; Colorectal Cancer; Head and Neck Squamous Cell Carcinoma; Non Small Cell Lung Cancer; Urothelial Carcinoma
• Interventions: Procedure: Core Needle or Forceps Biopsy

• Registration Number: NCT05520099
• Lead Sponsor: Elephas

Brief Summary

The primary objective of this study is to determine the ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform across a basket of solid tumors, using in-vivo RECIST 1.1 as the reference method.

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.

Study Timeline

• Study First Submitted: 2022-08-26
• Study First Submitted QC: 2022-08-26
• Study First Posted: 2022-08-29
• Study Start: 2023-06-26
• Status Verified: 2024-07
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants suspected of or diagnosed with Stage III or IV/metastatic cancer	Core Needle or Forceps Biopsy	Subjects suspected or diagnosed with Stage III or IV: * Bladder: Urothelial Carcinoma (UC) * Kidney: Clear Cell Renal Cell Carcinoma (ccRCC) Subjects suspected or diagnosed with Stage IV/metastatic: * 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 * Lung: Non-small cell lung cancer (NSCLC) * Skin: Cutaneous Melanoma, excluding Uveal Melanoma * Uterus: endometrial cancer Subjects suspected or diagnosed with: * Any metastatic solid tumor with high TMB, MSI-High or dMMR and are being considered for treatment with ICI therapy. * Any metastatic solid tumor that the clinician plans to treat with ICI therapy.

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of Cybrid Score for Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors	3 years	The ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform will be determined using in-vivo RECIST 1.1 as the reference method.

Secondary Outcome Measures

Name	Time	Method
Determine the Area Under the Receiver Operating Characteristic Curve (AUC) of Cybrid Score and Compare to the AUCs of Current FDA Approved Predictive Biomarkers PD-L1 and Tumor Mutation Burden (TMB)	3 years	The AUC of Cybrid 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.

Trial Locations

Locations (11)

Meritus Center for Clinical Research; 🇺🇸 Hagerstown, Maryland, United States

Meritus Health; 🇺🇸 Hagerstown, Maryland, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Salinas Valley Memorial Healthcare System; 🇺🇸 Salinas, California, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States

University of South Florida (Tampa General Hospital); 🇺🇸 Tampa, Florida, United States

Roswell Park Comprehensive Cancer Center; 🇺🇸 Buffalo, New York, United States

Cleveland Clinic Florida; 🇺🇸 Stuart, Florida, United States

University of Louisville James Graham Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States

John Theurer Cancer Center; 🇺🇸 Hackensack, New Jersey, United States