Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)

Elephas

Status: Enrolling

Conditions: MSI-H Colorectal Cancer; Melanoma (Skin Cancer); DMMR Colorectal Cancer; Cancer; Liver Cancer; Endometrial Cancer; NSCLC (Non-small-cell Lung Cancer); Bladder Cancer; Immunotherapy; Skin Cancer; Kidney Cancer; Head and Neck Cancer; Advanced Solid Tumors Cancer; TNBC, Triple Negative Breast Cancer; Colorectal Cancer

Treatments: Procedure: Biopsy

Study type: Observational

Funder types: Industry

Identifiers

NCT07327489

ELEPHAS-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

2,000 participants in 1 patient group

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.

Treatment:

Procedure: Biopsy