Trial Title:
Observational Basket Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform
NCT ID:
NCT05520099
Condition:
Colorectal Cancer
Head and Neck Squamous Cell Carcinoma
Non Small Cell Lung Cancer
Cutaneous Melanoma
Endometrial Cancer
Urothelial Carcinoma
Clear Cell Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Melanoma
Carcinoma, Squamous Cell
Carcinoma, Renal Cell
Endometrial Neoplasms
Carcinoma, Transitional Cell
Squamous Cell Carcinoma of Head and Neck
Conditions: Keywords:
Core Needle Biopsy
Live tumor fragments
Immunotherapy
Immunotherapy prediction
3D culture
Ex vivo platform
Immune checkpoint inhibitors
Non Small Cell Lung Cancer
NSCLC
Head and Neck Squamous Cell Carcinoma
HNSCC
Clear Cell Renal Cell Carcinoma
ccRCC
Urothelial Carcinoma
Melanoma
Colon Cancer
Rectal Cancer
Endometrial Cancer
Forceps Biopsy
Metastatic solid tumor
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Core Needle or Forceps Biopsy
Description:
Subjects must be clinically able, at investigator discretion, to undergo additional core
needle or forceps biopsy passes during their biopsy. These additional biopsies may either
be collected from the primary tumor or a metastatic site amenable to additional passes
(e.g., liver or lymph nodes) per the clinician.
Arm group label:
Participants suspected of or diagnosed with Stage III or IV/metastatic cancer
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.
Criteria for eligibility:
Study pop:
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: MSI-High/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.
Sampling method:
Non-Probability Sample
Criteria:
1. Written informed consent and HIPAA authorization for release of personal health
information prior to registration. NOTE: HIPAA authorization may be included in the
informed consent or obtained separately.
2. Age ≥ 18 years at the time of consent.
3. Subjects must meet one of the following criteria:
- 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. NOTE: This can be either in the setting of a trial, compassionate
use, or the use of appropriate LDT tests that per clinician, render the
patient eligible for ICI therapy, either frontline or a later line.
4. Subjects must be clinically able, at investigator discretion, to undergo additional
core needle or forceps biopsy passes during their biopsy.
5. 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.
6. Subjects with a newly confirmed diagnosis who have previously undergone a standard
of care biopsy must be willing to undergo a separate biopsy procedure solely for the
purposes of this study.
7. Female subjects must not be pregnant.
8. Subjects with a known auto-immune disease that would render them ineligible for
immune-oncology treatment are not eligible.
9. Immunocompromised subjects, and subjects known to be HIV positive and currently
receiving antiretroviral therapy are not eligible. NOTE: Patients known to be HIV
positive, but without clinical evidence of an immunocompromised state, are eligible
for this trial.
10. Subjects who are enrolled or plan to be enrolled in a blinded oncology treatment
trial are not eligible.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Salinas Valley Memorial Healthcare System
Address:
City:
Salinas
Zip:
93901
Country:
United States
Status:
Recruiting
Contact:
Last name:
Juan Morales
Email:
jmorales3@salinasvalleyhealth.com
Investigator:
Last name:
Geetha Varma, MD
Email:
Principal Investigator
Facility:
Name:
AdventHealth Orlando
Address:
City:
Orlando
Zip:
32803
Country:
United States
Status:
Recruiting
Contact:
Last name:
Joseph Dunn
Email:
joseph.dunn@adventhealth.com
Investigator:
Last name:
Mark Socinski, MD
Email:
Principal Investigator
Facility:
Name:
Cleveland Clinic Florida
Address:
City:
Stuart
Zip:
34994
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Irene Ball
Email:
BallI@ccf.org
Investigator:
Last name:
Kelley Kozma, MS, DO
Email:
Principal Investigator
Facility:
Name:
University of South Florida (Tampa General Hospital)
Address:
City:
Tampa
Zip:
33606
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
University of Louisville James Graham Brown Cancer Center
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Danial Malik
Email:
danial.malik@louisville.edu
Investigator:
Last name:
Robert Martin, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Meritus Health
Address:
City:
Hagerstown
Zip:
21742
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sheronda Brown, Ed.D
Email:
sheronda.brown@meritushealth.com
Investigator:
Last name:
Victoria Giffi, MD
Email:
Principal Investigator
Facility:
Name:
John Theurer Cancer Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Diane Russomanno
Email:
diane.russomanno@hmhn.org
Investigator:
Last name:
John Gibbs, MD
Email:
Principal Investigator
Facility:
Name:
Roswell Park Comprehensive Cancer Center
Address:
City:
Buffalo
Zip:
14203
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
John Gaeddert
Email:
john.gaeddert@roswellpark.org
Investigator:
Last name:
Edwin Yau, MD, PhD
Email:
Principal Investigator
Facility:
Name:
University of North Carolina at Chapel Hill
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Markeela Lipscomb
Email:
markeela_lipscomb@med.unc.edu
Contact backup:
Last name:
Desma Jones
Email:
desma_jones@med.unc.edu
Investigator:
Last name:
Nima Kokabi, MD
Email:
Principal Investigator
Facility:
Name:
University of Wisconsin
Address:
City:
Madison
Zip:
53705
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sara John
Email:
sjohn2@uwhealth.org
Investigator:
Last name:
Giuseppe Toia, MD, MS
Email:
Principal Investigator
Start date:
June 26, 2023
Completion date:
January 2027
Lead sponsor:
Agency:
Elephas
Agency class:
Industry
Collaborator:
Agency:
Hoosier Cancer Research Network
Agency class:
Other
Source:
Elephas
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05520099
