Collecting tissue to improve cancer treatment predictions
Observational Basket Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform (CYBRID-02)
This study is testing a new way to predict how well immunotherapy will work for people with different types of cancer by using small samples of their tumors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 216 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Elephas Industry-sponsored |
| Drugs / interventions | Pembrolizumab |
| Locations | 11 sites (Salinas, California and 10 other locations) |
| Trial ID | NCT05520099 on ClinicalTrials.gov |
What this trial studies
This observational trial aims to evaluate the accuracy of the Cybrid live tumor diagnostic platform in predicting responses to immunotherapy across various solid tumors. Participants will undergo core needle or forceps biopsy to obtain small 3D live tumor fragments, which will be analyzed alongside their clinical responses to checkpoint inhibitors. The study will compare the platform's predictive AI scores with traditional diagnostic methods to assess its sensitivity and specificity. By focusing on tumors such as colorectal cancer, lung cancer, and melanoma, the trial seeks to enhance personalized treatment strategies for cancer patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced stages of specific cancers such as colorectal, lung, head and neck, melanoma, and endometrial cancers.
Not a fit: Patients with early-stage cancers or those not diagnosed with the specified types of solid tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate predictions of which cancer treatments will be effective for individual patients.
How similar studies have performed: While the approach of using live tumor fragments for predictive diagnostics is innovative, similar studies have shown promise in improving treatment predictions for cancer patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Salinas, California and 10 other locations
- Salinas Valley Memorial Healthcare System — Salinas, California, United States (Recruiting)
- AdventHealth Orlando — Orlando, Florida, United States (Recruiting)
- Cleveland Clinic Florida — Stuart, Florida, United States (Recruiting)
- University of South Florida (Tampa General Hospital) — Tampa, Florida, United States (Active_not_recruiting)
- University of Louisville James Graham Brown Cancer Center — Louisville, Kentucky, United States (Recruiting)
- Meritus Center for Clinical Research — Hagerstown, Maryland, United States (Recruiting)
- Meritus Health — Hagerstown, Maryland, United States (Not_yet_recruiting)
- John Theurer Cancer Center — Hackensack, New Jersey, United States (Recruiting)
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (Not_yet_recruiting)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Catarina Costa
- Email: ClinicalTrials@elephas.com
- Phone: (609) 955 4927
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.