This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Observational Basket Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform (CYBRID-02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05520099
Recruitment Status : Recruiting
First Posted : August 29, 2022
Last Update Posted : March 7, 2024
Sponsor:
Collaborator:
Hoosier Cancer Research Network
Information provided by (Responsible Party):
Elephas

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Colorectal Cancer Head and Neck Squamous Cell Carcinoma Non Small Cell Lung Cancer Cutaneous Melanoma Endometrial Cancer Urothelial Carcinoma Clear Cell Renal Cell Carcinoma Procedure: Core Needle or Forceps Biopsy

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 216 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Basket Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform (CYBRID-02)
Actual Study Start Date : June 26, 2023
Estimated Primary Completion Date : January 2027
Estimated Study Completion Date : January 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Participants suspected of or diagnosed with Stage III or IV/metastatic cancer

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.
 Procedure: Core Needle or Forceps Biopsy
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Sensitivity and Specificity of Cybrid Score for Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors [ Time Frame: 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 :
  1. 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) [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Fresh tissue sample using core needle biopsy or forceps biopsy.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05520099


Contacts
Layout table for location contacts
Contact: Catarina Costa 609 955 4927 ClinicalTrials@elephas.com
Contact: Rae Richards 317.634.5842 ext 38 rrichards@hoosiercancer.org

Locations
Layout table for location information
United States, California
Salinas Valley Memorial Healthcare System Not yet recruiting
Salinas, California, United States, 93901
Contact: Juan Morales       jmorales3@salinasvalleyhealth.com   
Principal Investigator: Geetha Varma, MD         
United States, Florida
AdventHealth Orlando Not yet recruiting
Orlando, Florida, United States, 32803
Contact: Joseph Dunn       joseph.dunn@adventhealth.com   
Principal Investigator: Mark Socinski, MD         
United States, Kentucky
University of Louisville James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Danial Malik       danial.malik@louisville.edu   
Principal Investigator: Robert Martin, MD, PhD         
United States, New Jersey
John Theurer Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Diane Russomanno       diane.russomanno@hmhn.org   
Principal Investigator: John Gibbs, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Markeela Lipscomb    919-843-3670    markeela_lipscomb@med.unc.edu   
Contact: Desma Jones    919-843-9463    desma_jones@med.unc.edu   
Principal Investigator: Nima Kokabi, MD         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53705
Contact: Sara John    608-262-5421    sjohn2@uwhealth.org   
Principal Investigator: Giuseppe Toia, MD, MS         
Sponsors and Collaborators
Elephas
Hoosier Cancer Research Network
Investigators
Layout table for investigator information
Study Director: Jon Oliner, MD, PhD Elephas
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Elephas
ClinicalTrials.gov Identifier: NCT05520099    
Other Study ID Numbers: HCRN BSK22-562
First Posted: August 29, 2022    Key Record Dates
Last Update Posted: March 7, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elephas:
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
Additional relevant MeSH terms:
Layout table for MeSH 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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Skin Neoplasms
Skin Diseases
Neoplasms, Squamous Cell
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms