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Participants suspected of or diagnosed with Stage III or IV/metastatic cancer for Bladder Cancer (CYBRID-02 Trial)

N/A
Recruiting
Research Sponsored by Elephas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

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.

Eligible Conditions
  • Bladder Cancer
  • Colorectal Cancer
  • Skin Cancer
  • Endometrial Cancer
  • Renal Cell Carcinoma
  • Non-Small Cell Lung Cancer
  • Head and Neck Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sensitivity and Specificity of Cybrid Score for Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors
Secondary study objectives
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)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants suspected of or diagnosed with Stage III or IV/metastatic cancerExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Elephas Biosciences CorporationUNKNOWN
Hoosier Cancer Research NetworkOTHER
68 Previous Clinical Trials
3,540 Total Patients Enrolled
ElephasLead Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled
~139 spots leftby Jan 2027
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