Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT06349642
Status
Recruiting

Conditions

  • Early Stage Lung Non-Small Cell Carcinoma
  • Early Stage Triple-Negative Breast Carcinoma
  • Metastatic Bladder Urothelial Carcinoma
  • Metastatic Cervical Carcinoma
  • Metastatic Clear Cell Renal Cell Carcinoma
  • Metastatic Colorectal Carcinoma
  • Metastatic Endometrial Carcinoma
  • Metastatic Esophageal Carcinoma
  • Metastatic Liver Carcinoma
  • Metastatic Lung Non-Small Cell Carcinoma
  • Metastatic Malignant Skin Neoplasm
  • Metastatic Malignant Solid Neoplasm
  • Recurrent Cervical Carcinoma
  • Recurrent Colorectal Carcinoma
  • Recurrent Endometrial Carcinoma
  • Recurrent Esophageal Carcinoma
  • Recurrent Liver Carcinoma
  • Recurrent Lung Non-Small Cell Carcinoma
  • Recurrent Malignant Skin Neoplasm
  • Recurrent Malignant Solid Neoplasm
  • Resectable Lung Non-Small Cell Carcinoma
  • Resectable Malignant Solid Neoplasm
  • Resectable Triple-Negative Breast Carcinoma
  • Stage III Renal Cell Cancer AJCC v8
  • Stage IV Cervical Cancer AJCC v8
  • Stage IV Renal Cell Cancer AJCC v8
  • Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo optional research blood sample.
  • Tissue Collection — PROCEDURE
    Tissue specimen collection will be completed with your scheduled standard of care biopsy if possible. If standard of care biopsy is already completed or the research biopsy wasn\'t collected at the time as your standard of care biopsy, then the research biopsy will be scheduled for a different day for research purposes only.

Study Details

This study is being done to collect tissue samples to test how accurately a tumor response platform, Elephas, can predict clinical response across multiple types of immunotherapies, chemoimmunotherapy and tumor types.

Key Dates

Start date
Apr 24, 2024
Status verified
Mar 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
324 participants (estimated)

Arms

  • Arm: Observational
    Patients undergo tissue biopsy and may optionally undergo blood sample collection and have their medical records reviewed on study. Patients receive standard treatment with checkpoint inhibitors during the study and undergo standard tumor assessments during screening and follow-up.

Primary Outcome Measure

Accuracy of the Elephas Score for predicting clinical response in neoadjuvant patients [ Time Frame: Up to 3 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaPhoenixArizona85054
Clinical Trials Referral Office
855-776-0015
Parminder Singh, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224
Clinical Trials Referral Office
855-776-0015
Dev Mukhopadhyay, PhD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
855-776-0015
Matthew Block, MD, PhD (PRINCIPAL_INVESTIGATOR)

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