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

ConditionsEarly Stage Triple-Negative Breast CarcinomaMetastatic Bladder Urothelial CarcinomaMetastatic Cervical CarcinomaMetastatic Clear Cell Renal Cell CarcinomaMetastatic Colorectal CarcinomaMetastatic Endometrial CarcinomaMetastatic Esophageal CarcinomaMetastatic Liver CarcinomaMetastatic Lung Non-Small Cell CarcinomaMetastatic Malignant Skin NeoplasmMetastatic Malignant Solid NeoplasmResectable Lung Non-Small Cell CarcinomaEarly Stage Lung Non-Small Cell CarcinomaResectable Malignant Solid NeoplasmResectable Triple-Negative Breast CarcinomaStage III Renal Cell Cancer AJCC v8Stage IV Cervical Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8Recurrent Cervical CarcinomaRecurrent Colorectal CarcinomaRecurrent Endometrial CarcinomaRecurrent Esophageal CarcinomaRecurrent Liver CarcinomaRecurrent Lung Non-Small Cell CarcinomaRecurrent Malignant Skin NeoplasmRecurrent Malignant Solid Neoplasm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Lung: Non-small Cell Lung Cancer (NSCLC)

Skin: Cutaneous Malignancy, excluding Uveal Melanoma

Esophageal Cancer

Cervical Cancer

Disqualifiers

Pregnant women because this study involves a greater than minimal risk procedure (biopsy)

Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety for the biopsy

Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy

NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial

Trial population

Patients at Mayo Clinic in Rochester who are suspected of or diagnosed with Stage III or IV/metastatic cancer or receiving neoadjuvant (pre-operative) checkpoint inhibitors (CPI) for a resectable early stage of solid malignancies

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo optional research blood sample.

  • Tissue Collection

    Procedure/Surgery

    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.

Treatment groups

324 Participants
are divided into 1 treatment group
Group A: Observational2 interventions

Trial outcomes

Primary outcomes

1

Accuracy of the Elephas Score for predicting clinical response in neoadjuvant patients

Assessed based on pathologic complete response (pCR) during checkpoint inhibitor (CPI) treatment. Clinical non-response will be defined as non-pathological complete response. Patients who cannot have pathologic complete response determined will be excluded from the primary analysis.

Time frame
Up to 3 years
2

Accuracy of the Elephas Score for predicting clinical response in locally advanced/metastatic patients

Assessed based on Response Evaluation Criteria In Solid Tumors (RECIST) score for best overall response \[complete response (CR) or partial response (PR)\] during checkpoint inhibitor (CPI) treatment. Clinical non-response will be defined as either stable disease (SD) or disease progression (PD). Patients who cannot have best response determined will be excluded from the primary analysis.

Time frame
Up to 3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Elephas Biosciences Corporation

Collaborator

Source ClinicalTrials.gov
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