RecruitingPhase not listed

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

Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects tumor tissue to test how well a tool called Elephas predicts response to cancer treatment. It looks at treatments that help the immune system fight cancer, used alone or with chemotherapy. It is for people with certain suspected or confirmed solid tumors, including advanced cancers and some early cancers treated before surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have an eligible cancer that has spread or returned: certain lung, skin, esophageal, cervical, endometrial, liver, or colon cancers; tumors with certain gene changes; or other solid tumors eligible or planned for immune checkpoint treatment, which helps the immune system attack cancer.
  • Other eligible groups include certain stage III or IV kidney or bladder cancers and other solid tumors planned or eligible for immune checkpoint treatment. Early cancers that can be removed by surgery may also qualify for this treatment before surgery, including triple-negative breast cancer and certain lung cancers. The study doctor checks eligibility.
  • For locally advanced or spread cancer, tumors must be measurable under study rules. Tumors in areas treated with radiation do not count, nor do tumors measured only by a physical exam. For treatment before surgery, the study doctor must approve eligibility for an approved immune checkpoint drug.
  • If cancer is newly diagnosed or suspected, have had no cancer treatment before the biopsy. If stage I–III cancer has spread, stop cancer treatment for at least 2–4 weeks before the biopsy, depending on the drug.
  • Be able to do all or most daily self-care and be up and about at least half of waking hours, even if unable to work.
  • If able to become pregnant, have a negative pregnancy test within 7 days before joining. Do not be pregnant or breastfeeding, and use suitable birth control when needed.
  • Be willing and medically able to have extra tissue taken during a usual biopsy or have a research-only biopsy. A biopsy removes a small tissue sample.
  • Give written consent to join. A second known cancer is allowed if joining does not disrupt usual whole-body cancer treatment for the suspected main cancer.

Who can't join

  • Are pregnant.
  • Have a serious illness that the study doctor thinks makes joining unsuitable or makes biopsy safety hard to assess.
  • Have a weakened immune system. The criteria also list people with HIV who are taking HIV medicines, but note that people with HIV without signs of a weakened immune system may join.
  • Have an uncontrolled illness, such as an active infection, or a mental health condition or social situation that would keep you from following study rules.
  • Are in, or plan to join, a blinded cancer treatment trial, where treatment assignments are kept hidden.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Subjects must meet one of the following criteria: * Subjects suspected of or diagnosed with the following Stage IV/metastatic or recurrent malignancies: * Lung: Non-small Cell Lung Cancer (NSCLC) * Skin: Cutaneous Malignancy, excluding Uveal Melanoma * Esophageal Cancer * Cervical Cancer * Endometrial Cancer * Colon Cancer: Mismatch repair deficient (dMMR) CRC only * All solid tumors with high tumor mutation burden (TMB) * All solid tumors that are microsatellite instability high (MSI-H) * All mismatch repair deficient (dMMR) solid tumors * Liver Cancer * Any solid tumor with measurable disease that is eligible for pure ICI therapy or that the clinician plans to treat with immune checkpoint inhibitor (ICI) therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate laboratory developed tests (LDTs) that, per clinician, render the patient eligible for ICI therapy, either frontline or a later line. OR * Subjects suspected of or diagnosed with the following Stage III per provider discretion or IV/metastatic malignancies: * Kidney: Clear Cell Renal Cell Carcinoma (ccRCC) * Bladder: Urothelial Carcinoma (UC) * Any solid tumor with measurable disease that is eligible for pure ICI therapy or that the clinician plans to treat with ICI therapy. NOTE: This can be 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 OR * Patients who will be receiving neoadjuvant CPI for the following resectable early-stage malignancies: * Breast Cancer: Triple negative breast cancer (TNBC) * Lung: Non-small cell lung cancer (NSCLC) * NOTE: Patients with suspected NSCLC who would be eligible for neoadjuvant checkpoint inhibitor (CPI) are eligible to enroll per provider discretion * Any solid tumor that is eligible for pure ICI therapy or that the clinician plans to treat with ICI therapy. NOTE: This can be 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 * LOCALLY ADVANCED/METASTATIC PATIENTS: Measurable disease as defined per protocol NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible. * NEOADJUVANT PATIENTS: Subjects must be eligible based on investigator discretion to receive approved CPI therapy. * Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. * Subjects who are Stage I, II, or III and have progressed to metastatic cannot have received any anti-cancer treatment for at least 2 - 4 weeks (depending upon the washout period of prior anti-cancer treatment) prior to biopsy as per the agents used. * ECOG Performance Status (PS) 0, 1 or 2. * Negative pregnancy test done ≤7 days prior to enrollment, for persons of childbearing potential only * Female subjects must not be pregnant or breastfeeding and must use appropriate methods of contraception when applicable. * Subjects must be clinically able, at investigator discretion, and willing to undergo either: * additional biopsy passes during their standard of care biopsy, OR * a biopsy for research only, if applicable. * NOTE: These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to biopsies per the clinician. * Subjects with a known secondary cancer diagnosis are eligible to participate if participation does not interfere with systemic anti-cancer standard of care treatment for suspected primary diagnosis. * Provide written informed consent Exclusion Criteria: * 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 * Uncontrolled intercurrent illness including, but not limited to: * ongoing or active infection * psychiatric illness/social situations that would limit compliance with study requirements * Subjects who are enrolled or plan to be enrolled in a blinded cancer therapeutic treatment trial

Study sites (3)

AZ

FL

MN