Lung Cancer Clinical Trial
Observational Basket Trial to Predict Response to Immune Checkpoint Inhibitors Across Solid Tumors
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.
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.
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.
Age â‰¥ 18 years at the time of consent.
ECOG â‰¤ 3.
Suspected of or diagnosed with Stage IV/metastatic:
Lung: Non-small cell lung cancer (NSCLC)
Head and Neck: Squamous Cell Carcinoma (HNSCC), excluding nasopharyngeal and salivary gland cancers
Kidney: Clear Cell Renal Cell Carcinoma (ccRCC)
Bladder: Urothelial Carcinoma (UC)
Skin: Cutaneous Melanoma, excluding Uveal Melanoma
Must be clinically able, at investigator discretion, to undergo extra core needle biopsy passes during their biopsy from a tumor site that yields a biopsy of at least 10 mm in length, and ideally longer. NOTE: To prevent risk of pneumothorax, no CNBs will be taken through lung tissue.
Must be eligible based on investigator discretion to receive CPI monotherapy or combination therapy (e.g. combining two CPIs such as anti-PD-1 plus anti-CTLA-4) or CPI therapy in combination with chemotherapy or genome-targeted therapy.
Must be treatment-naÃ¯ve at the time of biopsy if they are newly diagnosed.
Participants who are Stage I, II, or III and have progressed to metastatic cannot have received any anti-cancer treatment for at least 2 months prior to biopsy.
Participants with a confirmed diagnosis who have previously undergone a standard of care (SOC) biopsy must be willing to undergo a separate biopsy procedure solely for the purposes of this study.
Must be receiving standard of care anti-cancer treatment as described above. NOTE: Subjects that enroll in another interventional clinical trial at any point for the duration of the study will no longer be eligible and, therefore, will be taken off study.
Subjects with relapsing Stage IV cancer who are undergoing or plan to undergo a second line of treatment are not eligible.
Measurable disease according to RECIST 1.1.
Female participants must not be pregnant or breastfeeding.
Subjects with a secondary cancer diagnosis are eligible to participate, if participation does not interfere with systemic anti-cancer standard of care treatment for primary diagnosis.
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