Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Immune Checkpoint Inhibitors

Immunomodulating Agents

Liver Extracts

Subjects suspected of or diagnosed with Stage IV NSCLC and meet one of the following criteria:

1. Subjects who are undiagnosed, have undergone imaging and are suspected to have Stage IV lung cancer.
2. Subjects with a Stage I, II, or III diagnosis of NSCLC, who are being re-biopsied after imaging-confirmed progression to metastatic disease
3. Subjects who have a confirmed diagnosis of NSCLC, and have undergone a SOC biopsy procedure and will undergo a separate procedure for the purposes of this study.
4. Subjects who have a previous Stage IV/metastatic NSCLC diagnosis and have already received first line treatment.

Subjects must be clinically able, at investigator discretion, to undergo additional core needle or forceps biopsy passes during their biopsy. These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to additional passes (e.g., liver or lymph nodes) per the clinician.

Core Needle or Forceps Biopsy

Catarina Costa

Saima Chaabane

Fereidoun Abtin, MD

Ingrid Halvorson

Heather Chalfin, MD

Laura Parisi

Richard Zuniga, MD

April Bell

Paras Patel, MD

Lorie A Fares

Andrea G Mosko

Alan Gowan, DO

Fred Hausheer, MD, FACP

The primary objective of this study is to determine the ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform 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 immune checkpoint inhibitors (ICIs) 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 ICIs such as Pembrolizumab (Keytruda). These LTFs contain both tumor cells and infiltrating immune cells, which are critical in determining response to ICIs and other immunotherapies.

In this observational clinical trial, 200 Non-Small Cell Lung Cancer (NSCLC) participants will be recruited and their actual clinical response to ICIs (using RECIST 1.1) 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 ICIs like PDL1, MSI, and TMB.

Fresh tissue sampling using core needle or forceps biopsy.

Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform

Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform (CYBRID-01)

The ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform will be determined using in-vivo RECIST 1.1 as the reference method.

The AUC of Cybrid Score will be established with a clinically meaningful confidence interval and compared to the AUCs of established FDA approved biomarkers for predicting clinical response to ICIs.

Elephas

Standard of care immune checkpoint inhbitors

Darlene Kocher

Jonathon Barnette

Clinical Trials Nurse Navigator

Steve Williamson, MD

Jun Zhang, MD, PhD

To test whether it is feasible to perform the 3D-EX functional predictive response bioassay in the context of patients with advanced/metastatic NSCLC receiving immune checkpoint inhibitors in the standard of care clinical setting.

Non-small cell lung cancer (NSCLC), which accounts for approximately 85% of all lung cancer cases, remains the leading cause of cancer death worldwide. Immunotherapy such as using immune checkpoint inhibitors (ICIs) to target the programmed death-1 and its ligand (PD-1/L1) has revolutionized our management of this deadly disease.

However, a large proportion of patients do not derive benefit due to primary, adaptive or acquired resistance. Hence, better identifying this patient population, understanding the resistance mechanism and exploring novel combinations with current SOC immunotherapy are urgently needed to continue to benefit our NSCLC patients.

The investigators hypothesize that patient-derived immune cell containing ex-vivo tumoroids could serve these purposes. In this study, the investigators plan to develop such a 3D ex-vivo system utilizing fresh biopsied tissue from NSCLC patients. The investigators plan to prospectively evaluate the value of these ex-vivo tumoroids in immunotherapy naive advanced/metastatic NSCLC patients who will be receiving anti-PD-1/L1 (with or without anti-CTLA-4) per standard-of-care.

3-4 cores fresh tissue using 20g or larger core biopsy

Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC

Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC (TUMORIN)

Twenty-five patients will be enrolled. The bioassay will be considered to be feasible if the 3D Ex-Vivo assay results are obtained on at least 20 patients.

To test whether the 3D-EX functional response bioassay can predict tumor response (using RECIST v1.1) in patients with advanced/metastatic NSCLC, receiving treatment with immune checkpoint inhibitors, in a standard clinical setting.

Nilogen Oncosystems

Associate Professor

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All patients enrolled will have biopsies (on primary tumor or on a metastasis) before treatment in order to obtain a chemogram by ex vivo 3D culture cells

biopsy to obtain a chemogram

Pascale Mariani, MD

Prospective, open labelled, multicenter trial to evaluate the feasibility of ex vivo culture 3D (chemogram obtaining) on biopsies in order to estimate the predictive value of this technique for treatment response in patients treated by two different chemotherapies (FOLFOX or FOLFIRI) for colorectal cancer.

The CULTURE 3D study is a prospective, open labelled, multicenter trial. The aim is to evaluate the feasibility of ex vivo culture 3D (chemogram) on biopsies in order to estimate the predictive value of this technique for treatment response in patients treated by two different chemotherapies (FOLFOX or FOLFIRI) for colorectal cancer.

Patients will have biopsies in a metastasis or in the primitive tumor before treatment. The sample will be used for a 3D ex vivo cells culture. A chemogram will be made based on cells proliferation data (Ki67) and apoptosis (M30).

Results from this chemogram will not interfere with the treatment combination choice.

The treatment response will be evaluated by the RECIST assessment and will be then compared to the chemogram.

Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer

Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer: a Preliminary Study

In ex vivo 3D culture from tumor biopsies, number of interpretable chemogram.

Number of chemogram showing the same response to treatment than patient RECIST 1.1 measured response.

on untreated and treated fragments : proliferating index (ki67) and apoptosis (M30) will be assessed.

Institut Curie

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Melanoma

Carcinoma, Transitional Cell

Carcinoma, Squamous Cell

Carcinoma, Renal Cell

Melanoma, Cutaneous Malignant

Endometrial Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplasms, Squamous Cell

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Head and Neck Neoplasms

Transitional Cell Carcinoma

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

Herbal and Botanical

Cola

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.

Rae Richards

Juan Morales

Geetha Varma, MD

Joseph Dunn

Mark Socinski, MD

Irene Ball

Kelley Kozma, MS, DO

Jennifer Burgess

Matthew Anderson, MD, PhD

Danial Malik

Robert Martin, MD, PhD

Diane Russomanno

John Gibbs, MD

John Gaeddert

Edwin Yau, MD, PhD

Markeela Lipscomb

Desma Jones

Nima Kokabi, MD

Sara John

Giuseppe Toia, MD, MS

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.

Fresh tissue sample using core needle biopsy or forceps biopsy.

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

Observational Basket Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform (CYBRID-02)

Hoosier Cancer Research Network

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform	NCT05478538	Non Small Cell ... Metastatic Non ... NSCLC Metastatic NSCL...	Core Needle or ...	18 Years -	Elephas
Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC	NCT05332925	Lung Cancer NSCLC NSCLC Stage IV	Standard of car...	18 Years - 110 Years	University of Kansas Medical Center
Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer	NCT02849106	Colorectal Canc...	biopsy to obtai...	18 Years -	Institut Curie
Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform	NCT05478538	Non Small Cell ... Metastatic Non ... NSCLC Metastatic NSCL...	Core Needle or ...	18 Years -	Elephas
Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer	NCT02849106	Colorectal Canc...	biopsy to obtai...	18 Years -	Institut Curie
Observational Basket Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform	NCT05520099	Colorectal Canc... Head and Neck S... Non Small Cell ... Cutaneous Melan... Endometrial Can... Urothelial Carc... Clear Cell Rena...	Core Needle or ...	18 Years -	Elephas
Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform	NCT05478538	Non Small Cell ... Metastatic Non ... NSCLC Metastatic NSCL...	Core Needle or ...	18 Years -	Elephas

Spots Global Cancer Trial Database for 3d culture

Every month we try and update this database with for 3d culture cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for 3d culture

Every month we try and update this database with for 3d culture cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for 3d culture cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.