Study on Using Pre-treatment Tumor Biopsies to Predict Response to PD-1PD-L1 Immunotherapy in Various Cancers
Led by Cofactor Genomics, Inc. · Updated on 2025-03-12
1650
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are collecting de-identified tumor samples along with clinical and demographic data from cancer patients who have had or are scheduled for a tumor biopsy before starting treatment with PD-1PD-L1 inhibitors. The study aims to use these samples and information to develop and validate a diagnostic test that may help predict how patients respond to immunotherapy. This observational study involves multiple types of cancer including head and neck, lung, breast, and others.
Participants are included if they have one of several specified cancers and have undergone or will undergo a tumor biopsy before beginning anti-PD-1PD-L1 treatment. The study does not require extra biopsies beyond those collected as part of standard care. Patients must have had medical imaging of the tumor before treatment and provide consent for their tissue and data to be used in related future studies. The main diagnostic tool studied is the OncoPrism assay, which analyzes the immune components of tumor tissue.
During the study, participants tumor specimens and medical data are collected and de-identified to protect privacy. Researchers will review how patients respond to PD-1PD-L1 inhibitors over six months. No additional treatments or procedures are required beyond standard care and consent. The study is sponsored by Cofactor Genomics, Inc., and participation involves tracking tumor biopsy samples and clinical outcomes over time until the study ends in February 2027.
CONDITIONS
Brief Title
A Multicenter Cancer Biospecimen Collection Study
Research Team
C
Clinical Trial Coordinator
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Have one of the following cancers: head and neck squamous cell carcinoma, non-small-cell lung cancer, small cell lung cancer, urothelial carcinoma, gastric or gastroesophageal junction adenocarcinoma, cervical cancer, esophageal squamous cell carcinoma, triple-negative breast cancer, hepatocellular carcinoma, renal cell carcinoma, or colorectal cancer
Have received or be scheduled to receive at least one dose of anti-PD-1/PD-L1 immunotherapy
Have had or will have a tumor biopsy before starting anti-PD-1/PD-L1 immunotherapy
Have undergone or will undergo medical imaging (CT or MRI) of the tumor before treatment
Willing to provide electronic informed consent
Able to speak, read, and understand English fluently
Be 18 years of age or older
Have sufficient tumor tissue available to meet the study requirements
You will not qualify if you...
Unable or unwilling to provide informed consent
Do not have one of the specified cancer types
Have already participated in this trial
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for consent and eligibility confirmation
Diagnostic Evaluation
Duration - Up to 1 month prior to immunotherapy
Participants provide pre-treatment tumor biopsy samples taken as part of standard care before starting immunotherapy. Medical imaging (CT or MRI) of the tumor is also performed before treatment.
1 to 2 visits depending on biopsy and imaging schedules
Long-term Monitoring
Duration - 6 months
Participants are observed to assess their response to PD-1/PD-L1 inhibitor treatment over 6 months.
Visits as part of routine care; no additional study visits required
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
11
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Published Research Related To This Trial
Multicenter validation of an RNA-based assay to predict anti-PD-1 disease control in patients with recurrent or metastatic head and neck squamous cell carcinoma: the PREDAPT study.