RecruitingObservational

Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies

NCT ID: NCT04510129Sponsor: Cofactor Genomics, Inc.Last updated: 2025-03-12

Summary

This study will collect de-identified tumor samples, with correlated clinical/demographic data and tissue histology, from patients selected or scheduled for pre-treatment tumor biopsy or who have had a recent pre-treatment tumor biopsy. These specimens and clinical data may be used in subsequent studies for the development and validation of a diagnostic test.

Detailed description

This study will establish a prospective cohort of pre-treatment tumor specimens with correlated de-identified clinical and demographic data and tissue histology from cancer patients who are undergoing treatment with PD-1/PD-L1 inhibitors. Patients who have undergone pre-anti-PD-1/PD-L1-treatment tumor biopsy or who are scheduled for tumor biopsy prior to anti-PD-1/PD-L1 treatment will be enrolled. The study will not require a study-specific tumor biopsy; any biopsies taken prior to treatment as part of standard of care are eligible for this study. Biopsies must not have been taken after immunotherapy treatment began. Participants will be asked to provide their consent for the potential use of their biospecimens in subsequent studies for the development and validation of a diagnostic test.

Arms & interventions

Diagnostic TestOncoPrism™ assay
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

Outcome measures

Primary

PD-L1/PD-1 inhibitor response
No response to treatment with PD-L1/PD-1 inhibitor and response to treatment with PD-L1/PD-1 inhibitor.
Time frame: 6 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

Inclusion Criteria: 1. Subject must have a disease of interest. Specifically, subject must have one of: 1. head and neck squamous cell carcinoma (HNSCC) 2. non-small-cell lung cancer (NSCLC) 3. small cell lung cancer (SCLC) 4. urothelial carcinoma (UCC) 5. gastric or gastroesophageal junction adenocarcinoma 6. cervical cancer 7. esophageal squamous cell carcinoma (ESCC) 8. triple-negative breast cancer (TNBC) 9. hepatocellular carcinoma (HCC) 10. renal cell carcinoma (RCC) 11. colorectal cancer (CRC) 2. Subject must have received, or be scheduled to receive, at least one dose of anti-PD-1/PD-L1 immunotherapy for treatment of their cancer. 3. Subject must have had, or will have, a tumor biopsy prior to treatment with anti-PD-1/PD-L1 immunotherapy. 4. Subject must have undergone, or will undergo, medical imaging (e.g. CT or MRI) of the tumor prior to treatment with anti-PD-1/PD-L1 immunotherapy. 5. Willing to provide electronic informed consent per IRB-approved protocol. 6. Able to speak, read, and comprehend English fluently. 7. Subject is 18 years of age or older. 8. Subjects must have sufficient tissue available to fulfill the specimen requirements of the study. Exclusion Criteria: 1. Inability or unwillingness to provide informed consent. 2. Subject who does/did not have one of the cancers listed above (other histologies). 3. Subject has already participated in this trial.

Study locations (1)

Curebase

San Francisco, California, 94131

Recruiting

Study Director · Contact

(628) 200-4082 predapthelp@curebase.com

References

Flanagan KC, Earls J, Hiken J, Wellinghoff RL, Ponder MM, McLeod HL, Westra WH, Vavinskaya V, Sutton L, Deichaite I, Macdonald OK, Welaya K, Wade J 3rd, Azzi G, Pippas AW, Slim J, Bank B, Sui X, Kossman SE, Shenkenberg TD, Alexander WL, Price KA, Ley J, Messina DN, Glasscock JI, Colevas AD, Cohen EEW, Adkins D, Duncavage EJ. 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. J Immunother Cancer. 2024 Nov 3;12(11):e009573. doi: 10.1136/jitc-2024-009573.(PubMed)