A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head & Neck Squamous Cell Carcinoma (HNSCC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTempus AI
About this trial
The study is a prospective, longitudinal, non-interventional, multicenter study of participants with HNSCC who will have tissue and blood based molecular biomarker profiling during their standard of care treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years of age
Willing and able to provide informed consent
Histologically- or cytologically-confirmed metastatic or unresectable, recurrent HNSCC unsuitable for local therapies
Intended for first line anti-PD1 or PDL1 monotherapy or combination therapy
Disqualifiers
Non-squamous histologies (eg, nasopharynx or salivary gland)
Relapse or recurrence within 6 months of first line chemotherapy and / or chemoradiotherapy
Tumors that are PD-L1 negative (CPS <1)
Clinical evidence of an active second invasive malignancy within <2 years of enrollment with the exception of stable prostate cancer on watchful waiting, in situ cervical cancer, in situ breast carcinoma or localized non-melanoma skin cancers
Trial population
This protocol targets patients with metastatic or unresectable, recurrent HNSCC intended for first line immunotherapy or combination therapy.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: Metastatic or unresectable recurrent HNSCC
Trial outcomes
Primary outcomes
1
Explore DNA, RNA, immune and other multiomic biomarkers to better understand prognostic or predictive biomarkers and to inform future research for new relevant biomarkers.
Use NGS, ctNDA assessments, RNA analysis, and other multiomic testing to uncover biomarkers of collected blood and tissue samples that may predict outcomes, identify markers related to disease, identify markers related to mechanism of drug action, and inform future research.
Time frame
5 yearsSecondary outcomes
1
Explore changes in relevant DNA, RNA, immune and multiomic biomarkers in longitudinal blood samples, and diagnostic and progression biopsy samples, to understand real-world outcomes and resistance mechanisms.
Correlate biomarkers of collected blood and tissue samples with standard of care therapy real-world outcomes such as overall survival, progression free survival, time to next treatment, and time to treatment discontinuation.
Time frame
5 years2
Explore changes in ctDNA from longitudinal blood samples to assess ctDNA as a response biomarker.
Assess changes in ctNDA of collected blood samples using ctDNA clearance factors such as time to clearance, best overall clearance rate, best confirmed clearance, duration, time to ctDNA recurrence with standard of care therapy real-world outcomes such as overall survival, progression free survival, time to next treatment, and time to treatment discontinuation.
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tempus AI
Lead sponsor
AstraZeneca
Collaborator
Source ClinicalTrials.gov