A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head & Neck Squamous Cell Carcinoma (HNSCC)

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

TEMPUS PHOENIX HNSCC STUDY: A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head & Neck Squamous Cell Carcinoma (HNSCC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06163534
• Other study ID #: TP-CA-006
• Secondary ID: Pro00074943
• Status: Recruiting
• Start date: May 2024
• Est. completion date: March 1, 2028

Study information

• Verified date: May 2024
• Source: Tempus AI
• Contact: Phoenix HNSCC
• Phone: (833) 514-4187
• Email: phoenix[@]tempus.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 1, 2028
• Est. primary completion date: March 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =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

• Must submit fresh or archived block tumor sample representative of current disease per laboratory manual

Exclusion Criteria:

• 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

• Unable to comply with study procedures (i.e., not willing or able to have additional blood samples collected)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Locations

Country	Name	City	State
United States	City of Hope	Duarte	California
United States	Oncology Hematology Associates	Springfield	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Tempus AI	AstraZeneca

Country where clinical trial is conducted

United States, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years
Secondary	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.	5 years
Secondary	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.	5 years