Longitudinal biomarker profiling for patients with head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study involves the collection of tissue and blood samples from patients with head and neck squamous cell carcinoma (HNSCC) during their standard treatment. It aims to perform multi-omic biomarker profiling to better understand the molecular characteristics of the disease. Participants will be monitored over time to assess changes in their biomarker profiles as they undergo treatment. The study is non-interventional and focuses on patients who are unsuitable for local therapies and are intended for first-line anti-PD1 or PDL1 therapy.

Why it matters

Who can join: the full rules

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 tumor tissue 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)

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• USC/Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• University of California, Los Angeles
  Los Angeles, California, United States Recruiting
• Stanford
  Palo Alto, California, United States Recruiting
• Providence Medical Foundation
  Santa Rosa, California, United States Recruiting
• Mayo Clinic Florida
  Jacksonville, Florida, United States Recruiting

Study contacts

• Study coordinator: Phoenix HNSCC
• Email: phoenix@tempus.com
• Phone: (833) 514-4187

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Neoadjuvant therapy with nimotuzumab, toripalimab, nab-paclitaxel, and cisplatin for locally advanced head and neck cancer

  This study tests a pre-surgery treatment combining targeted therapy, immunotherapy, and chemotherapy to see if it helps patients with locally advanced, resectable head and neck squamous cell carcinoma.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Hebei, Hebei · NCT07906587

• ICG with near-infrared imaging to visualize head and neck cancer during surgery

  This study tests whether first-window indocyanine green fluorescence seen during surgery matches the cancer extent seen on pathology in patients with head and neck squamous cell carcinoma.

  Recruiting Phase 2 Washington University School of Medicine · St Louis, Missouri · NCT07825597

• ABBV-253 in adults with advanced solid tumors

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  Recruiting at 3 sites Phase 1 AbbVie · Grand Rapids, Michigan and 2 other locations · NCT07807956

• Online Sharing for Head & Neck Cancer Support

  A mobile app designed for adults with head and neck cancer undergoing radiotherapy to see if daily social sharing and peer interaction can help reduce psychological distress.

  Recruiting West China Hospital · Chengdu, Sichuan · NCT07766226

• Telisotuzumab Adizutecan with Pembrolizumab as first-line treatment for recurrent or metastatic head and neck cancer

  This study tests a combination treatment to see if it helps people with newly diagnosed recurrent or metastatic head and neck squamous cell carcinoma who express the c-Met protein.

  Recruiting at 5 sites Phase 2 AbbVie · Duarte, California and 4 other locations · NCT07744126

• Mild heat therapy added to standard treatment for locally advanced head and neck cancer

  This early-stage trial tests whether mild hyperthermia can be safely added to standard radiotherapy with or without chemotherapy for locally advanced head and neck cancer.

  Recruiting Phase 1 Erasmus Medical Center · Rotterdam, South Holland · NCT07690618

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.