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

Официальное название

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

Обзор

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.

Первичные конечные точки

• Explore DNA, RNA, immune and other multiomic biomarkers to better understand prognostic or predictive biomarkers and to inform future research for new relevant biomarkers. [Срок оценки: 5 years]

Вторичные конечные точки (2)

• 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. [Срок оценки: 5 years]
• Explore changes in ctDNA from longitudinal blood samples to assess ctDNA as a response biomarker. [Срок оценки: 5 years]

Критерии участия

Критерии включения

• ≥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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 29 центров

• City of Hope — Duarte
• USC/Norris Comprehensive Cancer Center — Los Angeles
• University of California, Los Angeles — Los Angeles
• Stanford — Palo Alto
• Providence Medical Foundation — Santa Rosa
• Morehouse — Atlanta
• Piedmont Healthcare — Atlanta
• Winship Cancer Institute, Emory University — Atlanta
• … и ещё 21 центр

Пуэрто-Рико · 1 центр

• Pan American Cancer for Oncology — San Juan

Публикации

• Hsieh RW, Borson S, Tsagianni A, Zandberg DP. Immunotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck. Front Oncol. 2021 Sep 1;11:705614. doi: 10.3389/fonc.2021.705614. eCollection 2021. PMID 34540672
• Head and neck cancer - risk factors and prevention. Cancer.Net. Published June 25, 2012. Accessed August 11, 2023. https://www.cancer.net/cancer-types/head-and-neck-cancer/risk-factors-and-prevention
• Kimple RJ, Harari PM. The prognostic value of HPV in head and neck cancer patients undergoing postoperative chemoradiotherapy. Ann Transl Med. 2015 May;3(Suppl 1):S14. doi: 10.3978/j.issn.2305-5839.2015.01.37. No abstract available. PMID 26046059
• Ionna F, Bossi P, Guida A, Alberti A, Muto P, Salzano G, Ottaiano A, Maglitto F, Leopardo D, De Felice M, Longo F, Tafuto S, Della Vittoria Scarpati G, Perri F. Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: A Big and Intriguing Challenge Which May Be Resolved by Integrated Treatments Combining Locoregional and Systemic Therapies. Cancers (Basel). 2021 May 14;13(10):2371. doi: PMID 34069092
• Samra B, Tam E, Baseri B, Shapira I. Checkpoint inhibitors in head and neck cancer: current knowledge and perspectives. J Investig Med. 2018 Oct;66(7):1023-1030. doi: 10.1136/jim-2018-000743. Epub 2018 Jun 25. PMID 29941547
• Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056/NEJMoa0802656. PMID 18784101
• Burtness B, Harrington KJ, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Hong RL, Gonzalez Mendoza R, Roy A, Zhang Y, Gumuscu B, Cheng JD, Jin F, Rischin D; KEYNOTE-048 Investigators. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metas PMID 31679945
• Wang HC, Yeh TJ, Chan LP, Hsu CM, Cho SF. Exploration of Feasible Immune Biomarkers for Immune Checkpoint Inhibitors in Head and Neck Squamous Cell Carcinoma Treatment in Real World Clinical Practice. Int J Mol Sci. 2020 Oct 15;21(20):7621. doi: 10.3390/ijms21207621. PMID 33076306

Идентификаторы

NCT: NCT06163534 · TP-CA-006 · Pro00074943

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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