Testing the Addition of an Anti-cancer Drug, Ipatasertib, to the Usual Immunotherapy Treatment (Pembrolizumab) in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck : A Phase 2 Study of Ipatasertib in Combination With Pembrolizumab for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck

PRIMARY OBJECTIVE:I. To compare progression-free survival (PFS) in first line relapsed/metastatic (R/M) head and neck squamous cell cancer (HNSCC) patients treated with the combination ipatasertib and pembrolizumab versus pembrolizumab monotherapy treatment.SECONDARY OBJECTIVES:I. To evaluate the safety and tolerability of the combination ipatasertib and pembrolizumab in first line R/M HNSCC patients.II. To describe overall response rate (ORR) and duration of response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in first line R/M HNSCC treated patients with the combination ipatasertib and pembrolizumab and pembrolizumab monotherapy treatment.III. To assess changes in the tumor microenvironment by immunophenotyping with the combination ipatasertib and pembrolizumab and pembrolizumab monotherapy treatment.IV. To assess changes in Akt, ERK, and MEK signaling with the combination ipatasertib and pembrolizumab and pembrolizumab monotherapy treatment.V. To determine changes in immune-cell population in peripheral blood with the combination ipatasertib and pembrolizumab and pembrolizumab monotherapy treatment.EXPLORATORY OBJECTIVE:I. To investigate the relationship between the combination ipatasertib and pembrolizumab treatment and biomarkers which may predict response, such as tumor PD-L1 expression and alterations in the PI3K/AKT pathway.OUTLINE: Patients are randomized to 1 of 2 arms.ARM I: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and ipatasertib orally (PO) once daily (QD) on days 1-14 of each cycle. Cycles repeat every 21 days for a period of 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy on study, undergo collection of blood samples on study and during follow up, and undergo computed tomography (CT) scans throughout the trial.ARM II: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for a period of 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy on study, undergo collection of blood samples on study and during follow up, and undergo CT scans throughout the trial.After completion of study treatment, patients are followed every 3 months until disease progression, the next line of therapy is started, or death, whichever occurs first..

Medienart:	Klinische Studie

Erscheinungsjahr:	2024
Erschienen:	2024

Enthalten in:	ClinicalTrials.gov - (2024) vom: 25. März Zur Gesamtaufnahme - year:2024

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Laryngeal Neoplasms Mouth Neoplasms Neoplasms, Squamous Cell Phase: Phase 2 Recruitment Status: Recruiting Recurrence Squamous Cell Carcinoma of Head and Neck Study Type: Interventional

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: December 29, 2021, Last downloaded: ClinicalTrials.gov processed this data on April 03, 2024, Last updated: April 03, 2024

Study ID:	NCT05172258 NCI-2021-13902 PHII-216 10496 UM1CA186717
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PPN (Katalog-ID):	CTG000083836