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A Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck- GALAXIES H&N-202
360 patients around the world
Available in Spain, Brazil, Argentina, United States
GlaxoSmithKline
5Research sites
360Patients around the world
This study is for people with
Head and neck cancer
Squamous cell carcinoma of the head and neck
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Have histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapies. A) Subjects must not have had prior systemic therapy administered in the R/M setting. Chemoradiation therapy which was completed more than 4 months prior to signing consent if given as part of multimodal treatment for locally advanced disease is allowed B) The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx C) Subjects may not have a primary tumor site of nasopharynx (any histology)Has measurable (target) disease based on RECIST 1.1 as determined by the investigator.Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of R/M HNSCC. Although a fresh tumor tissue sample obtained within 90 days of screening is highly preferred, an archival tumor specimen (≤2 years old) is acceptable. Biopsies obtained prior to the administration of any systemic therapy administered for the treatment of a participant's tumor (such as neoadjuvant/adjuvant therapy) are not acceptable. Needle or excisional biopsies or resected tissue is required. Cytological specimens such as fine needle aspirates, bone marrow samples, or cell blocks are not acceptable. Bone specimen is not acceptable.Has tumor Programmed death ligand 1 (PD-L1) expressionIf the primary tumor site is oropharyngeal carcinoma, the participant must have Human papillomavirus (HPV) results
- Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting Programmed death protein 1 (PD-1), PD-L1, Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), T cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine based inhibitory motif domains (TIGIT), Cluster of differentiation (CD) 96, or other immune checkpoint pathways.Participants with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, esophageal, colon, endometrial, cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period.Have active tumor bleeding or a high risk of bleeding (examples include but are not limited to radiographic evidence of major blood vessel invasion/infiltration or tumor demonstrates >90 degree abutment or encasement of a major vessel [carotid, jugular, bronchial artery] and/or exhibits other high-risk features such as arteriovenous fistula).Has PD within 4 months of completion of curatively intended treatment for locoregionally advanced HNSCCParticipants with any carcinomatous meningitis or leptomeningeal spread and those with uncontrolled or symptomatic Central Nervous System (CNS) metastasesActive autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years. (Stable, medically managed autoimmune endocrinopathies are acceptable if participant otherwise meets entry criteria.)
Sites
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Instituto de Oncología Ángel H. Roffo - CABA, Buenos Aires
Recruiting
Isis Clínica Especializada - Santa Fe
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Consultorios Médicos Dr. Doreski
Recruiting
StudyGALAXIES H&N-202
SponsorGlaxoSmithKline
Conditions
Squamous cell carcinoma of the head and neck
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06062420
