Clinical Trials List
2023-10-31 - 2027-12-31
Phase II
Recruiting4
ICD-10C76.0
Malignant neoplasm of head, face and neck
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9195.0
Malignant neoplasm of other and ill-defined sites of head, face and neck
A Phase 2, Randomized, Open-label, Platform Study Using a Master Protocol to Evaluate Novel Immunotherapy Combinations as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck
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Trial Applicant
GlaxoSmithKline
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/06/23
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃彥霖 無
- YA-FANG CHEN 無
- Hsiang-Fong Kao 無
- 陽明翰
- RUEY-LONG HONG 無
- 廖斌志 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Injection solution
Injection solution
Injection solution
Active Ingredient
GSK4428859A
GSK6097608
Dosage Form
Solution For Infusion
Solution For Infusion
Dosage
Endpoints
Inclution Criteria
Have histologically or cytologically-confirmed HNSCC that is R/M and 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 1
Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of R/M HNSCC. A fresh tumor tissue sample obtained within 90 days of screening is highly preferred, If fresh biopsy is not possible, an archival tumor specimen is acceptable unless it was obtained prior to administration of chemoradiation for the treatment of a participant's tumor. 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) expression
If the primary tumor site is oropharyngeal carcinoma, the participant must have Human papillomavirus (HPV) results
Exclusion Criteria
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 HNSCC
Participants with any carcinomatous meningitis or leptomeningeal spread and those with uncontrolled or symptomatic Central Nervous System (CNS) metastases
Active 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.)
The Estimated Number of Participants
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Taiwan
17 participants
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Global
300 participants
