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

Launched by GLAXOSMITHKLINE · Sep 29, 2023

Keywords

ClinConnect Summary

The GALAXIES H&N-202 clinical trial is studying new combinations of immunotherapy treatments for patients with a specific type of head and neck cancer called squamous cell carcinoma. This cancer is recurrent or metastatic, meaning it has come back or spread, and it shows a certain marker called PD-L1. The main goal of the study is to see how well these new treatments work and how safe they are compared to a treatment called dostarlimab.

To participate, patients need to have a confirmed diagnosis of this type of cancer that can't be cured with local therapies. They should not have received any prior systemic treatments for their cancer and must have measurable disease. Participants should be between 65 and 74 years old and will need to provide a tissue sample from their tumor. Throughout the trial, participants can expect to receive close monitoring of their health and the effects of the treatment. It's also important to note that certain health conditions and previous cancer treatments may prevent someone from being eligible for this study.

Gender

ALL

Eligibility criteria

• Inclusion 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 tumour. 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.)