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
The primary purpose of the study is to evaluate the antitumor activity and safety of novel immunotherapy combinations compared with dostarlimab in participants with Programmed death ligand 1 (PD-L1) positive Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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.)
Primary outcome measure(s)
Confirmed Objective Response Rate (ORR) compared between Sub studies and Dostarlimab monotherapy — Up to approximately 24 months Confirmed ORR is defined as the percentage of participants achieving confirmed Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment.
Trial sites (108)
Facility
City
Region
Status
GSK Investigational Site
New Haven
Connecticut
GSK Investigational Site
Iowa City
Iowa
GSK Investigational Site
St Louis
Missouri
GSK Investigational Site
Columbus
Ohio
GSK Investigational Site
Milwaukee
Wisconsin
GSK Investigational Site
Buenos Aires
Argentina
GSK Investigational Site
Capital Federal
Argentina
GSK Investigational Site
Ciudad Autonoma de Bueno
Argentina
GSK Investigational Site
Córdoba
Argentina
GSK Investigational Site
Florida
Argentina
GSK Investigational Site
Mendoza
Argentina
GSK Investigational Site
San Juan
Argentina
GSK Investigational Site
Santa Fe
Argentina
GSK Investigational Site
Santo André
Brazil
GSK Investigational Site
São Paulo
Brazil
GSK Investigational Site
São Paulo
Brazil
GSK Investigational Site
Calgary
Alberta
GSK Investigational Site
Edmonton
Alberta
GSK Investigational Site
Toronto
Ontario
GSK Investigational Site
Toronto
Ontario
GSK Investigational Site
Montreal
Quebec
GSK Investigational Site
Herlev
Denmark
GSK Investigational Site
Turku
Finland
GSK Investigational Site
Bordeaux
France
GSK Investigational Site
Caen
France
GSK Investigational Site
Marseille
France
GSK Investigational Site
Paris
France
GSK Investigational Site
Rouen
France
GSK Investigational Site
Villejuif
France
GSK Investigational Site
Frankfurt am Main
Hesse
GSK Investigational Site
Essen
North Rhine-Westphalia
GSK Investigational Site
Aachen
Germany
GSK Investigational Site
Berlin
Germany
GSK Investigational Site
Giessen
Germany
GSK Investigational Site
Hamburg
Germany
GSK Investigational Site
Regensburg
Germany
GSK Investigational Site
Ulm
Germany
GSK Investigational Site
Panórama
Central Macedonia
GSK Investigational Site
Haidari - Athens
Greece
GSK Investigational Site
Marousi
Greece
+ 68 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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