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
NCT06062420
Phase
Phase 2
Recruitment status
Active, not recruiting
Participants
Lead sponsor
GlaxoSmithKline
Start date
2023-11-14
Number of sites
- Summary
- 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).
- Short title
- 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
- Official title
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2027-12-31
- First posted
- 2023-10-02
- Registry last updated
- 2026-06-24
- Primary completion date
- 2026-09-01
- Start date
- 2023-11-14
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- GlaxoSmithKline
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06062420
- ClinicalTrials.gov ID
- NCT06062420
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
Confirmed Objective Response Rate (ORR) compared between Sub studies and Dostarlimab monotherapy
Timeframe: 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.
Number of Participants with Treatment Emergent Adverse Events (AEs), treatment emergent Serious Adverse Events (SAE) and treatment emergent Adverse Events of Special Interest (AESI)
Timeframe: Up to approximately 24 months
Number of Participants with TEAEs leading to dose modifications or study intervention discontinuation
Timeframe: Up to approximately 24 months
Number of Participants with Clinically Significant Findings in Vital signs, Electrocardiogram (ECG), and Laboratory test parameters
Timeframe: Up to approximately 24 months
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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
- 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.)
Sources for eligibility
- GSK Investigational SiteNew Haven, United States
- GSK Investigational SiteIowa City, United States
- GSK Investigational SiteSt Louis, United States
- GSK Investigational SiteColumbus, United States
- GSK Investigational SiteMilwaukee, United States
- GSK Investigational SiteBuenos Aires, Argentina
- GSK Investigational SiteCapital Federal, Argentina
- GSK Investigational SiteCiudad Autonoma de Bueno, Argentina
- GSK Investigational SiteCórdoba, Argentina
- GSK Investigational SiteFlorida, Argentina
- GSK Investigational SiteMendoza, Argentina
- GSK Investigational SiteSan Juan, Argentina
- GSK Investigational SiteSanta Fe, Argentina
- GSK Investigational SiteSanto André, Brazil
- GSK Investigational SiteSão Paulo, Brazil
- GSK Investigational SiteSão Paulo, Brazil
- GSK Investigational SiteCalgary, Canada
- GSK Investigational SiteEdmonton, Canada
- GSK Investigational SiteToronto, Canada
- GSK Investigational SiteToronto, Canada
- GSK Investigational SiteMontreal, Canada
- GSK Investigational SiteHerlev, Denmark
- GSK Investigational SiteTurku, Finland
- GSK Investigational SiteBordeaux, France
- GSK Investigational SiteCaen, France
And 83 more, listed on the interactive page.
Sources for sites
- 2023
- 2023-503428-24
Sources for references
Related records
Drugs (4)
Collaborators (1)
- iTeos Therapeutics