A Phase 2 interventional study of Dostarlimab and Belrestotug in Neoplasms, Head and Neck, sponsored by GlaxoSmithKline. Active, not recruiting at 108 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
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).
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 316 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Dostarlimab
Drug: Dostarlimab · Drug: Belrestotug
Drug: Dostarlimab · Drug: Nelistotug
Drug: Dostarlimab · Drug: Belrestotug · Drug: Nelistotug
Drug: Dostarlimab · Drug: Remzistotug
Dostarlimab will be administered.
Belrestotug will be administered.
Nelistotug will be administered.
Remzistotug will be administered.
Confirmed Objective Response Rate (ORR) compared between Sub studies and Dostarlimab monotherapy
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.
Time frame: Up to approximately 24 months
Number of Participants with Treatment Emergent Adverse Events (AEs), treatment emergent Serious Adverse Events (SAE) and treatment emergent Adverse Events of Special Interest (AESI)
Time frame: Up to approximately 24 months
Number of Participants with TEAEs leading to dose modifications or study intervention discontinuation
Time frame: Up to approximately 24 months
Number of Participants with Clinically Significant Findings in Vital signs, Electrocardiogram (ECG), and Laboratory test parameters
Time frame: Up to approximately 24 months
Showing the first 100 of 108 sites across 20 countries.
Plan to share: Yes — Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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