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Testing new immunotherapy combinations for advanced head and neck cancer

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

PHASE2 · GlaxoSmithKline · NCT06062420

This study is testing new combinations of immunotherapy drugs to see if they can help people with advanced head and neck cancer feel better compared to a standard treatment.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment360 (estimated)
Ages18 Years and up
SexAll
SponsorGlaxoSmithKline (industry)
Drugs / interventionsdostarlimab, immunotherapy
Locations121 sites (New Haven, Connecticut and 120 other locations)
Trial IDNCT06062420 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of novel combinations of immunotherapy drugs in patients with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma. Participants will receive either the new drug combinations or dostarlimab, a known treatment, to compare their antitumor activity. The study aims to include patients who have not received prior systemic therapy for their cancer and have measurable disease. The research will be conducted at multiple sites across the United States.

Who should consider this trial

Good fit: Ideal candidates are adults with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma who have not received prior systemic therapy.

Not a fit: Patients with nasopharyngeal tumors or those who have received prior systemic therapy for their cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced head and neck cancer.

How similar studies have performed: Other studies have shown promise with immunotherapy approaches in similar cancer types, indicating potential for success in this novel combination.

Eligibility criteria

Show full inclusion / exclusion 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.)

Where this trial is running

New Haven, Connecticut and 120 other locations

+71 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Neoplasms, Head and Neck, Dostarlimab, Belrestotug, Nelistotug, GSK4381562, PD-L1, HNSCC

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.