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Novel Immunotherapy Combinations for Head and Neck Cancer

Phase 2
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
Has tumor Programmed death ligand 1 (PD-L1) expression
Must not have
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
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new cancer treatment to see if it can help those with advanced head and neck cancer.

Who is the study for?
This trial is for adults with PD-L1 positive recurrent or metastatic squamous cell carcinoma of the head and neck, who haven't had systemic therapy in this setting. They must have a performance status that allows daily living activities (ECOG PS 0-1), measurable disease, and provide a recent tumor sample. Excluded are those with prior immune checkpoint inhibitor treatment, certain other cancers within the last 2 years, high bleeding risk tumors, recent progression after curative treatment, CNS metastases or active autoimmune diseases.
What is being tested?
The study tests new immunotherapy combinations against dostarlimab to see which is better at fighting cancer in patients with specific head and neck cancers. Participants will be randomly assigned to receive either one of the novel treatments like Belrestotug or GSK6097608 or the known drug dostarlimab.
What are the potential side effects?
Potential side effects may include typical immunotherapy reactions such as fatigue, skin reactions, inflammation of organs (like colitis), hormonal imbalances due to endocrine effects; however exact side effects will vary by drug combination.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My tumor shows PD-L1 expression.
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My cancer is in my throat, mouth, or voice box.
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My head or neck cancer is confirmed and cannot be cured with surgery or radiation.
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My throat cancer has been tested for HPV.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have previously been treated with drugs that boost the immune system to fight cancer.
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My tumor is bleeding or at high risk of bleeding.
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I do not have cancer spread to the brain or spinal cord that is causing symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Confirmed Objective Response Rate (ORR) compared between Sub studies and Dostarlimab monotherapy
Secondary study objectives
Confirmed Objective Response Rate (ORR) compared between Sub study 3 and Sub studies 1 and 2
DCR compared between sub study 3 and Sub studies 1 and 2
Disease Control Rate (DCR) compared between Sub studies and Dostarlimab monotherapy
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: Sub study 4: Dostarlimab and GSK4381562Experimental Treatment2 Interventions
Group II: Sub study 3: Dosarlimab and Belrestotug and nelistotugExperimental Treatment3 Interventions
Group III: Sub study 2: Dostarlimab and nelistotugExperimental Treatment2 Interventions
Group IV: Sub study 1: Dostarlimab and BelrestotugExperimental Treatment2 Interventions
Group V: Dostarlimab MonotherapyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dostarlimab
2020
Completed Phase 3
~1760

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,805 Previous Clinical Trials
8,379,143 Total Patients Enrolled
iTeos TherapeuticsIndustry Sponsor
10 Previous Clinical Trials
2,199 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,604 Previous Clinical Trials
6,144,511 Total Patients Enrolled
~240 spots leftby May 2027
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