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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 24 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 24 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Confirmed Objective Response Rate (ORR) compared between Sub studies and Dostarlimab monotherapy

Secondary outcome measures

Cmax and Cmin of Belrestotug

Cmax and Cmin of GSK6097608

Confirmed Objective Response Rate (ORR) compared between Sub study 3 and Sub studies 1 and 2

+17 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Sub study 3: Dosarlimab and Belrestotug and GSK6097608Experimental Treatment3 Interventions

Group II: Sub study 2: Dostarlimab and GSK6097608Experimental Treatment2 Interventions

Group III: Sub study 1: Dostarlimab and BelrestotugExperimental Treatment2 Interventions

Group IV: Dostarlimab MonotherapyExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dostarlimab

2020

Completed Phase 2

~1000

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,755 Previous Clinical Trials

8,070,475 Total Patients Enrolled

15 Trials studying Head and Neck Neoplasms

2,637 Patients Enrolled for Head and Neck Neoplasms

iTeos TherapeuticsIndustry Sponsor

7 Previous Clinical Trials

1,037 Total Patients Enrolled

1 Trials studying Head and Neck Neoplasms

254 Patients Enrolled for Head and Neck Neoplasms

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,595 Previous Clinical Trials

6,143,580 Total Patients Enrolled

5 Trials studying Head and Neck Neoplasms

1,202 Patients Enrolled for Head and Neck Neoplasms

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What sort of hazard could patients be exposed to if treated with Dostarlimab Monotherapy?

"While the efficacy of Dostarlimab Monotherapy still needs to be determined, there is some data available that suggests it's safety. Therefore, our team at Power gave this a score of 2 on a scale from 1 to 3."

Answered by AI

How many locations can participants access this trial?

"At present, 104 clinics are participating in this trial and enrolling patients. The list of sites includes Boston, Saint Louis and Omaha among many others. To reduce the burden of travelling for those who decide to be part of the study, it is beneficial to pick a nearby clinic."

Answered by AI

Are there still available spots for participants in this experiment?

"As verified on clinicaltrials.gov, this medical experiment is not currently seeking candidates. This trial was initially advertised on September 22nd 2023 and the information has been updated as recently as September 29th 2023. Despite this trial being inactive in terms of recruitment, there are more than one thousand other studies that require volunteers at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 2 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

2023. "Phase 2 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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06062420.

All > Omaha