Recruiting NCT06256588

A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

Phase III Interventional Neoplasms, Head and Neck

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Dostarlimab, Placebo.
Who it may be relevant to: Registry conditions: Neoplasms, Head and Neck. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Belgium, Brazil +26
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate Dostarlimab as Sequential Therapy After Chemoradiation in Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

Overview

The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions

Drug Dostarlimab
Dostarlimab will be administered as an intravenous (IV) infusion
Drug Placebo
Placebo will be administered as an IV infusion

Primary outcome measures

Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR) [Time frame: Up to approximately 5 years]

Secondary outcome measures (9)

Overall Survival (OS) [Time frame: Up to approximately 5 years]
Event-free Survival (EFS) assessed by investigator [Time frame: Up to approximately 5 years]
Number of Participants with treatment emergent adverse events (TEAEs), Immune-mediated TEAEs, and serious adverse events (SAEs) by severity [Time frame: Up to approximately 5 years]
Number of Participants with TEAEs and SAEs leading to dose delays, withdrawals or death [Time frame: Up to approximately 5 years]
Number of participants with clinically significant changes in laboratory, vital signs, and safety assessment parameters [Time frame: Up to approximately 5 years]
Serum Concentration of Dostarlimab [Time frame: Up to approximately 15 months]
Serum Concentration of Dostarlimab at End of Infusion (C-EoI) [Time frame: Up to approximately 15 months]
Serum Predose trough concentration (Ctrough) of Dostarlimab [Time frame: Up to approximately 15 months]
Number of Participants with Anti-Drug Antibodies against Dostarlimab [Time frame: Up to approximately 15 months]

Eligibility criteria

Inclusion criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

Has newly diagnosed unresected Locally Advanced (LA) histologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx or larynx and completed cisplatin plus radiotherapy (termed "CRT" in this protocol) with curative intent and has no evidence of distant metastatic disease.
Has provided acceptable core or excisional biopsy obtained prior to CRT:

PD-L1 positive tumor status
If the primary tumor site is oropharyngeal carcinoma, the participant must have p16 immunohistochemistry (IHC) testing.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Has adequate organ function.

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

Has received prior radiation therapy (RT), systemic therapy, targeted therapy, or surgery for management of head and neck cancer not considered part of CRT. Participants receiving induction chemotherapy are excluded. CRT combinations with components other than cisplatin and RT (e.g., experimental agents, including radiosensitizers/radioprotectants, cetuximab) are not eligible.
Has cancer outside of the oropharynx, larynx, hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer. Has more than one primary HNSCC tumor.
Has experienced any of the following with prior immunotherapy: any immune-related adverse event (irAE) of Grade ≥3, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or Drug Rash with Eosinophilia and Systemic Symptoms \[DRESS\] syndrome), or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary.
Has undergone any major surgical procedure or experienced significant traumatic injury that has not resolved by the time of randomization.
Has any history of interstitial lung disease or pneumonitis (past or current).
Has cirrhosis of any stage or current unstable liver biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.
Has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the study results, interfere with their participation for the full duration of the study intervention, or indicate it is not in the best interest of the participant to participate, in the opinion of the investigator.
Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention.
Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent directed to another stimulatory or coinhibitory T-cell receptor \[e.g., Cytotoxic T-lymphocyte associated protein 4 (CTLA4), OX-40, CD137\]
Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the Screening Visit through 120 days after the last dose of study intervention.
Has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to dostarlimab or its excipients.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

United States · 36 centers

GSK Investigational Site — Jonesboro
GSK Investigational Site — Los Angeles
GSK Investigational Site — Solvang
GSK Investigational Site — Stockton
GSK Investigational Site — Torrance
GSK Investigational Site — Farmington
GSK Investigational Site — New Haven
GSK Investigational Site — Washington D.C.
… and 28 more centers

China · 32 centers

GSK Investigational Site — Chongqing
GSK Investigational Site — Baoding
GSK Investigational Site — Nanyang
GSK Investigational Site — Beijing
GSK Investigational Site — Changsha
… and 27 more centers

Japan · 27 centers