Clinical trial NCT06256588: A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Neoplasms, Head and Neck
Keywords: JEMPERLI
Dostarlimab
Placebo
Chemoradiation
HNSCC
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2024-02-13
Enrollment: 864
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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 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 tissue demonstrating:

  * PD-L1 positive tumor status
  * If the primary tumor site is oropharyngeal carcinoma, the participant must have p16 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, systemic therapy, targeted therapy, or radical surgery for management of head and neck cancer not considered part of CRT.
* 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 experienced any of the following with prior immunotherapy: any 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 \[Stevens-Johnson Syndrome, toxic epidermal necrolysis, or DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) syndrome\], or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary.
* Has undergone any major surgical procedure or experienced significant traumatic injury within 28 days prior to enrolment.
* Has any history of interstitial lung disease or pneumonitis (past or current).
* Has cirrhosis 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.

Primary outcomes:
measure: Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 5 years
measure: Event-free Survival (EFS) assessed by investigator
timeFrame: Up to approximately 5 years
measure: Number of Participants with treatment emergent adverse events (TEAEs), Immune-mediated TEAEs, and serious adverse events (SAEs) by severity
timeFrame: Up to approximately 5 years
measure: Number of Participants with TEAEs and SAEs leading to dose delays, withdrawals or death
timeFrame: Up to approximately 5 years
measure: Number of participants with clinically significant changes in laboratory, vital signs, and safety assessment parameters
timeFrame: Up to approximately 5 years
measure: Serum Concentration of Dostarlimab
timeFrame: Up to approximately 15 months
measure: Serum Concentration of Dostarlimab at End of Infusion (C-EoI)
timeFrame: Up to approximately 15 months
measure: Serum Predose trough concentration (Ctrough) of Dostarlimab
timeFrame: Up to approximately 15 months
measure: Number of Participants with Anti-Drug Antibodies against Dostarlimab
timeFrame: Up to approximately 15 months
Other outcomes:
Locations:
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country: Portugal
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country: Romania
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city: Bucuresti
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city: Craiova
country: Romania
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city: Craiova
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city: Floresti
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country: Romania
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country: Romania
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country: Spain
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city: Jerez
country: Spain
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city: L'Hospitalet De Llobrega
country: Spain
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city: Madrid
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city: Madrid
country: Spain
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city: Madrid
country: Spain
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city: Pamplona
country: Spain
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city: Salamanca
country: Spain
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country: Spain
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city: Zaragoza
country: Spain
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country: Sweden
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country: Sweden
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country: Sweden
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country: Taiwan
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country: Taiwan
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country: Taiwan
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country: Taiwan
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country: Turkey
facility: GSK Investigational Site
city: Ankara
country: Turkey
facility: GSK Investigational Site
city: Ankara
country: Turkey
facility: GSK Investigational Site
city: Ankara
country: Turkey
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city: Istanbul
country: Turkey
facility: GSK Investigational Site
city: Istanbul
country: Turkey
facility: GSK Investigational Site
city: Istanbul
country: Turkey
facility: GSK Investigational Site
state: Şişli
city: Edinburgh
country: United Kingdom
facility: GSK Investigational Site
city: Gloucester
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Nottingham
country: United Kingdom
facility: GSK Investigational Site
city: Sutton
country: United Kingdom
facility: GSK Investigational Site
city: Wolverhampton
country: United Kingdom
facility: GSK Investigational Site
Study officials:
References: