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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06256588




Registration number
NCT06256588
Ethics application status
Date submitted
5/02/2024
Date registered
13/02/2024

Titles & IDs
Public title
A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
Scientific 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
Secondary ID [1] 0 0
2023-508613-17
Secondary ID [2] 0 0
221530
Universal Trial Number (UTN)
Trial acronym
JADE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms, Head and Neck 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dostarlimab
Treatment: Drugs - Placebo

Experimental: Arm A: Dostarlimab -

Placebo comparator: Arm B: Placebo -


Treatment: Drugs: Dostarlimab
Dostarlimab will be administered as an intravenous (IV) infusion

Treatment: Drugs: Placebo
Placebo will be administered as an IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
Event-free Survival (EFS) assessed by investigator
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [3] 0 0
Number of Participants with treatment emergent adverse events (TEAEs), Immune-mediated TEAEs, and serious adverse events (SAEs) by severity
Timepoint [3] 0 0
Up to approximately 5 years
Secondary outcome [4] 0 0
Number of Participants with TEAEs and SAEs leading to dose delays, withdrawals or death
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
Number of participants with clinically significant changes in laboratory, vital signs, and safety assessment parameters
Timepoint [5] 0 0
Up to approximately 5 years
Secondary outcome [6] 0 0
Serum Concentration of Dostarlimab
Timepoint [6] 0 0
Up to approximately 15 months
Secondary outcome [7] 0 0
Serum Concentration of Dostarlimab at End of Infusion (C-EoI)
Timepoint [7] 0 0
Up to approximately 15 months
Secondary outcome [8] 0 0
Serum Predose trough concentration (Ctrough) of Dostarlimab
Timepoint [8] 0 0
Up to approximately 15 months
Secondary outcome [9] 0 0
Number of Participants with Anti-Drug Antibodies against Dostarlimab
Timepoint [9] 0 0
Up to approximately 15 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/07/2029
Actual
Sample size
Target
864
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
GSK Investigational Site - Ballarat
Recruitment hospital [2] 0 0
GSK Investigational Site - Blacktown
Recruitment hospital [3] 0 0
GSK Investigational Site - Douglas
Recruitment hospital [4] 0 0
GSK Investigational Site - Geelong
Recruitment hospital [5] 0 0
GSK Investigational Site - Herston
Recruitment hospital [6] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
3350 - Ballarat
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
4814 - Douglas
Recruitment postcode(s) [4] 0 0
3220 - Geelong
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment outside Australia
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London
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Nottingham
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Sutton
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United Kingdom
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
GSKClinicalSupportHD@gsk.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Available to whom?
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.gsk.com/en-gb/innovation/trials/data-transparency/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06256588