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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06256588
Registration number
NCT06256588
Ethics application status
Date submitted
5/02/2024
Date registered
13/02/2024
Date last updated
29/05/2024
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
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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
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Secondary ID [1]
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2023-508613-17-00
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Secondary ID [2]
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221530
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Universal Trial Number (UTN)
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Trial acronym
JADE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neoplasms, Head and Neck
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0
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Condition category
Condition code
Cancer
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0
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0
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Non melanoma skin cancer
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Cancer
0
0
0
0
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Head and neck
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
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Assessment method [1]
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Event Free Survival (EFS) is defined as the time from the date of randomization to the date of an event, where an event is defined as locoregional progression or recurrence, or distant metastasis per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as per BICR; Salvage surgery at the primary tumor site; Neck dissection or surgery performed >20 weeks after completion of or Death from any cause.
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Timepoint [1]
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Up to approximately 5 years
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from date of randomization to the date of death by any cause.
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Timepoint [1]
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Up to approximately 5 years
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Secondary outcome [2]
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Event-free Survival (EFS) assessed by investigator
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Assessment method [2]
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Event Free Survival (EFS) is defined as the time from the date of randomization to the date of an event as per primary endpoint, however with investigator assessment per RECIST 1.1
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Timepoint [2]
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Up to approximately 5 years
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Secondary outcome [3]
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Number of Participants with treatment emergent adverse events (TEAEs), Immune-mediated TEAEs, and serious adverse events (SAEs) by severity
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Assessment method [3]
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0
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Timepoint [3]
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Up to approximately 5 years
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Secondary outcome [4]
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Number of Participants with TEAEs and SAEs leading to dose delays, withdrawals or death
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Assessment method [4]
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0
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Timepoint [4]
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Up to approximately 5 years
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Secondary outcome [5]
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Number of participants with clinically significant changes in laboratory, vital signs, and safety assessment parameters
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Assessment method [5]
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0
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Timepoint [5]
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Up to approximately 5 years
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Secondary outcome [6]
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Serum Concentration of Dostarlimab
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Assessment method [6]
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0
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Timepoint [6]
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Up to approximately 15 months
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Secondary outcome [7]
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Serum Concentration of Dostarlimab at End of Infusion (C-EoI)
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Assessment method [7]
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0
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Timepoint [7]
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Up to approximately 15 months
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Secondary outcome [8]
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Serum Predose trough concentration (Ctrough) of Dostarlimab
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Assessment method [8]
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0
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Timepoint [8]
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Up to approximately 15 months
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Secondary outcome [9]
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Number of Participants with Anti-Drug Antibodies against Dostarlimab
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Assessment method [9]
0
0
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Timepoint [9]
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Up to approximately 15 months
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/03/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
13/07/2029
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Actual
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Sample size
Target
864
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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GSK Investigational Site - Blacktown
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Recruitment hospital [2]
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GSK Investigational Site - Herston
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Recruitment hospital [3]
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GSK Investigational Site - Ballarat
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GSK Investigational Site - Geelong
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Recruitment hospital [5]
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GSK Investigational Site - Melbourne
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Recruitment hospital [6]
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GSK Investigational Site - Douglas
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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3350 - Ballarat
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Recruitment postcode(s) [4]
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3220 - Geelong
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment postcode(s) [6]
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4814 - Douglas
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Recruitment outside Australia
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Arkansas
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California
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District of Columbia
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United States of America
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Georgia
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United States of America
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Indiana
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Iowa
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Kansas
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Kentucky
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Ohio
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Saitama
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Japan
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Shizuoka
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Japan
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Tokyo
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Japan
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Tottori
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Korea, Republic of
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Busan
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Mexico
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Jalisco
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Mexico
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Oaxaca
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Mexico
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Ciudad de Mexico
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Norway
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Bergen
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Norway
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Oslo
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Norway
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Tromsø
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Poland
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Bielsko-Biala
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Poland
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Gliwice
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Poland
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Katowice
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Poland
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Koszalin
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Poland
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Olsztyn
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Poland
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Przemysl
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Poland
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Siedlce
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Poland
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Warszawa
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Portugal
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Coimbra
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Portugal
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Faro
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Portugal
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Lisboa
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Portugal
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Matosinhos
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Country [139]
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Portugal
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Porto
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Portugal
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Vila Nova de Gaia
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Country [141]
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Romania
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State/province [141]
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Arges
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Country [142]
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Romania
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State/province [142]
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Bucharest
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Country [143]
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Romania
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Bucuresti
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Country [144]
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Romania
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Craiova
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Country [145]
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Romania
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Iasi
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Country [146]
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Romania
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Oradea
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Country [147]
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Romania
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Suceava
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Country [148]
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Romania
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Timisoara
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Country [149]
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Spain
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State/province [149]
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Cádiz
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Country [150]
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Spain
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Murcia
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Country [151]
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Spain
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(Barakaldo) Vizcaya
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Country [152]
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Spain
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Barcelona
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Country [153]
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Spain
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Lugo
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Spain
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Madrid
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Country [155]
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Spain
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Pamplona
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Country [156]
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Spain
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Salamanca
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Country [157]
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Spain
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Santander
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Country [158]
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Spain
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Zaragoza
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Country [159]
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Sweden
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State/province [159]
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Göteborg
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Country [160]
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Sweden
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State/province [160]
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Stockholm
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Country [161]
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Sweden
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State/province [161]
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Uppsala
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Country [162]
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Taiwan
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State/province [162]
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Changhua
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Country [163]
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Taiwan
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State/province [163]
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Kaohsiung
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Country [164]
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Taiwan
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State/province [164]
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Taichung
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Country [165]
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Taiwan
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State/province [165]
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Taipei
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Country [166]
0
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Turkey
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State/province [166]
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Ankara
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Country [167]
0
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Turkey
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State/province [167]
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Antalya
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Country [168]
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Turkey
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State/province [168]
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Istanbul
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Country [169]
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United Kingdom
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State/province [169]
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Surrey
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Country [170]
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United Kingdom
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West Midlands
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Country [171]
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United Kingdom
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Edinburgh
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Country [172]
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United Kingdom
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Gloucester
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Country [173]
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United Kingdom
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0
London
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Country [174]
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0
United Kingdom
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State/province [174]
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Nottingham,
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06256588
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
Name
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0
US GSK Clinical Trials Call Center
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Address
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0
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0
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Phone
0
0
877-379-3718
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0
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Email
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0
[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06256588
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