Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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
Query!
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
Query!
Secondary ID [1]
0
0
2023-508613-17
Query!
Secondary ID [2]
0
0
221530
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
JADE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Neoplasms, Head and Neck
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Non melanoma skin cancer
Query!
Cancer
0
0
0
0
Query!
Head and neck
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Up to approximately 5 years
Query!
Secondary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
OS is defined as the time from date of randomization to the date of death by any cause.
Query!
Timepoint [1]
0
0
Up to approximately 5 years
Query!
Secondary outcome [2]
0
0
Event-free Survival (EFS) assessed by investigator
Query!
Assessment method [2]
0
0
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
Query!
Timepoint [2]
0
0
Up to approximately 5 years
Query!
Secondary outcome [3]
0
0
Number of Participants with treatment emergent adverse events (TEAEs), Immune-mediated TEAEs, and serious adverse events (SAEs) by severity
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Up to approximately 5 years
Query!
Secondary outcome [4]
0
0
Number of Participants with TEAEs and SAEs leading to dose delays, withdrawals or death
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Up to approximately 5 years
Query!
Secondary outcome [5]
0
0
Number of participants with clinically significant changes in laboratory, vital signs, and safety assessment parameters
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Up to approximately 5 years
Query!
Secondary outcome [6]
0
0
Serum Concentration of Dostarlimab
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Up to approximately 15 months
Query!
Secondary outcome [7]
0
0
Serum Concentration of Dostarlimab at End of Infusion (C-EoI)
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Up to approximately 15 months
Query!
Secondary outcome [8]
0
0
Serum Predose trough concentration (Ctrough) of Dostarlimab
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
Up to approximately 15 months
Query!
Secondary outcome [9]
0
0
Number of Participants with Anti-Drug Antibodies against Dostarlimab
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
Up to approximately 15 months
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
21/03/2024
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
13/07/2029
Query!
Actual
Query!
Sample size
Target
864
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - Ballarat
Query!
Recruitment hospital [2]
0
0
GSK Investigational Site - Blacktown
Query!
Recruitment hospital [3]
0
0
GSK Investigational Site - Douglas
Query!
Recruitment hospital [4]
0
0
GSK Investigational Site - Geelong
Query!
Recruitment hospital [5]
0
0
GSK Investigational Site - Herston
Query!
Recruitment hospital [6]
0
0
GSK Investigational Site - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3350 - Ballarat
Query!
Recruitment postcode(s) [2]
0
0
2148 - Blacktown
Query!
Recruitment postcode(s) [3]
0
0
4814 - Douglas
Query!
Recruitment postcode(s) [4]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [5]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [6]
0
0
3004 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arkansas
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
District of Columbia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Indiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Iowa
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kansas
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kentucky
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Maryland
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Massachusetts
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Missouri
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Nebraska
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New York
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Ohio
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
South Carolina
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Tennessee
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Texas
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Virginia
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Washington
Query!
Country [21]
0
0
Argentina
Query!
State/province [21]
0
0
Buenos Aires
Query!
Country [22]
0
0
Argentina
Query!
State/province [22]
0
0
Ciudad Autonoma de Buenos Aires
Query!
Country [23]
0
0
Argentina
Query!
State/province [23]
0
0
Ciudad Autonoma de Buenos Aire
Query!
Country [24]
0
0
Argentina
Query!
State/province [24]
0
0
Cordoba
Query!
Country [25]
0
0
Argentina
Query!
State/province [25]
0
0
Rosario
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
San Juan
Query!
Country [27]
0
0
Argentina
Query!
State/province [27]
0
0
San Miguel de TucumAn
Query!
Country [28]
0
0
Argentina
Query!
State/province [28]
0
0
Viedma
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Bruxelles
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Charleroi
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Edegem
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
Gent
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Yvoir
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
Barretos
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
Belo Horizonte
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
Florianopolis
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
Joinville
Query!
Country [38]
0
0
Brazil
Query!
State/province [38]
0
0
Porto Alegre
Query!
Country [39]
0
0
Brazil
Query!
State/province [39]
0
0
Salvador
Query!
Country [40]
0
0
Brazil
Query!
State/province [40]
0
0
Sao Jose Do Rio Preto
Query!
Country [41]
0
0
Brazil
Query!
State/province [41]
0
0
SAo Paulo
Query!
Country [42]
0
0
Brazil
Query!
State/province [42]
0
0
VitOria
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
Hamilton
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
Montreal
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
Toronto
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Vancouver
Query!
Country [47]
0
0
China
Query!
State/province [47]
0
0
Beijing
Query!
Country [48]
0
0
China
Query!
State/province [48]
0
0
Changsha
Query!
Country [49]
0
0
China
Query!
State/province [49]
0
0
Changzhou
Query!
Country [50]
0
0
China
Query!
State/province [50]
0
0
Chengdu
Query!
Country [51]
0
0
China
Query!
State/province [51]
0
0
Dongguan
Query!
Country [52]
0
0
China
Query!
State/province [52]
0
0
Fuzhou
Query!
Country [53]
0
0
China
Query!
State/province [53]
0
0
Guangzhou
Query!
Country [54]
0
0
China
Query!
State/province [54]
0
0
Hangzhou
Query!
Country [55]
0
0
China
Query!
State/province [55]
0
0
Hefei
Query!
Country [56]
0
0
China
Query!
State/province [56]
0
0
Hengyang
Query!
Country [57]
0
0
China
Query!
State/province [57]
0
0
Jinan
Query!
Country [58]
0
0
China
Query!
State/province [58]
0
0
Lanzhou
Query!
Country [59]
0
0
China
Query!
State/province [59]
0
0
Linyi
Query!
Country [60]
0
0
China
Query!
State/province [60]
0
0
Nanchang
Query!
Country [61]
0
0
China
Query!
State/province [61]
0
0
Nanning
Query!
Country [62]
0
0
China
Query!
State/province [62]
0
0
Shanghai
Query!
Country [63]
0
0
China
Query!
State/province [63]
0
0
Shenyang
Query!
Country [64]
0
0
China
Query!
State/province [64]
0
0
Taiyuan
Query!
Country [65]
0
0
China
Query!
State/province [65]
0
0
Wuhan
Query!
Country [66]
0
0
China
Query!
State/province [66]
0
0
Xiamen
Query!
Country [67]
0
0
China
Query!
State/province [67]
0
0
Zhengzhou
Query!
Country [68]
0
0
China
Query!
State/province [68]
0
0
Zhuhai
Query!
Country [69]
0
0
Czechia
Query!
State/province [69]
0
0
Olomouc
Query!
Country [70]
0
0
Czechia
Query!
State/province [70]
0
0
Prague
Query!
Country [71]
0
0
Czechia
Query!
State/province [71]
0
0
Praha 8
Query!
Country [72]
0
0
Czechia
Query!
State/province [72]
0
0
Praha
Query!
Country [73]
0
0
Czechia
Query!
State/province [73]
0
0
Zlin
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Caen Cedex 5
Query!
Country [75]
0
0
France
Query!
State/province [75]
0
0
Dijon Cedex
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Marseille cedex 5
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Poitiers
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Rennes Cedex
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Rouen Cedex 1
Query!
Country [80]
0
0
France
Query!
State/province [80]
0
0
Valenciennes cedex
Query!
Country [81]
0
0
France
Query!
State/province [81]
0
0
Vanduvre-lEs-Nancy Cedex
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Augsburg
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Berlin
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
Erlangen
Query!
Country [85]
0
0
Germany
Query!
State/province [85]
0
0
Essen
Query!
Country [86]
0
0
Germany
Query!
State/province [86]
0
0
Hamburg
Query!
Country [87]
0
0
Germany
Query!
State/province [87]
0
0
Hannover
Query!
Country [88]
0
0
Germany
Query!
State/province [88]
0
0
Straubing
Query!
Country [89]
0
0
Greece
Query!
State/province [89]
0
0
Athens
Query!
Country [90]
0
0
Greece
Query!
State/province [90]
0
0
Larissa
Query!
Country [91]
0
0
Greece
Query!
State/province [91]
0
0
Thessaloniki
Query!
Country [92]
0
0
Hungary
Query!
State/province [92]
0
0
Gyor
Query!
Country [93]
0
0
Hungary
Query!
State/province [93]
0
0
Kaposvar
Query!
Country [94]
0
0
Hungary
Query!
State/province [94]
0
0
Nyiregyhaza
Query!
Country [95]
0
0
Hungary
Query!
State/province [95]
0
0
SalgOtarjAn
Query!
Country [96]
0
0
India
Query!
State/province [96]
0
0
Bengaluru
Query!
Country [97]
0
0
India
Query!
State/province [97]
0
0
Bhubaneswar
Query!
Country [98]
0
0
India
Query!
State/province [98]
0
0
Hyderabad
Query!
Country [99]
0
0
India
Query!
State/province [99]
0
0
Kolkata
Query!
Country [100]
0
0
India
Query!
State/province [100]
0
0
Mumbai
Query!
Country [101]
0
0
India
Query!
State/province [101]
0
0
Nashik
Query!
Country [102]
0
0
India
Query!
State/province [102]
0
0
Nehru Nagar Belagavi Karnataka 590010
Query!
Country [103]
0
0
India
Query!
State/province [103]
0
0
Surat
Query!
Country [104]
0
0
India
Query!
State/province [104]
0
0
Trivandrum
Query!
Country [105]
0
0
India
Query!
State/province [105]
0
0
Vijayawada
Query!
Country [106]
0
0
Israel
Query!
State/province [106]
0
0
Haifa
Query!
Country [107]
0
0
Israel
Query!
State/province [107]
0
0
Jerusalem
Query!
Country [108]
0
0
Israel
Query!
State/province [108]
0
0
Tel Aviv
Query!
Country [109]
0
0
Italy
Query!
State/province [109]
0
0
Milano
Query!
Country [110]
0
0
Italy
Query!
State/province [110]
0
0
Napoli
Query!
Country [111]
0
0
Italy
Query!
State/province [111]
0
0
Padova
Query!
Country [112]
0
0
Italy
Query!
State/province [112]
0
0
Pavia
Query!
Country [113]
0
0
Italy
Query!
State/province [113]
0
0
Prato
Query!
Country [114]
0
0
Italy
Query!
State/province [114]
0
0
Roma
Query!
Country [115]
0
0
Italy
Query!
State/province [115]
0
0
Rozzano MI
Query!
Country [116]
0
0
Italy
Query!
State/province [116]
0
0
Savona
Query!
Country [117]
0
0
Japan
Query!
State/province [117]
0
0
Aichi
Query!
Country [118]
0
0
Japan
Query!
State/province [118]
0
0
Chiba
Query!
Country [119]
0
0
Japan
Query!
State/province [119]
0
0
Ehime
Query!
Country [120]
0
0
Japan
Query!
State/province [120]
0
0
Fukuoka
Query!
Country [121]
0
0
Japan
Query!
State/province [121]
0
0
Hokkaido
Query!
Country [122]
0
0
Japan
Query!
State/province [122]
0
0
Hyogo
Query!
Country [123]
0
0
Japan
Query!
State/province [123]
0
0
Iwate
Query!
Country [124]
0
0
Japan
Query!
State/province [124]
0
0
Kanagawa
Query!
Country [125]
0
0
Japan
Query!
State/province [125]
0
0
Kyoto
Query!
Country [126]
0
0
Japan
Query!
State/province [126]
0
0
Miyagi
Query!
Country [127]
0
0
Japan
Query!
State/province [127]
0
0
Niigata
Query!
Country [128]
0
0
Japan
Query!
State/province [128]
0
0
Osaka
Query!
Country [129]
0
0
Japan
Query!
State/province [129]
0
0
Saitama
Query!
Country [130]
0
0
Japan
Query!
State/province [130]
0
0
Shizuoka
Query!
Country [131]
0
0
Japan
Query!
State/province [131]
0
0
Tokyo
Query!
Country [132]
0
0
Japan
Query!
State/province [132]
0
0
Tottori
Query!
Country [133]
0
0
Korea, Republic of
Query!
State/province [133]
0
0
Busan
Query!
Country [134]
0
0
Korea, Republic of
Query!
State/province [134]
0
0
Pusan
Query!
Country [135]
0
0
Korea, Republic of
Query!
State/province [135]
0
0
Seoul
Query!
Country [136]
0
0
Korea, Republic of
Query!
State/province [136]
0
0
Suwon Gyeonggi-do
Query!
Country [137]
0
0
Mexico
Query!
State/province [137]
0
0
Ciudad de Mexico
Query!
Country [138]
0
0
Mexico
Query!
State/province [138]
0
0
Guadalajara
Query!
Country [139]
0
0
Mexico
Query!
State/province [139]
0
0
Oaxaca
Query!
Country [140]
0
0
Norway
Query!
State/province [140]
0
0
Bergen
Query!
Country [141]
0
0
Norway
Query!
State/province [141]
0
0
Oslo
Query!
Country [142]
0
0
Norway
Query!
State/province [142]
0
0
Troms
Query!
Country [143]
0
0
Poland
Query!
State/province [143]
0
0
Bielsko-Biala
Query!
Country [144]
0
0
Poland
Query!
State/province [144]
0
0
Gliwice
Query!
Country [145]
0
0
Poland
Query!
State/province [145]
0
0
Katowice
Query!
Country [146]
0
0
Poland
Query!
State/province [146]
0
0
Koszalin
Query!
Country [147]
0
0
Poland
Query!
State/province [147]
0
0
Olsztyn
Query!
Country [148]
0
0
Poland
Query!
State/province [148]
0
0
Przemysl
Query!
Country [149]
0
0
Poland
Query!
State/province [149]
0
0
Siedlce
Query!
Country [150]
0
0
Poland
Query!
State/province [150]
0
0
Warszawa
Query!
Country [151]
0
0
Portugal
Query!
State/province [151]
0
0
Coimbra
Query!
Country [152]
0
0
Portugal
Query!
State/province [152]
0
0
Faro
Query!
Country [153]
0
0
Portugal
Query!
State/province [153]
0
0
Lisboa
Query!
Country [154]
0
0
Portugal
Query!
State/province [154]
0
0
Matosinhos
Query!
Country [155]
0
0
Portugal
Query!
State/province [155]
0
0
Porto
Query!
Country [156]
0
0
Portugal
Query!
State/province [156]
0
0
Vila Nova de Gaia
Query!
Country [157]
0
0
Romania
Query!
State/province [157]
0
0
Bucharest
Query!
Country [158]
0
0
Romania
Query!
State/province [158]
0
0
Bucuresti
Query!
Country [159]
0
0
Romania
Query!
State/province [159]
0
0
Craiova
Query!
Country [160]
0
0
Romania
Query!
State/province [160]
0
0
Iasi
Query!
Country [161]
0
0
Romania
Query!
State/province [161]
0
0
Oradea
Query!
Country [162]
0
0
Romania
Query!
State/province [162]
0
0
Pitesti
Query!
Country [163]
0
0
Romania
Query!
State/province [163]
0
0
Suceava
Query!
Country [164]
0
0
Romania
Query!
State/province [164]
0
0
Timisoara
Query!
Country [165]
0
0
Spain
Query!
State/province [165]
0
0
BaracaldoVizcaya
Query!
Country [166]
0
0
Spain
Query!
State/province [166]
0
0
Barcelona
Query!
Country [167]
0
0
Spain
Query!
State/province [167]
0
0
Cartagena Murcia
Query!
Country [168]
0
0
Spain
Query!
State/province [168]
0
0
HebrOn
Query!
Country [169]
0
0
Spain
Query!
State/province [169]
0
0
Jerez
Query!
Country [170]
0
0
Spain
Query!
State/province [170]
0
0
L'Hospitalet De Llobrega
Query!
Country [171]
0
0
Spain
Query!
State/province [171]
0
0
Lugo
Query!
Country [172]
0
0
Spain
Query!
State/province [172]
0
0
Madrid
Query!
Country [173]
0
0
Spain
Query!
State/province [173]
0
0
Pamplona
Query!
Country [174]
0
0
Spain
Query!
State/province [174]
0
0
Salamanca
Query!
Country [175]
0
0
Spain
Query!
State/province [175]
0
0
Santander
Query!
Country [176]
0
0
Spain
Query!
State/province [176]
0
0
Zaragoza
Query!
Country [177]
0
0
Sweden
Query!
State/province [177]
0
0
Goteborg
Query!
Country [178]
0
0
Sweden
Query!
State/province [178]
0
0
Stockholm
Query!
Country [179]
0
0
Sweden
Query!
State/province [179]
0
0
Uppsala
Query!
Country [180]
0
0
Taiwan
Query!
State/province [180]
0
0
Changhua
Query!
Country [181]
0
0
Taiwan
Query!
State/province [181]
0
0
Kaohsiung
Query!
Country [182]
0
0
Taiwan
Query!
State/province [182]
0
0
Taichung
Query!
Country [183]
0
0
Taiwan
Query!
State/province [183]
0
0
Taipei
Query!
Country [184]
0
0
Turkey
Query!
State/province [184]
0
0
Ankara
Query!
Country [185]
0
0
Turkey
Query!
State/province [185]
0
0
Antalya
Query!
Country [186]
0
0
Turkey
Query!
State/province [186]
0
0
Istanbul
Query!
Country [187]
0
0
United Kingdom
Query!
State/province [187]
0
0
Edinburgh
Query!
Country [188]
0
0
United Kingdom
Query!
State/province [188]
0
0
Gloucester
Query!
Country [189]
0
0
United Kingdom
Query!
State/province [189]
0
0
London
Query!
Country [190]
0
0
United Kingdom
Query!
State/province [190]
0
0
Nottingham
Query!
Country [191]
0
0
United Kingdom
Query!
State/province [191]
0
0
Sutton
Query!
Country [192]
0
0
United Kingdom
Query!
State/province [192]
0
0
Wolverhampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
GlaxoSmithKline
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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)
Query!
Trial website
https://clinicaltrials.gov/study/NCT06256588
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
US GSK Clinical Trials Call Center
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
877-379-3718
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
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)
Query!
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.
Query!
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.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Query!
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