Phase
Condition
Head And Neck Cancer
Lung Cancer
Treatment
GSK4381562
Dostarlimab
Nelistotug
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have histologically or cytologically-confirmed HNSCC that is R/M and is consideredincurable by local therapies. A) Subjects must not have had prior systemic therapyadministered in the R/M setting. Chemoradiation therapy which was completed morethan 4 months prior to signing consent if given as part of multimodal treatment forlocally advanced disease is allowed B) The eligible primary tumor locations areoropharynx, oral cavity, hypopharynx, and larynx C) Subjects may not have a primarytumor site of nasopharynx (any histology)
Has measurable (target) disease based on RECIST 1.1 as determined by theinvestigator.
Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
Provides a tumor tissue sample obtained at the time of or after the initialdiagnosis of R/M HNSCC. A fresh tumor tissue sample obtained within 90 days ofscreening is highly preferred, If fresh biopsy is not possible, an archival tumorspecimen is acceptable unless it was obtained prior to administration ofchemoradiation for the treatment of a participant's tumour. Needle or excisionalbiopsies or resected tissue is required. Cytological specimens such as fine needleaspirates, bone marrow samples, or cell blocks are not acceptable. Bone specimen isnot acceptable.
Has tumor Programmed death ligand 1 (PD-L1) expression
If the primary tumor site is oropharyngeal carcinoma, the participant must haveHuman papillomavirus (HPV) results
Exclusion
Exclusion Criteria:
Has received prior therapy with any immune checkpoint inhibitors, includingantibodies or drugs targeting Programmed death protein 1 (PD-1), PD-L1, CytotoxicT-lymphocyte-associated protein 4 (CTLA-4), T cell immunoreceptor withimmunoglobulin and immunoreceptor tyrosine based inhibitory motif domains (TIGIT),Cluster of differentiation (CD) 96, or other immune checkpoint pathways.
Participants with previous malignancies (except non-melanoma skin cancers, and thefollowing in situ cancers: bladder, gastric, esophageal, colon, endometrial,cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved atleast 2 years prior to study entry AND no additional therapy is required during thestudy period.
Have active tumor bleeding or a high risk of bleeding (examples include but are notlimited to radiographic evidence of major blood vessel invasion/infiltration ortumor demonstrates >90 degree abutment or encasement of a major vessel [carotid,jugular, bronchial artery] and/or exhibits other high-risk features such asarteriovenous fistula).
Has PD within 4 months of completion of curatively intended treatment forlocoregionally advanced HNSCC
Participants with any carcinomatous meningitis or leptomeningeal spread and thosewith uncontrolled or symptomatic Central Nervous System (CNS) metastases
Active autoimmune disease that has required systemic disease-modifying orimmunosuppressive treatment within the last 2 years. (Stable, medically managedautoimmune endocrinopathies are acceptable if participant otherwise meets entrycriteria.)
Study Design
Connect with a study center
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires C1181ACH
ArgentinaActive - Recruiting
GSK Investigational Site
Buenos Aires, C1426ABP
ArgentinaActive - Recruiting
GSK Investigational Site
Capital Federal, C1181ACH
ArgentinaActive - Recruiting
GSK Investigational Site
Ciudad AutOnoma De Bueno, C1417DTN
ArgentinaActive - Recruiting
GSK Investigational Site
Ciudad AutOnoma de Buenos Aires, C1426ABP
ArgentinaSite Not Available
GSK Investigational Site
Ciudad Autonoma De Bueno, C1056ABI
ArgentinaActive - Recruiting
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, C1417DTN
ArgentinaSite Not Available
GSK Investigational Site
Cordoba, 5000
ArgentinaActive - Recruiting
GSK Investigational Site
Florida, B1602DQD
ArgentinaActive - Recruiting
GSK Investigational Site
Mendoza, M5500AYB
ArgentinaActive - Recruiting
GSK Investigational Site
San Juan, 5400
ArgentinaActive - Recruiting
GSK Investigational Site
Santa Fe, 3000
ArgentinaActive - Recruiting
GSK Investigational Site
SAo Paulo, 01246-000
BrazilActive - Recruiting
GSK Investigational Site
Santo Andre, 09060-650
BrazilActive - Recruiting
GSK Investigational Site
São Paulo, 01221-020
BrazilSite Not Available
GSK Investigational Site
Calgary, Alberta T3N 4N1
CanadaActive - Recruiting
GSK Investigational Site
Edmonton, Alberta T6G 1Z2
CanadaActive - Recruiting
GSK Investigational Site
Toronto, Ontario M4N 3M5
CanadaActive - Recruiting
GSK Investigational Site
Montreal, Quebec H3T 1E2
CanadaActive - Recruiting
GSK Investigational Site
Herlev,
DenmarkActive - Recruiting
GSK Investigational Site
Turku, 20520
FinlandActive - Recruiting
GSK Investigational Site
Bordeaux, 33075
FranceActive - Recruiting
GSK Investigational Site
Bordeaux Cedex, 33075
FranceSite Not Available
GSK Investigational Site
Caen Cedex 5, 14075
FranceActive - Recruiting
GSK Investigational Site
Marseille, 13005
FranceSite Not Available
GSK Investigational Site
Marseille cedex 5, 13005
FranceActive - Recruiting
GSK Investigational Site
Paris, 75005
FranceActive - Recruiting
GSK Investigational Site
Rouen, 76038
FranceSite Not Available
GSK Investigational Site
Rouen Cedex 1, 76038
FranceActive - Recruiting
GSK Investigational Site
Saint Herblain, 44805
FranceSite Not Available
GSK Investigational Site
Villejuif Cedex, 94805
FranceActive - Recruiting
GSK Investigational Site
Aachen, 52074
GermanyActive - Recruiting
GSK Investigational Site
Berlin, 12200
GermanyActive - Recruiting
GSK Investigational Site
Essen, 45122
GermanyActive - Recruiting
GSK Investigational Site
Frankfurt, 60488
GermanyActive - Recruiting
GSK Investigational Site
Giessen, 35392
GermanyActive - Recruiting
GSK Investigational Site
Hamburg, 20246
GermanyActive - Recruiting
GSK Investigational Site
Leipzig, 04103
GermanyActive - Recruiting
GSK Investigational Site
Regensburg, 93053
GermanyActive - Recruiting
GSK Investigational Site
Ulm, 89075
GermanyActive - Recruiting
GSK Investigational Site
Athens,
GreeceSite Not Available
GSK Investigational Site
Haidari - Athens, 12462
GreeceActive - Recruiting
GSK Investigational Site
Haidari, Athens, 12462
GreeceSite Not Available
GSK Investigational Site
Marousi,
GreeceActive - Recruiting
GSK Investigational Site
Thessaloniki, 54622
GreeceActive - Recruiting
GSK Investigational Site
Gyor, 9024
HungaryActive - Recruiting
GSK Investigational Site
KecskemEt, 6000
HungaryActive - Recruiting
GSK Investigational Site
Kecskemét, 6000
HungarySite Not Available
GSK Investigational Site
Nyiregyhaza, 4400
HungaryActive - Recruiting
GSK Investigational Site
Nyíregyháza, 4400
HungarySite Not Available
GSK Investigational Site
PEcs, 7624
HungaryActive - Recruiting
GSK Investigational Site
Pécs, 7624
HungarySite Not Available
GSK Investigational Site
Szolnok, 5000
HungaryActive - Recruiting
GSK Investigational Site
Rozzano (MI), Lombardia 20089
ItalySite Not Available
GSK Investigational Site
Bari, 70124
ItalyActive - Recruiting
GSK Investigational Site
Bologna, 40139
ItalyActive - Recruiting
GSK Investigational Site
Firenze, 50134
ItalyActive - Recruiting
GSK Investigational Site
Genova, 16132
ItalyActive - Recruiting
GSK Investigational Site
Milano, 20133
ItalyActive - Recruiting
GSK Investigational Site
Napoli, 80131
ItalyActive - Recruiting
GSK Investigational Site
Novara, 28100
ItalyActive - Recruiting
GSK Investigational Site
Padova, 35128
ItalyActive - Recruiting
GSK Investigational Site
Roma, 00144
ItalyActive - Recruiting
GSK Investigational Site
Rozzano MI, 20089
ItalyActive - Recruiting
GSK Investigational Site
Aichi, 464-8681
JapanActive - Recruiting
GSK Investigational Site
Chiba, 277-8577
JapanActive - Recruiting
GSK Investigational Site
Hyogo, 650-0017
JapanActive - Recruiting
GSK Investigational Site
Osaka, 541-8567
JapanActive - Recruiting
GSK Investigational Site
Saitama, 350-1298
JapanActive - Recruiting
GSK Investigational Site
Shizuoka, 411-8777
JapanActive - Recruiting
GSK Investigational Site
Tokyo, 104-0045
JapanActive - Recruiting
GSK Investigational Site
Daegu, 42601
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Daegu-si, 42601
Korea, Republic ofSite Not Available
GSK Investigational Site
Seongnam-si Gyeonggi-do, 13620
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Seongnam-si, Gyeonggi-do, 13620
Korea, Republic ofSite Not Available
GSK Investigational Site
Seoul, 03722
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Suwon Kyunggi-do, 443-721
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Oslo, 0379
NorwayActive - Recruiting
GSK Investigational Site
Bielsko-Biala, 43-300
PolandActive - Recruiting
GSK Investigational Site
Gliwice, 44-102
PolandActive - Recruiting
GSK Investigational Site
Katowice, 40-514
PolandActive - Recruiting
GSK Investigational Site
Koszalin, 75-581
PolandActive - Recruiting
GSK Investigational Site
Krakow, 31-826
PolandActive - Recruiting
GSK Investigational Site
Poznan, 60-569
PolandSite Not Available
GSK Investigational Site
Przemysl, 37-700
PolandActive - Recruiting
GSK Investigational Site
Siedlce, 08-110
PolandActive - Recruiting
GSK Investigational Site
Warszawa, 04-141
PolandActive - Recruiting
GSK Investigational Site
Almada, 2801-951
PortugalActive - Recruiting
GSK Investigational Site
Lisboa, 1649-035
PortugalActive - Recruiting
GSK Investigational Site
Porto, 4099-001
PortugalActive - Recruiting
GSK Investigational Site
Brasov, 500283
RomaniaActive - Recruiting
GSK Investigational Site
Bucharest, 030171
RomaniaActive - Recruiting
GSK Investigational Site
Bucuresti, 013823
RomaniaActive - Recruiting
GSK Investigational Site
Craiova, 200542
RomaniaActive - Recruiting
GSK Investigational Site
Floresti, 407280
RomaniaActive - Recruiting
GSK Investigational Site
Iasi, 700483
RomaniaActive - Recruiting
GSK Investigational Site
Oradea, 410469
RomaniaActive - Recruiting
GSK Investigational Site
Pitesti, 110283
RomaniaActive - Recruiting
GSK Investigational Site
Suceava, 720214
RomaniaActive - Recruiting
GSK Investigational Site
Barcelona, 08023
SpainActive - Recruiting
GSK Investigational Site
JaEn, 23007
SpainActive - Recruiting
GSK Investigational Site
Jaén, 23007
SpainSite Not Available
GSK Investigational Site
Madrid, 28040
SpainActive - Recruiting
GSK Investigational Site
Pozuelo De AlarcOn Madr, 28223
SpainActive - Recruiting
GSK Investigational Site
Pozuelo De Alarcón/Madrid, 28223
SpainSite Not Available
GSK Investigational Site
Salamanca, 37007
SpainActive - Recruiting
GSK Investigational Site
Santander, 39008
SpainActive - Recruiting
GSK Investigational Site
Valencia, 46009
SpainActive - Recruiting
GSK Investigational Site
Zaragoza, 50009
SpainActive - Recruiting
GSK Investigational Site
Stockholm, SE-171 76
SwedenSite Not Available
GSK Investigational Site
Uppsala, SE- 75 185
SwedenSite Not Available
GSK Investigational Site
Changhua, 500
TaiwanActive - Recruiting
GSK Investigational Site
Tainan, 704
TaiwanActive - Recruiting
GSK Investigational Site
Taipei, 11217
TaiwanActive - Recruiting
GSK Investigational Site
Taipei City, 11217
TaiwanSite Not Available
GSK Investigational Site
Ankara, 06100
TurkeyActive - Recruiting
GSK Investigational Site
Antalya, 07020
TurkeyActive - Recruiting
GSK Investigational Site
Istanbul, 34662
TurkeyActive - Recruiting
GSK Investigational Site
Izmir, 35040
TurkeyActive - Recruiting
GSK Investigational Site
New Haven, Connecticut 06511
United StatesActive - Recruiting
GSK Investigational Site
Columbus, Georgia 43210-1240
United StatesActive - Recruiting
GSK Investigational Site
Chicago, Illinois 60637
United StatesActive - Recruiting
GSK Investigational Site
Iowa City, Iowa 52242-1009
United StatesActive - Recruiting
GSK Investigational Site
Boston, Massachusetts 02215
United StatesActive - Recruiting
GSK Investigational Site
Saint Louis, Missouri 63021
United StatesActive - Recruiting
GSK Investigational Site
Omaha, Nebraska 68198
United StatesActive - Recruiting
GSK Investigational Site
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
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