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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06062420
Other study ID # 219885
Secondary ID 2023-503428-24-0
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 14, 2023
Est. completion date August 12, 2027

Study information

Verified date January 2024
Source GlaxoSmithKline
Contact US GSK Clinical Trials Call Center
Phone 877-379-3718
Email GSKClinicalSupportHD@gsk.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of the study is to evaluate the antitumor activity and safety of novel immunotherapy combinations compared with dostarlimab in participants with Programmed death ligand 1 (PD-L1) positive Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC).


Recruitment information / eligibility

Status Recruiting
Enrollment 360
Est. completion date August 12, 2027
Est. primary completion date September 17, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Have histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapies. A) Subjects must not have had prior systemic therapy administered in the R/M setting. Chemoradiation therapy which was completed more than 4 months prior to signing consent if given as part of multimodal treatment for locally advanced disease is allowed B) The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx C) Subjects may not have a primary tumor site of nasopharynx (any histology) - Has measurable (target) disease based on RECIST 1.1 as determined by the investigator. - 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 initial diagnosis of R/M HNSCC. Although a fresh tumor tissue sample obtained within 90 days of screening is highly preferred, an archival tumor specimen (=2 years old) is acceptable. Biopsies obtained prior to the administration of any systemic therapy administered for the treatment of a participant's tumor (such as neoadjuvant/adjuvant therapy) are not acceptable. Needle or excisional biopsies or resected tissue is required. Cytological specimens such as fine needle aspirates, bone marrow samples, or cell blocks are not acceptable. Bone specimen is not acceptable. - Has tumor Programmed death ligand 1 (PD-L1) expression - If the primary tumor site is oropharyngeal carcinoma, the participant must have Human papillomavirus (HPV) results Exclusion Criteria: - Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting Programmed death protein 1 (PD-1), PD-L1, Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), T cell immunoreceptor with immunoglobulin 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 the following in situ cancers: bladder, gastric, esophageal, colon, endometrial, cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period. - Have active tumor bleeding or a high risk of bleeding (examples include but are not limited to radiographic evidence of major blood vessel invasion/infiltration or tumor demonstrates >90 degree abutment or encasement of a major vessel [carotid, jugular, bronchial artery] and/or exhibits other high-risk features such as arteriovenous fistula). - Has PD within 4 months of completion of curatively intended treatment for locoregionally advanced HNSCC - Participants with any carcinomatous meningitis or leptomeningeal spread and those with uncontrolled or symptomatic Central Nervous System (CNS) metastases - Active autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years. (Stable, medically managed autoimmune endocrinopathies are acceptable if participant otherwise meets entry criteria.)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dostarlimab
Dostarlimab will be administered.
Belrestotug
Belrestotug will be administered.
GSK6097608
GSK6097608 will be administered.

Locations

Country Name City State
Argentina GSK Investigational Site Capital Federal Buenos Aires
Argentina GSK Investigational Site Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina GSK Investigational Site Ciudad Autónoma de Buenos Aires Buenos Aires
Argentina GSK Investigational Site Ciudad Autónoma de Buenos Aires
Argentina GSK Investigational Site Cordoba
Argentina GSK Investigational Site Florida Buenos Aires
Argentina GSK Investigational Site Mendoza
Argentina GSK Investigational Site San Juan
Argentina GSK Investigational Site Santa Fe
Brazil GSK Investigational Site Santo Andre Sao Paulo
Brazil GSK Investigational Site São Paulo
Brazil GSK Investigational Site São Paulo
Brazil GSK Investigational Site São Paulo
Canada GSK Investigational Site Calgary Alberta
Canada GSK Investigational Site Edmonton Alberta
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Toronto Ontario
Denmark GSK Investigational Site Herlev
Finland GSK Investigational Site Turku
France GSK Investigational Site Bordeaux Cedex
France GSK Investigational Site Caen Cedex 5
France GSK Investigational Site Marseille
France GSK Investigational Site Paris
France GSK Investigational Site Rouen
France GSK Investigational Site Saint Herblain
France GSK Investigational Site Villejuif Cedex
Germany GSK Investigational Site Aachen Nordrhein-Westfalen
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Essen Nordrhein-Westfalen
Germany GSK Investigational Site Frankfurt Hessen
Germany GSK Investigational Site Giessen Hessen
Germany GSK Investigational Site Hamburg
Germany GSK Investigational Site Leipzig Sachsen
Germany GSK Investigational Site Regensburg Bayern
Germany GSK Investigational Site Ulm Baden-Wuerttemberg
Greece GSK Investigational Site Athens
Greece GSK Investigational Site Haidari, Athens
Greece GSK Investigational Site Thessaloniki
Greece GSK Investigational Site Thessaloniki
Hungary GSK Investigational Site Gyor
Hungary GSK Investigational Site Kecskemét
Hungary GSK Investigational Site Nyíregyháza
Hungary GSK Investigational Site Pécs
Hungary GSK Investigational Site Szolnok
Italy GSK Investigational Site Bari Puglia
Italy GSK Investigational Site Bologna Emilia-Romagna
Italy GSK Investigational Site Firenze Toscana
Italy GSK Investigational Site Genova Liguria
Italy GSK Investigational Site Milano Lombardia
Italy GSK Investigational Site Napoli Campania
Italy GSK Investigational Site Novara Piemonte
Italy GSK Investigational Site Padova Veneto
Italy GSK Investigational Site Roma Lazio
Italy GSK Investigational Site Roma Lazio
Italy GSK Investigational Site Rozzano (MI) Lombardia
Japan GSK Investigational Site Aichi
Japan GSK Investigational Site Chiba
Japan GSK Investigational Site Hyogo
Japan GSK Investigational Site Osaka
Japan GSK Investigational Site Saitama
Japan GSK Investigational Site Shizuoka
Japan GSK Investigational Site Tokyo
Korea, Republic of GSK Investigational Site Daegu-si
Korea, Republic of GSK Investigational Site Seongnam-si, Gyeonggi-do
Korea, Republic of GSK Investigational Site Seoul
Korea, Republic of GSK Investigational Site Seoul
Norway GSK Investigational Site Oslo
Poland GSK Investigational Site Bielsko-Biala
Poland GSK Investigational Site Gliwice
Poland GSK Investigational Site Koszalin
Poland GSK Investigational Site Krakow
Poland GSK Investigational Site Poznan
Poland GSK Investigational Site Przemysl
Poland GSK Investigational Site Siedlce
Poland GSK Investigational Site Warszawa
Portugal GSK Investigational Site Almada
Portugal GSK Investigational Site Lisboa
Portugal GSK Investigational Site Porto
Portugal GSK Investigational Site Porto
Romania GSK Investigational Site Brasov
Romania GSK Investigational Site Bucharest
Romania GSK Investigational Site Bucharest
Romania GSK Investigational Site Bucharest
Romania GSK Investigational Site Bucuresti
Romania GSK Investigational Site Bucuresti
Romania GSK Investigational Site Craiova
Romania GSK Investigational Site Craiova
Romania GSK Investigational Site Floresti
Romania GSK Investigational Site Iasi
Romania GSK Investigational Site Oradea
Romania GSK Investigational Site Pitesti Arges
Romania GSK Investigational Site Suceava
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Jaén
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Pozuelo De Alarcón/Madrid
Spain GSK Investigational Site Salamanca
Spain GSK Investigational Site Santander
Spain GSK Investigational Site Valencia
Spain GSK Investigational Site Zaragoza
Sweden GSK Investigational Site Stockholm
Taiwan GSK Investigational Site Changhua
Taiwan GSK Investigational Site Tainan
Taiwan GSK Investigational Site Taipei
Taiwan GSK Investigational Site Taipei City
Turkey GSK Investigational Site Ankara
Turkey GSK Investigational Site Antalya
Turkey GSK Investigational Site Istanbul
Turkey GSK Investigational Site Izmir
United States GSK Investigational Site Boston Massachusetts
United States GSK Investigational Site Chicago Illinois
United States GSK Investigational Site Columbus Ohio
United States GSK Investigational Site Iowa City Iowa
United States GSK Investigational Site Milwaukee Wisconsin
United States GSK Investigational Site New Haven Connecticut
United States GSK Investigational Site Omaha Nebraska
United States GSK Investigational Site Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
GlaxoSmithKline iTeos Therapeutics

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Italy,  Japan,  Korea, Republic of,  Norway,  Poland,  Portugal,  Romania,  Spain,  Sweden,  Taiwan,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Confirmed Objective Response Rate (ORR) compared between Sub studies and Dostarlimab monotherapy Confirmed ORR is defined as the percentage of participants achieving confirmed Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment. Up to approximately 24 months
Secondary Overall Survival (OS) compared between Sub studies and Dostarlimab monotherapy OS is defined as the time from the date of randomization to the date of death due to any cause. Up to approximately 24 months
Secondary Duration of Response (DOR) compared between Sub studies and Dostarlimab monotherapy DOR per RECIST 1.1 by investigator assessment, defined as the time from the date of first documented objective response (CR or PR) to the date of first documented Disease progression (PD) or death due to any cause, whichever comes first. Up to approximately 24 months
Secondary Progression Free Survival (PFS) compared between Sub studies and Dostarlimab monotherapy PFS per RECIST 1.1 by investigator assessment, defined as the time from the date of randomization to the date of first documented PD or death due to any cause, whichever comes first. Up to approximately 24 months
Secondary Disease Control Rate (DCR) compared between Sub studies and Dostarlimab monotherapy DCR is defined as the percentage of participants achieving CR or PR, or Stable disease (SD) greater than or equal to (=) 6 months, per RECIST 1.1 by investigator assessment. Up to approximately 24 months
Secondary Rate of Circulating Tumor Deoxyribonucleic Acid (ctDNA) Molecular Response The rate of ctDNA molecular response, is defined as the percentage of participants achieving a =50% decrease in ctDNA level compared to baseline, measured by plasma ctDNA assessment Up to approximately 24 months
Secondary Confirmed Objective Response Rate (ORR) compared between Sub study 3 and Sub studies 1 and 2 Confirmed ORR is defined as the percentage of participants achieving confirmed CR or PR per RECIST version 1.1 by investigator assessment. Up to approximately 24 months
Secondary Overall Survival (OS) compared between Sub study 3 and Sub studies 1 and 2 OS is defined as the time from the date of randomization to the date of death due to any cause. Up to approximately 24 months
Secondary Duration of Response (DOR) compared between Sub study 3 and Sub studies 1 and 2 DOR per RECIST v 1.1 by investigator assessment, defined as the time from the date of first documented objective response (CR or PR) to the date of first documented PD or death due to any cause, whichever comes first. Up to approximately 24 months
Secondary Progression Free Survival (PFS) compared between Sub study 3 and Sub studies 1 and 2 PFS per RECIST 1.1 by investigator assessment, defined as the time from the date of randomization to the date of first documented PD or death due to any cause, whichever comes first. Up to approximately 24 months
Secondary DCR compared between sub study 3 and Sub studies 1 and 2 DCR is defined as the percentage of participants achieving CR or PR, or Stable disease (SD) = 6 months, per RECIST v1.1 by investigator assessment. Up to approximately 24 months
Secondary Rate of ctDNA Molecular Response compared between sub study 3 and Sub studies 1 and 2 Up to approximately 24 months
Secondary Number of Participants with Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI) Up to approximately 24 months
Secondary Number of Participants with TEAEs or SAEs leading to dose modifications or study intervention discontinuation Up to approximately 24 months
Secondary Number of Participants with Clinically Significant Findings in Physical examination, Vital signs, Electrocardiogram (ECG), Echocardiogram (ECHO), Multigated acquisition (MUGA) and Laboratory test parameters Up to approximately 24 months
Secondary Number of Participants with Anti-Drug Antibodies (ADA) against Dostarlimab Up to approximately 24 months
Secondary Number of Participants with Anti-Drug Antibodies (ADA) against Belrestotug Up to approximately 24 months
Secondary Number of Participants with Anti-Drug Antibodies (ADA) against GSK6097608 Up to approximately 24 months
Secondary Maximum Concentration (Cmax) and Minimum Concentration (Cmin) of Dostarlimab Up to approximately 24 months
Secondary Cmax and Cmin of Belrestotug Up to approximately 24 months
Secondary Cmax and Cmin of GSK6097608 Up to approximately 24 months
See also
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