Informations générales (source: ClinicalTrials.gov)
A Phase 2, Randomized, Open-label, Platform Study Using a Master Protocol to Evaluate Novel Immunotherapy Combinations as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck
Interventional
Phase 2
GlaxoSmithKline (Voir sur ClinicalTrials)
novembre 2023
mai 2027
03 août 2024
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:38 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Caroline EVEN | 11/06/2024 12:54:39 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| GSK Investigational Site - 13005 - Marseille cedex 5 - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 14075 - Caen Cedex 5 - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 33075 - Bordeaux - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 75005 - Paris - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 76038 - Rouen Cedex 1 - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
| GSK Investigational Site - 94805 - Villejuif Cedex - France | US GSK Clinical Trials Call Center | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Have histologically or cytologically-confirmed HNSCC that is R/M and 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. A fresh tumor tissue sample obtained within 90 days of
screening is highly preferred, If fresh biopsy is not possible, an archival tumor
specimen (≤2 years old) is acceptable even if this predates the R/M diagnosis.
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
- Have histologically or cytologically-confirmed HNSCC that is R/M and 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. A fresh tumor tissue sample obtained within 90 days of
screening is highly preferred, If fresh biopsy is not possible, an archival tumor
specimen (≤2 years old) is acceptable even if this predates the R/M diagnosis.
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
- 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.)