Etude : SKYSCRAPER-07 / YO42137



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : SKYSCRAPER-07 / YO42137

Situation thérapeutique : Métastatique ou localement avancé

Traitement : Immunothérapie

Cadre réglementaire : RIPH1

Dernière MÀJ : 30/11/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab With or Without Tiragolumab (Anti-TIGIT Antibody), in Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma

Spécialité : Organes digestifs
Localisation : C15 - Tumeur maligne de l'oesophage
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable locally advanced esophageal squamous cell carcinoma and who have completed definitive concurrent chemoradiation therapy. Participants will be randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A), tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C).

STUDY ARMS:
- Experimental: Arm A: Tiragolumab + Atezolizumab
Participants will receive atezolizumab followed by tiragolumab.
Tiragolumab at a fixed dose of 600 milligrams (mg) administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle

- Experimental: Arm B: Tiragolumab Placebo + Atezolizumab
Participants will receive atezolizumab followed by tiragolumab matching placebo.
Tiragolumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

- Placebo Comparator: Arm C: Tiragolumab Placebo + Atezolizumab Placebo
Atezolizumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Participants will receive matching placebos to tiragolumab and atezolizumab.

MAIN OBJECTIVE:
• To evaluate the efficacy of tiragolumab + atezolizumab compared with double placebo on the basis of investigator (INV) assessed progression free survival and overall survival
• To evaluate the efficacy of placebo + atezolizumab compared with double placebo on the basis of overall survival.

SECONDARY OBJECTIVES:
• To evaluate the efficacy of placebo + atezolizumab compared with double placebo on the basis of INV assessed progression-free survival
• To evaluate the efficacy of tiragolumab + atezolizumab versus placebo + atezolizumab
• To evaluate the efficacy of tiragolumab + atezolizumab and placebo + atezolizumab compared with double placebo and the efficacy of tiragolumab + atezolizumab versus placebo + atezolizumab
• To evaluate safety and tolerability of tiragolumab + atezolizumab and placebo + atezolizumab compared with double placebo
• To characterize pharmacokinetics of tiragolumab and atezolizumab
• To evaluate immune response to tiragolumab and atezolizumab.

Phase : III

Stade : Localement avancé

1
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : • Age >=18 years
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus
• Unresectable locally advanced disease
• Definitive concurrent chemoradiation treatment according to regional oncology guidelines for esophageal cancer
• Representative archival formalin-fixed, paraffin-embedded tumor specimens, collected prior to initiation of definitive chemoradiotherapy
• Adequate hematologic and end-organ function
• Women of childbearing potential must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period, for 5 months after the final dose of atezolizumab/placebo, and for 90 days after the final dose of tiragolumab/placebo.
• Men must agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab/placebo

Critères de non-inclusion : • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-TIGIT therapeutic antibodies
• Any unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE) Grade >= 2 from the prior chemoradiation therapy with the exception of irreversible and manageable hearing loss
• Prior allogeneic stem cell or solid organ transplantation
• Active or history of autoimmune disease or immune deficiency
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g.,
bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
• Malignancy other than esophageal cancer within 2 years prior to
screening, with the exception of malignancies with a negligible risk of
metastasis or death
• Treatment with any other investigational agent, including EGFR inhibitors, with therapeutic intent for esophageal cancer prior to randomization.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04543617
Promoteur :
HOFFMANN-LA ROCHE
Type de sponsor : Industriel
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Docteur Anthony TURPIN

TEC / ARC / IDE :
Céline SAUDEMONT-GILLET
celine.gillet@
chu-lille.fr
Tel: 03 62.94.39.51, Poste 29813

Statut de l'essai : OUVERT

MAJ : 04/10/2021