Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma MedDRA version: 21.0 Level: LLT Classification code 10055476 Term: Esophageal squamous cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Durvalumab
Product Code: MEDI4736
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: durvalumab
CAS Number: 1428935-60-7
Current Sponsor code: MEDI4736
Conce
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 18 years or older at the time of signing the ICF. • Histologically or cytologically confirmed esophageal squamous cell carcinoma, and present with locally advanced disease (Stage II-IVA). • Unresectable or refusing surgery, and has been deemed suitable for definitive chemoradiation therapy. • Patients with at least an evaluable lesion per RECIST 1.1 • Mandatory provision of available tumor tissue for PD-L1 expression analysis. • ECOG PS 0 or 1. • Adequate organ and marrow function. • Life expectancy of more than 3 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 280 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 320
Exclusion criteria
Exclusion criteria: • Histologically or cytologically confirmed small cell esophageal carcinoma, esophageal adenocarcinoma or other mixed carcinoma. • Prior anti-cancer treatment for ESCC. • Patient with a great risk of perforation and massive bleeding. • History of allogeneic organ transplantation. • Active or prior documented autoimmune or inflammatory disorders. • Uncontrolled intercurrent illness. • History of another primary malignancy. • Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus. • Known allergy or hypersensitivity to any of the study interventions or any of the study interventions excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in terms of PFS using BICR assessments according to RECIST 1.1 in patients with PD-L1 TAP=1% tumors;Secondary Objective: - To assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in terms of PFS using BICR assessments according to RECIST 1.1 in all randomized patients - To assess the efficacy of durvalumab + dCRT compared to placebo + dCRT in terms of OS, APF24, ORR, DoR, DCR, TTP, PFS2, and OS36 in all randomized patients and in patients with PD-L1 TAP=1% tumors - To assess patient-reported symptoms, functioning, and HRQoL in patients treated with durvalumab + dCRT compared to placebo + dCRT using patient reported outcome measures - To assess the PK of durvalumab when in combination with dCRT in all randomized patients - To investigate the immunogenicity of durvalumab and durvalumab in combination with dCRT in all randomized patients;Primary end point(s): PFS using BICR assessments according to RECIST 1.1 in patients with PD-L1 TAP=1% tumors;Timepoint(s) of evaluation of this end point: up to 56 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -PFS using BICR assessments according to RECIST 1.1 in all randomized patients - OS, OS36, PFS2 - APF24,ORR, DoR, DCR and TTP per RECIST 1.1 as assessed by BICR in all randomized patients and in patients with PD-L1 TAP=1% tumors - Time to deterioration and change from baseline in symptoms, functioning, and HRQoL as measured by EORTC QLQ-C30 and QLQ-OES18 - Concentration of durvalumab in blood - ADA in all randomized patients;Timepoint(s) of evaluation of this end point: Until end of study | — |
Countries
Belgium, Brazil, Canada, China, France, Japan, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, Taiwan, Thailand, United States
Contacts
Public ContactClinical Study Information Center
AstraZeneca
Outcome results
None listed