Esophageal Carcinoma
Conditions
Brief summary
Part 1 (5-Fluorouracil [5-FU] plus cisplatin [FP] and paclitaxel plus cisplatin [TP] Safety Run-in): Number of Participants With Dose Limiting Toxicities (DLTs), Part 1 (FP and TP Safety Run-in): Number of Participants With Adverse Events (AEs), Part 1 (FP and TP Safety Run-in): Number of Participants who Discontinued Study Treatment Due to an AE, Part 2 (Main Study): Overall Survival (OS) in all Participants
Detailed description
Part 2 (Main Study): Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in all Participants, Part 2 (Main Study): Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR in all Participants, Part 2 (Main Study): Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR in all Participants, Part 2 (Main Study): OS in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10, Part 2 (Main Study): PFS per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10, Part 2 (Main Study): ORR per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10, Part 2 (Main Study): DOR per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10, Part 2 (Main Study): Number of Participants With AEs, Part 2 (Main Study): Number of Participants who Discontinued Study Treatment Due to an AE, Part 2 (Main Study): Change From Baseline in Health-related Quality of life (HRQoL) Score Using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30), Part 2 (Main Study): Change From Baseline in HRQoL Score Using EORTC Quality of Life Questionnaire-Oesophageal Module (QLQ-OES18), Part 2 (Main Study): Time to Deterioration (TTD) in HRQoL Score Using EORTC QLQ-C30, Part 2 (Main Study): TTD in HRQoL Score Using EORTC QLQ-OES18
Interventions
DRUGFLUOROURACIL
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGLenvatinib
DRUGCALCIUM FOLINATE
DRUGCISPLATIN
DRUGOXALIPLATIN
Sponsors
Merck Sharp & Dohme LLC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 (5-Fluorouracil [5-FU] plus cisplatin [FP] and paclitaxel plus cisplatin [TP] Safety Run-in): Number of Participants With Dose Limiting Toxicities (DLTs), Part 1 (FP and TP Safety Run-in): Number of Participants With Adverse Events (AEs), Part 1 (FP and TP Safety Run-in): Number of Participants who Discontinued Study Treatment Due to an AE, Part 2 (Main Study): Overall Survival (OS) in all Participants | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 2 (Main Study): Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in all Participants, Part 2 (Main Study): Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR in all Participants, Part 2 (Main Study): Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR in all Participants, Part 2 (Main Study): OS in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10, Part 2 (Main Study): PFS per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10, Part 2 (Main Study): ORR per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10, Part 2 (Main Study): DOR per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10, Part 2 (Main Study): Number of Participants With AEs, Part 2 (Main Study): Number of Participants who Discontinued Study Treatment Due to an AE, Part 2 (Main Study): Change From | — |
Countries
Denmark, France, Hungary, Italy, Romania, Spain
Outcome results
None listed