A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) plus Pembrolizumab (MK-3475) plus Chemotherapy Compared with Standard of Care Therapy as First-line Intervention in Participants with Advanced/Metastatic Gastroesophageal Adenocarcinoma (LEAP-015)

Conditions

Advanced/Metastatic Gastroesophageal Adenocarcinoma

Brief summary

Part 1: Number of Participants with Dose Limiting Toxicities (DLTs), Part 1: Number of Participants with Adverse Events (AEs), Part 1: Number of Participants who Discontinued Study Treatment Due to an AE, Part 2: Overall Survival (OS) in Participants with Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1, Part 2: OS in All Participants, Part 2: 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 Participants with PD-L1 CPS ≥1, Part 2: PFS Per RECIST 1.1 as Assessed by BICR in All Participants

Detailed description

Part 2: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR in Participants with PD-L1 CPS ≥1, Part 2: ORR Per RECIST 1.1 as Assessed by BICR in All Participants, Part 2: Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR in Participants with PD-L1 CPS ≥1, Part 2: DOR Per RECIST 1.1 as Assessed by BICR in All Participants, Part 2: Number of Participants with AEs, Part 2: Number of Participants who Discontinued Study Treatment Due to an AE

Related papers

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Interventions

DRUGLenvatinib

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGCalciumfolinat-GRY® 100 mg/10 ml Injektionslösung

DRUGFLUOROURACIL

DRUGCALCIUM LEVOFOLINATE

DRUGCAPECITABINE

DRUGCALCIUM FOLINATE

DRUGOXALIPLATIN

DRUGCalciumfolinat Kabi 10 mg/ml Injektions-/Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part 1: Number of Participants with Dose Limiting Toxicities (DLTs), Part 1: Number of Participants with Adverse Events (AEs), Part 1: Number of Participants who Discontinued Study Treatment Due to an AE, Part 2: Overall Survival (OS) in Participants with Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1, Part 2: OS in All Participants, Part 2: 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 Participants with PD-L1 CPS ≥1, Part 2: PFS Per RECIST 1.1 as Assessed by BICR in All Participants	—

Measure

Time frame

Part 1: Number of Participants with Dose Limiting Toxicities (DLTs), Part 1: Number of Participants with Adverse Events (AEs), Part 1: Number of Participants who Discontinued Study Treatment Due to an AE, Part 2: Overall Survival (OS) in Participants with Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1, Part 2: OS in All Participants, Part 2: 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 Participants with PD-L1 CPS ≥1, Part 2: PFS Per RECIST 1.1 as Assessed by BICR in All Participants

—

Secondary

Measure	Time frame
Part 2: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR in Participants with PD-L1 CPS ≥1, Part 2: ORR Per RECIST 1.1 as Assessed by BICR in All Participants, Part 2: Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR in Participants with PD-L1 CPS ≥1, Part 2: DOR Per RECIST 1.1 as Assessed by BICR in All Participants, Part 2: Number of Participants with AEs, Part 2: Number of Participants who Discontinued Study Treatment Due to an AE	—