Advanced/Metastatic HER2 Negative Gastric/Gastroesophageal Junction Adenocarcinoma
Conditions
Interventions
Biological: Pembrolizumab
400 mg Q6W by IV infusion
Other Names:
MK-3475
Keytruda(R)
Biological: Lenvatinib
Administered PO QD, 8 mg induction/14 mg consolidation.
Other Names:
MK-7902
E7080
Drug:
Sponsors
Fujita Tomoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ cancer -Has had major surgery within 28 days prior to first dose of study interventions -Has had radiotherapy within 14 days of randomization -Has a known additional malignancy that is progressing or has required active treatment within the past 5 years -Has known CNS metastases and/or carcinomatous meningitis -Has severe hypersensitivity (>=Grade 3) to treatment with an monoclonal antibody (mAb) or known sensitivity or intolerance to any component of lenvatinib, pembrolizumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum containing products -Has had an allogeneic tissue/solid organ transplant -Has perforation risks or significant gastrointestinal (GI) bleeding -Has GI obstruction, poor oral intake (CAPOX participants), or difficulty in taking oral medication (CAPOX participants) -Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor -Has received prior therapy with anti- vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor or anti-VEGF mAb -Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug -Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) -Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation -Has inadequate cardiac function -Has a history of (noninfectious) pneumonitis that required steroids or current pneumonitis -Has poorly controlled diarrhea -Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment. -Has peripheral neuropathy >=Grade 2 -Has a known history of human immunodeficiency virus (HIV) or HIV 1/2 antibodies -Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection -Has weight loss of >20% within the last 3 months
Exclusion criteria
Exclusion criteria: Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ cancer -Has had major surgery within 28 days prior to first dose of study interventions -Has had radiotherapy within 14 days of randomization -Has a known additional malignancy that is progressing or has required active treatment within the past 5 years -Has known CNS metastases and/or carcinomatous meningitis -Has severe hypersensitivity (>=Grade 3) to treatment with an monoclonal antibody (mAb) or known sensitivity or intolerance to any component of lenvatinib, pembrolizumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum containing products -Has had an allogeneic tissue/solid organ transplant -Has perforation risks or significant gastrointestinal (GI) bleeding -Has GI obstruction, poor oral intake (CAPOX participants), or difficulty in taking oral medication (CAPOX participants) -Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor -Has received prior therapy with anti- vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor or anti-VEGF mAb -Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug -Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) -Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation -Has inadequate cardiac function -Has a history of (noninfectious) pneumonitis that required steroids or current pneumonitis -Has poorly controlled diarrhea -Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment. -Has peripheral neuropathy >=Grade 2 -Has a known history of human immunodeficiency virus (HIV) or HIV 1/2 antibodies -Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection -Has weight loss of >20% within the last 3 months
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 | — |
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 | — |
Countries
Argentina, Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Guatemala, Hong Kong, Ireland, Israel, Italy, Japan, Peru, Poland, Russia, South Korea, Spain, Taiwan, the United States, Turkey, United Kingdom
Contacts
Public ContactMSDJRCT inquiry mailbox
MSD K.K.
Outcome results
None listed