JRCT ID: jRCT2051200127
Registered date:29/01/2021
Pembrolizumab plus Lenvatinib plus Chemotherapy for the Treatment of Advanced/Metastatic HER2 Negative Gastric/Gastroesophageal Junction Adenocarcinoma
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Advanced/Metastatic HER2 Negative Gastric/Gastroesophageal Junction Adenocarcinoma |
Date of first enrollment | 05/02/2021 |
Target sample size | 120 |
Countries of recruitment | Australia,Japan,China,Japan,Hong Kong,Japan,South Korea,Japan,Taiwan,Japan,Belgium,Japan,Germany,Japan,Spain,Japan,France,Japan,United Kingdom,Japan,Israel,Japan,Italy,Japan,Poland,Japan,Russia,Japan,Turkey,Japan,Argentina,Japan,Chile,Japan,Colombia,Japan,Guatemala,Japan,Peru,Japan,Canada,Japan,the United States,Japan,Ireland,Japan |
Study type | Interventional |
Intervention(s) | 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: Oxaliplatin 130 mg/m^2 administered by IV infusion on Day 1 of Weeks 1 and 4 of each Q6W cycle as part of CAPOX chemotherapy, or 85 mg/m^2 administered by IV infusion on Day 1 and Week 1, 3 and 5 of each Q6W cycle as part of mFOLFOX6 chemotherapy. Drug: Capecitabine 1000 mg/m^2 administered PO twice daily (BID) on Days 1-14, 22-35 of each Q6W cycle as part of CAPOX chemotherapy. Drug: Leucovorin Administered by IV infusion at 400 mg/m^2 on Day 1, and Week 1, 3 and 5 of each Q6W cycle as part of mFOLFOX6 chemotherapy. Drug: 5-FU 400 mg/m^2 bolus IV infusion followed by 2400 mg/m^2 continuous IV infusion administered on Day 1, and Week 1, 3, 5, of each Q2W cycle as part of mFOLFOX6 chemotherapy. |
Outcome(s)
Primary Outcome | 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 |
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Secondary Outcome | 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 |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include 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 |
Exclude 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 |
Related Information
Primary Sponsor | Tanaka Yoshiyuki |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT04662710 |
Contact
Public contact | |
Name | MSDJRCT inquiry mailbox |
Address | KITANOMARU SQUARE, 1-13-12, Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan Tokyo Japan 102-8667 |
Telephone | +81-3-6272-1957 |
msdjrct@merck.com | |
Affiliation | MSD K.K. |
Scientific contact | |
Name | Yoshiyuki Tanaka |
Address | KITANOMARU SQUARE, 1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan Tokyo Japan 102-8667 |
Telephone | +81-3-6272-1957 |
msdjrct@merck.com | |
Affiliation | MSD K.K. |