Pembrolizumab plus Lenvatinib plus Chemotherapy for the Treatment of Advanced/Metastatic HER2 Negative Gastric/Gastroesophageal Junction Adenocarcinoma
- Conditions
- Advanced/Metastatic HER2 Negative Gastric/Gastroesophageal Junction Adenocarcinoma
- Registration Number
- JPRN-jRCT2051200127
- Lead Sponsor
- Koh Yasuhiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method