Gastric Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : pembrolizumab + chemotherapy
INN of investigational material : pembrolizumab, cisplatin, 5-fluorouracil, oxaliplatin, capecitabine
Therapeutic category
Sponsors
MSD K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with known programmed cell death ligand 1 (PD-L1) expression status 2)Has human epidermal growth factor receptor 2 (HER2) negative cancer 3)Male participants who have agreed to use a contraception method as described in the study protocol during the treatment period and through 95 days after the last dose of chemotherapy, and who have agreed not to donate sperm. 4)Female participants who are not pregnant, not breastfeeding, and meet at least one of the following conditions: a) Not a woman of childbearing potential or b) A woman of childbearing potential who has agreed to use a contraception method as described in the study protocol during the treatment period and up to 180 days after the last dose of chemotherapy or up to 120 days after the last dose of MK-3475, whichever is last and agrees not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period. 5)Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator assessment 6)Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated 7)Has provided tumor tissue sample deemed adequate for PD-L1 biomarker analysis 8)Has provided tumor tissue sample for microsatellite instability (MSI) biomarker analysis 9)Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the start of study intervention 10)Has adequate organ function
Exclusion criteria
Exclusion criteria: 1)Has squamous cell or undifferentiated gastric cancer 2)Has had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, anticipation of the need for major surgery during the course of study intervention, or has not recovered adequately from the toxicity and/or complications from previous surgery 3)Has preexisting peripheral neuropathy >Grade 1 4)Is a WOCBP who has a positive urine pregnancy test within 24 hours for urine or within 72 hours for serum prior to randomization or treatment allocation 5)Has had previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer. Participants may have received prior neoadjuvant and/or adjuvant therapy as long as it was completed >=6 months prior to randomization 6)Has received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1 or anti-programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX- 40, CD137) 7)Has received prior systemic anticancer therapy including investigational agents within 4 weeks prior to randomization or has not recovered from all adverse events (AEs) due to any previous therapies to =Grade 3) to pembrolizumab and/or any of its excipients 15)Has an active autoimmune disease that has required systemic treatment in past 2 years 16)Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis 17)Has an active infection requiring systemic therapy 18)Has a known history of human immunodeficiency virus (HIV) infection 19)Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as Hepatitis C virus [HCV] ribonucleic acid [RNA] detected qualitatively) infection 20)Has a known history of active tuberculosis 21)Has a history or current evidence of any condition (eg, known deficiency of the enzyme dihydropyrimidine dehydrogenase), therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy - OS: The time from randomization to death due to any cause - PFS: The time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Efficacy - Objective response (OR): Complete response (CR) or partial response (PR) - DOR: The time from first response (CR or PR) to subsequent disease progression, or death from any cause, whichever occurs first - Adverse events (AEs) - Study intervention discontinuation due to AEs | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Contacts
Public Contactmailbox MSDJRCT
MSD K.K.
Outcome results
None listed