locally advanced resectable gastric or GEJ adenocarcinoma
Conditions
Interventions
investigational material(s)
Generic name etc : pembrolizumab + chemotherapy (cisplatin + capecitabine or 5-FU)
INN of investigational material : pembrolizumab, cisplatin, capecitabine, 5-FU
Therapeuti
Sponsors
MSD K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have previously untreated localized gastric or GEJ adenocarcinoma as defined by T3 or greater primary lesion or the presence of any positive nodes - N+ (clinical nodes) without evidence of metastatic disease. 2. Plan to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice. 3. Be willing to provide tissue from a tumor lesion at baseline and at time of surgery 4. Have an ECOG performance status of 0 to 1, to be performed within 3 days prior to the first dose of study treatment 5. Have adequate organ function 6. Male participants of childbearing potential must agree to use an adequate method of contraception as outlined in the protocol, for the course of the study through 180 days after the last dose of chemotherapy. 7. Female participants of childbearing potential must be willing to use an adequate method of contraception as outlined in the protocol, for the course of the study through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater. 8. Have a life expectancy of greater than 6 months
Exclusion criteria
Exclusion criteria: 1. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. 2. Has an active infection requiring systemic therapy. 3. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. 4. 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 co-inhibitory T-cell receptor (ie, CTLA-4, OX-40, CD137) or has previously participated in a MSD pembrolizumab (MK-3475) clinical study. 5. Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy. 6. Has a diagnosis of immunodeficiency. Is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose of study treatment. 7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. 8. Has a known severe hypersensitivity (>= Grade 3) to any of the study chemotherapy agents and/or to any of their excipients. 9. Has an active autoimmune disease that has required systemic treatment in past 2 years. 10. Has a known history of human immunodeficiency virus (HIV) infection. 11. 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. 12. Has a known history of active tuberculosis (TB; Bacillus tuberculosis). 13. Female participants: Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater. 14. Male participants: Is expecting to father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of chemotherapy. 15. Has received a live vaccine within 30 days prior to the first dose of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy safety 1) To evaluate Event-free Survival (EFS). Event-free survival (EFS) based on RECIST 1.1 as assessed by the investigator. EFS is defined as the time from randomization to the first of the following events: - Radiographic disease progression per RECIST 1.1 - Local or distant recurrence as assessed by CT scan or biopsy if indicated (for participants who are disease free after surgery) - Clinical progression as evidenced by peritoneal carcinomatosis confirmed by pre operative laparoscopy or laparotomy (for participants who are confirmed to be free of peritoneal involvement by laparoscopy at screening) - Death due to any cause A second primary malignancy is not considered as an EFS event. 2) To evaluate Pathological Complete Response (pathCR). pathCR Rate: pathCR rate is defined as the proportion of participants having pathCR. 3) To evaluate Overall Survival (OS). OS is defined as the time from randomization to death due to any cause. 4) To evaluate the safety and tolerability. AEs, Study treatment discontinuations due to AEs. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy To evaluate the disease-free survival (DFS). DFS based on RECIST 1.1 as assessed by investigator. DFS is defined as the time from post-surgery baseline scan until the first occurrence of: - Local or distant recurrence - Death from any cause | — |
Countries
Europe, Japan, North America
Contacts
Public ContactMSDJRCT inquiry mailbox
MSD K.K.
Outcome results
None listed