. 2021 Feb 15;13(4):805. doi: 10.3390/cancers13040805

Table 4.

Eligibility criteria.

Key Inclusion Criteria	Key Exclusion Criteria
(1) Histologically confirmed gastric or esophagogastric junction adenocarcinoma. (2) Unresectable advanced, recurrent, or metastatic disease. (3) Confirmed MSI-H status by the MSI-IVD Kit (FALCO). However, subjects found to be MSI-H by other assays or to be mismatch repair (MMR)-deficient by immunohistochemistry are also eligible. In this case, MSI-H must be confirmed with the MSI-IVD Kit after enrollment. (4) Not amenable to curative approaches such as definitive chemoradiation or surgery. (5) No prior systemic anticancer treatment given as primary therapy for advanced or metastatic disease. (6) Prior adjuvant, neoadjuvant, or definitive chemotherapy, radiotherapy, or chemoradiotherapy for locally advanced gastric cancer is permitted if given as part of a curative-intent regimen and completed before enrollment. A recurrence-free period of 24 weeks is required after completion of neoadjuvant or adjuvant chemotherapy, or after completion of multimodal therapies (chemotherapy or chemoradiotherapy), for locally advanced disease. (7) ECOG performance status of 0 or 1. (8) At least one measurable lesion by computed tomography or magnetic resonance imaging per RECIST 1.1 criteria. (9) Tumor tissue must be provided for biomarker analysis in accordance with separately specified procedures.	(1) Failure to have recovered from major surgery or significant traumatic injury for at least 14 days before enrollment. (2) Radiation therapy for local control or pain control within 14 days prior to enrollment. (3) Blood transfusion or treatment with hematopoietics within 14 days before enrollment. (4) Other prior malignancy requiring active treatment within the 3 years before enrollment, with the exception of locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast. (5) Active or suspected autoimmune disease. Type 1 diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement, and skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted for enrollment. In case of uncertainty, it is recommended that a coordinating investigator be consulted prior to obtaining informed consent. (6) Conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses of >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. (7) Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4, or with any other antibody or drug specifically targeting T cell costimulatory or checkpoint pathways.

Key Inclusion Criteria

Key Exclusion Criteria

(1)
Histologically confirmed gastric or esophagogastric junction adenocarcinoma.
(2)
Unresectable advanced, recurrent, or metastatic disease.
(3)
Confirmed MSI-H status by the MSI-IVD Kit (FALCO). However, subjects found to be MSI-H by other assays or to be mismatch repair (MMR)-deficient by immunohistochemistry are also eligible. In this case, MSI-H must be confirmed with the MSI-IVD Kit after enrollment.
(4)
Not amenable to curative approaches such as definitive chemoradiation or surgery.
(5)
No prior systemic anticancer treatment given as primary therapy for advanced or metastatic disease.
(6)
Prior adjuvant, neoadjuvant, or definitive chemotherapy, radiotherapy, or chemoradiotherapy for locally advanced gastric cancer is permitted if given as part of a curative-intent regimen and completed before enrollment. A recurrence-free period of 24 weeks is required after completion of neoadjuvant or adjuvant chemotherapy, or after completion of multimodal therapies (chemotherapy or chemoradiotherapy), for locally advanced disease.
(7)
ECOG performance status of 0 or 1.
(8)
At least one measurable lesion by computed tomography or magnetic resonance imaging per RECIST 1.1 criteria.
(9)
Tumor tissue must be provided for biomarker analysis in accordance with separately specified procedures.

(1)
Failure to have recovered from major surgery or significant traumatic injury for at least 14 days before enrollment.
(2)
Radiation therapy for local control or pain control within 14 days prior to enrollment.
(3)
Blood transfusion or treatment with hematopoietics within 14 days before enrollment.
(4)
Other prior malignancy requiring active treatment within the 3 years before enrollment, with the exception of locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
(5)
Active or suspected autoimmune disease. Type 1 diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement, and skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted for enrollment. In case of uncertainty, it is recommended that a coordinating investigator be consulted prior to obtaining informed consent.
(6)
Conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses of >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
(7)
Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4, or with any other antibody or drug specifically targeting T cell costimulatory or checkpoint pathways.

Abbreviations: MSI-H, microsatellite instability-high; ECOG, Eastern Cooperative Oncology Group; RECIST, Response Evaluation Criteria in Solid Tumors; PD-1, programmed cell death-1; PD-L1, programmed cell death-ligand 1; CTLA-4, cytotoxic T lymphocyte-associated protein-4.