臨床研究等提出・公開システム

無作為化、プラセボ対照、多施設共同、二重盲検、第III相試験

Randomized, Placebo and active control, multi-site, Double-blind, Phase III

1) 転移性病変がなく、原発部位がT3以深又はリンパ節転移陽性と定義される未治療の局所性胃腺癌あるいは食道胃接合部腺癌と診断された患者。
2) 各地域で実施されている標準的な臨床病期分類に基づき、術前補助療法及び外科的切除術が予定されている患者。
3) ベースライン及び手術時の腫瘍検体を提供する意思のある患者。
4) 治験薬初回投与前3日以内のECOG Performance Status が0又は1であった患者。
5) 適切な臓器機能が保持された患者。
6) 生殖可能な男性患者：化学療法の最終投与後180日まで、プロトコールに記載した適切な避妊法を使用することに同意する患者。
7) 妊娠可能な女性患者：化学療法の最終投与後180日及び MK-3475の最終投与後120日まで、プロトコールに記載した適切な避妊法を使用することに同意する患者。
8) 6ヵ月以上の生存が期待される患者。

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

1) 間質性肺疾患／肺臓炎を合併、若しくはステロイド投与が必要な（非感染性の）間質性肺疾患／肺臓炎の既往を有する患者。なお、間質性肺疾患／肺臓炎には放射線肺臓炎も含む。
2) 全身性の治療を必要とする活動性の感染症を有する患者。
3) 治験薬初回投与前4週間以内に他の治験に参加し、治験薬若しくは医療機器を用いた、又は現在用いている患者。
4) 抗PD-1、抗PD-L1、抗PD-L2の薬剤又は他のT 細胞補助刺激受容体（例：CTLA-4、OX-40、CD137）を標的とした薬剤の治療歴を有する患者、又は過去にMK-3475の臨床試験に参加した患者。
5) 過去に、原疾患に対して全身性の治療（未承認薬も含む）を受けた患者。
6) 免疫不全症を有する患者。治験薬初回投与前14日以内に長期全身性コルチコステロイド治療（プレドニゾロン換算で10 mg/日を超える）や他の免疫抑制剤による治療を受けた患者。
7) 過去5年以内に進行性又は治療が必要な他の悪性腫瘍の既往がある患者。
注：根治可能な治療を受けた皮膚の基底細胞癌、皮膚の扁平上皮癌、上皮内癌（乳癌又は子宮頸部上皮内癌など）の患者は除外しない。
8) 治験薬として用いる化学療法及び／又はその添加剤に対してGrade 3以上の重度な過敏反応の既往歴を有する患者。
9) 過去2年以内に全身性の治療を要した活動性の自己免疫疾患を有する患者。
10) HIV 感染の既往を有する患者。
11) B 型肝炎（HBs 抗原陽性）の既往歴又は活動性のC 型肝炎（HCV RNA 定性陽性等）を有する患者。
12) 活動性の結核（Bacillus tuberculosis）の既往を有する患者。
13) 妊娠中若しくは授乳中の女性患者、又はスクリーニング時来院から化学療法の最終投与後180日及びMK-3475の最終投与後120日までの予定される治験期間中に妊娠を希望する女性患者。
14) スクリーニング時来院から化学療法の最終投与後180日までの予定される治験期間中にパートナーの妊娠を希望する男性患者。
15) 治験薬初回投与前30日以内に生ワクチンの接種を受けた患者。

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.

18歳以上

18age old over

上限なし

No limit

男性・女性

Both

試験完了

completed