臨床研究等提出・公開システム

単一群、非盲検、非対照、単群比較、治療

Single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose

・組織学的に悪性胸膜中皮腫と診断され、かつ、進行／切除不能であること
・modified RECISTに基づく治験担当医師の評価により、少なくとも1つの測定可能病変を有する、全身療法を受けたことがない患者
・初回投与前3日以内のECOG PSが0又は1の患者
・3ヵ月以上の生存が見込まれる患者
・適切な臓器機能を有する患者
男性患者：
・以下の項目に同意した男性患者
・精子を提供しないこと。
・異性間性交渉をしない
又は
・無精子が確認されない限り、避妊法の使用に同意すること。
女性患者：
・妊娠しておらず、授乳中でなく、かつ以下の条件のいずれかを満たす女性患者：
・妊娠可能な女性に該当しない。
又は
・妊娠可能な女性であるが、避妊法を用いている、又は異性間性交渉をしない。

- Has histologically confirmed diagnosis of advanced/unresectable malignant pleural mesothelioma (MPM)
- Have at least one measurable disease, which is systemic therapy naive, radiologically assessed by the local site investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST)
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days before the first administration
- Has a life expectancy of at least 3 months
- Demonstrate adequate organ function
- Male participants are eligible to participate if they agree to refrain from donating sperm, plus either agree to remain abstinent or agree to use contraception unless confirmed to be azoospermic
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child bearing potential (WOCBP), OR is a WOCBP and using a contraceptive method or be abstinent from heterosexual intercourse

・治験薬の割付け前72時間以内の妊娠検査の結果が陽性であった妊娠可能な女性
・抗PD-1、抗PD-L1、抗PD-L2の薬剤又は他の補助刺激性又は共抑制性T細胞受容体（CTLA-4、OX-40、CD137等）を標的とした薬剤の治療歴を有する患者
・悪性胸膜中皮腫に対する全身療法（治験薬も含む）を受けた患者
注：患者が術前又は術後補助療法を受けていた場合、少なくとも割付け前6ヵ月までに最終投与を完了し、術前又は術後補助療法によるすべての毒性から回復（Grade 1以下又はベースラインまで）していること。Grade 2以下のニューロパチーの患者は組入れ可能。
・治験薬初回投与前6ヵ月以内に肺に対して30 Gyを超える放射線療法を受けた患者
・治験薬初回投与前7日までに緩和放射線療法を完了していない患者
注：放射線療法に関連したすべての毒性から回復しており、コルチコステロイド投与を必要とせず、放射線性肺臓炎の既往がないこと。
・治験薬初回投与前3ヵ月以内に大手術を受けた患者
・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
・現在他の治験薬の治験に参加している、又は治験薬初回投与前4週間以内に他の治験薬の治験に参加した、若しくは治験用の医療機器を用いた患者
・免疫不全状態と診断された患者、又は治験薬初回投与前7日以内に長期全身性ステロイド療法（プレドニゾロン換算で10 mg／日超）や他の免疫抑制療法による治療を受けた患者
・過去5年以内に進行性又は治療が必要な他の悪性腫瘍を有する患者
ただし、根治的治療を受けた皮膚の基底細胞癌、皮膚の扁平上皮癌、上皮内がん（例：上皮内乳癌及び子宮頸部上皮内癌）の患者は組入れ可能。
・活動性の中枢神経系（CNS）への転移又は癌性髄膜炎を有する患者
・モノクローナル抗体又は治験薬の添加剤に対する重度（Grade 3以上）の過敏症を有する患者
・間質性肺疾患／肺臓炎を合併している、も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。
・治療を必要とする心嚢液、症候性の腹水又は胸水を有する患者。治療（胸腔穿刺又は穿刺による治療を含む）により臨床的に症状が安定している患者は組入れ可能。
・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
・治験担当医師の判断により、治験結果に影響を与える、患者の治験の完遂を妨げる、又は、患者の治験の参加が患者の利益とならないと考えられるあらゆる疾患、治療歴又は臨床検査値異常の既往又は合併を有する患者

- A WOCBP who has a positive pregnancy test within 72 hours prior to treatment allocation
- Has received prior therapy with an anti-programmed cell-death 1 (anti PD-1), anti programmed cell-death ligand 1 (anti-PD-L1), or anti programmed cell-death ligand 2 (anti PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.,CTLA-4, OX-40, CD137)
- Has previously received systemic anti-cancer therapy (including investigational agents) to MPM. Note: Participants who received (neo) adjuvant previously may be eligible, only if the last dose of chemotherapy was completed at least 6 months before registration. Such participants must have recovered from all adverse events (AEs) due to previous (neo) adjuvant therapies to <=Grade 1 or baseline. Participants with <=Grade 2 neuropathy may be eligible.
- Received radiation therapy to the lung that is > 30 gray (Gy) within 6 months of the first dose of trial treatment
- Completed palliative radiotherapy within 7 days of the first dose of trial treatment. Note: Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- Had a major surgery within 3 months prior to the first administration in this study
- Has received a live vaccine within 30 days prior to the first dose of study drug
- 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 intervention
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
- 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
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has had a severe hypersensitivity reaction (>=Grade 3) to treatment a monoclonal antibody/components of the study intervention
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Is being treated for pericardial effusion, or has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
- Has an active infection requiring systemic therapy
- Has a history or current evidence of any condition, 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 the participant to participate, in the opinion of the treating investigator

20歳以上

20age old over

上限なし

No limit

男性・女性

Both

試験完了

completed