臨床研究等提出・公開システム

単群非盲検試験

Single Group Assignment

・組織学的に膀胱の高リスク筋層非浸潤性移行上皮癌（T1、High Grade Ta又はCIS）と診断された患者。移行上皮癌と非移行上皮癌の混合型も組入れ可能であるが、混合型の場合は移行上皮癌が主な組織型でなければならない。
・2回以上の膀胱鏡検査／TURBTの実施により切除可能な病変がない患者。（ただし、経尿道的切除で完全に切除できずにCISが残存している患者は組入れ可。）
・十分なBCG療法を実施し、BCG不応性と診断された患者。
・外科医により根治的膀胱全摘除術が不適格であると診断された、又は根治的膀胱全摘除術の施行を希望しない患者。
・バイオマーカー解析用に組織検体を提供できる患者
・Eastern Cooperative Oncology Group（ECOG）Performance Status（PS）が0、1又は2の患者。
・適切な臓器機能が保持された患者。
・妊娠する可能性がある女性患者は、治験薬の初回投与前の尿又は血清妊娠検査で陰性でなければならない。また、適切な避妊法を使用することに同意しなければならない。
・生殖機能を有する男性患者は、適切な避妊法を使用することに同意しなければならない。

- Have a histologically-confirmed diagnosis of high-risk non-muscle-invasive (T1, High Grade Ta and/or CIS) transitional cell carcinoma of the bladder. Subjects with tumors of mixed transitional/non-transitional cell histology are allowed, but transitional cell carcinoma must be the predominant histology.
- Fully resected disease at study entry (residual CIS acceptable).
- Have been treated with adequate BCG therapy and have developed high-risk NMIBC that is unresponsive to BCG therapy.
- Have elected not to undergo, or are considered ineligible for radical cystectomy, as determined by the treating surgeon.
- Have provided tissue for biomarker analysis from the most recent cystoscopy/TURBT procedures from which tumor sample is available.
- Have a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Have adequate organ function.
- Female participants of childbearing potential have a negative urine or serum pregnancy test and must be willing to use an adequate method of contraception.
- Male participants must be willing to use an adequate method of contraception.

・筋層浸潤性（T2、T3、T4）で局所進行により切除不能な又は転移性の尿路上皮癌の患者。
・膀胱以外の尿路上皮（すなわち、尿道、尿管又は腎盂）に筋層非浸潤性移行上皮癌を併発している患者。
・治験薬の初回投与前4週間以内に他の治験薬又は医療機器を用いた臨床試験に参加している、又は参加した患者。
・直近の膀胱鏡検査／TURBTから治験薬の初回投与までの間に、膀胱内化学療法又は免疫療法を実施した患者。
・治験薬の初回投与前2週間以内に化学療法、低分子分子標的薬療法、放射線療法を実施した患者、若しくは前治療による毒性から回復していない患者。
・進行性又は治療を要する他の悪性腫瘍を有する患者。ただし、皮膚の基底細胞癌、根治的治療を受けた皮膚の扁平上皮癌、及び子宮頸部上皮内癌の患者を除く。根治的治療（外科的治療又は放射線治療）を受けた前立腺癌の既往を持つ患者。
・過去2年以内に全身性の治療を必要とした活動性の自己免疫疾患を有する患者。
・非感染性の肺臓炎（間質性肺疾患）の既往又は活動性の徴候を有する患者。
・全身治療を要する活動性の感染症を有する患者。
・妊娠中、授乳中の患者、又はスクリーニング来院から治験薬最終投与後120日までの治験期間中に本人又はパートナーの妊娠を希望する患者。
・抗PD-1薬、抗PD-L1薬、抗PD-L2薬又は他の共抑制性T 細胞受容体を標的とする薬剤による治療歴を有する患者。
・ヒト免疫不全ウイルス（HIV）の感染を有する患者。
・活動性のB型肝炎又はC型肝炎を有する患者。
・治験薬の初回投与前30日以内に生ワクチンを投与した患者。

- Has muscle-invasive, locally advanced nonresectable, or metastatic urothelial carcinoma (i.e., T2, T3, T4, and / or stage IV).
- Has concurrent extra-vesical (i.e., urethra, ureter, or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium.
- Currently participating or has participated in a study of an investigational agent and received study therapy or received investigational device within 4 weeks prior to the first dose of study treatment.
- Received intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy / Transurethral Resection of Bladder Tumor (TURBT) to starting study treatment.
- Received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to starting study treatment or not recovered from adverse events due to a previously administered agent.
- Known additional malignancy that is progressing or requires active treatment excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. A history of prostate cancer that was treated with definitive intent (surgically or through radiation therapy) is acceptable provided that the following criteria are met: Stage T2N0M0 or lower; Gleason score <=7 and prostatic-specific antigen (PSA) undetectable for at least 1 year while off androgen deprivation therapy that was either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to study allocation.
- Active autoimmune disease that has required systemic treatment in the past 2 years.
- Evidence of interstitial lung disease or active non-infectious pneumonitis.
- Active infection requiring systemic therapy.
- Pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial through 120 days after the last dose of study treatment.
- Prior therapy with an anti-programmed cell death 1 (PD-1), anti-PD-ligand 2 (L2) agent, or with an agent directed to another co-inhibitory T-cell receptor.
- Known human immunodeficiency virus (HIV).
- Known active Hepatitis B or C infection.
- Received a live virus vaccine within 30 days of planned start of study treatment.
- Has had an allogeneic tissue/solid organ transplant.

18歳以上

18age old over

上限なし

No limit

男性・女性

Both

実施中

progressing