고위험 근육 침윤성 요로상피암종(MIUC) 참가자를 대상으로 Nivolumab 단독 투여와 Nivolumab 단독 투여 시 Autogene Cevumeran의 유효성과 안전성을 평가하기 위한 연구 (IMCODE004)
고위험 근육 침윤성 요로상피암종 환자의 보조 요법으로서 Autogene Cevumeran + Nivolumab과 Nivolumab의 유효성과 안전성을 평가하는 무작위 제2상, 이중 맹검, 다기관 연구
The original purpose of this study was to evaluate the efficacy of adjuvant treatment with autogene cevumeran plus nivolumab compared with nivolumab in participants with high risk MIUC. In this study participants will be enrolled in a safety run-in phase to receive autogene cevumeran + nivolumab. This phase will be conducted to monitor and ensure the safety of study participants. After all participants in the safety run-in have been enrolled to receive autogene cevumeran + nivolumab, further participants will be randomized in either autogene cevumeran + nivolumab or the nivolumab monotherapy arm.
Following the Sponsor's decision to phase out the study, as of Protocol Version 5, the primary purpose of the study is to ensure treatment continuity and safety for the participants who continue to participate in the study and receive study treatment.
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 장소
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Thessaloniki, 그리스, 546 39
- Theageneio Hospital
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Lørenskog, 노르웨이, 1474
- Akershus universitetssykehus
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Kaohisung, 대만, DUMMY_VALUE
- Chang Gung Medical Foundation - Kaohsiung
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Seongnam-si, 대한민국, 463-707
- Seoul National University Bundang Hospital
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Seoul, 대한민국, 03080
- Seoul National University Hospital
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Seoul, 대한민국, 05505
- Asan Medical Center
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Seoul, 대한민국, 06351
- Samsung Medical Center
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Aalborg, 덴마크, 9000
- Aalborg Universitetshospital
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Aarhus N, 덴마크, 8200
- Aarhus Universitetshospital
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Herlev, 덴마크, 2730
- Herlev Hospital
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Berlin, 독일, 10967
- Vivantes Klinikum Am Urban
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Heidelberg, 독일, 69120
- Uniklinikum Heidelberg
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Herne, 독일, 44625
- Marien Hospital Herne
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Stuttgart, 독일, 70174
- Klinikum Stuttgart - Katharinenhospital
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New Jersey
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Basking Ridge, New Jersey, 미국, 07920
- Memorial Sloan Kettering Cancer Center Basking Ridge
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Middletown, New Jersey, 미국, 07748
- MSK Monmouth
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Montvale, New Jersey, 미국, 07645
- MSK Bergen
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New York
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Commack, New York, 미국, 11725
- MSK Commack
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Harrison, New York, 미국, 10604
- MSK Westchester
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New York, New York, 미국, 10065
- Memorial Sloan Kettering Cancer Center
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Uniondale, New York, 미국, 11553
- MSK Nassau
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Gothenburg, 스웨덴, 413 45
- Sahlgrenska University Hospital
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Madrid, 스페인, 28040
- Hospital Clinico San Carlos
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Seville, 스페인, 41013
- Hospital Universitario Virgen del Rocio
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Zaragoza, 스페인, 50009
- Hospital Clinico Universitario Lozano Blesa
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, 스페인, 08908
- ICO L'Hospitalet
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Sant Andreu de la Barca, Barcelona, 스페인, 08740
- Vall d'Hebron Institute of Oncology (VHIO), Barcelona
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Ciudad Autonoma Buenos Aires, 아르헨티나, C1199ABB
- Hospital Italiano
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London, 영국, EC1M 6BQ
- Barts & London School of Med;Medical Oncology
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Apulia
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Bari, Apulia, 이탈리아, 70124
- A.O. Universitaria Ospedale Consorziale Policlinico Di Bari
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Lazio
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Rome, Lazio, 이탈리아, 00144
- IFO - Istituto Regina Elena
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Piedmont
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Orbassano, Piedmont, 이탈리아, 10043
- A.O. Universitaria S. Luigi Gonzaga
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Veneto
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Verona, Veneto, 이탈리아, 37134
- A.O.U di Verona Policlinico G.B. Rossi
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Quebec
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Montreal, Quebec, 캐나다, H3T 1E2
- Jewish General Hospital
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Montreal, Quebec, 캐나다, H4A 3J1
- McGill University Health Center
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Bydgoszcz, 폴란드, 85-796
- Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
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Skórzewo, 폴란드, 60-185
- AIDPORT Sp. z o. o.
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South Australia
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Elizabeth Vale, South Australia, 호주, 5112
- Lyell McEwin Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Participants must have the capacity to participate/enroll in the study and to provide informed consent
- Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma [TCC]) of the bladder or upper urinary tract
- Tumor-node-metastasis (TNM ) classification (Union for International Cancer Control [UICC]/American Joint Committee on Cancer [AJCC] 7th edition) at pathological examination of surgical resection specimen of (y)pT3-4 or (y)pN+ and M0
- Surgical resection of MIUC of the bladder or upper tract
- Participants who have received neoadjuvant chemotherapy (NAC), including antibody drug-conjugate, either alone or in combination with a checkpoint inhibitor (CPI), are eligible
- Participants who have not received any prior NAC are also eligible, provided they meet one of the following criteria, which would make them ineligible to receive adjuvant cisplatin-based therapy: participant refusal, cisplatin ineligibility or investigator decision
- Tumor tissue must be provided for biomarker analysis
- Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan of the pelvis, abdomen, and chest no more than 28 days prior to randomization
- Full recovery from cystectomy or nephroureterectomy within 120 days following surgery
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- Negative human immunodeficiency virus (HIV) test at screening
- Negative hepatitis B surface antigen (HbsAg) test at screening
- Positive hepatitis B surface antibody (HBsAb), or a negative HBsAb at screening accompanied by either of the following: negative total hepatitis B core antibody (HBcAb) or positive total HBcAb test followed by quantitative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < 500 international units/milliliter (IU/mL)
- Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening
Exclusion Criteria:
- Partial cystectomy in the setting of bladder cancer primary tumor or partial nephroureterectomy in the setting of renal pelvis primary tumor
- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
- Adjuvant chemotherapy, immunotherapy, or radiation therapy for UC following surgical resection
- Prior active malignancies within 3 years prior to randomization
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Autogene Cevumeran + Nivolumab
Participants will receive autogene cevumeran along with nivolumab intravenously (IV) at a recommended dose at specified timepoints. |
Autogene cevumeran will be administered as an IV infusion per the schedule specified in the arm.
다른 이름들:
Nivolumab will be administered as an IV infusion per the schedule specified in the arm.
다른 이름들:
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활성 비교기: Nivolumab
Participants will receive 480 milligrams (mg) of nivolumab, IV, once every 4 weeks (Q4W) for 1 year. |
Nivolumab will be administered as an IV infusion per the schedule specified in the arm.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Number of Participants With Adverse Events (AEs)
기간: Up to approximately 15 months
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Up to approximately 15 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- BO45230
- 2023-509023-40-00 (씨티스)
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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