BCG-처치 경험이 없는 고등급 비근육침습성 방광암 환자에서 방광내 TARA-002와 방광내 화학요법(연구자 선택)의 효능 및 안전성 비교 (ADVANCED-3)
BCG-경험이 없는 고등급 비근육침윤성 방광암 환자에서 방광내 TARA-002와 연구자의 선택에 따른 방광내 화학요법의 효능 및 안전성을 비교 평가하는 3상 무작위 연구
The goal of this clinical trial is to learn if TARA-002 can treat high-grade non-muscle invasive bladder cancer (NMIBC) in BCG-naïve adults 18 years of age or older.
The main questions it aims to answer are:
- Can the study drug help participants with this type of cancer?
- Is the study drug safe?
- What are the side effects of the study drug?
Researchers will compare TARA-002 to chemotherapy to see if TARA-002 works to treat NMIBC.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 3단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Chief R&D Officer
- 전화번호: 16468440337
- 이메일: clinicaltrials@protaratx.com
연구 장소
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Arizona
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Queen Creek, Arizona, 미국, 85140
- 모병
- East Valley Urology Center of Arizona
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연락하다:
- Use Central Contact
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Arkansas
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Little Rock, Arkansas, 미국, 72211
- 모병
- Arkansas Urology
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연락하다:
- Use Central Contact
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California
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Bakersfield, California, 미국, 93301
- 모병
- Michael Oefelein Clinical Trials
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Georgia
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Atlanta, Georgia, 미국, 30319
- 모병
- Urology of Greater Atlanta - Sandy Springs
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연락하다:
- Use Central Contact
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Missouri
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St Louis, Missouri, 미국, 63110
- 모병
- Renown Regional Medical Center
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연락하다:
- Use Central Contact
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South Carolina
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Myrtle Beach, South Carolina, 미국, 29572
- 모병
- START - Carolinas
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연락하다:
- Use Central Contact
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Texas
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Arlington, Texas, 미국, 76017
- 모병
- Urology Partners of North Texas
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연락하다:
- Use Central Contact
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Austin, Texas, 미국, 78745
- 모병
- Urology Austin, LLC
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연락하다:
- Use Central Contact
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Houston, Texas, 미국, 77027
- 모병
- Houston Metro Urology
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연락하다:
- Use Central Contact
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Ivano-Frankivsk, 우크라이나, 76018
- 모병
- Arenia - Ivano-Frankivsk
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연락하다:
- Use Central Contact
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Kapitanivka, 우크라이나, 08111
- 모병
- Arensia Kapitanivka - PPDS
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연락하다:
- Use Central Contact
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or female participants 18 years of age or older at the time of signing informed consent
- Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry
- Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease
- Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis, or participants who received ≤2 doses of BCG within the 24 months prior to the most recent CIS diagnosis
Exclusion Criteria:
- Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory
- Central confirmed variant histology
- Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment
- Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past)
- Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history
For more information on eligibility criteria, please contact the Sponsor.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: TARA-002 (Arm A)
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Participants will receive 6 weekly instillations of TARA-002. Participants confirmed to have a CR at Week 12 will enter the maintenance treatment period and will receive 3 additional weekly instillations of TARA-002 every 3 months up to Month 19, and then 3 weekly doses at Month 25. Participants who are eligible for reinduction at Week 12 will receive 6 additional weekly instillations of TARA-002. Participants who undergo reinduction and are confirmed to have a CR at Week 24 will enter the maintenance regimen treatment period and will receive 3 weekly instillations of TARA-002 every 3 months up to Month 19, and then 3 weekly doses at Month 25. |
|
활성 비교기: 연구자의 선택에 따른 방광 내 화학요법
|
Participants will receive 6 weekly instillations of Investigator's choice of intravesical chemotherapy. Participants confirmed to have a CR at Week 12 will enter the maintenance regimen treatment period and will receive one intravesical instillation of Investigator's choice of intravesical chemotherapy every 1 month up to Month 25. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of high-grade complete response
기간: Month 6
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Incidence of high-grade complete response of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy determined by cystoscopy, urine cytology, and bladder biopsy (if applicable) |
Month 6
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Duration of high-grade complete response
기간: Up to Month 60
|
Duration of high-grade complete response of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
Up to Month 60
|
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Treatment emergent adverse events
기간: Up to Month 60
|
Incidence and severity of treatment emergent adverse events (TEAEs) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
Up to Month 60
|
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Treatment emergent serious adverse events
기간: Up to Month 60
|
Incidence and severity of treatment emergent serious adverse events (TESAEs) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
Up to Month 60
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High-grade complete response rate
기간: At Months 3, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60
|
High-grade complete response rate of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy determined by cystoscopy, urine cytology, and bladder biopsy (if applicable) |
At Months 3, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60
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High-grade complete response rate (CIS only)
기간: Month 6
|
High-grade complete response rate of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy determined by cystoscopy, urine cytology, and bladder biopsy (if applicable) in sub-group of participants with CIS only |
Month 6
|
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Event-free survival
기간: Up to Month 60
|
Event-free survival (EFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
Up to Month 60
|
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Recurrence-free survival
기간: Up to Month 60
|
Recurrence-free survival (RFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
Up to Month 60
|
|
Progression-free survival
기간: Up to Month 60
|
Progression-free survival (PFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
Up to Month 60
|
|
Disease-specific progression-free survival
기간: Up ro Month 60
|
Disease-specific progression-free survival (DSPFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
Up ro Month 60
|
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Overall survival
기간: Up to Month 60
|
Overall survival (OS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
Up to Month 60
|
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Disease-specific survival
기간: Up to Month 60
|
Disease-specific survival (DSS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
Up to Month 60
|
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Time to cystectomy
기간: Up to Month 60
|
Time to cystectomy of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
Up to Month 60
|
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Time to recurrence delayed cystectomy
기간: Up to Month 60
|
Time to recurrence delayed cystectomy of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
Up to Month 60
|
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Time to progression
기간: Up to Month 60
|
Time to progression of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
Up to Month 60
|
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Time to disease worsening
기간: Up to Month 60
|
Time to disease worsening of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy |
Up to Month 60
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- TARA-002-301
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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