재발/내화성 소 세포 폐암을 가진 중국 참가자에서 BMS-986489의 안전성, 내약성, 약동학 및 예비 효능을 평가하는 연구
재발/내화성 소형 세포 폐가있는 중국 참가자에서 BMS-986489 (BMS-986012 + Nivolumab 고정 용량 조합)의 안전성, 내약성, 약동학 및 예비 효능을 평가하기위한 개방형, 단일 암, 다기관, 1 단계 연구. 암
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of BMS-986489 in Chinese participants with R/R SCLC (Relapsed/Refractory Small Cell Lung Cancer).
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 1단계
연락처 및 위치
연구 장소
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Shanghai, 중국, 200120
- Local Institution - 0002
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100142
- Local Institution - 0004
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Shandong
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Jinan, Shandong, 중국, 250117
- Local Institution - 0003
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Linyi, Shandong, 중국, 276001
- Local Institution - 0001
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Zhejiang
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Hangzhou, Zhejiang, 중국, 310016
- Local Institution - 0005
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Participants must have histologically or cytologically documented SCLC (small cell lung cancer). Participants with either limited or extensive disease stage at the initial diagnosis, who have received at least one prior line of systemic therapy, are eligible.
i) For initial limited stage (LS) SCLC:.
A. Those who progressed or recurred after more than 6 months treatment-free interval following treatment of curative surgical resection, systemic therapy, or radiotherapy, and subsequently received at least one line of systemic therapy to treat the recurrence or progression, and then progressed, or were intolerant to the prior systemic therapy per the assessment of investigators, these participants will be eligible, or
B. Who progressed or recurred within 6 months after treatment of curative surgical resection, systemic therapy, or radiotherapy, no matter if these participants have received subsequent systemic therapy, these participants will be eligible.
ii) For initial extensive stage (ES) SCLC, participants must have received at least one line of platinum-based systemic therapy (with/without immunotherapy), and then progressed, or been intolerant to the prior systemic therapy per the assessment of investigators.
A. Note: 1) For ES-SCLC with only one line of platinum-based regimen as well as chemotherapy-free interval is more than 6months when progression, only when participants refuse or are ineligible for re-treatment with platinum-based doublet per the assessment of investigators, these participants will be eligible. 2) If participants receive re-treatment with a platinum-based regimen, it is considered a second line of therapy.
- Participants must have a life expectancy of ≥12 weeks.
- Participants must have at least 1 measurable lesion outside the central nervous system (CNS) by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Exclusion Criteria:
- Untreated symptomatic CNS metastases.
- Leptomeningeal disease.
- Pleural effusion which cannot be controlled with appropriate interventions.
- Malignancy-related superior vena cava syndrome.
- Participants with an active, known or suspected, autoimmune disease.
- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to first study treatment.
- Unresolved toxicity from prior anti-tumor therapy.
- Prior treatment with an anti-fuc-GM1 therapy or any other drug specifically targeting fuc-GM1.
- Other protocol-defined inclusion/exclusion criteria apply.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: BMS-986489
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Specified dose on specified days |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
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Number of participants with adverse events (AEs)
기간: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Number of participants with Serious AEs (SAEs)
기간: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Number of participants with AEs leading to discontinuation of study treatment
기간: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Number of participants with select AEs
기간: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Number of participants with immune-mediated AEs (IMAEs)
기간: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Number of deaths
기간: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Number of participants with laboratory abnormalities
기간: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Maximum observed concentration (Cmax) for BMS-986012
기간: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Time of maximum observed concentration (Tmax) for BMS-986012
기간: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Trough observed plasma concentration (Ctrough) for BMS-986012
기간: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Concentration at the end of a dosing interval (Ctau) for BMS-986012
기간: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Average concentration over a dosing interval ([AUC(TAU)/TAU]) (Cavg(TAU)) for BMS-986012
기간: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Area under the concentration-time curve within one dosing interval (AUC(TAU)) for BMS-986012
기간: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Total body clearance (CLT) for BMS-986012
기간: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Observed concentration at end of infusion (Ceoi) for BMS-986012
기간: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of participants with anti-drug antibodies (ADAs) to BMS-986012
기간: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Number of participants with ADAs to nivolumab
기간: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Ctrough for nivolumab
기간: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Ceoi for nivolumab
기간: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Overall Response (OR)
기간: Up to 19 months after last participant's first treatment
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Achievement of best response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, assessed by the investigator. |
Up to 19 months after last participant's first treatment
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Disease Control (DC)
기간: Up to 19 months after last participant's first treatment
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Achievement of best response of CR or PR or stable disease (SD) using RECIST v1.1 criteria, assessed by the investigator. |
Up to 19 months after last participant's first treatment
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Duration of Response (DOR)
기간: Up to 19 months after last participant's first treatment
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Time from first response (CR or PR) to first documented disease progression by investigator or death, whichever occurs first. For participants who did not have an event, the DOR will be censored on the date of their last tumor assessment. |
Up to 19 months after last participant's first treatment
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공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Bristol-Myers Squibb, Bristol-Myers Squibb
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
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
기타 연구 ID 번호
기타 연구 ID 번호
- CA245-0002
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
IPD 공유 기간
See Plan Description
IPD 공유 액세스 기준
See Plan Description
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .