비소세포폐암(NSCLC) 또는 간세포암종(HCC)에 대한 CCR2/5 억제제 또는 항IL-8과 함께 하는 신보조제 니볼루맙
Tisch Cancer Institute - BMS 연구 번호 CA027-005: NSCLC 또는 HCC에 대한 신보강 Nivolumab + BMS-813160(CCR2/5-억제제) 또는 BMS-986253(항IL-8)
The purpose of this research study is to study the effect of giving nivolumab with CCR2/5-inhibitor or anti-IL-8 before surgery, and after surgery, with the goal of determining if this medicine results in:
- A significant immune response against their tumor (which the study team will see in the tumor that is taken out at the time of surgery)
- Improvement in long term survival rates
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Objectives:
Cohorts A,B (NSCLC):
Primary Objective: Major Pathologic Response (MPR) Secondary Objectives: Time to surgery, tolerability and safety, radiographic response
Cohorts C,D,E (HCC):
Primary Objective: Significant tumor necrosis (STN) Secondary Objectives: Time to surgery, tolerability and safety, radiographic response
Diagnosis and Main Inclusion Criteria:
Patients must have disease deemed resectable before enrollment.
Study Product:
Nivolumab 480mg (q4w, dosed twice before surgery and three times following recovery from surgery) BMS-813160 (CCR2/5-inhibitor) 300mg oral twice a day for 28 days BMS-986253 (anti-IL-8) 2400mg once
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
New York
-
New York, New York, 미국, 10029
- Icahn School of Medicine at Mount Sinai
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosis of NSCLC or HCC
- Willing to provide blood samples
- Willing to undergo leukapheresis at Mount Sinai Hospital or New York Blood Bank
- Willing to have excisional or core needle biopsies
- At least 18 years of age
- ECOG 0-1
- Surgical candidate for resection of their tumor
- Agree to use adequate contraception
- Adequate organ and marrow function
Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy within 4 months for a different primary tumor or patients who have received locoregional therapy for the target lesion
- Patients receiving any other investigational agents
- Patients with metastatic disease for whom the intent of surgery would not be curative
- Uncontrolled intercurrent illness
- Pregnant or nursing
- Has a diagnosis of primary immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days
- Has active autoimmune disease that has required systemic treatment in the past year
- Has a known additional malignancy that is progressing and/or requires active treatment
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not the in the best interest of the patient to participate
- HIV positive with detectable viral load or anyone not on stable anti-viral regimen
- Has known active Hepatitis B
- History of allogeneic hematopoietic cell transplantation or solid organ transplantation
- Documented allergic or hypersensitivity response to any protein therapeutics
- Patients may not have prolonged QRS or QTc
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 |
|---|---|
|
실험적: Cohort A
NSCLC: Nivolumab + BMS-813160 |
q4w, dosed twice before surgery and three times following recovery from surgery by injection 300mg oral twice a day for 28 days
다른 이름들:
|
|
실험적: Cohort B
NSCLC: Nivolumab + BMS-986253 |
q4w, dosed twice before surgery and three times following recovery from surgery by injection 2400mg once by injection
다른 이름들:
|
|
실험적: Cohort C
HCC: Nivolumab |
q4w, dosed twice before surgery and three times following recovery from surgery by injection |
|
실험적: Cohort D
HCC: Nivolumab + BMS-813160 |
q4w, dosed twice before surgery and three times following recovery from surgery by injection 300mg oral twice a day for 28 days
다른 이름들:
|
|
실험적: Cohort E
HCC: Nivolumab + BMS-986253 |
q4w, dosed twice before surgery and three times following recovery from surgery by injection 2400mg once by injection
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Major Pathologic Response (MPR)
기간: 2 Years
|
MPR is defined as <10% viable tumor within resection, at time of surgery. |
2 Years
|
|
Significant Tumor Necrosis (STN)
기간: 2 Years
|
STN is defined as necrosis of >70% of tumor base on pathologic analysis of gross tumor resection at time of surgery. |
2 Years
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to Surgery
기간: 2 Years
|
Measured as the time in days that elapses between the first dose of neoadjuvant therapy and surgical resection. |
2 Years
|
|
Percent of individuals who experience adverse events
기간: 2 Years
|
Safety and Tolerability defined by the percent of individuals who experience adverse events at any point during the neoadjuvant period, or within 30 days following the final dose of nivolumab received. |
2 Years
|
|
Percent of individuals who experience radiographic response
기간: 2 Years
|
As per RECIST v1.1 as determined by pre-surgical imaging, following receipt of the neoadjuvant therapy. For NSCLC this will be based on CT imaging, while for HCC this imaging will be based on MRI radiographic post-contract subtraction. |
2 Years
|
|
Progression-free survival (PFS)
기간: 2 Years
|
Defined as the time, in days, between treatment initiation and when the patient is found to have recurrent and/or metastatic disease on imaging, or death for any reason. |
2 Years
|
|
Overall Survival (OS)
기간: 5 Years
|
Defined as the time, in days, between treatment initiation and when the patient dies from any cause regardless of etiology. |
5 Years
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Thomas Marron, MD PhD, Icahn School of Medicine at Mount Sinai
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
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
- GCO 19-1754
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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