A Study Evaluating the Effect of Pembrolizumab (MK-3475) in Participants With Renal Cell Cancer (MK-3475-031)
2020년 6월 22일 업데이트: Merck Sharp & Dohme LLC
A Clinical Trial to Evaluate the Effect of Neoadjuvant MK-3475 (Pembrolizumab) Therapy on Intratumoral Immune Infiltrates in Renal Cell Cancer (RCC) Patients Undergoing Surgical Resection
This study will examine the effect of treatment with the neoadjuvant antibody pembrolizumab (MK-3475) on tumors of participants with renal cell cancer (RCC).
The primary hypotheses are that pembrolizumab is well tolerated in participants undergoing RCC tumor resection; and that pembrolizumab will stimulate a 2-fold or greater increase in intratumoral lymphocytic infiltration in at least 30% of participants with RCC.
연구 개요
상태
종료됨
정황
연구 유형
중재적
등록 (실제)
10
단계
- 1단계
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Have a newly diagnosed RCC, with a primary tumor diameter of more than 4 cm (>= T1b), not previously treated, and be a candidate for operative tumor resection
- Be willing and able to undergo pre-treatment baseline image-guided core biopsy of their primary RCC
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- Demonstrate adequate organ function
- Female is not breast feeding, is postmenopausal or surgically sterile; demonstrates non-pregnant state, and agrees to use two acceptable methods of birth control throughout the trial, until 120 days after the last dose of treatment
- Male with female partner of childbearing potential agrees to use adequate method of contraception throughout study, until 120 days after last dose of treatment or last blood draw.
Exclusion Criteria:
- Is currently participating in, or has participated in a study with an investigational agent or device within 4 weeks prior to first dose of study therapy
- Has a diagnosis of immunosuppression or has received systemic steroid therapy, or any other form of immunosuppressive therapy within 4 weeks prior to first dose of study therapy
- Has had prior chemotherapy, targeted small molecule, or radiation therapy for treatment of RCC
- Has a known additional (other than RCC) malignancy that is progressing or requires active treatment
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has an active, or documented history of autoimmune disease, with the exceptions of vitiligo or resolved childhood asthma/atopy
- Has a history of (non-infectious) pneumonitis that required treatment with steroids or current pneumonitis.
- Has an active infection requiring systematic therapy
- Is receiving anticoagulant therapy, with the exception of low dosage aspirin
- Has severe cardiovascular disease or symptomatic ischemic heart disease
- Has hepatic decompensation
- Has uncontrolled thyroid dysfunction
- Has uncontrolled diabetes mellitus
- Has known psychiatric or substance abuse disorders
- Female is pregnant or breastfeeding
- Is expecting to conceive children within the projected maximum duration of the trial, extending through 120 days after the last dose of treatment or the last blood draw
- Has received prior therapy with any antibody or drug (including ipilimumab) specifically targeting T-cell co-stimulation or checkpoint pathway
- Has a known history of human immunodeficiency virus (HIV)
- Has known active hepatitis B or C
- Has received a live vaccine within 30 days prior to screening
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Neoadjuvant Pembrolizumab + RCC Resection
Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles).
Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04.
|
200 mg administered by IV, once every 3-week cycle for a maximum of 2 cycles
다른 이름들:
Standard of care surgical resection of RCC tumor
200 mg administered by IV, once every 3-week cycle for a maximum of 17 cycles
다른 이름들:
|
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실험적: RCC Resection
Participants received SOC renal cell carcinoma (RCC) surgical resection; and then may have received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles).
Post-resection pembrolizumab was only administered to participants who enrolled under Protocol Amendment 04.
|
Standard of care surgical resection of RCC tumor
200 mg administered by IV, once every 3-week cycle for a maximum of 17 cycles
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants With an Adverse Event (AE) During the Neoadjuvant Pembrolizumab Regimen
기간: Up to Week 16
|
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
The number of participants who experienced an AE during their regimen of neoadjuvant pembrolizumab was presented.
|
Up to Week 16
|
|
Number of Participants Who Discontinued Treatment Due to an Adverse Event
기간: Up to 56 weeks
|
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
The number of participants who discontinued study drug due to an adverse event is presented.
|
Up to 56 weeks
|
|
Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral CD3+ Lymphocytic Infiltration
기간: Baseline and Week 7
|
The number of participants who received neoadjuvant pembrolizumab and showed a 2-fold or greater change from baseline in intratumoral CD3+ lymphocytic infiltration is presented.
Evaluations were based on pathologist score.
|
Baseline and Week 7
|
|
Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral CD8+ Lymphocytic Infiltration
기간: Baseline and Week 7
|
The number of participants who received neoadjuvant pembrolizumab and showed a 2-fold or greater change from baseline in intratumoral CD8+ lymphocytic infiltration is presented.
Evaluations were based on pathologist score.
|
Baseline and Week 7
|
|
Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral FoxP3+ Lymphocytic Infiltration
기간: Baseline and Week 7
|
The number of participants who received neoadjuvant pembrolizumab and showed a 2-fold or greater change from baseline in intratumoral FoxP3+ (forkhead box protein P3 positive) lymphocytic infiltration is presented.
Evaluations were based on pathologist score.
|
Baseline and Week 7
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Levels of Gene Expression of Immune Modulatory Receptors in Tumors of Participants Treated With Neoadjuvant Pembrolizumab
기간: Baseline and Week 7
|
The change from baseline in levels of gene expression of immune modulatory receptors in tumors of participants treated with neoadjuvant pembrolizumab was presented.
|
Baseline and Week 7
|
|
Change From Baseline in Number of T Cells in Tumors of Participants Treated With Neoadjuvant Pembrolizumab
기간: Baseline and Week 7
|
The change from baseline in number of T cells in tumors of participants treated with neoadjuvant pembrolizumab was presented.
|
Baseline and Week 7
|
|
Change From Baseline in Number of Activated T Cells in Peripheral Blood of Participants Treated With Neoadjuvant Pembrolizumab
기간: Baseline and Week 7
|
The change from baseline in the number of activated T cells in peripheral blood of participants treated with neoadjuvant pembrolizumab was presented.
|
Baseline and Week 7
|
|
Change From Baseline in Levels of Programmed Cell Death 1 Ligand 1 (PD-L1) Protein in Tumors of Participants Treated With Neoadjuvant Pembrolizumab
기간: Baseline and Week 7
|
The change from baseline in levels of programmed cell death 1 ligand 1 (PD-L1) protein in tumors of participants treated with neoadjuvant pembrolizumab in participants who received neoadjuvant pembrolizumab was presented.
|
Baseline and Week 7
|
|
Change From Baseline in Levels of Programmed Cell Death 1 Ligand 2 (PD-L2) Protein in Tumors of Participants Treated With Neoadjuvant Pembrolizumab
기간: Baseline and Week 7
|
The change from baseline in levels of programmed cell death 1 ligand 2 (PD-L2) protein in tumors of participants treated with neoadjuvant pembrolizumab in participants who received neoadjuvant pembrolizumab was presented.
|
Baseline and Week 7
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2014년 12월 3일
기본 완료 (실제)
2019년 7월 5일
연구 완료 (실제)
2019년 7월 5일
연구 등록 날짜
최초 제출
2014년 8월 6일
QC 기준을 충족하는 최초 제출
2014년 8월 6일
처음 게시됨 (추정)
2014년 8월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 7월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 6월 22일
마지막으로 확인됨
2020년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 3475-031
- 2014-002526-12 (EudraCT 번호)
- MK-3475-031 (기타 식별자: Merck)
- KEYNOTE-031 (기타 식별자: Merck)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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아니
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