- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07801027
A Trial of Pembrolizumab With Chemotherapy or Chemoradiotherapy in Participants From India With Different Types of Cancer (MK-3475-G44/KEYNOTE-G44)
A Prospective, Open-label, Phase 4 Study to Evaluate the Safety of Pembrolizumab (KEYTRUDA®) in Combination With Indication-specific Chemotherapy or Chemoradiotherapy in Participants Across Multiple Indications in India (KEYNOTE-G44)
The goal of this study is to assess the safety of pembrolizumab with chemotherapy or chemoradiotherapy in participants in India for:
- Advanced gastric or gastroesophageal junction [GEJ] cancer that is (human epidermal growth factor receptor 2 [HER2]-negative and has a programmed death-ligand 1 [PD-L1] combined positive score [CPS] ≥1
- Advanced and/or unresectable biliary tract cancer [BTC], and
- High-risk, locally advanced cervical cancer
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 4단계
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Cohort 1:
- The participant must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, with locally confirmed programmed death-ligand 1 (PD-L1) CPS ≥1.
- Has locally confirmed human epidermal growth factor receptor 2 (HER2) negative cancer.
Cohort 2:
- Has a histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (BTC) (intra or extrahepatic cholangiocarcinoma or gallbladder cancer).
Cohort 3:
- Has high-risk locally advanced cervical cancer.
- Has histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.
All Cohorts:
- If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks and will continue it.
- If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.
Exclusion Criteria:
Cohort 1:
- Has squamous cell or undifferentiated gastric cancer.
- Has had previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has had major surgery, open biopsy, or significant traumatic injury within 28 days prior to first dose of study.
- Had active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks or tumor bleeding within 2 weeks prior to the first dose of study intervention.
Cohort 2:
- Has ampullary cancer.
- Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology, and/or mucinous cystic neoplasms.
- Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) BTC (intra or extrahepatic cholangiocarcinoma or gallbladder cancer), with the exception of neoadjuvant/adjuvant therapy, which is allowed.
- Has known active CNS metastases and/or carcinomatous meningitis.
- Had active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks or tumor bleeding within 2 weeks prior to the first dose of study intervention.
Cohort 3:
- Has undergone a previous hysterectomy defined as removal of the entire uterus or will have a hysterectomy as part of their initial cervical cancer therapy.
All Cohorts:
- Has hypokalemia.
- Has hypomagnesemia.
- Has hypocalcemia.
- Received prior therapy with an anti-programmed cell death protein 1 (PD-1), anti-PD-L1, or anti-programmed death-ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
- Has active autoimmune disease that has required systemic treatment in the past 2 years.
- Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease.
- Has a known additional invasive malignancy that is progressing or has required active treatment within the past 3 years.
- Has history of human immunodeficiency virus (HIV) infection.
- Has known active tuberculosis.
- Has not adequately recovered from major surgery or is having ongoing surgical complications.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Cohort 1 (Gastric)
Participants with human epidermal growth factor receptor 2 (HER2)-negative advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma with programmed death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 will receive 200 mg of pembrolizumab intravenously (IV) every 3 weeks (Q3W) for maximum of 35 cycles plus either 800mg/m^2/day of 5-fluorouracil (5-FU) IV on Days 1 through 5, Q3W and 80mg/m^2 of cisplatin IV on Day 1, Q3W OR 1000mg/m^2 of capecitabine orally twice daily on Days 1 through 14, Q3W and 130mg/m^2 oxaliplatin IV on Day 1, Q3W.
A cycle is 21 days.
|
IV 주입으로 투여
다른 이름들:
IV 주입으로 투여
다른 이름들:
Administered as an IV infusion
다른 이름들:
Administered as an IV infusion
다른 이름들:
Administered as an oral tablet
다른 이름들:
|
|
실험적: Cohort 2 (Biliary)
Participants with advanced/unresectable biliary tract cancer (BTC) will receive 200 mg pembrolizumab IV Q3W for a maximum of 35 cycles plus 1000 mg/m^2 of gemcitabine IV on Days 1 and 8, Q3W and 25 mg/m^2 of cisplatin IV on Days 1 and 8, Q3W for a maximum of 8 cycles.
A cycle is 21 days.
|
IV 주입으로 투여
다른 이름들:
Administered as an IV infusion
다른 이름들:
Administered as an IV infusion
다른 이름들:
|
|
실험적: Cohort 3 (Cervical)
Participants with high-risk locally advanced cervical cancer will receive 200 mg pembrolizumab IV Q3W for a maximum of 35 cycles plus 40 mg/m^2 of cisplatin IV weekly for up to 5 infusions concurrent with radiotherapy (RT) and external beam RT and brachytherapy (BT).
A cycle is 21 days.
|
IV 주입으로 투여
다른 이름들:
Administered as an IV infusion
다른 이름들:
External beam radiation per the Radiation Manual
Internal radiation - brachytherapy per the Radiation Manual
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants Who Experienced One or More Adverse Events (AEs)
기간: Up to approximately 27 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants that experience AEs will be reported.
|
Up to approximately 27 months
|
|
Number of Participants Who Discontinued Study Intervention Due to an AE
기간: Up to approximately 24 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants who discontinue study intervention due to AEs will be reported.
|
Up to approximately 24 months
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Medical Director, Merck Sharp & Dohme LLC
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
- 비뇨생식기 질환
- 생식기 질환
- 비뇨생식기 신생물
- 부위별 신생물
- 여성 비뇨 생식기 질환
- 여성 비뇨 생식기 질환 및 임신 합병증
- 위장관 신생물
- 소화계 신생물
- 소화기계 질환
- 위장병
- 위장병
- 자궁 질환
- 생식기 질환, 여성
- 생식기 신생물, 여성
- 자궁 경부 질환
- 자궁 신생물
- 신생물
- 위 신생물
- 자궁경부 신생물
- 유기 화학 물질
- 이종 사이 클릭 화합물, 1- 링
- 이종 사이 클릭 화합물
- 치료학
- 핵산, 뉴클레오티드 및 뉴 클레오 시드
- 무기 화학 물질
- 염소 화합물
- 질소 화합물
- 조정 복합체
- 데 옥시 시티 딘
- 시티 딘
- 피리 미딘 뉴 클레오 시드
- 피리 미딘
- 뉴 클레오 시드
- 우라실
- 피리 미디 논
- 백금 화합물
- 방사선 요법
- 데 옥시 리보 뉴 클레오 시드
- 카페시타빈
- 옥살리플라틴
- 젬시타빈
- 플루오로우라실
- 시스플라틴
- 펨브 롤리 주맙
- 상완골
기타 연구 ID 번호
- 3475-G44
- MK-3475-G44 (기타 식별자: MSD)
- KEYNOTE-G44 (기타 식별자: MSD)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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