임상 레이더 AI | ||
|---|---|---|
임상시험 NCT04210115은(는) 식도 편평 세포암 (ESCC), 위식도 접합부 암 (GEJC), 식도 선암 (EAC)에 대해 진행중, 모집종료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975) 3상 703 전체 생존기간
The purpose of this study is to assess the efficacy and safety of treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Event-free Survival (EFS) and Overall Survival (OS) in:
- participants whose tumors express Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
- participants whose tumors express PD-L1 CPS ≥1
- all par...
Participants receive pembrolizumab or placebo PLUS one of two chemotherapy regimens PLUS radiation therapy for up to approximately one year. The chemotherapy regimens are either:
- FP (5-fluorouracil \[5-FU\] + cisplatin) or
- FOLFOX (5-FU + oxaliplatin + leucovorin or levoleucovorin).
A Randomized, Double-blind, Placebo-controlled Phase 3 Trial of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Receiving Concurrent Definitive Chemoradiotherapy (KEYNOTE 975)
- 3475-975
- MK-3475-975 (기타 식별자) (MSD)
- KEYNOTE-975 (기타 식별자) (MSD)
- PHRR200210-002490 (등록 식별자) (PHRR)
- 205261 (등록 식별자) (Japic-CTI)
- 2022-501531-16 (등록 식별자) (EU CT)
- 2019-002006-51 (EudraCT 번호)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Programmed Death-Ligand 2 (PDL2, PD-L2)
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Pembrolizumab+FP or FOLFOX Therapy+Radiotherapy Participants receive pembrolizumab 200 mg on Day 1 of each 3-week cycle for 8 cycles followed by pembrolizumab 400 mg on Day 1 of each 6-week cycle for 5 cycles PLUS either:
* FP therapy: cisplatin 75 mg/m\^2 on Day 1 of Weeks 1, 5, 8 and 11 PLUS 5-fluorouracil (5-FU)\] 1000 mg/m\^2 per day on Days 1-4 of Weeks 1, 5, 8 and 11 OR 800 mg/m\^2/day on each of Days 1-5 at Weeks 1, 5, 8, and 11 PLUS radiotherapy (either 5...더 보기 | pembrolizumab IV infusion cisplatin IV infusion 5-FU IV infusion 방사선 요법 external radiation leucovorin IV infusion levoleucovorin IV infusion oxaliplatin IV infusion |
위약 대조군Placebo+FP or FOLFOX Therapy+Radiotherapy Participants receive placebo on Day 1 of each 3-week cycle for 8 cycles followed by placebo on Day 1 of each 6-week cycle for 5 cycles PLUS either:
* FP therapy: cisplatin 75 mg/m\^2 on Day 1 of Weeks 1, 5, 8 and 11 PLUS 5-FU 1000 mg/m\^2 per day on Days 1-4 of Weeks 1, 5, 8 and 11 OR 800 mg/m\^2/day on each of Days 1-5 at Weeks 1, 5, 8, and 11 PLUS radiotherapy (either 50 Gy in 25 fractions OR 60 Gy in 30 fractions...더 보기 | 위약 IV infusion cisplatin IV infusion 5-FU IV infusion 방사선 요법 external radiation leucovorin IV infusion levoleucovorin IV infusion oxaliplatin IV infusion |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Event-free Survival (EFS) | EFS is defined as the time from randomization to an event defined as local, regional, or distant radiological recurrence as assessed by the investigator; clinical recurrence as assessed by the investigator with histopathologic confirmation (in the absence of radiological disease recurrence by investigator assessment); or death from any cause, whichever occurs first. | Up to ~60 months |
Overall Survival (OS) | OS is defined as the time from randomization to death from any cause. | Up to ~72 months |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Number of participants with an adverse event (AE) | An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. | Up to ~15 months |
Number of participants discontinuing study treatment due to an adverse event (AE) | An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. | Up to ~12 months |
- Has histologically or cytologically confirmed diagnosis of CTX N+ M0 or cT2-T4a NX M0 ESCC, GEJC, EAC, or histologically or cytologically confirmed diagnosis of cTX N+ M1 cervical or upper thoracic esophageal carcinoma with supraclavicular lymph node metastases only
- Is deemed suitable for dCRT
- Is ineligible for curative surgery based on the documented opinion of a qualified medical/surgical/radiation oncologist.
- Is not expected to require tumor resection during the course of the study
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days of the first dose of study treatment
- Has adequate organ function
- Male participants must use adequate contraception (a male condom plus partner use of an additional contraceptive method) unless confirmed to be azoospermic (vasectomized or secondary to medical cause) and refrain from donating sperm during the study treatment period and through 90 days after the last dose of chemotherapy
- Female participants who are a Woman of Childbearing Potential (WOCBP) must use contraception that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the study treatment period through 180 days after the last dose of chemotherapy or 120 days after the last dose of pembrolizumab, whichever is greater, and agree not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period
- Female participants must not be pregnant or breastfeeding
- Has direct invasion of tumor into adjacent organs such as the aorta or trachea or has radiographic evidence of >90 degree encasement or invasion of a major blood vessel, or of intratumoral cavitation
- Has had major surgery other than for insertion of a feeding tube, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipates the need for major surgery during study treatment; participants with gastric or esophageal fistulae are excluded
- Has had weight loss of >20% in the previous 3 months
- Has had prior chemotherapy or radiotherapy for esophageal cancer
- Has had a myocardial infarction within the past 6 months
- Has symptomatic congestive heart failure
- Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-programmed cell death-ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137)
- Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention; administration of killed vaccines is allowed
- Has received any prior systemic anticancer therapy for esophageal cancer including investigational agents
- Has not recovered from all adverse events (AEs) due to previous non-anticancer therapies to ≤Grade 1 or Baseline
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded from the study. Participants with localized prostate cancer that has undergone potentially curative treatment can be enrolled in the study.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab, any of the study chemotherapy agents, or their excipients
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of Hepatitis B or known active Hepatitis C virus infection
- Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment (180 days for participants receiving cisplatin who are breastfeeding)
- Has had an allogeneic tissue/solid organ transplant
Jeonranamdo
Kyonggi-do
Seoul
California
Georgia
Kansas
Louisiana
Maryland
Massachusetts
Michigan
Missouri
Nevada
New Jersey
New York
Oklahoma
Oregon
Pennsylvania
Tennessee
Utah
Washington
Wisconsin
Buenos Aires F.D.
Bruxelles-Capitale, Region de
Oost-Vlaanderen
Vlaams-Brabant
West-Vlaanderen
Rio Grande do Sul
Santa Catarina
Alberta
Manitoba
Ontario
Quebec
Region M. de Santiago
Región de la Araucanía
Región del Biobío
Anhui
Fujian
Hubei
Hunan
Jiangsu
Jiangxi
Shanghai Municipality
Sichuan
Tianjin Municipality
Zhejiang
Brno-mesto
Moravskoslezský kraj
Olomoucký kraj
Praha 5
Capital Region
Region Syddanmark
Harju
Tartu
Ain
Calvados
Cote-d Or
Haute-Vienne
Hauts-de-Seine
Marne
Pays de la Loire Region
Provence-Alpes-Côte d'Azur Region
Somme
Vendee
Baden-Wurttemberg
North Rhine-Westphalia
Rhineland-Palatinate
Baranya
Bekes County
Lombardy
Milano
Tuscany
Aichi-ken
Chiba
Kanagawa
Saitama
Shizuoka
Mexico City
Muni Metro de Lima
Benguet
Cebu
Iloilo
National Capital Region
Lisbon District
București
Cluj
Constanța County
Dolj
Mureș County
Baskortostan, Respublika
Kaluzskaja Oblast
Moscow
Samara Oblast
Sankt-Peterburg
Sverdlovsk Oblast
Tatarstan, Respublika
Istanbul
Aberdeen City
Cambridgeshire
England
London, City of
Nottinghamshire
Surrey
Worcestershire