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머크KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04) 1상, 2상 55
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임상시험 NCT07232602은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 방광암에 대해 진행되며, 1상 2상 중재연구으로 현재 상태는 모집중입니다. 연구는 2026년 2월 9일에 시작되어 55명의 참여자를 모집하고 있습니다. 머크이(가) 진행하며, 2030년 10월 18일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 20일에 갱신되었습니다.
간단한 개요
Researchers are looking for new ways to treat people with urothelial cancer (UC) that is locally advanced or metastatic. The standard treatment for locally advanced or metastatic UC is enfortumab vedotin (EV) given with pembrolizumab.
The goals of this study are to learn about:
- The safety of the study treatment when given with standard treatment and if people tolerate it
- The number of people who have the cancer...
상세한 설명
This is a substudy of the master protocol MK-3475-U04 (KEYMAKER-U04)
공식 제목
A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents in Combination With Enfortumab Vedotin Plus Pembrolizumab as First-Line Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma: KEYMAKER-U04-Substudy 04D
질환명
방광암기타 연구 식별자
- 3475-04D
- U1111-1322-3713 (등록 식별자) (UTN)
- 2025-522253-19-00 (등록 식별자) (EU CT)
- MK-3475-04D (기타 식별자) (MSD)
NCT 번호
실제 연구 시작일
2026-02-09
최신 업데이트 게시
2026-03-20
예상 연구 완료일
2030-10-18
계획된 등록 인원
55
연구종류
중재연구
단계/상
1상
2상
2상
상태
모집중
주요 목적
치료
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Arm A: MK-3120 + Enfortumab Vedotin (EV) + Pembrolizumab Participants will receive MK-3120 administered intravenously on Day 1 and Day 8 of each 3-week cycle and EV administered intravenously on Day 1 and Day 8 of each 3-week cycle until documented disease progression or any other discontinuation criterion is met and Pembrolizumab 200 mg administered intravenously on Day 1 of each 3-week cycle for up to 35 cycles (\~2 years). | MK-3120 Administered via intravenous (IV) infusion on day 1 and day 8 of each 3-week cycle EV Administered via IV infusion on day 1 and day 8 of each 3-week cycle Pembrolizumab Administered via IV infusion on day 1 of each 3-week cycle Rescue Medication Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF). |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Number of Participants Who Experience an Adverse Event (AE) | 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 Experience a Dose Limiting Toxicity (DLT) | DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next treatment. The number of participants who experience a DLT as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 will be presented. | Up to approximately 21 days |
Number of Participants Who Discontinue Study Treatment Due to an AE | 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 discontinue study intervention due to an AE will be reported. | Up to approximately 24 months |
Objective Response Rate (ORR) as Assessed by Investigator | ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Investigator will be presented. | Up to approximately 58 months |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Duration of Response (DOR) as Assessed by Investigator | For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by investigator will be presented. | Up to approximately 58 months |
Serum Maximum Concentration (Cmax) of MK-3120 Antibody-Drug Conjugate (ADC) | Cmax is defined as the peak concentration over the dosing interval. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax of MK-3120 ADC. | Predose and at designated time points post-dose (up to approximately 24 months) |
Serum Trough Concentration (Ctrough) of MK-3120 ADC | Ctrough is defined as the trough concentration. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough of MK-3120 ADC. | Predose and at designated time points post-dose (up to approximately 24 months) |
Serum Cmax of MK-3120 Total Antibodies (TAb) | Cmax is defined as the peak concentration over the dosing interval. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax of MK-3120 TAb. | Predose and at designated time points post-dose (up to approximately 24 months) |
Serum Ctrough of MK-3120 TAb | Ctrough is defined as the trough concentration. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough of MK-3120 TAb. | Predose and at designated time points post-dose (up to approximately 24 months) |
Plasma Cmax of MK-3120 Free Payload | Cmax is defined as the peak concentration over the dosing interval. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax of MK-3120 Free Payload. | Predose and at designated time points post-dose (up to approximately 24 months) |
Plasma Ctrough of MK-3120 Free Payload | Ctrough is defined as the trough concentration. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough of MK-3120 Free Payload. | Predose and at designated time points post-dose (up to approximately 24 months) |
Serum Cmax of EV ADC | Cmax is defined as the peak concentration over the dosing interval. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax of EV ADC. | Predose and at designated time points post-dose (up to approximately 24 months) |
Serum Ctrough of EV ADC | Ctrough is defined as the trough concentration. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough of EV ADC. | Predose and at designated time points post-dose (up to approximately 24 months) |
Serum Cmax of EV TAb | Cmax is defined as the peak concentration over the dosing interval. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax of Enfortumab Vedotin (EV) TAb. | Predose and at designated time points post-dose (up to approximately 24 months) |
Serum Ctrough of EV TAb | Ctrough is defined as the trough concentration. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough of EV TAb. | Predose and at designated time points post-dose (up to approximately 24 months) |
Plasma Cmax of EV Free Payload | Cmax is defined as the peak concentration over the dosing interval. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax of Enfortumab Vedotin (EV) Free Payload. | Predose and at designated time points post-dose (up to approximately 24 months) |
Plasma Ctrough of EV Free Payload | Ctrough is defined as the trough concentration. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough of EV Free Payload. | Predose and at designated time points post-dose (up to approximately 24 months) |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
The main inclusion criteria include but are not limited to the following:
- Has histologically documented urothelial carcinoma (UC) that is locally advanced and unresectable or metastatic
- Must provide a newly obtained or archival tumor tissue sample (core or excisional biopsy)
- Must not have received prior systemic therapy for locally advanced or metastatic UC
- If infected with Human Immunodeficiency Virus (HIV), has well controlled HIV on antiretroviral therapy
- If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load before randomization
- If participant has a history of hepatitis C virus (HCV), has undetectable HCV viral load before randomization
The main exclusion criteria include but are not limited to the following:
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
- Has active keratitis or corneal ulcerations
- Has active inflammatory bowel disease requiring immunosuppressive medication, or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention
- Has a history of uncontrolled diabetes
- Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has known active central nervous system metastases and/or carcinomatous meningitis
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids, or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy
- If infected with HIV, has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has concurrent active HBV and HCV infection
- Has a history of stem cell/solid organ transplant
머크연구 대표 연락처
연락처: Toll Free Number, 1-888-577-8839, [email protected]
11 5개국에 임상시험 장소
Severance Hospital, Yonsei University Health System ( Site 5903), Seoul, 03722, South Korea
Study Coordinator, 연락처, +8215887757
모집중
Asan Medical Center ( Site 5901), Seoul, 05505, South Korea
Study Coordinator, 연락처, +8216887575
모집중
Samsung Medical Center ( Site 5902), Seoul, 06351, South Korea
Study Coordinator, 연락처, +8215993114
모집중
California
UCSF Medical Center at Mission Bay ( Site 5044), San Francisco, California, 94158, United States
Study Coordinator, 연락처, 415-699-7286
모집중
Ohio
Cleveland Clinic Taussig Cancer ( Site 5036), Cleveland, Ohio, 44195, United States
Study Coordinator, 연락처, 216-444-8311
모집중
Utah
Huntsman Cancer Institute ( Site 5041), Salt Lake City, Utah, 84112-5550, United States
Study Coordinator, 연락처, 801-585-0155
모집중
Gironde
CHU de Bordeaux Hop St ANDRE ( Site 5607), Bordeaux, Gironde, 33075, France
Study Coordinator, 연락처, +33556794708
모집중
Rambam Health Care Campus ( Site 5501), Haifa, 3109601, Israel
Study Coordinator, 연락처, +97247772688
모집중
Rabin Medical Center ( Site 5504), Petah Tikva, 4941492, Israel
Study Coordinator, 연락처, +97239377377
모집중
Hospital Universitari Vall de Hebron ( Site 5767), Barcelona, 08035, Spain
Study Coordinator, 연락처, +34932543450
모집중
Hospital Clinico San Carlos ( Site 5765), Madrid, 28040, Spain
Study Coordinator, 연락처, +34913303546
모집중