ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT04626479 के लिए कार्सिनोमा, रीनल सेल वर्तमान में सक्रिय, भर्ती नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
खोज पर वापस जाएँ
मर्कSubstudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) चरण I, चरण II 400
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT04626479 का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन कार्सिनोमा, रीनल सेल से जुड़ा हुआ है और यह एक चरण I चरण II हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में सक्रिय, भर्ती नहीं चल रहा है। इसकी शुरुआत 16 दिसंबर 2020 को हुई थी, और इसमें कुल 400 प्रतिभागियों के नामांकन की योजना है। मर्क इस परीक्षण का नेतृत्व कर रहे हैं और इसके 31 मई 2026 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 12 फ़रवरी 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
Substudy 03A is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03).
The goal of substudy 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) clear cell renal cell carcinoma (ccRCC).
This substudy will have two phases: a safety l...
और दिखाएँआधिकारिक शीर्षक
A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (U03): Substudy 03A in First Line Metastatic Participants
स्वास्थ्य स्थितियां
कार्सिनोमा, रीनल सेलप्रकाशन
इस नैदानिक परीक्षण के बारे में प्रकाशित वैज्ञानिक लेख और शोध पत्र:अन्य अध्ययन आईडी
- 3475-03A
- MK-3475-03A (अन्य पहचानकर्ता) (MSD)
- 2023-506838-68-00 (रजिस्ट्री पहचानकर्ता) (EU CT)
- U1111-1294-4527 (रजिस्ट्री पहचानकर्ता) (UTN)
- 2019-003609-84 (यूड्रैक्ट संख्या)
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2020-12-16
अंतिम अद्यतन प्रकाशित
2026-02-12
अध्ययन की समाप्ति तिथि (अनुमानित)
2026-05-31
नामांकन (अनुमानित)
400
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण I
चरण II
चरण II
स्थिति
सक्रिय, भर्ती नहीं
प्रमुख शब्द
receptor tyrosine kinase inhibitor
programmed cell death 1 (PD-1, PD1)
programmed cell death ligand 1 (PD-L1, PDL1)
programmed cell death 1 (PD-1, PD1)
programmed cell death ligand 1 (PD-L1, PDL1)
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
प्रयोगात्मकCoformulation Pembrolizumab/Quavonlimab + Lenvatinib Participants will receive pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg) PLUS lenvatinib 20 mg. Pembrolizumab/quavonlimab will be administered intravenously (IV) once every 6 weeks (Q6W) for up to 17 administrations (up to \~2 years). Lenvatinib will be administered orally once-daily (QD) until progressive disease or discontinuation. | Lenvatinib Administered via oral capsule at a dose of 20 mg QD Pembrolizumab/Quavonlimab Administered via IV infusion at a dose of 400 mg/25 mg Q6W |
प्रयोगात्मकCoformulation Favezelimab/Pembrolizumab+ Lenvatinib Participants will receive favezelimab/pembrolizumab (coformulation of favezelimab 800 mg and pembrolizumab 200 mg) PLUS lenvatinib 20 mg. Favezelimab/Pembrolizumab will be administered IV once every 3 weeks (Q3W) for up to 35 administrations (up to \~2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation. | Favezelimab/Pembrolizumab Administered via IV infusion at a dose of 800 mg/200 mg Q3W Lenvatinib Administered via oral capsule at a dose of 20 mg QD |
प्रयोगात्मकPembrolizumab + Belzutifan + Lenvatinib Participants will receive pembrolizumab 400 mg PLUS belzutifan 120 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered IV Q6W for up to 17 administrations (up to \~2 years). Both belzutifan and lenvatinib will be administered orally QD until progressive disease or discontinuation. | Pembrolizumab Administered via IV infusion at a dose of 400 mg Q6W Belzutifan Administered via oral tablet at a dose of 120 mg QD Lenvatinib Administered via oral capsule at a dose of 20 mg QD |
प्रयोगात्मकPembrolizumab + Lenvatinib Participants will receive pembrolizumab 400 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered IV Q6W for up to 17 administrations (up to \~ 2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation. | Pembrolizumab Administered via IV infusion at a dose of 400 mg Q6W Lenvatinib Administered via oral capsule at a dose of 20 mg QD |
प्रयोगात्मकCoformulation Vibostolimab/Pembrolizumab+Belzutifan Participants will receive vibostolimab/pembrolizumab (coformulation of 200 mg vibostolimab and pembrolizumab 200 mg). Vibostolimab/pembrolizumab will be administered IV once every 3 weeks (Q3W) for up to 35 administrations (up to \~2 years). Belzutifan will be administered orally QD until progressive disease or discontinuation. | Belzutifan Administered via oral tablet at a dose of 120 mg QD Vibostolimab/Pembrolizumab Administered via IV infusion at a dose of 200 mg/200 mg Q6W |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Safety Lead-in Phase: Number of participants who experience one or more dose-limiting toxicities (DLTs) | DLTs are defined as one or more of the following toxicities: (1) grade (gr) 4 nonhematologic toxicity (2) gr 4 hematologic toxicity lasting \>7 days OR gr 4 platelet count decreased of any duration OR gr 3 platelet count decreased if associated with bleeding (3) gr 3 nonhematologic toxicity except gr 3 fatigue (lasting ≤3 days), diarrhea, nausea, vomiting or rash without standard of care (4) gr 3 or 4 nonhematologic abnormality if medical intervention is required or if it leads to hospitalization or persists for \>1 week (5) gr 3 or 4 febrile neutropenia (6) gr 3 or 4 alanine aminotransferase, aspartate aminotransferase and/or bilirubin laboratory value (7) treatment related adverse event (AE) causing study intervention discontinuation during the first 21 days (8) treatment related AE causing intervention administration delay for \>14 days during the first 21 days (9) gr 5 toxicity. The number of participants who experience one or more DLTs in the safety lead-in phase will be presented. | Up to ~21 days |
Safety Lead-in Phase: Number of participants who experience one or more adverse events (AEs) | 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 experience one or more AEs in the safety lead-in phase will be presented. | Up to ~21 days |
Safety Lead-in Phase: 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 who discontinue study treatment due to an AE in the safety lead-in phase will be presented. | Up to ~21 days |
Efficacy Phase: Number of participants who experience one or more DLTs | DLTs are defined as one or more of the following toxicities: (1) grade (gr) 4 nonhematologic toxicity (2) gr 4 hematologic toxicity lasting \>7 days OR gr 4 platelet count decreased of any duration OR gr 3 platelet count decreased if associated with bleeding (3) gr 3 nonhematologic toxicity except gr 3 fatigue (lasting ≤3 days), diarrhea, nausea, vomiting or rash without standard of care (4) gr 3 or 4 nonhematologic abnormality if medical intervention is required or if it leads to hospitalization or persists for \>1 week (5) gr 3 or 4 febrile neutropenia (6) gr 3 or 4 alanine aminotransferase, aspartate aminotransferase and/or bilirubin laboratory value (7) treatment related adverse event (AE) causing study intervention discontinuation during the first 21 days (8) treatment related AE causing intervention administration delay for \>14 days during the first 21 days (9) gr 5 toxicity. The number of participants who experience one or more DLTs in the efficacy phase will be presented. | Up to ~21 days |
Efficacy Phase: Number of participants who experience one or more AEs | 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 experience one or more AEs in the efficacy phase will be presented. | Up to ~43 months |
Efficacy Phase: 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 who discontinue study treatment due to an AE in the efficacy phase will be presented. | Up to ~43 months |
Efficacy Phase: Objective response rate (ORR) | ORR is defined as the percentage of participants in the analysis population who have a 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, taking as reference the baseline sum of diameters). Responses are according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). | Up to ~43 months |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Efficacy Phase: Duration of response (DOR) | For participants in the analysis population who demonstrate a confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters), DOR is defined as the time from first documented evidence of CR or PR until progressive disease or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 by BICR. | Up to ~43 months |
Efficacy Phase: Progression-free survival (PFS) | PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 by BICR. | Up to ~43 months |
Efficacy Phase: Overall survival (OS) | OS is defined as the time from randomization to death due to any cause. | Up to ~43 months |
Efficacy Phase: Clinical benefit rate (CBR) | CBR is defined as the percentage of participants who have achieved CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) of ≥6 months. Responses are according to RECIST 1.1 by BICR. | Up to ~43 months |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
- Has a histologically confirmed diagnosis of locally advanced/metastatic ccRCC
- Has received no prior systemic therapy for advanced RCC; prior neoadjuvant/adjuvant therapy for RCC is acceptable if completed ≥12 months before randomization/allocation.
- Is able to swallow oral medication
- Has adequate organ function
- Participants receiving bone resorptive therapy must have therapy initiated at least 2 weeks before randomization/allocation
- Has resolution of toxic effects of the most recent prior therapy to ≤Grade 1
- Has adequately controlled blood pressure (BP ≤150/90 mm Hg) with no change in hypertensive medications within 1 week before randomization/allocation
- Male participants are abstinent from heterosexual intercourse or agree to use contraception during treatment with and for at least 7 days after the last dose of lenvatinib and /or belzutifan; 7 days after lenvatinib and/or belzutifan is stopped, if the participant is only receiving pembrolizumab, pembrolizumab/quavonlimab, favezelimab/pembrolizumab or a combination of the aforementioned drugs, no contraception is needed
- Female participants must not be pregnant and not be a woman of childbearing potential (WOCBP) or is a WOCBP abstinent from heterosexual intercourse or using contraception during the intervention period and for at least 120 days after the last dose of pembrolizumab, pembrolizumab/quavonlimab, favezelimab/pembrolizumab for 30 days after the last dose of lenvatinib or belzutifan, whichever occurs last and must abstain from breastfeeding during the study intervention period and for at least 120 days after study intervention
- Has urine protein ≥1 g/24 hours and has any of the following: (a) a pulse oximeter reading <92% at rest, or (b) requires intermittent supplemental oxygen, or (c) requires chronic supplemental oxygen (d) active hemoptysis within 3 weeks prior to the first dose of study intervention
- Has clinically significant cardiovascular disease within 12 months from the first dose of study intervention administration
- Has had major surgery within 3 weeks before first dose of study interventions
- Has a history of lung disease
- Has a history of inflammatory bowel disease
- Has preexisting gastrointestinal (GI) or non-GI fistula
- Has malabsorption due to prior GI surgery or disease
- Has received prior radiotherapy within 2 weeks of start of study intervention
- Has received a live or live attenuated vaccine within 30 days before the first dose of study drug; killed vaccines are allowed
- Has received more than 4 previous systemic anticancer treatment regimens
- Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has an active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy is not considered a form of systemic treatment and is allowed
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of Hepatitis B
- Has had an allogenic tissue/solid organ transplant
मर्ककोई संपर्क डेटा नहीं।
55 14 देशों में अध्ययन स्थान
California
University of California at San Francisco ( Site 1008), San Francisco, California, 94158, United States
Connecticut
Yale-New Haven Hospital-Yale Cancer Center ( Site 1011), New Haven, Connecticut, 06510, United States
Illinois
University of Chicago ( Site 1013), Chicago, Illinois, 60637, United States
Iowa
University of Iowa ( Site 1012), Iowa City, Iowa, 52242, United States
Michigan
Henry Ford Health System ( Site 1014), Detroit, Michigan, 48202, United States
New York
Laura and Isaac Perlmutter Cancer Center ( Site 1016), New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center ( Site 1002), New York, New York, 10065, United States
North Carolina
Duke Cancer Institute ( Site 1015), Durham, North Carolina, 27710, United States
Pennsylvania
UPMC Cancer Center/Hillman Cancer Center ( Site 1017), Pittsburgh, Pennsylvania, 15232, United States
Texas
UTSW Medical Center ( Site 1003), Dallas, Texas, 75390, United States
New South Wales
Western Sydney Local Health District ( Site 1601), Blacktown, New South Wales, 2148, Australia
St George Hospital ( Site 1602), Kogarah, New South Wales, 2217, Australia
Queensland
Royal Brisbane and Women s Hospital ( Site 1603), Herston, Queensland, 4029, Australia
Victoria
Austin Health ( Site 1600), Heidelberg, Victoria, 3084, Australia
Ontario
Princess Margaret Cancer Centre ( Site 1101), Toronto, Ontario, M5G 1Z5, Canada
Quebec
Jewish General Hospital ( Site 1100), Montreal, Quebec, H3T 1E2, Canada
Region M. de Santiago
FALP-UIDO ( Site 2100), Santiago, Region M. de Santiago, 7500921, Chile
Oncovida ( Site 2107), Santiago, Region M. de Santiago, 7510032, Chile
Bradfordhill-Clinical Area ( Site 2101), Santiago, Region M. de Santiago, 8420383, Chile
Región de la Araucanía
James Lind Centro de Investigación del Cáncer ( Site 2108), Temuco, Región de la Araucanía, 4800827, Chile
CIDO SpA-Oncology ( Site 2106), Temuco, Región de la Araucanía, 4810148, Chile
Región de Valparaíso
ONCOCENTRO APYS-ACEREY ( Site 2103), Viña del Mar, Región de Valparaíso, 2520598, Chile
Bogota D.C.
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1900), Bogotá, Bogota D.C., 111321, Colombia
Cesar Department
Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1905), Valledupar, Cesar Department, 200001, Colombia
Departamento de Córdoba
Oncomédica S.A.S ( Site 1904), Montería, Departamento de Córdoba, 230002, Colombia
Valle del Cauca Department
Fundación Valle del Lili ( Site 1901), Cali, Valle del Cauca Department, 760032, Colombia
Ain
Institut De Cancerologie De Lorraine ( Site 1204), Vandœuvre-lès-Nancy, Ain, 54519, France
Alsace
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1203), Strasbourg, Alsace, 67200, France
Haute-Garonne
Institut Claudius Regaud ( Site 1200), Toulouse, Haute-Garonne, 31059, France
Val-de-Marne
Gustave Roussy ( Site 1202), Villejuif, Val-de-Marne, 94800, France
Pest County
Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 2301), Budapest, Pest County, 1122, Hungary
Rambam MC ( Site 1500), Haifa, 3525408, Israel
Hadassah Medical Center-Oncology ( Site 1504), Jerusalem, 9112001, Israel
Rabin Medical Center ( Site 1502), Petah Tikva, 4941492, Israel
Sheba Medical Center - Oncology Division ( Site 1501), Ramat Gan, 52621, Israel
Sourasky Medical Center ( Site 1503), Tel Aviv, 6423906, Israel
North Holland
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 2402), Amsterdam, North Holland, 1066CX, Netherlands
South Holland
Erasmus Medisch Centrum ( Site 2401), Rotterdam, South Holland, 3015 GD, Netherlands
Auckland City Hospital ( Site 1700), Auckland, 1023, New Zealand
Kuyavian-Pomeranian Voivodeship
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2201), Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Masovian Voivodeship
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 2200, Warsaw, Masovian Voivodeship, 02-781, Poland
Pomeranian Voivodeship
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 2202), Gdansk, Pomeranian Voivodeship, 80-952, Poland
Seoul
Asan Medical Center ( Site 1800), Songpagu, Seoul, 05505, South Korea
Severance Hospital ( Site 1802), Seoul, 03722, South Korea
Samsung Medical Center ( Site 1801), Seoul, 06351, South Korea
Catalonia
Hospital Universitari Vall d Hebron ( Site 1300), Barcelona, Catalonia, 08035, Spain
Hospital Universitario Ramon y Cajal ( Site 1301), Madrid, 28034, Spain
England
Southampton General Hospital ( Site 1403), Southampton, England, SO16 6YD, United Kingdom
Glasgow City
The Beatson West of Scotland Cancer Centre ( Site 1405), Glasgow, Glasgow City, G12 0YN, United Kingdom
Lancashire
Royal Preston Hospital ( Site 1406), Preston, Lancashire, PR2 9HT, United Kingdom
Leicestershire
Leicester Royal Infirmary ( Site 1408), Leicester, Leicestershire, LE1 5WW, United Kingdom
London, City of
Barts Health NHS Trust ( Site 1401), London, London, City of, EC1A 7BE, United Kingdom
Midlothian
Western General Hospital ( Site 1402), Edinburgh, Midlothian, EH4 2XU, United Kingdom
Wales
Velindre Cancer Centre Hospital ( Site 1407), Cardiff, Wales, CF14 2TL, United Kingdom
The Christie NHS Foundation Trust ( Site 1400), Manchester, M20 4BX, United Kingdom