Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)
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Studienlocations (3 von 53)
The Angeles Clinic and Research Institute ( Site 2009) 90025 Los Angeles United StatesRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 310-231-2121» Ansprechpartner anzeigenUCLA Hematology & Oncology ( Site 2004) 90095 Los Angeles United StatesRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 310-794-6892» Ansprechpartner anzeigenProvidence Saint John's Health Center ( Site 2010) 90404 Santa Monica United StatesAbgeschlossen» Google-Maps
University of Colorado, Anschutz Cancer Pavilion ( Site 2012) 80045 Aurora United StatesRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 720-848-0442» Ansprechpartner anzeigenSidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 2022) 21287 Baltimore United StatesRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 410-583-2970» Ansprechpartner anzeigenNYU Clinical Cancer Center ( Site 2002) 10016 New York United StatesAbgeschlossen» Google-MapsDuke Cancer Institute ( Site 2005) 27710 Durham United StatesAbgeschlossen» Google-MapsMartha Morehouse Tower ( Site 2020) 43221 Columbus United StatesRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 614-293-4320» Ansprechpartner anzeigenOregon Health & Science University ( Site 2013) 97239 Portland United StatesAbgeschlossen» Google-MapsUniversity of Pennsylvania Abramson Cancer Center ( Site 2008) 19104 Philadelphia United StatesRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 215-316-5151» Ansprechpartner anzeigenWest Cancer Center - East Campus ( Site 2014) 38138 Germantown United StatesRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 901-683-0055» Ansprechpartner anzeigenInova Schar Cancer Institute ( Site 2011) 22031 Fairfax United StatesRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 571-472-0631» Ansprechpartner anzeigenCalvary Mater Newcastle-Medical Oncology ( Site 2404) 2298 Waratah AustraliaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +61249211561» Ansprechpartner anzeigenMelanoma Institute Australia ( Site 2402) 2065 Wollstonecraft AustraliaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +61299117321» Ansprechpartner anzeigenTasman Oncology Research Pty Ltd ( Site 2403) 4120 Southport AustraliaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +61 7 5613 2480» Ansprechpartner anzeigenFiona Stanley Hospital ( Site 2401) 6150 Murdoch AustraliaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +61861522222» Ansprechpartner anzeigenCIDO SpA-Oncology ( Site 2256) 4810218 Temuco ChileRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 569 5 798 31 73» Ansprechpartner anzeigenIC La Serena Research ( Site 2254) 1720430 La Serena ChileRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 56953360057» Ansprechpartner anzeigenFALP-UIDO ( Site 2251) 7500921 Santiago ChileRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 56224457254» Ansprechpartner anzeigenOncovida ( Site 2257) 7510032 Santiago ChileRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 5624205100» Ansprechpartner anzeigenBradfordhill ( Site 2252) 8420383 Santiago ChileRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +56998744662» Ansprechpartner anzeigenFundación Valle del Lili ( Site 2265) 760032 Cali ColombiaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 6023319090» Ansprechpartner anzeigenHopital La Timone ( Site 2103) 13005 Marseille FranceRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +33491388591» Ansprechpartner anzeigenCHU de Bordeaux- Hopital Saint Andre ( Site 2108) 33075 Bordeaux FranceRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +33556794705» Ansprechpartner anzeigenInstitut Claudius Regaud ( Site 2105) 31059 Toulouse cedex 9 FranceRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 33531155675» Ansprechpartner anzeigenGustave Roussy ( Site 2101) 94805 Villejuif FranceRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +33142114210» Ansprechpartner anzeigenC.H. Lyon Sud ( Site 2102) 69495 Pierre Benite FranceRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +33478861628» Ansprechpartner anzeigenA.P.H. Paris, Hopital Saint Louis ( Site 2107) 75010 Paris FranceRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +33142499595» Ansprechpartner anzeigenGeneral Hospital of Athens "Laiko"-First Department of Internal Medicine ( Site 2212) 115 26 Athens GreeceRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 00306944681159» Ansprechpartner anzeigenEuropean Interbalkan Medical Center-Oncology Department ( Site 2211) 57001 Thessaloniki GreeceRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +302310400368» Ansprechpartner anzeigenSzegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 2221) 6720 Szeged HungaryRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +36704399976» Ansprechpartner anzeigenHaEmek Medical Center ( Site 2703) 1834111 Afula IsraelRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +97246495723» Ansprechpartner anzeigenRambam Health Care Campus-Oncology ( Site 2704) 3109601 Haifa IsraelRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +97247776700» Ansprechpartner anzeigenHadassah Ein Karem Jerusalem ( Site 2702) 9112001 Jerusalem IsraelRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +97226776781» Ansprechpartner anzeigenRabin Medical Center-Oncology ( Site 2705) 4941492 Petah-Tikva IsraelRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +972-3-9378077» Ansprechpartner anzeigenChaim Sheba Medical Center ( Site 2701) 5265601 Ramat Gan IsraelRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +97235304907» Ansprechpartner anzeigenFondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2399) 20133 Milano ItalyRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +390223902557» Ansprechpartner anzeigenIstituto Europeo di Oncologia ( Site 2301) 20141 Milano ItalyRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +390294372158» Ansprechpartner anzeigenIstituto Nazionale Tumori Fondazione Pascale ( Site 2302) 80131 Napoli ItalyRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +390815903431» Ansprechpartner anzeigenIstituto Oncologico Veneto IRCCS ( Site 2355) 35128 Padova ItalyRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 00390498215938» Ansprechpartner anzeigenPoliclinico Le Scotte - A.O. Senese ( Site 2377) 53100 Siena ItalyRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +390577586335» Ansprechpartner anzeigenNarodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( 02-781 Warszawa PolandRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 48225462031» Ansprechpartner anzeigenUniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 2231) 80-952 Gdańsk PolandRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 48585844571» Ansprechpartner anzeigenCANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2865) 6055 Port Elizabeth South AfricaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +27413630581» Ansprechpartner anzeigenLIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 2861) 0181 Pretoria South AfricaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +27123466701» Ansprechpartner anzeigenSandton Oncology Medical Group (Pty) Ltd-Research ( Site 2863) 2196 Sandton South AfricaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +27118830900» Ansprechpartner anzeigenSteve Biko Academic Hospital-Medical Oncology ( Site 2862) 0002 Tshwane South AfricaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +27123541771» Ansprechpartner anzeigenCape Town Oncology Trials ( Site 2864) 7570 Cape Town South AfricaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 27219443832» Ansprechpartner anzeigenHOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit 08036 Barcelona SpainRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +34932275402» Ansprechpartner anzeigenHospital Universitario Ramón y Cajal ( Site 2802) 28034 Madrid SpainRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +34913368263» Ansprechpartner anzeigenHôpitaux Universitaires de Genève (HUG)-Oncology ( Site 2603) 1211 Genève SwitzerlandRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +41223729862» Ansprechpartner anzeigenCHUV Centre Hospitalier Universitaire Vaudois ( Site 2602) 1011 Lausanne SwitzerlandAbgeschlossen» Google-MapsUniversitaetsspital Zuerich ( Site 2601) 8058 Zuerich Flughafen SwitzerlandRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +41442552588» Ansprechpartner anzeigen
1. Percentage of participants who experience a dose-limiting toxicity (DLT): Safety lead-in phase (Time Frame - Up to ~3 weeks): The percentage of participants who experience 1 or more protocol-defined DLTs during the safety lead-in period will be reported.
2. Percentage of participants who experience an adverse event (AE): Safety lead-in (Time Frame - Up to ~3 weeks): 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 percentage of participants who experience an AE during the safety lead-in period will be reported.
3. Percentage of participants who discontinue study treatment due to an AE: Safety lead-in (Time Frame - Up to ~3 weeks): 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 percentage of participants who discontinue study treatment due to an AE during the safety lead-in will be reported.
4. Percentage of participants who experience an adverse event (AE) (Time Frame - Up to ~28 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 percentage of participants who experience an AE will be reported.
5. Percentage of participants who discontinue study treatment due to an AE (Time Frame - Up to ~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 percentage of participants who discontinue study treatment due to an AE will be reported.
6. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) (Time Frame - Up to ~30 months): 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 RECIST 1.1 as assessed by blinded independent central review (BICR). RECIST 1.1 has been modified for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Secondary outcome:
1. Duration of Response (DOR) per RECIST 1.1 (Time Frame - Up to ~30 months): 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 (PD) or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by BICR. RECIST 1.1 has been modified for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Experimental: Pembrolizumab + Vibostolimab Participants will receive pembrolizumab intravenously (IV) plus vibostolimab IV at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Active Comparator: Pembrolizumab Participants will receive pembrolizumab IV at a specified dose on specified days for a total treatment duration of up to approximately 2 years.
Experimental: Coformulation Pembrolizumab/Quavonlimab Participants will receive coformulation of pembrolizumab and quavonlimab (MK-1308A) IV at a specified dose on specified days for a total treatment duration of up to approximately 2 years.
Experimental: Coformulation Pembrolizumab/Quavonlimab + Lenvatinib Participants will receive coformulation of pembrolizumab and quavonlimab IV plus lenvatinib orally at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Experimental: Coformulation Favezelimab/Pembrolizumab Participants will receive cofomulation of favezelimab + pembrolizumab (MK-4280A) IV at specified dose on specified days every 3 weeks (Q3W) for up to approximately 2 years
Experimental: Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA) Participants will receive coformulation of favezelimab and pembrolizumab IV Q3W for up to 35 cycles, plus ATRA orally (for 3 days surrounding each infusion of MK-4280A, including Days 1, 2, and 3 of Cycle 1 and on Days -1, 1, and 2 of all subsequent cycles).
Experimental: Coformulation Favezelimab/Pembrolizumab + Vibostolimab Participants will receive coformulation of favezelimab and pembrolizumab (MK-4280A) IV and vibostolimab IV at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Pembrolizumab (MK-3475 / KEYTRUDA® / ): Administered via IV infusion at a specified dose on specified days
Vibostolimab (MK-7684): Administered via IV infusion at a specified dose on specified days
Pembrolizumab/Quavonlimab (MK-1308A): Administered via IV infusion at a specified dose on specified days
Lenvatinib (MK-7902 / E7080 / LENVIMA® / ): Administered via oral capsule at a specified dose on specified days
Favezelimab/Pembrolizumab (MK-4280A): Administered via IV infusion at a specified dose on specified days
ATRA: Administered via oral capsule at a specified dose on specified days
Quelle: ClinicalTrials.gov
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"Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)"
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