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A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer ( SEAMARK )

计划状态

活跃，非招募

阶段

第二阶段

允许先接受免疫治疗

没有

CRC 指导的试验

是

药物

encorafenib, Braftovi, Erbitux, Keytruda

标签

MSI-H/ MMRd

Trial only for patients with metastatic MSI-H/MMRd colorectal cancer AND a BRAF mutation who have not started treatment yet. Some patients will receive the standard of care anti PD-1 pembrolizumab, while others will receive the combination of pembrolizumab (Keytruda, immunotherapy), cetuximab (Erbitux) and encorafenib (Braftovi, BRAF-inhbitor, oral).

No prior checkpoint inhibitor allowed, no prior BRAF inhibitor allowed.

有用链接

SEAMARK: Randomized phase 2 study of pembrolizumab + encorafenib + cetuximab vs pembrolizumab alone for first-line treatment of BRAF V600E–mutant microsatellite instability–high (MSI-H)/mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC).

地点	位置状态
美国
Mayo Clinic Building - Phoenix 亚利桑那州凤凰城 85054	活跃，非招募
Mayo Clinic Hospital 亚利桑那州凤凰城 85054	活跃，非招募
梅奥诊所 Scottsdale, Arizona 85259	活跃，非招募
Keck Hospital of USC 加利福尼亚州洛杉矶 90033	活跃，非招募
Keck School of Medicine of USC 加利福尼亚州洛杉矶 90033	活跃，非招募
LAC USC Medical Center 加利福尼亚州洛杉矶 90033	活跃，非招募
USC Norris Comprehensive Cancer Center 加利福尼亚州洛杉矶 90033	活跃，非招募
USC/Norris Comprehensive Cancer Center / Investigational Drug Services 加利福尼亚州洛杉矶 90033	活跃，非招募
USC/Norris Comprehensive Cancer Center 加利福尼亚州洛杉矶 90033	活跃，非招募
Keck Hospital of USC Pasadena Pasadena, California 91105	活跃，非招募
Mount Sinai Cancer Center 佛罗里达州迈阿密海滩 33140	活跃，非招募
University of Miami Hospital and Clinics, Sylvester Cancer Center 佛罗里达州迈阿密 33136	活跃，非招募
University of Miami Hospital and Clinics, Sylvester Cancer Center Plantation, Florida 33324	活跃，非招募
UChicago Medicine - River East 伊利诺伊州芝加哥 60611	活跃，非招募
University of Chicago Medical Center 伊利诺伊州芝加哥 60637	活跃，非招募
UChicago Medicine at Ingalls - Flossmoor Flossmoor, Illinois 60422	活跃，非招募
UChicago Medicine Ingalls Memorial Harvey, Illinois 60426	活跃，非招募
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital New Lenox, Illinois 60451	活跃，非招募
The University of Chicago Medicine Center of Advanced Care Orland Park Orland Park, Illinois 60462	活跃，非招募
UChicago Medicine at Ingalls - Tinley Park Tinley Park, Illinois 60477	活跃，非招募
Mayo Clinic Cancer Center Outpatient Pharmacy 明尼苏达州罗切斯特 55905	活跃，非招募
梅奥诊所明尼苏达州罗切斯特 55905	活跃，非招募
Columbia University Medical Center 纽约州纽约市 10032	活跃，非招募
The West Clinic, PLLC dba West Cancer Center 田纳西州日耳曼敦 38138	活跃，非招募
MD 安德森癌症中心德克萨斯州休斯顿 77030	活跃，非招募
澳大利亚
Chris O'Brien Lifehouse 新南威尔士州坎珀当 2050	活跃，非招募
GenesisCare North Shore 新南威尔士州圣莱昂纳兹 2065	活跃，非招募
Gallipoli Medical Research Foundation Brisbane, Queensland 4120	活跃，非招募
Greenslopes Private Hospital Greenslopes, Queensland 4120	活跃，非招募
Austin Health 维多利亚州海德堡 3084	活跃，非招募
彼得-麦克卡勒姆癌症中心墨尔本，维多利亚 3000	活跃，非招募
Royal Melbourne Hospital 维多利亚州帕克维尔 3052	活跃，非招募
比利时
Imelda General Hospital Bonheiden, Antwerpen 2820	活跃，非招募
儒勒-博尔代学院 Anderlecht, Bruxelles-capitale, Région DE 1070	活跃，非招募
Cliniques universitaires Saint-Luc Brussels, Bruxelles-capitale, Région DE 1200	活跃，非招募
UZ 根特 Gent, Oost-vlaanderen 9000	活跃，非招募
鲁汶工程大学 Leuven, Vlaams-brabant 3000	活跃，非招募
ZNA Middelheim Antwerpen 2020	活跃，非招募
加拿大
William Osler Health System Brampton, Ontario L6R 3J7	活跃，非招募
渥太华医院 - 综合院区安大略省渥太华 K1H 8L6	活跃，非招募
Sunnybrook Health Sciences - Odette Cancer Centre Toronto, Ontario M4N 3M5	活跃，非招募
CIUSSS de l'Est-de-l'Île-de-Montréal Montreal, Quebec h1t2m4	活跃，非招募
Saskatoon Cancer Center Saskatoon, Saskatchewan S7N4H4	活跃，非招募
Czechia
Fakultni nemocnice Hradec Kralove Hradec Kralove, Hradec Králové 500 05	活跃，非招募
Fakultni nemocnice Olomouc Olomouc, Olomoucký KRAJ 779 00	活跃，非招募
Fakultni Thomayerova nemocnice Prague, Praha 4 14059	活跃，非招募
Fakultni nemocnice Bulovka Prague, Praha 8 180 81	活跃，非招募
丹麦
医院 Copenhagen, Hovedstaden 2100	活跃，非招募
Herlev and Gentofte Hospital Copenhagen, Hovedstaden 2730	活跃，非招募
Aalborg Universitetshospital, Syd Aalborg, Nordjylland 9000	活跃，非招募
Vejle Sygehus Vejle, Syddanmark 7100	活跃，非招募
法国
乔治-蓬皮杜欧洲医院 Paris Cedex 15, Paris 75015	活跃，非招募
CHU Estaing Clermont Ferrand 63100	活跃，非招募
Centre Hospitalier Universitaire Estaing Clermont-Ferrand 63100	活跃，非招募
Institut Regional du Cancer de Montpellier - ICM Val d'Aurelle Montpellier Cedex 5 34298	活跃，非招募
Institut Régional du Cancer Montpellier 蒙彼利埃 34298	活跃，非招募
Hôpital Saint Antoine Paris 75571	活跃，非招募
德国
Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie Muenchen, Bayern 81737	活跃，非招募
Institut für Klinisch Onkologische Forschung Frankfurt, Hessen 60488	活跃，非招募
Klinikum Oldenburg Oldenburg, Niedersachsen 26133	活跃，非招募
Studiengesellschaft BSF Unternehmergesellschaft Halle (Saale), Sachsen-anhalt 06108	活跃，非招募
Universitätsklinikum Leipzig Leipzig, Sachsen 04103	活跃，非招募
Onkologische Schwerpunktpraxis Kurfuerstendamm Berlin 10707	活跃，非招募
Studiengesellschaft BSF UG Halle /Saale 06108	活跃，非招募
Facharztzentrum Eppendorf Hamburg 20249	活跃，非招募
意大利
Policlinico Universitario Monserrato Monserrato, Cagliari 09042	活跃，非招募
Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" Piazza Luigi Miraglia, 2 Napoli 坎帕尼亚，那不勒斯 80131	活跃，非招募
Ospedale di Guastalla Guastalla, Emilia-romagna 42016	活跃，非招募
IRCCS Casa Sollievo della Sofferenza San Giovanni Rotondo, Foggia 71013	活跃，非招募
ASST Grande Ospedale Metropolitano Niguarda Milan, Milano 20162	活跃，非招募
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia Candiolo, Torino 10060	活跃，非招募
Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno Livorno, Toscana 57124	活跃，非招募
Azienda Ospedaliero Universitaria Pisana Pisa, Toscana 56126	活跃，非招募
威尼托肿瘤研究所 IRCCS 威尼托帕多瓦 35128	活跃，非招募
Fondazione Poliambulanza Istituto Ospedaliero 布雷西亚 25124	活跃，非招募
Istituto Europeo di Oncologia IRCCS Milano 20141	活跃，非招募
Arcispedale Santa Maria Nuova Reggio Emilia 42123	活跃，非招募
荷兰
Maastricht UMC+ Maastricht, Limburg 6229 HX	活跃，非招募
Haaglanden MC - locatie Antoniushove Leidschendam, Zuid-holland 2262 BA	活跃，非招募
挪威
St. Olavs Hospital Trondheim, Sør-trøndelag 7030	活跃，非招募
Oslo Universitetssykehus Ullevål Oslo 0450	活跃，非招募
波兰
Przychodnia Lekarska KOMED Konin, Wielkopolskie 62-500	活跃，非招募
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza Brzozow 36-200	活跃，非招募
SPZOZ Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu Bytom 41-902	活跃，非招募
Copernicus Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii Gdansk 80-219	活跃，非招募
Radomskie Centrum Onkologii im. Bohaterow Radomskiego Czerwca 76 Radom 26-600	活跃，非招募
Slovakia
Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica Banska Bystrica 975 17	活跃，非招募
Onkologicky ustav sv. Alzbety, s.r.o. Bratislava 812 50	活跃，非招募
Narodny onkologicky ustav Bratislava 833 10	活跃，非招募
Vychodoslovensky onkologicky ustav, a.s. Kosice 04191	活跃，非招募
西班牙
CHUS - Hospital Clinico Universitario Santiago de Compostela, A Coruña [LA Coruña] 15706	活跃，非招募
埃尔切大学总医院 Elche, Alicante 03202	活跃，非招募
瓦尔德希伯伦大学医院 Barcelona, Barcelona [barcelona] 08035	活跃，非招募
Hospital Clínic de Barcelona Barcelona, Catalunya [cataluña] 08036	活跃，非招募
Institut Català d'Oncologia - L'Hospitalet L'Hospitalet de Llobregat, Catalunya [cataluña] 08908	活跃，非招募
Hospital Universitario Ramón y Cajal Madrid, Madrid, Comunidad DE 28034	活跃，非招募
十月十二日大学医院 Madrid, Madrid, Comunidad DE 28041	活跃，非招募
Hospital General Universitario Gregorio Marañon Madrid 28007	活跃，非招募
十月十二日大学医院马德里 28041	活跃，非招募
Hospital Universitario Virgen Del Rocio 塞维利亚 41013	活跃，非招募
巴伦西亚大学总医院 Valencia 46014	活跃，非招募
米格尔-塞尔维特大学医院 Zaragoza 50009	活跃，非招募
瑞典
Karolinska Universitetssjukhuset Solna Solna, Stockholms LÄN [se-01] 171 64	活跃，非招募
Södersjukhuset Stockholm, Stockholms LÄN [se-01] 11883	活跃，非招募
Skaraborgs Sjukhus Skövde Skövde 541 85	活跃，非招募
英国
Aberdeen Royal Infirmary Aberdeen, Aberdeen CITY AB25 2ZN	活跃，非招募
Guy's & St Thomas's NHS Foundation Trust London, England SE1 9RT	活跃，非招募
Royal Marsden Hospital (Chelsea) London, Kensington AND Chelsea SW3 6JJ	活跃，非招募
Guy's & St Thomas' NHS Foundation Trust London, London, CITY OF SE1 9RT	活跃，非招募
Royal Marsden Hospital (Sutton) London, Sutton, Surrey SM2 5PT	活跃，非招募
Heartlands Hospital Birmingham B9 5SS	活跃，非招募
The Royal Marsden NHS Foundation Trust 伦敦 SW3 6JJ	活跃，非招募

纳入标准

* Locally confirmed microsatellite instability-high/ deficient mismatch repair (MSI-H/dMMR) stage IV colorectal carcinoma
* Locally confirmed BRAF V600E mutation in tumor tissue or blood
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Have not received prior systemic regimens for metastatic disease.
* Measurable disease per RECIST 1.1
* 适当的器官功能

排除标准

排除标准：

* Colorectal adenocarcinoma that is RAS mutant or for which RAS mutation status is unknown
* Known active central nervous system metastases and/or carcinomatous meningitis; leptomeningeal disease
* Immunodeficiency or active autoimmune disease requiring systemic treatment in the past 2 years
* Presence of acute or chronic pancreatitis
* Clinically significant cardiovascular diseases (eg, thromboembolic or cerebrovascular accident events ≤ 12 wks prior)
* Received a live or live-attenuated vaccine within 30 days of planned start of study medication
* Previous treatment with any selective BRAF inhibitor (eg, encorafenib, dabrafenib, vemurafenib, XL281/BMS-908662) or any epidermal growth factor receptor (EGFR) inhibitor (eg, cetuximab, panitumumab).
* Previous treatment with an immune checkpoint inhibitor (eg, anti-programmed cell death [PD-1], anti-PD-L1 or anti-PD-L2 agent); or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).

NCT ID

NCT05217446

添加审判日期

2022-02-01

更新日期

2024-11-13