Buscador de ensayos clínicos

Ver en ClinicalTrials.gov Exportar CSV

A Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Capecitabine Versus Bevacizumab Plus Capecitabine in Participants With Unresectable or Metastatic Colorectal Cancer

Estado del programa

Activo, no recluta

Fase

Fase 1 Fase 2

Inmunoterapia previa permitida

Ensayo dirigido por el CRC

Sí

Drogas

Bevacizumab, capecitabine, LBL-007, Tislelizumab

Etiquetas

MSS/ MMRp

Comentarios

For MSS CRC patients who are about to start first line of treatment in the metastatic setting (no prior chemo for metastatic cancer allowed). Patients with BRAF V600E mutated cancer are excluded from participation.
Standard of care (bevacizumab + fluoropyrimidine (5-FU or capecitabine)) vs different combinations/ different doses of two experimental agents, immunotherapies:
tislelizumab: anti PD-1, checkpoint inhbitor.
LBL-007: anti LAG-3 antibody (immunotherapy targeting human Lymphocyte-activation gene3 (LAG-3).

Enlaces útiles

Liberty-201: maintenance capecitabine and bevacizumab with or without anti-lymphocyte activation gene 3 (LAG3) antibody LBL-007 plus anti-programmed cell death protein 1 (PD-1) antibody tislelizumab (TIS) for patients (pts) with metastatic or unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) colorectal cancer (CRC)

Ubicación	Situación
Estados Unidos
Alaska Oncology and Hematology, Llc Anchorage, Alaska 99508	Activo, no recluta
Centro Oncológico Banner Md Anderson Gilbert, Arizona 85234	Activo, no recluta
Toi Clinical Research Cerritos, California 90703	Activo, no recluta
Usc Norris Comprehensive Cancer Center (Nccc) Los Angeles, California 90033	Activo, no recluta
Valkyrie Ensayos clínicos Los Angeles, California 90067	Activo, no recluta
UCLA Los Ángeles, California 90095	Activo, no recluta
Hoag Memorial Presbyterian Newport, California 92663	Activo, no recluta
Kaiser Permanente Northern California Vallejo, California 94510	Activo, no recluta
Baptist Md Anderson Cancer Center Jacksonville, Florida 32207	Activo, no recluta
Fort Wayne Medical Oncology and Hematology Fort Wayne, Indiana 46804	Activo, no recluta
Baptist Health Lexington Lexington, Kentucky 40503	Activo, no recluta
University of Kentucky Markey Cancer Center Lexington, Kentucky 40536	Activo, no recluta
Norton Cancer Institute Louisville, Kentucky 40217	Activo, no recluta
Pontchartrain Cancer Center Covington, Louisiana 70433	Activo, no recluta
Ochsner Clinic Foundation New Orleans, Louisiana 70121	Activo, no recluta
Facultad de Medicina de la Universidad de Washington St Louis, Missouri 63110	Activo, no recluta
St Vincent Frontier Cancer Center Billings, Montana 59102	Activo, no recluta
Centros Oncológicos Integrales de Nevada Las Vegas, Nevada 89169	Activo, no recluta
Cancer Care Specialists Reno, Nevada 89511	Activo, no recluta
Centro Oncológico de la Universidad de Nuevo México Albuquerque, New Mexico 87102	Activo, no recluta
Perlmutter Cancer Center At Winthrop Oncology Hematology Associatesnyu Winthrop Hospital Mineola, New York 11501	Activo, no recluta
Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health Nueva York, Nueva York 10016	Activo, no recluta
Columbia University Medical Center Nueva York, Nueva York 10032	Activo, no recluta
Duke Cancer Center Durham, Carolina del Norte 27710	Activo, no recluta
University of Tennessee Medical Center Knoxville, Tennessee 37920	Activo, no recluta
Ut Southwestern Medical Center Dallas, Texas 75390	Activo, no recluta
Ut Health San Antonio Mays Cancer Center San Antonio, Texas 78229	Activo, no recluta
Especialistas en cáncer de Virginia Fairfax, Virginia 22031	Activo, no recluta
Cancer Care Northwest Spokane Valley, Washington 99216	Activo, no recluta
Multicare Health System Institute For Research and Innovation Tacoma, Washington 98405	Activo, no recluta
Australia
Blacktown Cancer and Haematology Centre Blacktown, Nueva Gales del Sur 2148	Activo, no recluta
Orange Health Service (Central West Cancer Care Centre) Orange, New South Wales 2800	Activo, no recluta
Riverina Cancer Care Centre Wagga Wagga, New South Wales 2650	Activo, no recluta
Calvary Mater Newcastle Waratah, New South Wales 2298	Activo, no recluta
Pindara Private Hospital Benowa, Queensland 4217	Activo, no recluta
Icon Cancer Centre South Brisbane South Brisbane, Queensland 4101	Activo, no recluta
Flinders Centre For Innovation in Cancer (Fcic) Bedford Park, South Australia 5042	Activo, no recluta
Lyell McEwin Hospital Elizabeth Vale, South Australia 5112	Activo, no recluta
Monash Health Clayton, Victoria 3168	Activo, no recluta
Austin Health Heidelberg, Victoria 3084	Activo, no recluta
The Alfred Hospital Melbourne, Victoria 3004	Activo, no recluta
St John of God, Murdoch Murdoch, Western Australia 6150	Activo, no recluta
Una investigación clínica Nedlands, Australia Occidental 6009	Activo, no recluta
China
The Second Hospital of Anhui Medical University Hefei, Anhui 230601	Activo, no recluta
Peking University First Hospital Beijing, Beijing 100034	Activo, no recluta
Beijing Tsinghua Changgung Hospital Beijing, Beijing 102218	Activo, no recluta
Fujian Medical University Union Hospital Fuzhou, Fujian 350001	Activo, no recluta
Quanzhou First Affliated Hospital of Fujian Medical University Quanzhou, Fujian 362000	Activo, no recluta
The First Affiliated Hospital of Xiamen University Xiamen, Fujian 361003	Activo, no recluta
Gansu Provincial Hospital Lanzhou, Gansu 730000	Activo, no recluta
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North) Guangzhou, Guangdong 510000	Activo, no recluta
Zhujiang Hospital of Southern Medical University Guangzhou, Guangdong 510000	Activo, no recluta
The First Affiliated Hospital of Shantou University Medical College Shantou, Guangdong 515041	Activo, no recluta
Nanyang Central Hospital Nanyang, Henan 473000	Activo, no recluta
Henan Cancer Hospital Zhengzhou, Henan 450000	Activo, no recluta
Hubei Cancer Hospital Wuhan, Hubei 430079	Activo, no recluta
Hunan Cancer Hospital Changsha, Hunan 410013	Activo, no recluta
The First Peoples Hospital of Changzhou Changzhou, Jiangsu 213000	Activo, no recluta
Nantong First Peoples Hospital Nantong, Jiangsu 215124	Activo, no recluta
Affiliated Hospital of Jiangnan University South Campus Wuxi, Jiangsu 214122	Activo, no recluta
Primer Hospital de la Universidad de Jilin Changchun, Jilin 130021	Activo, no recluta
General Hospital of Ningxia Medical University Yinchuan, Ningxia 750004	Activo, no recluta
Shandong Cancer Hospital Jinan, Shandong 250117	Activo, no recluta
Jining No.1 Peoples Hospital West Branch Jining, Shandong 272000	Activo, no recluta
Linyi Peoples Hospital Linyi, Shandong 276000	Activo, no recluta
Qingdao Municipal Hospital Qingdao, Shandong 266000	Activo, no recluta
Renji Hospital Shanghai Jiao Tong University School of Medicine Shanghai, Shanghai 200000	Activo, no recluta
Shanghai 10Th Peoples Hospital Shanghai, Shanghai 200072	Activo, no recluta
Shanghai East Hospital Branch Hospital Shanghai, Shanghai 200123	Activo, no recluta
Shanxi Provincial Cancer Hospital Taiyuan, Shanxi 030013	Activo, no recluta
Instituto del Cáncer y Hospital de la Universidad Médica de Tianjin Tianjin, Tianjin 300060	Activo, no recluta
Tianjin Union Medical Center (Nankai University Affiliated Hospital) Tianjin, Tianjin 300121	Activo, no recluta
Karamay Central Hospital of Xinjiang Karamay, Xinjiang 834009	Activo, no recluta
The Xinjiang Uygur Autonomous Region Peoples Hospital Urumqi, Xinjiang 830001	Activo, no recluta
The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou, Zhejiang 310009	Activo, no recluta
Puerto Rico
Pan American Oncology Trials, Llc Rio Piedras 00935	Activo, no recluta

Criterios de inclusión

Criterios de inclusión:

* Participant must have measurable disease as defined per RECIST version 1.1
* Has a histologically confirmed colorectal adenocarcinoma with metastatic or unresectable disease (Stage IV as defined by American Joint Committee on Cancer [AJCC] 8th edition)
* No prior systemic therapy for colorectal cancer (CRC) in the metastatic setting except for the induction treatment of first-line therapy. Note: Local regional treatment performed during induction systemic treatment is allowed
* Participants who have completed the first-line induction treatment, with an overall response of stable disease or better. The duration of induction treatment should be completed within approximately 6 months. The first dose of study treatment needs to occur within 2 weeks (for 2-week regimen) or 3 weeks (for 3-week regimen) to 6 weeks after Day 1 of the last cycle of induction therapy

Criterios de exclusión

Criterios de exclusión:

* Participants whose disease has become resectable at the investigator's discretion during or after induction treatment are not eligible
* Progressive disease occurred less than 6 months from completion of any prior neoadjuvant therapy (ie, chemotherapy with or without radiotherapy) or adjuvant therapy (ie, chemotherapy with or without radiotherapy), whichever occurred later
* Participants who have been treated with anti-epidermal growth factor receptor (EGFR) antibody in the induction treatment
* Any prior therapy targeting T-cell stimulation or checkpoint pathways
* Participants with B-raf proto-oncogene, serine/threonine kinase (BRAF)V600E mutations
* Have locally or centrally confirmed microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR) method or dMMR by immunohistochemistry (IHC) method

Note: Other protocol defined criteria may apply.

NCT ID

NCT05609370

Fecha en que se añadió el juicio

2022-11-08

Fecha de actualización

2025-06-11