A Study to Evaluate the Efficacy of VVD-133214 in Combination With Pembrolizumab Compared With Pembrolizumab Alone in Participants With Advanced Cancer of the Colon or Rectum
2026년 9월 15일 업데이트: Vividion Therapeutics, Inc.
A Phase 2, Randomized, Open-label Study of VVD-133214 in COmbination With Pembrolizumab Compared to Pembrolizumab Monotherapy in Participants With Advanced Colorectal Adenocarcinoma (CRC) Harboring Microsatellite Instability (MSI) and/or Deficient Mismatch Repair (DMMR)
Researchers are looking for a better way to treat people with advanced colorectal cancer.
Colorectal cancer (cancer of the colon or rectum) is one of the most common cancers worldwide. Treatments include surgery, chemotherapy, radiotherapy, and immunotherapy; however, these treatments do not work for everyone, may cause serious adverse events or may stop working eventually. New treatments and treatment combinations are needed, especially for cancers that cannot be removed with surgery or that have spread to other parts of the body (called advanced or metastatic cancer).
Cells normally repair themselves when mistakes happen as they divide. But in some people with cancer, the repair system does not work properly because of a problem called dMMR (deficient mismatch repair). As a result, mistakes build up in the cell's DNA, leading to a condition called MSI (microsatellite instability). Over time, these changes can cause cells to grow and behave abnormally, contributing to the development and growth of cancer.
To survive, some cancer cells with dMMR or MSI rely on a protein called Werner helicase. This protein helps repair some of the DNA damage allowing them to keep growing. Because these cancer cells depend more on Werner helicase than healthy cells, blocking this protein may help stop cancer cells from surviving while having less effect on healthy cells.
The study drug, VVD-133214, is designed to block the Werner helicase protein. Blocking this protein may help stop cancer cells from growing, while causing less harm to healthy cells. VVD-133214 is being studied in combination with pembrolizumab, an approved immunotherapy that helps the immune system recognize and attack cancer cells.
This study will test the combination of VVD-133214 and pembrolizumab in people with advanced colorectal cancer with MSI and/or dMMR who have not yet received treatment for their advanced disease. The study aims to find the best dose of VVD-133214 in combination with pembrolizumab and to test whether the combination is more effective than pembrolizumab alone.
Participants will receive treatment with VVD-133214 for as long as it can help them and does not cause serious adverse events. Treatment with pembrolizumab will stop after two years. Participants can also stop treatment at any time.
During the study, participants will have regular visits with the study doctor for tests, scans, and check-ups. These visits help check how well the cancer is responding to the treatment and monitor the participants' health.
The study will also monitor adverse events, which are any new or worsening medical problems that can happen during the study. Doctors record all adverse events, irrespective of whether the study doctor believes they are related to the study treatments, to help ensure participants' safety throughout the study.
After stopping treatment, participants will return for follow-up visits: 30 days after their last dose of VVD-133214 and/or 100 days after their last dose of pembrolizumab. After that, participants will have long-term follow-up visits every 90 days for as long as they agree to continue participating in follow-up.
연구 개요
연구 유형
중재적
등록 (추정된)
140
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Bayer Clinical Trials Contact
- 전화번호: 18888422937
- 이메일: clinical-trials-contact@bayer.com
연구 장소
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Athens, 그리스, 11526
- 아직 모집하지 않음
- Laiko General Hospital Of Athens- Oncology Department
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Cholargos/ Athens, 그리스, 155 62
- 아직 모집하지 않음
- Metropolitan General Hospital -Oncologic Clinical Trials and Research Clinic
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Pátrai, 그리스, 265 04
- 아직 모집하지 않음
- General University Hospital Of Patras- Division of Oncology, Department of Medicine
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Attica
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Athens, Attica, 그리스, 115 22
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- Saint Savvas Oncology Hospital -1st Internal Medicine - Oncology Department
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Athens, Attica, 그리스, 115 28
- 아직 모집하지 않음
- General Hospital Of Athens Alexandra-Plasma Cell Dyscrasias Unit, Department of Clinical Therapeutics, N.K.U.A
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Thessaloniki
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Pylaia, Thessaloniki, 그리스, 570 01
- 아직 모집하지 않음
- Athens Medical Center S.A./ European Interbalkan Medical Center - 4th Department of Medical Oncology
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The Hague, 네덜란드, 2545 AA
- 아직 모집하지 않음
- HagaZiekenhuis - Oncologie Interne Geneeskunde
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Keelung, 대만, 204201
- 아직 모집하지 않음
- Keelung Chang Gung Memorial Hospital - Division of Hematology and Oncology
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Taichung, 대만, 407219
- 아직 모집하지 않음
- Taichung Veterans General Hospital | Division of Colorectal Surgery
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Tainan, 대만, 71004
- 아직 모집하지 않음
- Chi Mei Medical Center, Yongkang Branch
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Kaohsiung
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Kaohsiung City, Kaohsiung, 대만, 803
- 아직 모집하지 않음
- Chang Gung Memorial Hospital Kaohsiung
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Tainan
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Tainan, Tainan, 대만, 704
- 아직 모집하지 않음
- National Cheng Kung University Hospital
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Taipei
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Taipei, Taipei, 대만, 11217
- 아직 모집하지 않음
- Taipei Veterans General Hospital
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Taipei, Taipei, 대만, 10507
- 아직 모집하지 않음
- Chang Gung Memorial Hospital at Linkou
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Seongnam-si, Gyeonggi-do, 대한민국, 13620
- 아직 모집하지 않음
- Seoul National University Bundang Hospital | Oncology
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Seoul
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Jongno -Gu, Seoul, 대한민국, 03080
- 아직 모집하지 않음
- Seoul National University Hospital | Oncology
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Seoul, Seoul, 대한민국, 03722
- 아직 모집하지 않음
- Severance Hospital | Oncology
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Seoul, Seoul, 대한민국, 05505
- 아직 모집하지 않음
- Asan Medical Center | Oncology
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Seoul, Seoul, 대한민국, 06351
- 아직 모집하지 않음
- Samsung Medical Center | Oncology
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Baden-Wurttemberg
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Ulm, Baden-Wurttemberg, 독일, 89081
- 아직 모집하지 않음
- Universitätsklinikum Ulm - Klinik für Innere Medizin I
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Bavaria
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Schweinfurt, Bavaria, 독일, 97422
- 아직 모집하지 않음
- Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH-Medizinische Klinik 2
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Free and Hanseatic City of Hamburg
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Hamburg, Free and Hanseatic City of Hamburg, 독일, 22763
- 아직 모집하지 않음
- Asklepios Klinik Altona - Onkologie, Hämatologie, Palliativmedizin, Rheumatologie und Pneumologie
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Hesse
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Frankfurt am Main, Hesse, 독일, 60488
- 아직 모집하지 않음
- Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
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Lower Saxony
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Oldenburg, Lower Saxony, 독일, 26133
- 아직 모집하지 않음
- Klinikum Oldenburg - Klinik für Onkologie und Hämatologie
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North Rhine-Westphalia
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Essen, North Rhine-Westphalia, 독일, 45147
- 아직 모집하지 않음
- Universitaetsklinikum Essen - Innere Klinik (Tumorforschung)
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State of Berlin
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Berlin, State of Berlin, 독일, 12559
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- DRK Kliniken Berlin-Köpenick - Darmzentrum
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Kuala Lumpur, 말레이시아, 59100
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- Universiti Malaya Medical Centre - Clinical Oncology Department
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Kuala Lumpur, 말레이시아, 59200
- 아직 모집하지 않음
- Cengild G.I. Medical Centre - Curie Oncology KL
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Pulau Pinang
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Perai, Pulau Pinang, 말레이시아, 13700
- 아직 모집하지 않음
- Sunway Medical Centre Penang - Department of Clinical Oncology
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Sabah
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Kota Kinabalu, Sabah, 말레이시아, 88996
- 아직 모집하지 않음
- Hospital Wanita Dan Kanak Kanak Sabah - Oncology and Radiotherapy
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Sarawak
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Kuching, Sarawak, 말레이시아, 93586
- 아직 모집하지 않음
- Hospital Umum Sarawak (Sarawak General Hospital) SGH
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Selangor
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Subang Jaya, Selangor, 말레이시아, 47500
- 아직 모집하지 않음
- Sunway Medical Centre - Medical Oncology
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Benito Juárez, 멕시코, 03100
- 아직 모집하지 않음
- Grupo Medico ASSET S.C
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Guadalajara, 멕시코, 44680
- 아직 모집하지 않음
- Renati Innovation SAPI de CV
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Mexico City, 멕시코, 3810
- 아직 모집하지 않음
- Oncare Viaducto Nápoles
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Monterrey, 멕시코, 64460
- 아직 모집하지 않음
- Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia
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Mexico City
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Mexico City, Mexico City, 멕시코, 14080
- 아직 모집하지 않음
- Instituto Nacional de Cancerologia
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Nuevo León
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Monterrey, Nuevo León, 멕시코, 66278
- 아직 모집하지 않음
- Hospital Zambrano Hellion
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Arizona
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Tucson, Arizona, 미국, 85719
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- University of Arizona Cancer Center - North Campus
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Michigan
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Ann Arbor, Michigan, 미국, 48109
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- University of Michigan Rogel Cancer Center
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Detroit, Michigan, 미국, 48202
- 아직 모집하지 않음
- Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
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West Virginia
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Morgantown, West Virginia, 미국, 26505
- 아직 모집하지 않음
- Mary Babb Randolph Cancer Center
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Ghent, 벨기에, 9000
- 아직 모집하지 않음
- UZ Gent - Digestive Oncology
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Roeselare, 벨기에, 8800
- 아직 모집하지 않음
- AZ Delta - Digestive oncology
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Brussels Capital
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Brussels, Brussels Capital, 벨기에, 1070
- 아직 모집하지 않음
- Institut Jules Bordet - Clinique D'Oncology
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Flemish Brabant
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Leuven, Flemish Brabant, 벨기에, 3000
- 아직 모집하지 않음
- UZ Leuven - Digestive oncology
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Hainaut
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La Louvière, Hainaut, 벨기에, 7100
- 아직 모집하지 않음
- CHU Helora - Hopital de La Louvière - Site Jolimont - Oncology department
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Espírito Santo
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Vitória, Espírito Santo, 브라질, 29047-660
- 아직 모집하지 않음
- Hospital Evangélico de Cachoeiro de Itapemirim
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Goiás
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Goiânia, Goiás, 브라질, 74605-070
- 아직 모집하지 않음
- Hospital Araujo Jorge Associaçao de Combate ao Cancer em Goias
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Rio Grande do Sul
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Ijuí, Rio Grande do Sul, 브라질, 98700-000
- 아직 모집하지 않음
- Nucleo de Ensino e Pesquisa do Hospital de Clinicas de Ijuí
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Pelotas, Rio Grande do Sul, 브라질, 96020-080
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- Unidade de Pesquisas Clinicas em Oncologia
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São Paulo
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Bauru, São Paulo, 브라질, 17033-490
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- NAIC - Instituto do Cancer
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Jaú, São Paulo, 브라질, 14784-400
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- Fundacao Pio XII - Hospital de Cancer de Barretos
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São Paulo, São Paulo, 브라질, 01246-000
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- Instituto do Cancer do Estado de Sao Paulo
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São Paulo, São Paulo, 브라질, 01308-050
- 아직 모집하지 않음
- Hospital Sirio Libanes - Oncology_Sao Paulo
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Canton of Zurich
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Zurich, Canton of Zurich, 스위스, 8091
- 빼는
- UniversitätsSpital Zürich (USZ) - Klinik für Medizinische Onkologie und Hämatologie
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Barcelona, 스페인, 08003
- 아직 모집하지 않음
- Hospital del Mar | Oncologia
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A Coruña
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Santiago de Compostela, A Coruña, 스페인, 15706
- 아직 모집하지 않음
- Complexo Hospitalario Universitario De Santiago | Oncologia
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Barcelona
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Barcelona, Barcelona, 스페인, 08035
- 아직 모집하지 않음
- Hospital Universitari Vall D Hebron | Oncologia
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Madrid
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Madrid, Madrid, 스페인, 28034
- 아직 모집하지 않음
- Hospital Universitario Ramon Y Cajal | Oncologia Medica
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Málaga
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Málaga, Málaga, 스페인, 20910
- 아직 모집하지 않음
- Hospital Universitario Virgen De La Victoria | Oncologia Medica
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Valencia
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Valencia, Valencia, 스페인, 46010
- 아직 모집하지 않음
- Hospital Clinico Universitario De Valencia | Oncologia
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Singapore, 싱가포르, 258499
- 아직 모집하지 않음
- OncoCare Cancer Centre | Gleneagles Medical Centre
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Singapore, 싱가포르, 329563
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- Curie Oncology | Farrer
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Singapore, 싱가포르, 168583
- 모병
- National Cancer Center Singapore - Oncology Department
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Singapore, 싱가포르, 119074
- 아직 모집하지 않음
- National University Cancer Institute (NCIS)
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Mar Del Plata, Buenos Aires,, 아르헨티나, 7600
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- Investigaciones Oncológicas C Colón
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Buenos Aires
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Buenos Aires, Buenos Aires, 아르헨티나, C1199ABB
- 아직 모집하지 않음
- Hospital Italiano de Buenos Aires
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Buenos Aires, Buenos Aires, 아르헨티나, C1414
- 아직 모집하지 않음
- Centro Medico Fleischer
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Buenos Aires, Buenos Aires, 아르헨티나, C1426ANZ
- 아직 모집하지 않음
- Instituto Alexander Fleming
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Córdoba Province
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Córdoba, Córdoba Province, 아르헨티나, X5000JHQ
- 아직 모집하지 않음
- Sanatorio Allende | Departamento de Investigación Clínica
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Río Negro Province
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Bariloche, Río Negro Province, 아르헨티나, RP82 8400
- 아직 모집하지 않음
- Fundacion INTECNUS
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Santa Fe Province
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Rosario, Santa Fe Province, 아르헨티나, S2000GAP
- 아직 모집하지 않음
- Sanatorio Parque - Oncology
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Greater London
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London, Greater London, 영국, NW1 2PG
- 아직 모집하지 않음
- University College Hospital | Cancer Clinical Trials Unit
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West Midlands
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Coventry, West Midlands, 영국, CV22DX
- 아직 모집하지 않음
- University Hospital Coventry | Oncology
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Milan, 이탈리아, 20141
- 아직 모집하지 않음
- Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative
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Naples, 이탈리아, 80131
- 아직 모집하지 않음
- A.O.U. Universita' Degli Studi Della Campania Luigi Vanvitelli - Oncoematologia
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Roma, 이탈리아, 00168
- 아직 모집하지 않음
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
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Rozzano, 이탈리아, 20089
- 아직 모집하지 않음
- Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
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Milan
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Milan, Milan, 이탈리아, 20162
- 아직 모집하지 않음
- ASST Grande Ospedale Metropolitano Niguarda - Oncologia Falck
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Anhui
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Bengbu, Anhui, 중국, 233004
- 아직 모집하지 않음
- the First Affiliated Hospital of Bengbu Medical College
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100142
- 아직 모집하지 않음
- Beijing Cancer Hospital - Oncology Department
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Fujian
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Fuzhou, Fujian, 중국, 350014
- 아직 모집하지 않음
- Fujian Cancer Hospital
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Guangdong
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Guangzhou, Guangdong, 중국, 510655
- 아직 모집하지 않음
- The Sixth Affiliated Hospital, Sun Yat-sen University
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Heilongjiang
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Harbin, Heilongjiang, 중국, 150000
- 아직 모집하지 않음
- Harbin Medical University Cancer Hospital
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Hubei
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Wuhan, Hubei, 중국, 430030
- 아직 모집하지 않음
- Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
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Shandong
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Jinan, Shandong, 중국, 250117
- 아직 모집하지 않음
- Shandong University - Shandong Cancer Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200032
- 아직 모집하지 않음
- Zhongshan hospital, Fudan university
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Sichuan
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Chengdu, Sichuan, 중국, 610041
- 아직 모집하지 않음
- West China Hospital Sichuan University
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Yunnan
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Kunming, Yunnan, 중국, 650118
- 아직 모집하지 않음
- Yunnan Cancer Hospital
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Zhejiang
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Hangzhou, Zhejiang, 중국, 310022
- 아직 모집하지 않음
- Zhejiang Cancer Hospital
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Hangzhou, Zhejiang, 중국, 310016
- 아직 모집하지 않음
- Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
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Edirne, 터키 (Türkiye), 22030
- 아직 모집하지 않음
- Trakya Univ. Tip Fak.
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Gaziantep, 터키 (Türkiye), 27470
- 아직 모집하지 않음
- Gaziantep Sehir Hastanesi -Medical Oncology Department
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Istanbul, 터키 (Türkiye), 34865
- 아직 모집하지 않음
- Kartal Dr Lutfi Kirdar Sehir Hastanesi- Medical Oncology
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Samsun, 터키 (Türkiye), 55200
- 아직 모집하지 않음
- VM Medical Park Samsun Hospital Medical Oncology Department
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Yenimahalle, 터키 (Türkiye), 6170
- 아직 모집하지 않음
- Ankara Etlik Sehir Hastanesi
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Ankara
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Bilkent Çankaya, Ankara, 터키 (Türkiye), 6800
- 아직 모집하지 않음
- Ankara Bilkent Sehir Hastanesi
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Istanbul
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Kadıköy, Istanbul, 터키 (Türkiye), 34722
- 아직 모집하지 않음
- İstanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçın Şehir Hastanesi
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Coimbra, 포르투갈, 3004-561
- 아직 모집하지 않음
- Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Oncologia
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Lisbon, 포르투갈, 1099-023
- 아직 모집하지 않음
- Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E. - Serviço de Oncologia Médica
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Lisbon, 포르투갈, 1169-050
- 아직 모집하지 않음
- Unidade Local de Saúde de São José, E.P.E - Hospital de Santo António dos Capuchos - Serviço de Oncologia Médica
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Lisbon, 포르투갈, 1649-035
- 아직 모집하지 않음
- START Research Portugal - ULSS Maria - Unidade de Ensaios de Fase I Start Lisbon
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Porto, 포르투갈, 4200-072
- 아직 모집하지 않음
- Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E. - Serviço de Oncologia Médica
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Bialystok, 폴란드, 15-027
- 아직 모집하지 않음
- Białostockie Centrum Onkologii im. M. Skłodowskiej-Curie w Białymstoku Oddział Onkologii Klinicznej
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Krakow, 폴란드, 30-727
- 아직 모집하지 않음
- Pratia MCM Krakow
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Krakow, 폴란드, 31-864
- 아직 모집하지 않음
- Comarch Healthcare SA Centrum Medyczne iMed24
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Lodz, 폴란드, 93-513
- 아직 모집하지 않음
- Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
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Opole, 폴란드, 45-061
- 아직 모집하지 않음
- Opolskie Centrum Onkologii
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Otwock, 폴란드, 05-400
- 아직 모집하지 않음
- Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
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Przemyśl, 폴란드, 37-700
- 아직 모집하지 않음
- Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu Oddział Onkologiczny z Pododdziałem Dziennej Chemioterapii
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Siedlce, 폴란드, 08-110
- 아직 모집하지 않음
- Mazowiecki Szpital Wojewódzki Siedleckie Centrum Onkologii Oddział Onkologii Klinicznej i Radioterapii
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Skorzewo, 폴란드, 60-185
- 아직 모집하지 않음
- Centrum Medyczne Pratia Poznan
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Warsaw, 폴란드, 02-034
- 아직 모집하지 않음
- Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie Państwowy Instytut Badawczy- Oddział Warszawa Wawelska
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Wroclaw, 폴란드, 50-417
- 아직 모집하지 않음
- Pratia Wroclaw
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Besançon, 프랑스, 25030
- 아직 모집하지 않음
- CHRU de Besancon - Hopital Jean Minjoz - Medical Oncology
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Dijon, 프랑스, 21000
- 아직 모집하지 않음
- Unicancer Dijon - Centre Georges Francois Leclerc - Oncologie medicale
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Marseille, 프랑스, 13009
- 아직 모집하지 않음
- Unicancer Marseille - Institut Paoli-Calmettes - Oncologie medicale
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Brittany Region
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Brest, Brittany Region, 프랑스, 29200
- 아직 모집하지 않음
- CHU Brest - Hopital La Cavale Blanche - service oncologie medicale
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Hong Kong SAR
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Hong Kong, Hong Kong SAR, 홍콩, 00000
- 아직 모집하지 않음
- Queen Mary Hospital
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Kowloon
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Kowloon, Kowloon, 홍콩, 00000
- 아직 모집하지 않음
- Hong Kong United Oncology Centre
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New Territories
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Shatin, New Territories, 홍콩, 00000
- 아직 모집하지 않음
- Prince of Wales Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1
- Have a known microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) tumor status confirmed per local standard of care (SoC), and have histologically or cytologically documented advanced (unresectable and/or metastatic) colorectal adenocarcinoma (CRC)
- No prior systemic treatment for metastatic disease and not amenable to curative resection
- Participants must have documented MSI and/or dMMR tumor status determined as part of the routine diagnostic workup in a certified laboratory
- Availability of formaldehyde-fixed paraffin-embedded (FFPE) archival tumor tissue for submission to Sponsor/central laboratory for retrospective central testing including a copy of a redacted pathology report if available
- Presence of measurable disease according to RECIST v1.1
- Adequate hematologic and end-organ function, defined using laboratory results obtained within 14 days prior to first dose of study treatment
- Females of childbearing potential must have negative serum pregnancy test before starting study treatment
Exclusion Criteria:
- Prior systemic treatment for advanced CRC. Participants may have received prior adjuvant chemotherapy as long as disease progression occurred at least 12 months after the last dose of adjuvant treatment
- Prior treatment with adjuvant immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2 agent, or anti-CTLA-4 agent, or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents, etc.)
- Known active or uncontrolled central nervous system (CNS) or brain metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) and/or carcinomatous meningitis
- Patients with active or history of autoimmune disease or immune deficiency that has required treatment in past 2 years
- History of malignancy other than CRC, within 5 years prior to screening. Participants with Lynch syndrome are not excluded.
- Participants requiring treatment with systemic immunosuppressive medication (such as corticosteroids) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
- Participants with active hepatitis B, hepatitis C or HIV
- Participants with known Werner Syndrome (WRN)
- Prior treatment with any WRN helicase inhibitor
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: VVD-133214 Dose 1 + Pembrolizumab
Participants will receive VVD-133214 in combination with pembrolizumab
|
VVD-133214 will be administered orally
Pembrolizumab will be administered by intravenous infusion (IV) every three weeks
|
|
실험적: VVD-133214 Dose 2 + Pembrolizumab
Participants will receive VVD-133214 in combination with pembrolizumab
|
VVD-133214 will be administered orally
Pembrolizumab will be administered by intravenous infusion (IV) every three weeks
|
|
활성 비교기: Pembrolizumab
Participants will receive pembrolizumab only (monotherapy)
|
Pembrolizumab will be administered by intravenous infusion (IV) every three weeks
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Landmark progression-free survival (PFS) rate at 6 months, as assessed by the investigator
기간: From start of study treatment until end of follow-up (up to approximately 36 months)
|
Defined as the proportion of participants who are alive and free from disease progression as per RECIST v1.1
|
From start of study treatment until end of follow-up (up to approximately 36 months)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence and severity of Adverse Events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)
기간: From start of study treatment up to 30 days following the last dose of study drug (100 days after last administration of pembrolizumab)
|
From start of study treatment up to 30 days following the last dose of study drug (100 days after last administration of pembrolizumab)
|
|
|
Recommended Phase 2 Dose (RP2D) of VVD-133214 in combination with pembrolizumab
기간: From start of study treatment until end of follow-up (up to approximately 36 months)
|
The RP2D will be based on incidence, severity and frequency of adverse events, anti-tumor activity, PK/PD, and assessment of disease biomarkers for two doses of VVD-133214 combined with the standard of care (SoC) dose of pembrolizumab
|
From start of study treatment until end of follow-up (up to approximately 36 months)
|
|
Maximum plasma concentration observed (Cmax) following single and multiple doses of VVD-133214
기간: Predose and multiple timepoints post-dose, up to approximately 36 months
|
Predose and multiple timepoints post-dose, up to approximately 36 months
|
|
|
Time of maximum plasma concentration observed (Tmax) following single and multiple doses of VVD-133214
기간: Predose and multiple timepoints post-dose, up to approximately 36 months
|
Predose and multiple timepoints post-dose, up to approximately 36 months
|
|
|
Area under the plasma concentration-time curve (AUC) following single and multiple doses of VVD-133214
기간: Predose and multiple timepoints post-dose, up to approximately 36 months
|
Predose and multiple timepoints post-dose, up to approximately 36 months
|
|
|
Overall response rate (ORR) according to RECIST v1.1 as assessed by the Investigator
기간: From start of study treatment until end of follow-up (up to approximately 36 months)
|
From start of study treatment until end of follow-up (up to approximately 36 months)
|
|
|
Disease control rate (DCR) according to RECIST v1.1 as assessed by the Investigator
기간: From start of study treatment until end of follow-up (up to approximately 36 months)
|
From start of study treatment until end of follow-up (up to approximately 36 months)
|
|
|
Duration of response (DOR) according to RECIST v1.1 as assessed by the Investigator
기간: From the time of first occurrence of a documented response until the time of documented disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
|
From the time of first occurrence of a documented response until the time of documented disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
|
|
|
Median progression-free survival (mPFS) according to RECIST v1.1 as assessed by the Investigator
기간: From the time of first occurrence of a documented response until the time of documented disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
|
From the time of first occurrence of a documented response until the time of documented disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 9월 11일
기본 완료 (추정된)
2028년 6월 30일
연구 완료 (추정된)
2030년 12월 31일
연구 등록 날짜
최초 제출
2026년 9월 2일
QC 기준을 충족하는 최초 제출
2026년 9월 2일
처음 게시됨 (실제)
2026년 9월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 15일
마지막으로 확인됨
2026년 9월 15일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- VVD-133214-02
- 2026-525507-26-00 (씨티스)
- 23236 (기타 식별자: Bayer ID)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access.
As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .