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
15 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
140
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Bayer Clinical Trials Contact
- Número de teléfono: 18888422937
- Correo electrónico: clinical-trials-contact@bayer.com
Ubicaciones de estudio
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Baden-Wurttemberg
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Ulm, Baden-Wurttemberg, Alemania, 89081
- Aún no reclutando
- Universitätsklinikum Ulm - Klinik für Innere Medizin I
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Bavaria
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Schweinfurt, Bavaria, Alemania, 97422
- Aún no reclutando
- 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, Alemania, 22763
- Aún no reclutando
- Asklepios Klinik Altona - Onkologie, Hämatologie, Palliativmedizin, Rheumatologie und Pneumologie
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Hesse
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Frankfurt am Main, Hesse, Alemania, 60488
- Aún no reclutando
- Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
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Lower Saxony
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Oldenburg, Lower Saxony, Alemania, 26133
- Aún no reclutando
- Klinikum Oldenburg - Klinik für Onkologie und Hämatologie
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North Rhine-Westphalia
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Essen, North Rhine-Westphalia, Alemania, 45147
- Aún no reclutando
- Universitaetsklinikum Essen - Innere Klinik (Tumorforschung)
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State of Berlin
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Berlin, State of Berlin, Alemania, 12559
- Aún no reclutando
- DRK Kliniken Berlin-Köpenick - Darmzentrum
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Mar Del Plata, Buenos Aires,, Argentina, 7600
- Aún no reclutando
- Investigaciones Oncológicas C Colón
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Buenos Aires
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Buenos Aires, Buenos Aires, Argentina, C1199ABB
- Aún no reclutando
- Hospital Italiano de Buenos Aires
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Buenos Aires, Buenos Aires, Argentina, C1414
- Aún no reclutando
- Centro Medico Fleischer
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Buenos Aires, Buenos Aires, Argentina, C1426ANZ
- Aún no reclutando
- Instituto Alexander Fleming
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Córdoba Province
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Córdoba, Córdoba Province, Argentina, X5000JHQ
- Aún no reclutando
- Sanatorio Allende | Departamento de Investigación Clínica
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Río Negro Province
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Bariloche, Río Negro Province, Argentina, RP82 8400
- Aún no reclutando
- Fundacion INTECNUS
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000GAP
- Aún no reclutando
- Sanatorio Parque - Oncology
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Espírito Santo
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Vitória, Espírito Santo, Brasil, 29047-660
- Aún no reclutando
- Hospital Evangélico de Cachoeiro de Itapemirim
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Goiás
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Goiânia, Goiás, Brasil, 74605-070
- Aún no reclutando
- 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, Brasil, 98700-000
- Aún no reclutando
- Nucleo de Ensino e Pesquisa do Hospital de Clinicas de Ijuí
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Pelotas, Rio Grande do Sul, Brasil, 96020-080
- Aún no reclutando
- Unidade de Pesquisas Clinicas em Oncologia
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São Paulo
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Bauru, São Paulo, Brasil, 17033-490
- Aún no reclutando
- NAIC - Instituto do Cancer
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Jaú, São Paulo, Brasil, 14784-400
- Aún no reclutando
- Fundacao Pio XII - Hospital de Cancer de Barretos
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São Paulo, São Paulo, Brasil, 01246-000
- Aún no reclutando
- Instituto do Cancer do Estado de Sao Paulo
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São Paulo, São Paulo, Brasil, 01308-050
- Aún no reclutando
- Hospital Sirio Libanes - Oncology_Sao Paulo
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Ghent, Bélgica, 9000
- Aún no reclutando
- UZ Gent - Digestive Oncology
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Roeselare, Bélgica, 8800
- Aún no reclutando
- AZ Delta - Digestive oncology
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Brussels Capital
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Brussels, Brussels Capital, Bélgica, 1070
- Aún no reclutando
- Institut Jules Bordet - Clinique D'Oncology
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Flemish Brabant
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Leuven, Flemish Brabant, Bélgica, 3000
- Aún no reclutando
- UZ Leuven - Digestive oncology
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Hainaut
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La Louvière, Hainaut, Bélgica, 7100
- Aún no reclutando
- CHU Helora - Hopital de La Louvière - Site Jolimont - Oncology department
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Seongnam-si, Gyeonggi-do, Corea del Sur, 13620
- Aún no reclutando
- Seoul National University Bundang Hospital | Oncology
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Seoul
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Jongno -Gu, Seoul, Corea del Sur, 03080
- Aún no reclutando
- Seoul National University Hospital | Oncology
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Seoul, Seoul, Corea del Sur, 03722
- Aún no reclutando
- Severance Hospital | Oncology
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Seoul, Seoul, Corea del Sur, 05505
- Aún no reclutando
- Asan Medical Center | Oncology
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Seoul, Seoul, Corea del Sur, 06351
- Aún no reclutando
- Samsung Medical Center | Oncology
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Barcelona, España, 08003
- Aún no reclutando
- Hospital del Mar | Oncologia
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A Coruña
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Santiago de Compostela, A Coruña, España, 15706
- Aún no reclutando
- Complexo Hospitalario Universitario De Santiago | Oncologia
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Barcelona
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Barcelona, Barcelona, España, 08035
- Aún no reclutando
- Hospital Universitari Vall D Hebron | Oncologia
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Madrid
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Madrid, Madrid, España, 28034
- Aún no reclutando
- Hospital Universitario Ramon Y Cajal | Oncologia Medica
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Málaga
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Málaga, Málaga, España, 20910
- Aún no reclutando
- Hospital Universitario Virgen De La Victoria | Oncologia Medica
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Valencia
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Valencia, Valencia, España, 46010
- Aún no reclutando
- Hospital Clinico Universitario De Valencia | Oncologia
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Arizona
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Tucson, Arizona, Estados Unidos, 85719
- Aún no reclutando
- University of Arizona Cancer Center - North Campus
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- Aún no reclutando
- University of Michigan Rogel Cancer Center
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Detroit, Michigan, Estados Unidos, 48202
- Aún no reclutando
- Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
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West Virginia
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Morgantown, West Virginia, Estados Unidos, 26505
- Aún no reclutando
- Mary Babb Randolph Cancer Center
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Besançon, Francia, 25030
- Aún no reclutando
- CHRU de Besancon - Hopital Jean Minjoz - Medical Oncology
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Dijon, Francia, 21000
- Aún no reclutando
- Unicancer Dijon - Centre Georges Francois Leclerc - Oncologie medicale
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Marseille, Francia, 13009
- Aún no reclutando
- Unicancer Marseille - Institut Paoli-Calmettes - Oncologie medicale
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Brittany Region
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Brest, Brittany Region, Francia, 29200
- Aún no reclutando
- CHU Brest - Hopital La Cavale Blanche - service oncologie medicale
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Athens, Grecia, 11526
- Aún no reclutando
- Laiko General Hospital Of Athens- Oncology Department
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Cholargos/ Athens, Grecia, 155 62
- Aún no reclutando
- Metropolitan General Hospital -Oncologic Clinical Trials and Research Clinic
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Pátrai, Grecia, 265 04
- Aún no reclutando
- General University Hospital Of Patras- Division of Oncology, Department of Medicine
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Attica
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Athens, Attica, Grecia, 115 22
- Aún no reclutando
- Saint Savvas Oncology Hospital -1st Internal Medicine - Oncology Department
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Athens, Attica, Grecia, 115 28
- Aún no reclutando
- 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, Grecia, 570 01
- Aún no reclutando
- Athens Medical Center S.A./ European Interbalkan Medical Center - 4th Department of Medical Oncology
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Hong Kong SAR
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Hong Kong, Hong Kong SAR, Hong Kong, 00000
- Aún no reclutando
- Queen Mary Hospital
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Kowloon
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Kowloon, Kowloon, Hong Kong, 00000
- Aún no reclutando
- Hong Kong United Oncology Centre
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New Territories
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Shatin, New Territories, Hong Kong, 00000
- Aún no reclutando
- Prince of Wales Hospital
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Milan, Italia, 20141
- Aún no reclutando
- Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative
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Naples, Italia, 80131
- Aún no reclutando
- A.O.U. Universita' Degli Studi Della Campania Luigi Vanvitelli - Oncoematologia
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Roma, Italia, 00168
- Aún no reclutando
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
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Rozzano, Italia, 20089
- Aún no reclutando
- Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
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Milan
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Milan, Milan, Italia, 20162
- Aún no reclutando
- ASST Grande Ospedale Metropolitano Niguarda - Oncologia Falck
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Kuala Lumpur, Malasia, 59100
- Aún no reclutando
- Universiti Malaya Medical Centre - Clinical Oncology Department
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Kuala Lumpur, Malasia, 59200
- Aún no reclutando
- Cengild G.I. Medical Centre - Curie Oncology KL
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Pulau Pinang
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Perai, Pulau Pinang, Malasia, 13700
- Aún no reclutando
- Sunway Medical Centre Penang - Department of Clinical Oncology
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Sabah
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Kota Kinabalu, Sabah, Malasia, 88996
- Aún no reclutando
- Hospital Wanita Dan Kanak Kanak Sabah - Oncology and Radiotherapy
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Sarawak
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Kuching, Sarawak, Malasia, 93586
- Aún no reclutando
- Hospital Umum Sarawak (Sarawak General Hospital) SGH
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Selangor
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Subang Jaya, Selangor, Malasia, 47500
- Aún no reclutando
- Sunway Medical Centre - Medical Oncology
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Benito Juárez, México, 03100
- Aún no reclutando
- Grupo Medico ASSET S.C
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Guadalajara, México, 44680
- Aún no reclutando
- Renati Innovation SAPI de CV
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Mexico City, México, 3810
- Aún no reclutando
- Oncare Viaducto Nápoles
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Monterrey, México, 64460
- Aún no reclutando
- Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia
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Mexico City
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Mexico City, Mexico City, México, 14080
- Aún no reclutando
- Instituto Nacional de Cancerologia
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Nuevo León
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Monterrey, Nuevo León, México, 66278
- Aún no reclutando
- Hospital Zambrano Hellion
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The Hague, Países Bajos, 2545 AA
- Aún no reclutando
- HagaZiekenhuis - Oncologie Interne Geneeskunde
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Bialystok, Polonia, 15-027
- Aún no reclutando
- Białostockie Centrum Onkologii im. M. Skłodowskiej-Curie w Białymstoku Oddział Onkologii Klinicznej
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Krakow, Polonia, 30-727
- Aún no reclutando
- Pratia MCM Krakow
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Krakow, Polonia, 31-864
- Aún no reclutando
- Comarch Healthcare SA Centrum Medyczne iMed24
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Lodz, Polonia, 93-513
- Aún no reclutando
- Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
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Opole, Polonia, 45-061
- Aún no reclutando
- Opolskie Centrum Onkologii
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Otwock, Polonia, 05-400
- Aún no reclutando
- Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
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Przemyśl, Polonia, 37-700
- Aún no reclutando
- Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu Oddział Onkologiczny z Pododdziałem Dziennej Chemioterapii
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Siedlce, Polonia, 08-110
- Aún no reclutando
- Mazowiecki Szpital Wojewódzki Siedleckie Centrum Onkologii Oddział Onkologii Klinicznej i Radioterapii
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Skorzewo, Polonia, 60-185
- Aún no reclutando
- Centrum Medyczne Pratia Poznan
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Warsaw, Polonia, 02-034
- Aún no reclutando
- Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie Państwowy Instytut Badawczy- Oddział Warszawa Wawelska
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Wroclaw, Polonia, 50-417
- Aún no reclutando
- Pratia Wroclaw
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Anhui
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Bengbu, Anhui, Porcelana, 233004
- Aún no reclutando
- the First Affiliated Hospital of Bengbu Medical College
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100142
- Aún no reclutando
- Beijing Cancer Hospital - Oncology Department
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Fujian
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Fuzhou, Fujian, Porcelana, 350014
- Aún no reclutando
- Fujian Cancer Hospital
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510655
- Aún no reclutando
- The Sixth Affiliated Hospital, Sun Yat-sen University
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Heilongjiang
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Harbin, Heilongjiang, Porcelana, 150000
- Aún no reclutando
- Harbin Medical University Cancer Hospital
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Hubei
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Wuhan, Hubei, Porcelana, 430030
- Aún no reclutando
- Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
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Shandong
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Jinan, Shandong, Porcelana, 250117
- Aún no reclutando
- Shandong University - Shandong Cancer Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200032
- Aún no reclutando
- Zhongshan hospital, Fudan university
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Sichuan
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Chengdu, Sichuan, Porcelana, 610041
- Aún no reclutando
- West China Hospital Sichuan University
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Yunnan
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Kunming, Yunnan, Porcelana, 650118
- Aún no reclutando
- Yunnan Cancer Hospital
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310022
- Aún no reclutando
- Zhejiang Cancer Hospital
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Hangzhou, Zhejiang, Porcelana, 310016
- Aún no reclutando
- Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
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Coimbra, Portugal, 3004-561
- Aún no reclutando
- Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Oncologia
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Lisbon, Portugal, 1099-023
- Aún no reclutando
- Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E. - Serviço de Oncologia Médica
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Lisbon, Portugal, 1169-050
- Aún no reclutando
- 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, Portugal, 1649-035
- Aún no reclutando
- START Research Portugal - ULSS Maria - Unidade de Ensaios de Fase I Start Lisbon
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Porto, Portugal, 4200-072
- Aún no reclutando
- Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E. - Serviço de Oncologia Médica
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Greater London
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London, Greater London, Reino Unido, NW1 2PG
- Aún no reclutando
- University College Hospital | Cancer Clinical Trials Unit
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West Midlands
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Coventry, West Midlands, Reino Unido, CV22DX
- Aún no reclutando
- University Hospital Coventry | Oncology
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Singapore, Singapur, 258499
- Aún no reclutando
- OncoCare Cancer Centre | Gleneagles Medical Centre
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Singapore, Singapur, 329563
- Aún no reclutando
- Curie Oncology | Farrer
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Singapore, Singapur, 168583
- Reclutamiento
- National Cancer Center Singapore - Oncology Department
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Singapore, Singapur, 119074
- Aún no reclutando
- National University Cancer Institute (NCIS)
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Canton of Zurich
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Zurich, Canton of Zurich, Suiza, 8091
- Retirado
- UniversitätsSpital Zürich (USZ) - Klinik für Medizinische Onkologie und Hämatologie
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Keelung, Taiwán, 204201
- Aún no reclutando
- Keelung Chang Gung Memorial Hospital - Division of Hematology and Oncology
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Taichung, Taiwán, 407219
- Aún no reclutando
- Taichung Veterans General Hospital | Division of Colorectal Surgery
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Tainan, Taiwán, 71004
- Aún no reclutando
- Chi Mei Medical Center, Yongkang Branch
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Kaohsiung
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Kaohsiung City, Kaohsiung, Taiwán, 803
- Aún no reclutando
- Chang Gung Memorial Hospital Kaohsiung
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Tainan
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Tainan, Tainan, Taiwán, 704
- Aún no reclutando
- National Cheng Kung University Hospital
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Taipei
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Taipei, Taipei, Taiwán, 11217
- Aún no reclutando
- Taipei Veterans General Hospital
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Taipei, Taipei, Taiwán, 10507
- Aún no reclutando
- Chang Gung Memorial Hospital at Linkou
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Edirne, Turquía (Türkiye), 22030
- Aún no reclutando
- Trakya Univ. Tip Fak.
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Gaziantep, Turquía (Türkiye), 27470
- Aún no reclutando
- Gaziantep Sehir Hastanesi -Medical Oncology Department
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Istanbul, Turquía (Türkiye), 34865
- Aún no reclutando
- Kartal Dr Lutfi Kirdar Sehir Hastanesi- Medical Oncology
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Samsun, Turquía (Türkiye), 55200
- Aún no reclutando
- VM Medical Park Samsun Hospital Medical Oncology Department
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Yenimahalle, Turquía (Türkiye), 6170
- Aún no reclutando
- Ankara Etlik Sehir Hastanesi
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Ankara
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Bilkent Çankaya, Ankara, Turquía (Türkiye), 6800
- Aún no reclutando
- Ankara Bilkent Sehir Hastanesi
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Istanbul
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Kadıköy, Istanbul, Turquía (Türkiye), 34722
- Aún no reclutando
- İstanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçın Şehir Hastanesi
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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
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Experimental: VVD-133214 Dose 2 + Pembrolizumab
Participants will receive VVD-133214 in combination with pembrolizumab
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VVD-133214 will be administered orally
Pembrolizumab will be administered by intravenous infusion (IV) every three weeks
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Comparador activo: Pembrolizumab
Participants will receive pembrolizumab only (monotherapy)
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Pembrolizumab will be administered by intravenous infusion (IV) every three weeks
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Landmark progression-free survival (PFS) rate at 6 months, as assessed by the investigator
Periodo de tiempo: From start of study treatment until end of follow-up (up to approximately 36 months)
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Defined as the proportion of participants who are alive and free from disease progression as per RECIST v1.1
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From start of study treatment until end of follow-up (up to approximately 36 months)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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)
Periodo de tiempo: From start of study treatment up to 30 days following the last dose of study drug (100 days after last administration of pembrolizumab)
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From start of study treatment up to 30 days following the last dose of study drug (100 days after last administration of pembrolizumab)
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Recommended Phase 2 Dose (RP2D) of VVD-133214 in combination with pembrolizumab
Periodo de tiempo: From start of study treatment until end of follow-up (up to approximately 36 months)
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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
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From start of study treatment until end of follow-up (up to approximately 36 months)
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Maximum plasma concentration observed (Cmax) following single and multiple doses of VVD-133214
Periodo de tiempo: Predose and multiple timepoints post-dose, up to approximately 36 months
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Predose and multiple timepoints post-dose, up to approximately 36 months
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Time of maximum plasma concentration observed (Tmax) following single and multiple doses of VVD-133214
Periodo de tiempo: Predose and multiple timepoints post-dose, up to approximately 36 months
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Predose and multiple timepoints post-dose, up to approximately 36 months
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Area under the plasma concentration-time curve (AUC) following single and multiple doses of VVD-133214
Periodo de tiempo: Predose and multiple timepoints post-dose, up to approximately 36 months
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Predose and multiple timepoints post-dose, up to approximately 36 months
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Overall response rate (ORR) according to RECIST v1.1 as assessed by the Investigator
Periodo de tiempo: From start of study treatment until end of follow-up (up to approximately 36 months)
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From start of study treatment until end of follow-up (up to approximately 36 months)
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Disease control rate (DCR) according to RECIST v1.1 as assessed by the Investigator
Periodo de tiempo: From start of study treatment until end of follow-up (up to approximately 36 months)
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From start of study treatment until end of follow-up (up to approximately 36 months)
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Duration of response (DOR) according to RECIST v1.1 as assessed by the Investigator
Periodo de tiempo: 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)
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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)
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Median progression-free survival (mPFS) according to RECIST v1.1 as assessed by the Investigator
Periodo de tiempo: 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)
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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)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
11 de septiembre de 2026
Finalización primaria (Estimado)
30 de junio de 2028
Finalización del estudio (Estimado)
31 de diciembre de 2030
Fechas de registro del estudio
Enviado por primera vez
2 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
2 de septiembre de 2026
Publicado por primera vez (Actual)
9 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de septiembre de 2026
Última verificación
15 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades Genéticas Congénitas
- Enfermedades metabólicas
- Enfermedades intestinales
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias colorrectales
- Neoplasias Intestinales
- Enfermedades del Colon
- Síndromes Neoplásicos Hereditarios
- Trastornos por deficiencia en la reparación del ADN
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Enfermedades Nutricionales y Metabólicas
- Neoplasias Colorrectales Hereditarias No Polipósicas
- pembrolizumab
Otros números de identificación del estudio
- VVD-133214-02
- 2026-525507-26-00 (Ctis)
- 23236 (Otro identificador: Bayer ID)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .