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
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About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Zaawansowany rak jelita grubego (nie da się go operować lub rozprzestrzenił się na inne części ciała) z potwierdzonym typem genetycznym MSI i/lub dMMR
- •Pacjent nie otrzymywał dotychczas żadnego leczenia systemowego (leków działających na cały organizm) na zaawansowanym etapie choroby
- •Dobry ogólny stan zdrowia (wynik ECOG 0 lub 1)
- •Dostępny guz do badań laboratoryjnych - próbka archiwalna ze zdiagnozowania
- •Widoczne zmiany nowotworowe mierzalne w badaniach obrazowych
- •Prawidłowe wyniki badań krwi i funkcji organów
- •Kobiety zdolne do zajścia w ciążę muszą mieć ujemny test ciążowy
✗ Disqualifies
- •Poprzednie leczenie systemowe zaawansowanego raka jelita grubego (chemia lub immunoterapia na etapie przerzutów)
- •Poprzednie leczenie immunoterapią (inhibitory PD-1, PD-L1, PD-L2 lub CTLA-4)
- •Przerzuty do mózgu lub opuchlizna mózgu powodująca objawy wymagające leczenia
- •Aktywna choroba autoimmunologiczna lub niedobór immunologiczny wymagające wcześniejszego leczenia
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 16, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (122)
University of Arizona Cancer Center - North Campus
Tucson, United States
University of Michigan Rogel Cancer Center
Ann Arbor, United States
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
Detroit, United States
Mary Babb Randolph Cancer Center
Morgantown, United States
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Centro Medico Fleischer
Buenos Aires, Argentina
Instituto Alexander Fleming
Buenos Aires, Argentina
Sanatorio Allende | Departamento de Investigación Clínica
Córdoba, Argentina
Fundación Intecnus
Bariloche, Argentina
Sanatorio Parque - Oncology
Rosario, Argentina
Investigaciones Oncológicas C Colón
Mar Del Plata, Buenos Aires,, Argentina
Institut Jules Bordet - Clinique D'Oncology
Brussels, Belgium
UZ Leuven - Digestive oncology
Leuven, Belgium
CHU Helora - Hopital de La Louvière - Site Jolimont - Oncology department
La Louvière, Belgium
UZ Gent - Digestive Oncology
Ghent, Belgium
AZ Delta - Digestive oncology
Roeselare, Belgium
Hospital Evangélico de Cachoeiro de Itapemirim
Vitória, Brazil
Hospital Araujo Jorge Associaçao de Combate ao Cancer em Goias
Goiânia, Brazil
Nucleo de Ensino e Pesquisa do Hospital de Clinicas de Ijuí
Ijuí, Brazil
Unidade de Pesquisas Clinicas em Oncologia
Pelotas, Brazil
NAIC - Instituto do Cancer
Bauru, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Jaú, Brazil
Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil
Hospital Sirio Libanes - Oncology_Sao Paulo
São Paulo, Brazil
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
Beijing Cancer Hospital - Oncology Department
Beijing, China
Fujian Cancer Hospital
Fuzhou, China
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, China
Shandong University - Shandong Cancer Hospital
Jinan, China
Zhongshan Hospital, Fudan University
Shanghai, China
West China Hospital Sichuan University
Chengdu, China
Yunnan Cancer Hospital
Kunming, China
Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
CHU Brest - Hopital La Cavale Blanche - service oncologie medicale
Brest, France
CHRU de Besancon - Hopital Jean Minjoz - Medical Oncology
Besançon, France
Unicancer Dijon - Centre Georges Francois Leclerc - Oncologie medicale
Dijon, France
Unicancer Marseille - Institut Paoli-Calmettes - Oncologie medicale
Marseille, France
Universitätsklinikum Ulm - Klinik für Innere Medizin I
Ulm, Germany
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH-Medizinische Klinik 2
Schweinfurt, Germany
Asklepios Klinik Altona - Onkologie, Hämatologie, Palliativmedizin, Rheumatologie und Pneumologie
Hamburg, Germany
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
Frankfurt am Main, Germany
Klinikum Oldenburg - Klinik für Onkologie und Hämatologie
Oldenburg, Germany
Universitaetsklinikum Essen - Innere Klinik (Tumorforschung)
Essen, Germany
DRK Kliniken Berlin-Köpenick - Darmzentrum
Berlin, Germany
Saint Savvas Oncology Hospital -1st Internal Medicine - Oncology Department
Athens, Greece
General Hospital Of Athens Alexandra-Plasma Cell Dyscrasias Unit, Department of Clinical Therapeutics, N.K.U.A
Athens, Greece
Athens Medical Center S.A./ European Interbalkan Medical Center - 4th Department of Medical Oncology
Pylaia, Greece
Laiko General Hospital Of Athens- Oncology Department
Athens, Greece
Metropolitan General Hospital -Oncologic Clinical Trials and Research Clinic
Cholargos/ Athens, Greece
General University Hospital Of Patras- Division of Oncology, Department of Medicine
Pátrai, Greece
Queen Mary Hospital
Hong Kong, Hong Kong
Hong Kong United Oncology Centre
Kowloon, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
ASST Grande Ospedale Metropolitano Niguarda - Oncologia Falck
Milan, Italy
Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative
Milan, Italy
A.O.U. Universita' Degli Studi Della Campania Luigi Vanvitelli - Oncoematologia
Naples, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
Roma, Italy
Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
Rozzano, Italy
Sunway Medical Centre Penang - Department of Clinical Oncology
Perai, Malaysia
Hospital Wanita Dan Kanak Kanak Sabah - Oncology and Radiotherapy
Kota Kinabalu, Malaysia
Hospital Umum Sarawak (Sarawak General Hospital) SGH
Kuching, Malaysia
Sunway Medical Centre - Medical Oncology
Subang Jaya, Malaysia
Universiti Malaya Medical Centre - Clinical Oncology Department
Kuala Lumpur, Malaysia
Cengild G.I. Medical Centre - Curie Oncology KL
Kuala Lumpur, Malaysia
Instituto Nacional de Cancerología
Mexico City, Mexico
Hospital Zambrano Hellion
Monterrey, Mexico
Grupo Medico ASSET S.C
Benito Juárez, Mexico
Renati Innovation SAPI de CV
Guadalajara, Mexico
Oncare Viaducto Nápoles
Mexico City, Mexico
Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia
Monterrey, Mexico
HagaZiekenhuis - Oncologie Interne Geneeskunde
The Hague, Netherlands
Białostockie Centrum Onkologii im. M. Skłodowskiej-Curie w Białymstoku Oddział Onkologii Klinicznej
Bialystok, Poland
Pratia McM Kraków
Krakow, Poland
Comarch Healthcare SA Centrum Medyczne iMed24
Krakow, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Lodz, Poland
Opolskie Centrum Onkologii
Opole, Poland
Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
Otwock, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu Oddział Onkologiczny z Pododdziałem Dziennej Chemioterapii
Przemyśl, Poland
Mazowiecki Szpital Wojewódzki Siedleckie Centrum Onkologii Oddział Onkologii Klinicznej i Radioterapii
Siedlce, Poland
Centrum Medyczne Pratia Poznan
Skorzewo, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie Państwowy Instytut Badawczy- Oddział Warszawa Wawelska
Warsaw, Poland
Pratia Wroclaw
Wroclaw, Poland
Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Oncologia
Coimbra, Portugal
Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E. - Serviço de Oncologia Médica
Lisbon, Portugal
Unidade Local de Saúde de São José, E.P.E - Hospital de Santo António dos Capuchos - Serviço de Oncologia Médica
Lisbon, Portugal
START Research Portugal - ULSS Maria - Unidade de Ensaios de Fase I Start Lisbon
Lisbon, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E. - Serviço de Oncologia Médica
Porto, Portugal
National University Cancer Institute (NCIS)
Singapore, Singapore
National Cancer Center Singapore - Oncology Department
Singapore, Singapore
OncoCare Cancer Centre | Gleneagles Medical Centre
Singapore, Singapore
Curie Oncology | Farrer
Singapore, Singapore
Seoul National University Hospital | Oncology
Jongno -Gu, South Korea
Severance Hospital | Oncology
Seoul, South Korea
Asan Medical Center | Oncology
Seoul, South Korea
Samsung Medical Center | Oncology
Seoul, South Korea
Seoul National University Bundang Hospital | Oncology
Seongnam-si, Gyeonggi-do, South Korea
Complexo Hospitalario Universitario De Santiago | Oncologia
Santiago de Compostela, Spain
Hospital Universitari Vall D Hebron | Oncologia
Barcelona, Spain
Hospital Universitario Ramon Y Cajal | Oncologia Medica
Madrid, Spain
Hospital Universitario Virgen De La Victoria | Oncologia Medica
Málaga, Spain
Hospital Clinico Universitario De Valencia | Oncologia
Valencia, Spain
Hospital del Mar | Oncologia
Barcelona, Spain
UniversitätsSpital Zürich (USZ) - Klinik für Medizinische Onkologie und Hämatologie
Zurich, Switzerland
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Chang Gung Memorial Hospital at Linkou
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Keelung Chang Gung Memorial Hospital - Division of Hematology and Oncology
Keelung, Taiwan
Taichung Veterans General Hospital | Division of Colorectal Surgery
Taichung, Taiwan
Chi Mei Medical Center, Yongkang Branch
Tainan, Taiwan
Ankara Bilkent Sehir Hastanesi
Bilkent Çankaya, Turkey (Türkiye)
İstanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçın Şehir Hastanesi
Kadıköy, Turkey (Türkiye)
Trakya Univ. Tip Fak.
Edirne, Turkey (Türkiye)
Gaziantep Sehir Hastanesi -Medical Oncology Department
Gaziantep, Turkey (Türkiye)
Kartal Dr Lutfi Kirdar Sehir Hastanesi- Medical Oncology
Istanbul, Turkey (Türkiye)
VM Medical Park Samsun Hospital Medical Oncology Department
Samsun, Turkey (Türkiye)
Ankara Etlik Sehir Hastanesi
Yenimahalle, Turkey (Türkiye)
University College Hospital | Cancer Clinical Trials Unit
London, United Kingdom
University Hospital Coventry | Oncology
Coventry, United Kingdom
Trial contact
Bayer Clinical Trials Contact
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/17/2026.
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