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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Vividion Therapeutics, Inc. • ClinicalTrials.gov ID: NCT07811193

Registry updated: 2026-10-21
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Description

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.

Interventions

  • VVD-133214 (Drug)
    VVD-133214 will be administered orally
  • Pembrolizumab (Drug)
    Pembrolizumab will be administered by intravenous infusion (IV) every three weeks

Eligibility criteria

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

Conditions

Colorectal Adenocarcinoma

Locations

  • University of Arizona Cancer Center - North Campus — Tucson, Arizona, United States
  • University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States
  • Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit — Detroit, Michigan, United States
  • Mary Babb Randolph Cancer Center — Morgantown, West Virginia, United States
  • Hospital Italiano de Buenos Aires — Buenos Aires, Buenos Aires, Argentina
  • Centro Medico Fleischer — Buenos Aires, Buenos Aires, Argentina
  • Instituto Alexander Fleming — Buenos Aires, Buenos Aires, Argentina
  • Investigaciones Oncológicas C Colón — Mar del Plata, Buenos Aires, Argentina
  • Sanatorio Allende | Departamento de Investigación Clínica — Córdoba, Córdoba Province, Argentina
  • Fundación Intecnus — Bariloche, Río Negro Province, Argentina
  • Sanatorio Parque - Oncology — Rosario, Santa Fe Province, Argentina
  • Institut Jules Bordet - Clinique D'Oncology — Brussels, Brussels Capital, Belgium
  • UZ Leuven - Digestive oncology — Leuven, Flemish Brabant, Belgium
  • CHU Helora - Hopital de La Louvière - Site Jolimont - Oncology department — La Louvière, Hainaut, Belgium
  • UZ Gent - Digestive Oncology — Ghent, Oost-Vlaaanderen, Belgium
  • AZ Delta - Digestive oncology — Roeselare, West-Vlaanderen, Belgium
  • Hospital Evangélico de Cachoeiro de Itapemirim — Vitória, Espírito Santo, Brazil
  • Hospital Araujo Jorge Associaçao de Combate ao Cancer em Goias — Goiânia, Goiás, Brazil
  • Nucleo de Ensino e Pesquisa do Hospital de Clinicas de Ijuí — Ijuí, Rio Grande do Sul, Brazil
  • Unidade de Pesquisas Clinicas em Oncologia — Pelotas, Rio Grande do Sul, Brazil
  • NAIC - Instituto do Cancer — Bauru, São Paulo, Brazil
  • Fundacao Pio XII - Hospital de Cancer de Barretos — Jaú, São Paulo, Brazil
  • Instituto do Cancer do Estado de Sao Paulo — São Paulo, São Paulo, Brazil
  • Hospital Sirio Libanes - Oncology_Sao Paulo — São Paulo, São Paulo, Brazil
  • The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui, China
  • Beijing Cancer Hospital - Oncology Department — Beijing, Beijing Municipality, China
  • Fujian Cancer Hospital — Fuzhou, Fujian, China
  • The Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China
  • Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology — Wuhan, Hubei, China
  • Shandong University - Shandong Cancer Hospital — Jinan, Shandong, China
  • Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China
  • West China Hospital Sichuan University — Chengdu, Sichuan, China
  • Yunnan Cancer Hospital — Kunming, Yunnan, China
  • Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department — Hangzhou, Zhejiang, China
  • Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China
  • CHRU de Besancon - Hopital Jean Minjoz - Medical Oncology — Besançon, Bourgogne-Franche-Comté, France
  • Unicancer Dijon - Centre Georges Francois Leclerc - Oncologie medicale — Dijon, Bourgogne-Franche-Comté, France
  • CHU Brest - Hopital La Cavale Blanche - service oncologie medicale — Brest, Brittany Region, France
  • Unicancer Marseille - Institut Paoli-Calmettes - Oncologie medicale — Marseille, Provence-Alpes-Côte d'Azur Region, France
  • Universitätsklinikum Ulm - Klinik für Innere Medizin I — Ulm, Baden-Wurttemberg, Germany
  • Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH-Medizinische Klinik 2 — Schweinfurt, Bavaria, Germany
  • Asklepios Klinik Altona - Onkologie, Hämatologie, Palliativmedizin, Rheumatologie und Pneumologie — Hamburg, Free and Hanseatic City of Hamburg, Germany
  • Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF) — Frankfurt am Main, Hesse, Germany
  • Klinikum Oldenburg - Klinik für Onkologie und Hämatologie — Oldenburg, Lower Saxony, Germany
  • Universitaetsklinikum Essen - Innere Klinik (Tumorforschung) — Essen, North Rhine-Westphalia, Germany
  • DRK Kliniken Berlin-Köpenick - Darmzentrum — Berlin, State of Berlin, Germany
  • Saint Savvas Oncology Hospital -1st Internal Medicine - Oncology Department — Athens, Attica, Greece
  • General Hospital Of Athens Alexandra-Plasma Cell Dyscrasias Unit, Department of Clinical Therapeutics, N.K.U.A — Athens, Attica, Greece
  • Athens Medical Center S.A./ European Interbalkan Medical Center - 4th Department of Medical Oncology — Pylaia, Thessaloniki, 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 SAR, Hong Kong
  • Hong Kong United Oncology Centre — Kowloon, Kowloon, Hong Kong
  • Prince of Wales Hospital — Shatin, New Territories, Hong Kong
  • A.O.U. Universita' Degli Studi Della Campania Luigi Vanvitelli - Oncoematologia — Naples, Campania, Italy
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica — Rome, Lazio, Italy
  • Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative — Milan, Lombardy, Italy
  • Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia — Rozzano, Lombardy, Italy
  • ASST Grande Ospedale Metropolitano Niguarda - Oncologia Falck — Milan, Milan, Italy
  • Universiti Malaya Medical Centre - Clinical Oncology Department — Kuala Lumpur, Kuala Lumpur, Malaysia
  • Cengild G.I. Medical Centre - Curie Oncology KL — Kuala Lumpur, Kuala Lumpur, Malaysia
  • Sunway Medical Centre Penang - Department of Clinical Oncology — Perai, Pulau Pinang, Malaysia
  • Hospital Wanita Dan Kanak Kanak Sabah - Oncology and Radiotherapy — Kota Kinabalu, Sabah, Malaysia
  • Hospital Umum Sarawak (Sarawak General Hospital) SGH — Kuching, Sarawak, Malaysia
  • Sunway Medical Centre - Medical Oncology — Subang Jaya, Selangor, Malaysia
  • Renati Innovation SAPI de CV — Guadalajara, Jalisco, Mexico
  • Grupo Medico ASSET S.C — Benito Juárez, Mexico City, Mexico
  • Instituto Nacional de Cancerología — Mexico City, Mexico City, Mexico
  • Oncare Viaducto Nápoles — Mexico City, Mexico City, Mexico
  • Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia — Monterrey, Nuevo León, Mexico
  • Hospital Zambrano Hellion — Monterrey, Nuevo León, Mexico
  • HagaZiekenhuis - Oncologie Interne Geneeskunde — The Hague, South Holland, Netherlands
  • Centrum Medyczne Pratia Poznan — Skórzewo, Greater Poland Voivodeship, Poland
  • Pratia McM Kraków — Krakow, Lesser Poland Voivodeship, Poland
  • Comarch Healthcare SA Centrum Medyczne iMed24 — Krakow, Lesser Poland Voivodeship, Poland
  • Pratia Wroclaw — Wroclaw, Lower Silesian Voivodeship, Poland
  • Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina — Otwock, Masovian Voivodeship, Poland
  • Mazowiecki Szpital Wojewódzki Siedleckie Centrum Onkologii Oddział Onkologii Klinicznej i Radioterapii — Siedlce, Masovian Voivodeship, Poland
  • Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie Państwowy Instytut Badawczy- Oddział Warszawa Wawelska — Warsaw, Masovian Voivodeship, Poland
  • Opolskie Centrum Onkologii — Opole, Opole Voivodeship, Poland
  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu Oddział Onkologiczny z Pododdziałem Dziennej Chemioterapii — Przemyśl, Podkarpackie Voivodeship, Poland
  • Białostockie Centrum Onkologii im. M. Skłodowskiej-Curie w Białymstoku Oddział Onkologii Klinicznej — Bialystok, Podlaskie Voivodeship, Poland
  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi — Lodz, Łódź Voivodeship, Poland
  • Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Oncologia — Coimbra, Beira Litoral, Portugal
  • Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E. - Serviço de Oncologia Médica — Lisbon, Lisbon District, Portugal
  • Unidade Local de Saúde de São José, E.P.E - Hospital de Santo António dos Capuchos - Serviço de Oncologia Médica — Lisbon, Lisbon District, Portugal
  • START Research Portugal - ULSS Maria - Unidade de Ensaios de Fase I Start Lisbon — Lisbon, Lisbon District, Portugal
  • Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E. - Serviço de Oncologia Médica — Porto, Porto District, Portugal
  • National University Hospital - National University Cancer Institute (NCIS) — Singapore, Singapore, Singapore
  • National Cancer Center Singapore - Oncology Department — Singapore, Singapore, Singapore
  • OncoCare Cancer Centre | Gleneagles Medical Centre — Singapore, Singapore, Singapore
  • Curie Oncology | Farrer — Singapore, Singapore, Singapore
  • Seoul National University Bundang Hospital | Oncology — Seongnam-si, Gyeonggi-do, Gyeonggi-do, South Korea
  • Seoul National University Hospital | Oncology — Jongno -Gu, Seoul, South Korea
  • Severance Hospital | Oncology — Seoul, Seoul, South Korea
  • Asan Medical Center | Oncology — Seoul, Seoul, South Korea
  • Samsung Medical Center | Oncology — Seoul, Seoul, South Korea
  • Complexo Hospitalario Universitario De Santiago | Oncologia — Santiago de Compostela, A Coruña, Spain
  • Hospital Universitari Vall D Hebron | Oncologia — Barcelona, Barcelona, Spain
  • Hospital del Mar | Oncologia — Barcelona, Catalonia, Spain
  • Hospital Universitario Ramon Y Cajal | Oncologia Medica — Madrid, Madrid, Spain
  • Hospital Universitario Virgen De La Victoria | Oncologia Medica — Málaga, Málaga, Spain
  • Hospital Clinico Universitario De Valencia | Oncologia — Valencia, Valencia, Spain
  • UniversitätsSpital Zürich (USZ) - Klinik für Medizinische Onkologie und Hämatologie — Zurich, Canton of Zurich, Switzerland
  • Chang Gung Memorial Hospital Kaohsiung — Kaohsiung City, Kaohsiung, Taiwan
  • Keelung Chang Gung Memorial Hospital - Division of Hematology and Oncology — Keelung, Keelung, Taiwan
  • Taichung Veterans General Hospital | Division of Colorectal Surgery — Taichung, Taichung, Taiwan
  • National Cheng Kung University Hospital — Tainan, Tainan, Taiwan
  • Chi Mei Medical Center, Yongkang Branch — Tainan, Tainan, Taiwan
  • Chang Gung Memorial Hospital at Linkou — Taipei, Taipei, Taiwan
  • Taipei Veterans General Hospital — Taipei, Taipei, Taiwan
  • Ankara Bilkent Sehir Hastanesi — Bilkent Çankaya, Ankara, Turkey (Türkiye)
  • Ankara Etlik Sehir Hastanesi — Yenimahalle, Ankara, Turkey (Türkiye)
  • Trakya Univ. Tip Fak. — Edirne, Edirne, Turkey (Türkiye)
  • Gaziantep Sehir Hastanesi -Medical Oncology Department — Gaziantep, Gaziantep, Turkey (Türkiye)
  • Kartal Dr Lutfi Kirdar Sehir Hastanesi- Medical Oncology — Istanbul, Istanbul, Turkey (Türkiye)
  • İstanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçın Şehir Hastanesi — Kadıköy, Istanbul, Turkey (Türkiye)
  • VM Medical Park Samsun Hospital Medical Oncology Department — Samsun, Samsun, Turkey (Türkiye)
  • University College Hospital | Cancer Clinical Trials Unit — London, Greater London, United Kingdom
  • University Hospital Coventry | Oncology — Coventry, West Midlands, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record