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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)

NCT ID NCT07811193

NEW Sponsor: Vividion Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

colorectal adenocarcinoma Colorectal Neoplasms, Hereditary Nonpolyposis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    121 sites in 21 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.O.U. Universita' Degli Studi Della Campania Luigi Vanvitelli - Oncoematologia

    Naples, 80131, Italy

  • ASST Grande Ospedale Metropolitano Niguarda - Oncologia Falck

    Milan, 20162, Italy

  • AZ Delta - Digestive oncology

    Roeselare, 8800, Belgium

  • Ankara Bilkent Sehir Hastanesi

    Bilkent Çankaya, Ankara, 6800, Turkey (Türkiye)

  • Ankara Etlik Sehir Hastanesi

    Yenimahalle, 6170, Turkey (Türkiye)

  • Asan Medical Center | Oncology

    Seoul, 05505, South Korea

  • Asklepios Klinik Altona - Onkologie, Hämatologie, Palliativmedizin, Rheumatologie und Pneumologie

    Hamburg, 22763, Germany

  • Athens Medical Center S.A./ European Interbalkan Medical Center - 4th Department of Medical Oncology

    Pylaia, Thessaloniki, 570 01, Greece

  • Beijing Cancer Hospital - Oncology Department

    Beijing, Beijing Municipality, 100142, China

  • Białostockie Centrum Onkologii im. M. Skłodowskiej-Curie w Białymstoku Oddział Onkologii Klinicznej

    Bialystok, 15-027, Poland

  • Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit

    Detroit, Michigan, 48202, United States

  • CHRU de Besancon - Hopital Jean Minjoz - Medical Oncology

    Besançon, 25030, France

  • CHU Brest - Hopital La Cavale Blanche - service oncologie medicale

    Brest, Brittany Region, 29200, France

  • CHU Helora - Hopital de La Louvière - Site Jolimont - Oncology department

    La Louvière, Hainaut, 7100, Belgium

  • Cengild G.I. Medical Centre - Curie Oncology KL

    Kuala Lumpur, 59200, Malaysia

  • Centro Medico Fleischer

    Buenos Aires, C1414, Argentina

  • Centrum Medyczne Pratia Poznan

    Skorzewo, 60-185, Poland

  • Chang Gung Memorial Hospital Kaohsiung

    Kaohsiung City, 803, Taiwan

  • Chang Gung Memorial Hospital at Linkou

    Taipei, 10507, Taiwan

  • Chi Mei Medical Center, Yongkang Branch

    Tainan, 71004, Taiwan

  • Comarch Healthcare SA Centrum Medyczne iMed24

    Krakow, 31-864, Poland

  • Complexo Hospitalario Universitario De Santiago | Oncologia

    Santiago de Compostela, A Coruña, 15706, Spain

  • Curie Oncology | Farrer

    Singapore, 329563, Singapore

  • DRK Kliniken Berlin-Köpenick - Darmzentrum

    Berlin, 12559, Germany

  • Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina

    Otwock, 05-400, Poland

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

    Roma, 00168, Italy

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    Jaú, São Paulo, 14784-400, Brazil

  • Fundación Intecnus

    Bariloche, Río Negro Province, RP82 8400, Argentina

  • Gaziantep Sehir Hastanesi -Medical Oncology Department

    Gaziantep, 27470, Turkey (Türkiye)

  • General Hospital Of Athens Alexandra-Plasma Cell Dyscrasias Unit, Department of Clinical Therapeutics, N.K.U.A

    Athens, Attica, 115 28, Greece

  • General University Hospital Of Patras- Division of Oncology, Department of Medicine

    Pátrai, 265 04, Greece

  • Grupo Medico ASSET S.C

    Benito Juárez, 03100, Mexico

  • HagaZiekenhuis - Oncologie Interne Geneeskunde

    The Hague, 2545 AA, Netherlands

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000, China

  • Hong Kong United Oncology Centre

    Kowloon, 00000, Hong Kong

  • Hospital Araujo Jorge Associaçao de Combate ao Cancer em Goias

    Goiânia, Goiás, 74605-070, Brazil

  • Hospital Clinico Universitario De Valencia | Oncologia

    Valencia, 46010, Spain

  • Hospital Evangélico de Cachoeiro de Itapemirim

    Vitória, Espírito Santo, 29047-660, Brazil

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABB, Argentina

  • Hospital Sirio Libanes - Oncology_Sao Paulo

    São Paulo, São Paulo, 01308-050, Brazil

  • Hospital Umum Sarawak (Sarawak General Hospital) SGH

    Kuching, Sarawak, 93586, Malaysia

  • Hospital Universitari Vall D Hebron | Oncologia

    Barcelona, 08035, Spain

  • Hospital Universitario Ramon Y Cajal | Oncologia Medica

    Madrid, 28034, Spain

  • Hospital Universitario Virgen De La Victoria | Oncologia Medica

    Málaga, 20910, Spain

  • Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia

    Monterrey, 64460, Mexico

  • Hospital Wanita Dan Kanak Kanak Sabah - Oncology and Radiotherapy

    Kota Kinabalu, Sabah, 88996, Malaysia

  • Hospital Zambrano Hellion

    Monterrey, Nuevo León, 66278, Mexico

  • Hospital del Mar | Oncologia

    Barcelona, 08003, Spain

  • Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia

    Rozzano, 20089, Italy

  • Institut Jules Bordet - Clinique D'Oncology

    Brussels, Brussels Capital, 1070, Belgium

  • Instituto Alexander Fleming

    Buenos Aires, C1426ANZ, Argentina

  • Instituto Nacional de Cancerología

    Mexico City, Mexico City, 14080, Mexico

  • Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E. - Serviço de Oncologia Médica

    Lisbon, 1099-023, Portugal

  • Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E. - Serviço de Oncologia Médica

    Porto, 4200-072, Portugal

  • Instituto do Cancer do Estado de Sao Paulo

    São Paulo, 01246-000, Brazil

  • Investigaciones Oncológicas C Colón

    Mar Del Plata, Buenos Aires,, 7600, Argentina

  • Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative

    Milan, 20141, Italy

  • Kartal Dr Lutfi Kirdar Sehir Hastanesi- Medical Oncology

    Istanbul, 34865, Turkey (Türkiye)

  • Keelung Chang Gung Memorial Hospital - Division of Hematology and Oncology

    Keelung, 204201, Taiwan

  • Klinikum Oldenburg - Klinik für Onkologie und Hämatologie

    Oldenburg, Lower Saxony, 26133, Germany

  • Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)

    Frankfurt am Main, Hesse, 60488, Germany

  • Laiko General Hospital Of Athens- Oncology Department

    Athens, 11526, Greece

  • Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH-Medizinische Klinik 2

    Schweinfurt, Bavaria, 97422, Germany

  • Mary Babb Randolph Cancer Center

    Morgantown, West Virginia, 26505, United States

  • Mazowiecki Szpital Wojewódzki Siedleckie Centrum Onkologii Oddział Onkologii Klinicznej i Radioterapii

    Siedlce, 08-110, Poland

  • Metropolitan General Hospital -Oncologic Clinical Trials and Research Clinic

    Cholargos/ Athens, 155 62, Greece

  • NAIC - Instituto do Cancer

    Bauru, São Paulo, 17033-490, Brazil

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie Państwowy Instytut Badawczy- Oddział Warszawa Wawelska

    Warsaw, 02-034, Poland

  • National Cancer Center Singapore - Oncology Department

    Singapore, 168583, Singapore

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National University Cancer Institute (NCIS)

    Singapore, 119074, Singapore

  • Nucleo de Ensino e Pesquisa do Hospital de Clinicas de Ijuí

    Ijuí, Rio Grande do Sul, 98700-000, Brazil

  • Oncare Viaducto Nápoles

    Mexico City, 3810, Mexico

  • OncoCare Cancer Centre | Gleneagles Medical Centre

    Singapore, 258499, Singapore

  • Opolskie Centrum Onkologii

    Opole, 45-061, Poland

  • Pratia McM Kraków

    Krakow, 30-727, Poland

  • Pratia Wroclaw

    Wroclaw, 50-417, Poland

  • Prince of Wales Hospital

    Shatin, New Territories, 00000, Hong Kong

  • Queen Mary Hospital

    Hong Kong, Hong Kong SAR, 00000, Hong Kong

  • Renati Innovation SAPI de CV

    Guadalajara, 44680, Mexico

  • START Research Portugal - ULSS Maria - Unidade de Ensaios de Fase I Start Lisbon

    Lisbon, 1649-035, Portugal

  • Saint Savvas Oncology Hospital -1st Internal Medicine - Oncology Department

    Athens, Attica, 115 22, Greece

  • Samsung Medical Center | Oncology

    Seoul, 06351, South Korea

  • Sanatorio Allende | Departamento de Investigación Clínica

    Córdoba, X5000JHQ, Argentina

  • Sanatorio Parque - Oncology

    Rosario, Santa Fe Province, S2000GAP, Argentina

  • Seoul National University Bundang Hospital | Oncology

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital | Oncology

    Jongno -Gu, Seoul, 03080, South Korea

  • Severance Hospital | Oncology

    Seoul, 03722, South Korea

  • Shandong University - Shandong Cancer Hospital

    Jinan, Shandong, 250117, China

  • Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department

    Hangzhou, Zhejiang, 310016, China

  • Sunway Medical Centre - Medical Oncology

    Subang Jaya, Selangor, 47500, Malaysia

  • Sunway Medical Centre Penang - Department of Clinical Oncology

    Perai, Pulau Pinang, 13700, Malaysia

  • Taichung Veterans General Hospital | Division of Colorectal Surgery

    Taichung, 407219, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004, China

  • The Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510655, China

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei, 430030, China

  • Trakya Univ. Tip Fak.

    Edirne, 22030, Turkey (Türkiye)

  • UZ Gent - Digestive Oncology

    Ghent, 9000, Belgium

  • UZ Leuven - Digestive oncology

    Leuven, Flemish Brabant, 3000, Belgium

  • Unicancer Dijon - Centre Georges Francois Leclerc - Oncologie medicale

    Dijon, 21000, France

  • Unicancer Marseille - Institut Paoli-Calmettes - Oncologie medicale

    Marseille, 13009, France

  • Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Oncologia

    Coimbra, 3004-561, Portugal

  • Unidade Local de Saúde de São José, E.P.E - Hospital dos Capuchos - Serviço de Oncologia Médica

    Lisbon, 1169-050, Portugal

  • Unidade de Pesquisas Clinicas em Oncologia

    Pelotas, Rio Grande do Sul, 96020-080, Brazil

  • Universitaetsklinikum Essen - Innere Klinik (Tumorforschung)

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universiti Malaya Medical Centre - Clinical Oncology Department

    Kuala Lumpur, 59100, Malaysia

  • University College Hospital | Cancer Clinical Trials Unit

    London, Greater London, NW1 2PG, United Kingdom

  • University Hospital Coventry | Oncology

    Coventry, West Midlands, CV22DX, United Kingdom

  • University of Arizona Cancer Center - North Campus

    Tucson, Arizona, 85719, United States

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • Universitätsklinikum Ulm - Klinik für Innere Medizin I

    Ulm, Baden-Wurttemberg, 89081, Germany

  • VM Medical Park Samsun Hospital Medical Oncology Department

    Samsun, 55200, Turkey (Türkiye)

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610041, China

  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu Oddział Onkologiczny z Pododdziałem Dziennej Chemioterapii

    Przemyśl, 37-700, Poland

  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi

    Lodz, 93-513, Poland

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032, China

  • İstanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçın Şehir Hastanesi

    Kadıköy, Istanbul, 34722, Turkey (Türkiye)

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