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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 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

140

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Argentina
      • Mar Del Plata, Buenos Aires,, Argentina, 7600
        • Non ancora reclutamento
        • Investigaciones Oncológicas C Colón
    • Buenos Aires
      • Buenos Aires, Buenos Aires, Argentina, C1199ABB
        • Non ancora reclutamento
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Buenos Aires, Argentina, C1414
        • Non ancora reclutamento
        • Centro Medico Fleischer
      • Buenos Aires, Buenos Aires, Argentina, C1426ANZ
        • Non ancora reclutamento
        • Instituto Alexander Fleming
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, X5000JHQ
        • Non ancora reclutamento
        • Sanatorio Allende | Departamento de Investigación Clínica
    • Río Negro Province
      • Bariloche, Río Negro Province, Argentina, RP82 8400
        • Non ancora reclutamento
        • Fundacion INTECNUS
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000GAP
        • Non ancora reclutamento
        • Sanatorio Parque - Oncology
  • Belgio
      • Ghent, Belgio, 9000
        • Non ancora reclutamento
        • UZ Gent - Digestive Oncology
      • Roeselare, Belgio, 8800
        • Non ancora reclutamento
        • AZ Delta - Digestive oncology
    • Brussels Capital
      • Brussels, Brussels Capital, Belgio, 1070
        • Non ancora reclutamento
        • Institut Jules Bordet - Clinique D'Oncology
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgio, 3000
        • Non ancora reclutamento
        • UZ Leuven - Digestive oncology
    • Hainaut
      • La Louvière, Hainaut, Belgio, 7100
        • Non ancora reclutamento
        • CHU Helora - Hopital de La Louvière - Site Jolimont - Oncology department
  • Brasile
    • Espírito Santo
      • Vitória, Espírito Santo, Brasile, 29047-660
        • Non ancora reclutamento
        • Hospital Evangélico de Cachoeiro de Itapemirim
    • Goiás
      • Goiânia, Goiás, Brasile, 74605-070
        • Non ancora reclutamento
        • Hospital Araujo Jorge Associaçao de Combate ao Cancer em Goias
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brasile, 98700-000
        • Non ancora reclutamento
        • Nucleo de Ensino e Pesquisa do Hospital de Clinicas de Ijuí
      • Pelotas, Rio Grande do Sul, Brasile, 96020-080
        • Non ancora reclutamento
        • Unidade de Pesquisas Clinicas em Oncologia
    • São Paulo
      • Bauru, São Paulo, Brasile, 17033-490
        • Non ancora reclutamento
        • NAIC - Instituto do Cancer
      • Jaú, São Paulo, Brasile, 14784-400
        • Non ancora reclutamento
        • Fundacao Pio XII - Hospital de Cancer de Barretos
      • São Paulo, São Paulo, Brasile, 01246-000
        • Non ancora reclutamento
        • Instituto do Cancer do Estado de Sao Paulo
      • São Paulo, São Paulo, Brasile, 01308-050
        • Non ancora reclutamento
        • Hospital Sirio Libanes - Oncology_Sao Paulo
  • Cina
    • Anhui
      • Bengbu, Anhui, Cina, 233004
        • Non ancora reclutamento
        • the First Affiliated Hospital of Bengbu Medical College
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100142
        • Non ancora reclutamento
        • Beijing Cancer Hospital - Oncology Department
    • Fujian
      • Fuzhou, Fujian, Cina, 350014
        • Non ancora reclutamento
        • Fujian Cancer Hospital
    • Guangdong
      • Guangzhou, Guangdong, Cina, 510655
        • Non ancora reclutamento
        • The Sixth Affiliated Hospital, Sun Yat-sen University
    • Heilongjiang
      • Harbin, Heilongjiang, Cina, 150000
        • Non ancora reclutamento
        • Harbin Medical University Cancer Hospital
    • Hubei
      • Wuhan, Hubei, Cina, 430030
        • Non ancora reclutamento
        • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
    • Shandong
      • Jinan, Shandong, Cina, 250117
        • Non ancora reclutamento
        • Shandong University - Shandong Cancer Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 200032
        • Non ancora reclutamento
        • Zhongshan hospital, Fudan university
    • Sichuan
      • Chengdu, Sichuan, Cina, 610041
        • Non ancora reclutamento
        • West China Hospital Sichuan University
    • Yunnan
      • Kunming, Yunnan, Cina, 650118
        • Non ancora reclutamento
        • Yunnan Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Cina, 310022
        • Non ancora reclutamento
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, Cina, 310016
        • Non ancora reclutamento
        • Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
  • Corea del Sud
      • Seongnam-si, Gyeonggi-do, Corea del Sud, 13620
        • Non ancora reclutamento
        • Seoul National University Bundang Hospital | Oncology
    • Seoul
      • Jongno -Gu, Seoul, Corea del Sud, 03080
        • Non ancora reclutamento
        • Seoul National University Hospital | Oncology
      • Seoul, Seoul, Corea del Sud, 03722
        • Non ancora reclutamento
        • Severance Hospital | Oncology
      • Seoul, Seoul, Corea del Sud, 05505
        • Non ancora reclutamento
        • Asan Medical Center | Oncology
      • Seoul, Seoul, Corea del Sud, 06351
        • Non ancora reclutamento
        • Samsung Medical Center | Oncology
  • Francia
      • Besançon, Francia, 25030
        • Non ancora reclutamento
        • CHRU de Besancon - Hopital Jean Minjoz - Medical Oncology
      • Dijon, Francia, 21000
        • Non ancora reclutamento
        • Unicancer Dijon - Centre Georges Francois Leclerc - Oncologie medicale
      • Marseille, Francia, 13009
        • Non ancora reclutamento
        • Unicancer Marseille - Institut Paoli-Calmettes - Oncologie medicale
    • Brittany Region
      • Brest, Brittany Region, Francia, 29200
        • Non ancora reclutamento
        • CHU Brest - Hopital La Cavale Blanche - service oncologie medicale
  • Germania
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Germania, 89081
        • Non ancora reclutamento
        • Universitätsklinikum Ulm - Klinik für Innere Medizin I
    • Bavaria
      • Schweinfurt, Bavaria, Germania, 97422
        • Non ancora reclutamento
        • Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH-Medizinische Klinik 2
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Germania, 22763
        • Non ancora reclutamento
        • Asklepios Klinik Altona - Onkologie, Hämatologie, Palliativmedizin, Rheumatologie und Pneumologie
    • Hesse
      • Frankfurt am Main, Hesse, Germania, 60488
        • Non ancora reclutamento
        • Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
    • Lower Saxony
      • Oldenburg, Lower Saxony, Germania, 26133
        • Non ancora reclutamento
        • Klinikum Oldenburg - Klinik für Onkologie und Hämatologie
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germania, 45147
        • Non ancora reclutamento
        • Universitaetsklinikum Essen - Innere Klinik (Tumorforschung)
    • State of Berlin
      • Berlin, State of Berlin, Germania, 12559
        • Non ancora reclutamento
        • DRK Kliniken Berlin-Köpenick - Darmzentrum
  • Grecia
      • Athens, Grecia, 11526
        • Non ancora reclutamento
        • Laiko General Hospital Of Athens- Oncology Department
      • Cholargos/ Athens, Grecia, 155 62
        • Non ancora reclutamento
        • Metropolitan General Hospital -Oncologic Clinical Trials and Research Clinic
      • Pátrai, Grecia, 265 04
        • Non ancora reclutamento
        • General University Hospital Of Patras- Division of Oncology, Department of Medicine
    • Attica
      • Athens, Attica, Grecia, 115 22
        • Non ancora reclutamento
        • Saint Savvas Oncology Hospital -1st Internal Medicine - Oncology Department
      • Athens, Attica, Grecia, 115 28
        • Non ancora reclutamento
        • General Hospital Of Athens Alexandra-Plasma Cell Dyscrasias Unit, Department of Clinical Therapeutics, N.K.U.A
    • Thessaloniki
      • Pylaia, Thessaloniki, Grecia, 570 01
        • Non ancora reclutamento
        • Athens Medical Center S.A./ European Interbalkan Medical Center - 4th Department of Medical Oncology
  • Hong Kong
    • Hong Kong SAR
      • Hong Kong, Hong Kong SAR, Hong Kong, 00000
        • Non ancora reclutamento
        • Queen Mary Hospital
    • Kowloon
      • Kowloon, Kowloon, Hong Kong, 00000
        • Non ancora reclutamento
        • Hong Kong United Oncology Centre
    • New Territories
      • Shatin, New Territories, Hong Kong, 00000
        • Non ancora reclutamento
        • Prince of Wales Hospital
  • Italia
      • Milan, Italia, 20141
        • Non ancora reclutamento
        • Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative
      • Naples, Italia, 80131
        • Non ancora reclutamento
        • A.O.U. Universita' Degli Studi Della Campania Luigi Vanvitelli - Oncoematologia
      • Roma, Italia, 00168
        • Non ancora reclutamento
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
      • Rozzano, Italia, 20089
        • Non ancora reclutamento
        • Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
    • Milan
      • Milan, Milan, Italia, 20162
        • Non ancora reclutamento
        • ASST Grande Ospedale Metropolitano Niguarda - Oncologia Falck
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Non ancora reclutamento
        • Universiti Malaya Medical Centre - Clinical Oncology Department
      • Kuala Lumpur, Malaysia, 59200
        • Non ancora reclutamento
        • Cengild G.I. Medical Centre - Curie Oncology KL
    • Pulau Pinang
      • Perai, Pulau Pinang, Malaysia, 13700
        • Non ancora reclutamento
        • Sunway Medical Centre Penang - Department of Clinical Oncology
    • Sabah
      • Kota Kinabalu, Sabah, Malaysia, 88996
        • Non ancora reclutamento
        • Hospital Wanita Dan Kanak Kanak Sabah - Oncology and Radiotherapy
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Non ancora reclutamento
        • Hospital Umum Sarawak (Sarawak General Hospital) SGH
    • Selangor
      • Subang Jaya, Selangor, Malaysia, 47500
        • Non ancora reclutamento
        • Sunway Medical Centre - Medical Oncology
  • Messico
      • Benito Juárez, Messico, 03100
        • Non ancora reclutamento
        • Grupo Medico ASSET S.C
      • Guadalajara, Messico, 44680
        • Non ancora reclutamento
        • Renati Innovation SAPI de CV
      • Mexico City, Messico, 3810
        • Non ancora reclutamento
        • Oncare Viaducto Nápoles
      • Monterrey, Messico, 64460
        • Non ancora reclutamento
        • Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia
    • Mexico City
      • Mexico City, Mexico City, Messico, 14080
        • Non ancora reclutamento
        • Instituto Nacional de Cancerologia
    • Nuevo León
      • Monterrey, Nuevo León, Messico, 66278
        • Non ancora reclutamento
        • Hospital Zambrano Hellion
  • Olanda
      • The Hague, Olanda, 2545 AA
        • Non ancora reclutamento
        • HagaZiekenhuis - Oncologie Interne Geneeskunde
  • Polonia
      • Bialystok, Polonia, 15-027
        • Non ancora reclutamento
        • Białostockie Centrum Onkologii im. M. Skłodowskiej-Curie w Białymstoku Oddział Onkologii Klinicznej
      • Krakow, Polonia, 30-727
        • Non ancora reclutamento
        • Pratia MCM Krakow
      • Krakow, Polonia, 31-864
        • Non ancora reclutamento
        • Comarch Healthcare SA Centrum Medyczne iMed24
      • Lodz, Polonia, 93-513
        • Non ancora reclutamento
        • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
      • Opole, Polonia, 45-061
        • Non ancora reclutamento
        • Opolskie Centrum Onkologii
      • Otwock, Polonia, 05-400
        • Non ancora reclutamento
        • Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
      • Przemyśl, Polonia, 37-700
        • Non ancora reclutamento
        • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu Oddział Onkologiczny z Pododdziałem Dziennej Chemioterapii
      • Siedlce, Polonia, 08-110
        • Non ancora reclutamento
        • Mazowiecki Szpital Wojewódzki Siedleckie Centrum Onkologii Oddział Onkologii Klinicznej i Radioterapii
      • Skorzewo, Polonia, 60-185
        • Non ancora reclutamento
        • Centrum Medyczne Pratia Poznan
      • Warsaw, Polonia, 02-034
        • Non ancora reclutamento
        • Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie Państwowy Instytut Badawczy- Oddział Warszawa Wawelska
      • Wroclaw, Polonia, 50-417
        • Non ancora reclutamento
        • Pratia Wroclaw
  • Portogallo
      • Coimbra, Portogallo, 3004-561
        • Non ancora reclutamento
        • Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Oncologia
      • Lisbon, Portogallo, 1099-023
        • Non ancora reclutamento
        • Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E. - Serviço de Oncologia Médica
      • Lisbon, Portogallo, 1169-050
        • Non ancora reclutamento
        • Unidade Local de Saúde de São José, E.P.E - Hospital de Santo António dos Capuchos - Serviço de Oncologia Médica
      • Lisbon, Portogallo, 1649-035
        • Non ancora reclutamento
        • START Research Portugal - ULSS Maria - Unidade de Ensaios de Fase I Start Lisbon
      • Porto, Portogallo, 4200-072
        • Non ancora reclutamento
        • Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E. - Serviço de Oncologia Médica
  • Regno Unito
    • Greater London
      • London, Greater London, Regno Unito, NW1 2PG
        • Non ancora reclutamento
        • University College Hospital | Cancer Clinical Trials Unit
    • West Midlands
      • Coventry, West Midlands, Regno Unito, CV22DX
        • Non ancora reclutamento
        • University Hospital Coventry | Oncology
  • Singapore
      • Singapore, Singapore, 258499
        • Non ancora reclutamento
        • OncoCare Cancer Centre | Gleneagles Medical Centre
      • Singapore, Singapore, 329563
        • Non ancora reclutamento
        • Curie Oncology | Farrer
      • Singapore, Singapore, 168583
        • Reclutamento
        • National Cancer Center Singapore - Oncology Department
      • Singapore, Singapore, 119074
        • Non ancora reclutamento
        • National University Cancer Institute (NCIS)
  • Spagna
      • Barcelona, Spagna, 08003
        • Non ancora reclutamento
        • Hospital del Mar | Oncologia
    • A Coruña
      • Santiago de Compostela, A Coruña, Spagna, 15706
        • Non ancora reclutamento
        • Complexo Hospitalario Universitario De Santiago | Oncologia
    • Barcelona
      • Barcelona, Barcelona, Spagna, 08035
        • Non ancora reclutamento
        • Hospital Universitari Vall D Hebron | Oncologia
    • Madrid
      • Madrid, Madrid, Spagna, 28034
        • Non ancora reclutamento
        • Hospital Universitario Ramon Y Cajal | Oncologia Medica
    • Málaga
      • Málaga, Málaga, Spagna, 20910
        • Non ancora reclutamento
        • Hospital Universitario Virgen De La Victoria | Oncologia Medica
    • Valencia
      • Valencia, Valencia, Spagna, 46010
        • Non ancora reclutamento
        • Hospital Clinico Universitario De Valencia | Oncologia
  • Stati Uniti
    • Arizona
      • Tucson, Arizona, Stati Uniti, 85719
        • Non ancora reclutamento
        • University of Arizona Cancer Center - North Campus
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48109
        • Non ancora reclutamento
        • University of Michigan Rogel Cancer Center
      • Detroit, Michigan, Stati Uniti, 48202
        • Non ancora reclutamento
        • Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
    • West Virginia
      • Morgantown, West Virginia, Stati Uniti, 26505
        • Non ancora reclutamento
        • Mary Babb Randolph Cancer Center
  • Svizzera
    • Canton of Zurich
      • Zurich, Canton of Zurich, Svizzera, 8091
        • Ritirato
        • UniversitätsSpital Zürich (USZ) - Klinik für Medizinische Onkologie und Hämatologie
  • Taiwan
      • Keelung, Taiwan, 204201
        • Non ancora reclutamento
        • Keelung Chang Gung Memorial Hospital - Division of Hematology and Oncology
      • Taichung, Taiwan, 407219
        • Non ancora reclutamento
        • Taichung Veterans General Hospital | Division of Colorectal Surgery
      • Tainan, Taiwan, 71004
        • Non ancora reclutamento
        • Chi Mei Medical Center, Yongkang Branch
    • Kaohsiung
      • Kaohsiung City, Kaohsiung, Taiwan, 803
        • Non ancora reclutamento
        • Chang Gung Memorial Hospital Kaohsiung
    • Tainan
      • Tainan, Tainan, Taiwan, 704
        • Non ancora reclutamento
        • National Cheng Kung University Hospital
    • Taipei
      • Taipei, Taipei, Taiwan, 11217
        • Non ancora reclutamento
        • Taipei Veterans General Hospital
      • Taipei, Taipei, Taiwan, 10507
        • Non ancora reclutamento
        • Chang Gung Memorial Hospital at Linkou
  • Turchia (Türkiye)
      • Edirne, Turchia (Türkiye), 22030
        • Non ancora reclutamento
        • Trakya Univ. Tip Fak.
      • Gaziantep, Turchia (Türkiye), 27470
        • Non ancora reclutamento
        • Gaziantep Sehir Hastanesi -Medical Oncology Department
      • Istanbul, Turchia (Türkiye), 34865
        • Non ancora reclutamento
        • Kartal Dr Lutfi Kirdar Sehir Hastanesi- Medical Oncology
      • Samsun, Turchia (Türkiye), 55200
        • Non ancora reclutamento
        • VM Medical Park Samsun Hospital Medical Oncology Department
      • Yenimahalle, Turchia (Türkiye), 6170
        • Non ancora reclutamento
        • Ankara Etlik Sehir Hastanesi
    • Ankara
      • Bilkent Çankaya, Ankara, Turchia (Türkiye), 6800
        • Non ancora reclutamento
        • Ankara Bilkent Sehir Hastanesi
    • Istanbul
      • Kadıköy, Istanbul, Turchia (Türkiye), 34722
        • Non ancora reclutamento
        • İstanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçın Şehir Hastanesi

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: VVD-133214 Dose 1 + Pembrolizumab
Participants will receive VVD-133214 in combination with pembrolizumab
Droga: VVD-133214
VVD-133214 will be administered orally
Droga: Pembrolizumab
Pembrolizumab will be administered by intravenous infusion (IV) every three weeks
Sperimentale: VVD-133214 Dose 2 + Pembrolizumab
Participants will receive VVD-133214 in combination with pembrolizumab
Droga: VVD-133214
VVD-133214 will be administered orally
Droga: Pembrolizumab
Pembrolizumab will be administered by intravenous infusion (IV) every three weeks
Comparatore attivo: Pembrolizumab
Participants will receive pembrolizumab only (monotherapy)
Droga: Pembrolizumab
Pembrolizumab will be administered by intravenous infusion (IV) every three weeks

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Landmark progression-free survival (PFS) rate at 6 months, as assessed by the investigator
Lasso di tempo: From start of study treatment until end of follow-up (up to approximately 36 months)
Defined as the proportion of participants who are alive and free from disease progression as per RECIST v1.1
From start of study treatment until end of follow-up (up to approximately 36 months)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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)
Lasso di tempo: From start of study treatment up to 30 days following the last dose of study drug (100 days after last administration of pembrolizumab)
From start of study treatment up to 30 days following the last dose of study drug (100 days after last administration of pembrolizumab)
Recommended Phase 2 Dose (RP2D) of VVD-133214 in combination with pembrolizumab
Lasso di tempo: From start of study treatment until end of follow-up (up to approximately 36 months)
The RP2D will be based on incidence, severity and frequency of adverse events, anti-tumor activity, PK/PD, and assessment of disease biomarkers for two doses of VVD-133214 combined with the standard of care (SoC) dose of pembrolizumab
From start of study treatment until end of follow-up (up to approximately 36 months)
Maximum plasma concentration observed (Cmax) following single and multiple doses of VVD-133214
Lasso di tempo: Predose and multiple timepoints post-dose, up to approximately 36 months
Predose and multiple timepoints post-dose, up to approximately 36 months
Time of maximum plasma concentration observed (Tmax) following single and multiple doses of VVD-133214
Lasso di tempo: Predose and multiple timepoints post-dose, up to approximately 36 months
Predose and multiple timepoints post-dose, up to approximately 36 months
Area under the plasma concentration-time curve (AUC) following single and multiple doses of VVD-133214
Lasso di tempo: Predose and multiple timepoints post-dose, up to approximately 36 months
Predose and multiple timepoints post-dose, up to approximately 36 months
Overall response rate (ORR) according to RECIST v1.1 as assessed by the Investigator
Lasso di tempo: From start of study treatment until end of follow-up (up to approximately 36 months)
From start of study treatment until end of follow-up (up to approximately 36 months)
Disease control rate (DCR) according to RECIST v1.1 as assessed by the Investigator
Lasso di tempo: From start of study treatment until end of follow-up (up to approximately 36 months)
From start of study treatment until end of follow-up (up to approximately 36 months)
Duration of response (DOR) according to RECIST v1.1 as assessed by the Investigator
Lasso di tempo: From the time of first occurrence of a documented response until the time of documented disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
From the time of first occurrence of a documented response until the time of documented disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
Median progression-free survival (mPFS) according to RECIST v1.1 as assessed by the Investigator
Lasso di tempo: From the time of first occurrence of a documented response until the time of documented disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
From the time of first occurrence of a documented response until the time of documented disease progression or death from any cause, whichever occurs first (up to approximately 36 months)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Vividion Therapeutics, Inc.

Collaboratori

Bayer

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

11 settembre 2026

Completamento primario (Stimato)

30 giugno 2028

Completamento dello studio (Stimato)

31 dicembre 2030

Date di iscrizione allo studio

Primo inviato

2 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 settembre 2026

Primo Inserito (Effettivo)

9 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 settembre 2026

Ultimo verificato

15 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • VVD-133214-02
  • 2026-525507-26-00 (Ctis)
  • 23236 (Altro identificatore: Bayer ID)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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