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

September 2, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VVD-133214 Dose 1 + Pembrolizumab
Participants will receive VVD-133214 in combination with pembrolizumab
Drug: VVD-133214
VVD-133214 will be administered orally
Drug: Pembrolizumab
Pembrolizumab will be administered by intravenous infusion (IV) every three weeks
Experimental: VVD-133214 Dose 2 + Pembrolizumab
Participants will receive VVD-133214 in combination with pembrolizumab
Drug: VVD-133214
VVD-133214 will be administered orally
Drug: Pembrolizumab
Pembrolizumab will be administered by intravenous infusion (IV) every three weeks
Active Comparator: Pembrolizumab
Participants will receive pembrolizumab only (monotherapy)
Drug: Pembrolizumab
Pembrolizumab will be administered by intravenous infusion (IV) every three weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Landmark progression-free survival (PFS) rate at 6 months, as assessed by the investigator
Time Frame: 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vividion Therapeutics, Inc.

Collaborators

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

September 2, 2026

First Submitted That Met QC Criteria

September 2, 2026

First Posted (Actual)

September 9, 2026

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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