Colorectal AdenocarcinomaPhase 2NCT07811193
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
A Phase 2 study testing VVD-133214 and Pembrolizumab in people with Colorectal Adenocarcinoma, run by Vividion Therapeutics, Inc. at 122 sites in 22 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenocarcinoma
- What is being tested?
- VVD-133214 and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 122 sitesin 22 countries
- Study dates
- 11 Sep 2026to 31 Dec 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Participants with active hepatitis B, hepatitis C or HIV
- Participants with known Werner Syndrome (WRN)
- Prior treatment with any WRN helicase inhibitor
Trial locations and contacts
122 sites in 22 countries. Contact the study team or a site near you to ask about taking part.
122 sites in 22 countries
China12 sites, 12 recruiting
- Recruiting
Beijing Cancer Hospital - Oncology Department
Beijing, Beijing Municipality, 100142
- Not yet recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
- Not yet recruiting
West China Hospital Sichuan University
Chengdu, Sichuan, 610041
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
- Not yet recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
- Not yet recruiting
Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
Hangzhou, Zhejiang, 310016
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
- Not yet recruiting
Shandong University - Shandong Cancer Hospital
Jinan, Shandong, 250117
- Not yet recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
- Not yet recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
- Not yet recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430030
Poland11 sites, 11 recruiting
- Not yet recruiting
Białostockie Centrum Onkologii im. M. Skłodowskiej-Curie w Białymstoku Oddział Onkologii Klinicznej
Bialystok, Podlaskie Voivodeship, 15-027
- Not yet recruiting
Pratia McM Kraków
Krakow, Lesser Poland Voivodeship, 30-727
- Not yet recruiting
Comarch Healthcare SA Centrum Medyczne iMed24
Krakow, Lesser Poland Voivodeship, 31-864
- Not yet recruiting
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Lodz, Łódź Voivodeship, 93-513
- Not yet recruiting
Opolskie Centrum Onkologii
Opole, Opole Voivodeship, 45-061
- Not yet recruiting
Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
Otwock, Masovian Voivodeship, 05-400
- Not yet recruiting
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu Oddział Onkologiczny z Pododdziałem Dziennej Chemioterapii
Przemyśl, Podkarpackie Voivodeship, 37-700
- Not yet recruiting
Mazowiecki Szpital Wojewódzki Siedleckie Centrum Onkologii Oddział Onkologii Klinicznej i Radioterapii
Siedlce, Masovian Voivodeship, 08-110
- Not yet recruiting
Centrum Medyczne Pratia Poznan
Skórzewo, Greater Poland Voivodeship, 60-185
- Not yet recruiting
Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie Państwowy Instytut Badawczy- Oddział Warszawa Wawelska
Warsaw, Masovian Voivodeship, 02-034
- Not yet recruiting
Pratia Wroclaw
Wroclaw, Lower Silesian Voivodeship, 50-417
Brazil8 sites, 8 recruiting
- Not yet recruiting
NAIC - Instituto do Cancer
Bauru, São Paulo, 17033-490
- Not yet recruiting
Hospital Araujo Jorge Associaçao de Combate ao Cancer em Goias
Goiânia, Goiás, 74605-070
- Not yet recruiting
Nucleo de Ensino e Pesquisa do Hospital de Clinicas de Ijuí
Ijuí, Rio Grande do Sul, 98700-000
- Not yet recruiting
Fundacao Pio XII - Hospital de Cancer de Barretos
Jaú, São Paulo, 14784-400
- Not yet recruiting
Unidade de Pesquisas Clinicas em Oncologia
Pelotas, Rio Grande do Sul, 96020-080
- Not yet recruiting
Instituto do Cancer do Estado de Sao Paulo
São Paulo, São Paulo, 01246-000
- Not yet recruiting
Hospital Sirio Libanes - Oncology_Sao Paulo
São Paulo, São Paulo, 01308-050
- Not yet recruiting
Hospital Evangélico de Cachoeiro de Itapemirim
Vitória, Espírito Santo, 29047-660
Argentina7 sites, 7 recruiting
- Not yet recruiting
Fundación Intecnus
Bariloche, Río Negro Province, RP82 8400
- Not yet recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires, C1199ABB
- Recruiting
Centro Medico Fleischer
Buenos Aires, Buenos Aires, C1414
- Not yet recruiting
Instituto Alexander Fleming
Buenos Aires, Buenos Aires, C1426ANZ
- Not yet recruiting
Sanatorio Allende | Departamento de Investigación Clínica
Córdoba, Córdoba Province, X5000JHQ
- Not yet recruiting
Investigaciones Oncológicas C Colón
Mar del Plata, Buenos Aires, 7600
- Not yet recruiting
Sanatorio Parque - Oncology
Rosario, Santa Fe Province, S2000GAP
Germany7 sites, 7 recruiting
- Not yet recruiting
DRK Kliniken Berlin-Köpenick - Darmzentrum
Berlin, State of Berlin, 12559
- Not yet recruiting
Universitaetsklinikum Essen - Innere Klinik (Tumorforschung)
Essen, North Rhine-Westphalia, 45147
- Not yet recruiting
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
Frankfurt am Main, Hesse, 60488
- Not yet recruiting
Asklepios Klinik Altona - Onkologie, Hämatologie, Palliativmedizin, Rheumatologie und Pneumologie
Hamburg, Free and Hanseatic City of Hamburg, 22763
- Not yet recruiting
Klinikum Oldenburg - Klinik für Onkologie und Hämatologie
Oldenburg, Lower Saxony, 26133
- Not yet recruiting
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH-Medizinische Klinik 2
Schweinfurt, Bavaria, 97422
- Not yet recruiting
Universitätsklinikum Ulm - Klinik für Innere Medizin I
Ulm, Baden-Wurttemberg, 89081
Taiwan7 sites, 7 recruiting
- Recruiting
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City, Kaohsiung, 803
- Not yet recruiting
Keelung Chang Gung Memorial Hospital - Division of Hematology and Oncology
Keelung, Keelung, 204201
- Not yet recruiting
Taichung Veterans General Hospital | Division of Colorectal Surgery
Taichung, Taichung, 407219
- Not yet recruiting
National Cheng Kung University Hospital
Tainan, Tainan, 704
- Not yet recruiting
Chi Mei Medical Center, Yongkang Branch
Tainan, Tainan, 71004
- Not yet recruiting
Chang Gung Memorial Hospital at Linkou
Taipei, Taipei, 10507
- Not yet recruiting
Taipei Veterans General Hospital
Taipei, Taipei, 11217
Turkey (Türkiye)7 sites, 7 recruiting
- Not yet recruiting
Ankara Bilkent Sehir Hastanesi
Bilkent Çankaya, Ankara, 6800
- Not yet recruiting
Trakya Univ. Tip Fak.
Edirne, Edirne, 22030
- Not yet recruiting
Gaziantep Sehir Hastanesi -Medical Oncology Department
Gaziantep, Gaziantep, 27470
- Not yet recruiting
Kartal Dr Lutfi Kirdar Sehir Hastanesi- Medical Oncology
Istanbul, Istanbul, 34865
- Not yet recruiting
İstanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçın Şehir Hastanesi
Kadıköy, Istanbul, 34722
- Not yet recruiting
VM Medical Park Samsun Hospital Medical Oncology Department
Samsun, Samsun, 55200
- Not yet recruiting
Ankara Etlik Sehir Hastanesi
Yenimahalle, Ankara, 6170
Greece6 sites, 6 recruiting
- Not yet recruiting
Saint Savvas Oncology Hospital -1st Internal Medicine - Oncology Department
Athens, Attica, 115 22
- Not yet recruiting
General Hospital Of Athens Alexandra-Plasma Cell Dyscrasias Unit, Department of Clinical Therapeutics, N.K.U.A
Athens, Attica, 115 28
- Not yet recruiting
Laiko General Hospital Of Athens- Oncology Department
Athens, 11526
- Not yet recruiting
Metropolitan General Hospital -Oncologic Clinical Trials and Research Clinic
Cholargos/ Athens, 155 62
- Not yet recruiting
General University Hospital Of Patras- Division of Oncology, Department of Medicine
Pátrai, 265 04
- Not yet recruiting
Athens Medical Center S.A./ European Interbalkan Medical Center - 4th Department of Medical Oncology
Pylaia, Thessaloniki, 570 01
Malaysia6 sites, 6 recruiting
- Not yet recruiting
Hospital Wanita Dan Kanak Kanak Sabah - Oncology and Radiotherapy
Kota Kinabalu, Sabah, 88996
- Recruiting
Universiti Malaya Medical Centre - Clinical Oncology Department
Kuala Lumpur, Kuala Lumpur, 59100
- Recruiting
Cengild G.I. Medical Centre - Curie Oncology KL
Kuala Lumpur, Kuala Lumpur, 59200
- Not yet recruiting
Hospital Umum Sarawak (Sarawak General Hospital) SGH
Kuching, Sarawak, 93586
- Not yet recruiting
Sunway Medical Centre Penang - Department of Clinical Oncology
Perai, Pulau Pinang, 13700
- Recruiting
Sunway Medical Centre - Medical Oncology
Subang Jaya, Selangor, 47500
Mexico6 sites, 6 recruiting
- Not yet recruiting
Grupo Medico ASSET S.C
Benito Juárez, Mexico City, 03100
- Not yet recruiting
Renati Innovation SAPI de CV
Guadalajara, Jalisco, 44680
- Not yet recruiting
Instituto Nacional de Cancerología
Mexico City, Mexico City, 14080
- Not yet recruiting
Oncare Viaducto Nápoles
Mexico City, Mexico City, 3810
- Not yet recruiting
Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia
Monterrey, Nuevo León, 64460
- Not yet recruiting
Hospital Zambrano Hellion
Monterrey, Nuevo León, 66278
Spain6 sites, 6 recruiting
- Not yet recruiting
Hospital Universitari Vall D Hebron | Oncologia
Barcelona, Barcelona, 08035
- Not yet recruiting
Hospital del Mar | Oncologia
Barcelona, Catalonia, 08003
- Not yet recruiting
Hospital Universitario Ramon Y Cajal | Oncologia Medica
Madrid, Madrid, 28034
- Not yet recruiting
Hospital Universitario Virgen De La Victoria | Oncologia Medica
Málaga, Málaga, 20910
- Not yet recruiting
Complexo Hospitalario Universitario De Santiago | Oncologia
Santiago de Compostela, A Coruña, 15706
- Not yet recruiting
Hospital Clinico Universitario De Valencia | Oncologia
Valencia, Valencia, 46010
Belgium5 sites, 5 recruiting
- Not yet recruiting
Institut Jules Bordet - Clinique D'Oncology
Brussels, Brussels Capital, 1070
- Not yet recruiting
UZ Gent - Digestive Oncology
Ghent, Oost-Vlaaanderen, 9000
- Not yet recruiting
CHU Helora - Hopital de La Louvière - Site Jolimont - Oncology department
La Louvière, Hainaut, 7100
- Not yet recruiting
UZ Leuven - Digestive oncology
Leuven, Flemish Brabant, 3000
- Not yet recruiting
AZ Delta - Digestive oncology
Roeselare, West-Vlaanderen, 8800
Italy5 sites, 5 recruiting
- Not yet recruiting
Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative
Milan, Lombardy, 20141
- Not yet recruiting
ASST Grande Ospedale Metropolitano Niguarda - Oncologia Falck
Milan, Milan, 20162
- Not yet recruiting
A.O.U. Universita' Degli Studi Della Campania Luigi Vanvitelli - Oncoematologia
Naples, Campania, 80131
- Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
Rome, Lazio, 00168
- Not yet recruiting
Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
Rozzano, Lombardy, 20089
Portugal5 sites, 5 recruiting
- Not yet recruiting
Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Oncologia
Coimbra, Beira Litoral, 3004-561
- Not yet recruiting
Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E. - Serviço de Oncologia Médica
Lisbon, Lisbon District, 1099-023
- Not yet recruiting
Unidade Local de Saúde de São José, E.P.E - Hospital de Santo António dos Capuchos - Serviço de Oncologia Médica
Lisbon, Lisbon District, 1169-050
- Not yet recruiting
START Research Portugal - ULSS Maria - Unidade de Ensaios de Fase I Start Lisbon
Lisbon, Lisbon District, 1649-035
- Not yet recruiting
Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E. - Serviço de Oncologia Médica
Porto, Porto District, 4200-072
South Korea5 sites, 5 recruiting
- Not yet recruiting
Seoul National University Hospital | Oncology
Jongno -Gu, Seoul, 03080
- Not yet recruiting
Seoul National University Bundang Hospital | Oncology
Seongnam-si, Gyeonggi-do, Gyeonggi-do, 13620
- Not yet recruiting
Severance Hospital | Oncology
Seoul, Seoul, 03722
- Not yet recruiting
Asan Medical Center | Oncology
Seoul, Seoul, 05505
- Not yet recruiting
Samsung Medical Center | Oncology
Seoul, Seoul, 06351
United States4 sites, 4 recruiting
- Not yet recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
- Not yet recruiting
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
Detroit, Michigan, 48202
- Not yet recruiting
Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26505
- Not yet recruiting
University of Arizona Cancer Center - North Campus
Tucson, Arizona, 85719
France4 sites, 4 recruiting
- Not yet recruiting
CHRU de Besancon - Hopital Jean Minjoz - Medical Oncology
Besançon, Bourgogne-Franche-Comté, 25030
- Not yet recruiting
CHU Brest - Hopital La Cavale Blanche - service oncologie medicale
Brest, Brittany Region, 29200
- Not yet recruiting
Unicancer Dijon - Centre Georges Francois Leclerc - Oncologie medicale
Dijon, Bourgogne-Franche-Comté, 21000
- Not yet recruiting
Unicancer Marseille - Institut Paoli-Calmettes - Oncologie medicale
Marseille, Provence-Alpes-Côte d'Azur Region, 13009
Singapore4 sites, 4 recruiting
- Recruiting
National University Hospital - National University Cancer Institute (NCIS)
Singapore, Singapore, 119074
- Recruiting
National Cancer Center Singapore - Oncology Department
Singapore, Singapore, 168583
- Not yet recruiting
OncoCare Cancer Centre | Gleneagles Medical Centre
Singapore, Singapore, 258499
- Not yet recruiting
Curie Oncology | Farrer
Singapore, Singapore, 329563
Hong Kong3 sites, 3 recruiting
- Not yet recruiting
Queen Mary Hospital
Hong Kong, Hong Kong SAR, 00000
- Recruiting
Hong Kong United Oncology Centre
Kowloon, Kowloon, 00000
- Not yet recruiting
Prince of Wales Hospital
Shatin, New Territories, 00000
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
University Hospital Coventry | Oncology
Coventry, West Midlands, CV22DX
- Not yet recruiting
University College Hospital | Cancer Clinical Trials Unit
London, Greater London, WC1E 6AG
Netherlands1 site, 1 recruiting
- Not yet recruiting
HagaZiekenhuis - Oncologie Interne Geneeskunde
The Hague, South Holland, 2545 AA
Switzerland1 site
- Withdrawn
UniversitätsSpital Zürich (USZ) - Klinik für Medizinische Onkologie und Hämatologie
Zurich, Canton of Zurich, 8091
About this study
Official title: 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).
Read more
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.
- Conditions
- Colorectal Adenocarcinoma
- Being tested
- VVD-133214, Pembrolizumab
- Keywords
- dMMR, MSI CRC, Pembrolizumab, Werner helicase, First line, Lynch Syndrome
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VVD-133214Drug
VVD-133214 will be administered orally
PembrolizumabDrug
Pembrolizumab will be administered by intravenous infusion (IV) every three weeks
| Study group | Role | What they receive |
|---|---|---|
| VVD-133214 Dose 1 + Pembrolizumab | Experimental | Participants will receive VVD-133214 in combination with pembrolizumab Receives: Drug: VVD-133214; Drug: Pembrolizumab |
| VVD-133214 Dose 2 + Pembrolizumab | Experimental | Participants will receive VVD-133214 in combination with pembrolizumab Receives: Drug: VVD-133214; Drug: Pembrolizumab |
| Pembrolizumab | Active comparator | Participants will receive pembrolizumab only (monotherapy) Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Landmark progression-free survival (PFS) rate at 6 months, as assessed by the investigator
Defined as the proportion of participants who are alive and free from disease progression as per RECIST v1.1
Measured: From start of study treatment until end of follow-up (up to approximately 36 months)
Secondary outcomes (9)
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)
Measured: 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
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start11 Sep 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vividion Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811193
- Sponsor's protocol ID
- VVD-133214-02
- Other IDs
- 2026-525507-26-00, 23236
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.