VVD-133214 with Pembrolizumab in advanced colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial compares VVD-133214 plus pembrolizumab versus pembrolizumab alone in adults with unresectable or metastatic colorectal adenocarcinoma that shows MSI or dMMR. Eligible participants have good performance status, measurable disease, no prior therapy for metastatic disease, and available archival tissue for central testing. The study uses RECIST 1.1 to assess response and requires adequate organ function. The trial is conducted at several U.S. cancer centers and involves collaboration between Vividion Therapeutics and Bayer.

Why it matters

Who can join: the full rules

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

Where it's running

• Centro Medico Fleischer
  Buenos Aires, Buenos Aires, Argentina Recruiting
• Beijing Cancer Hospital - Oncology Department
  Beijing, Beijing Municipality, China Recruiting
• Hong Kong United Oncology Centre
  Kowloon, Kowloon, Hong Kong Recruiting
• Universiti Malaya Medical Centre - Clinical Oncology Department
  Kuala Lumpur, Kuala Lumpur, Malaysia Recruiting
• Cengild G.I. Medical Centre - Curie Oncology KL
  Kuala Lumpur, Kuala Lumpur, Malaysia Recruiting
• Sunway Medical Centre - Medical Oncology
  Subang Jaya, Selangor, Malaysia Recruiting

+72 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: 18888422937

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.