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Phase 2 Study of ro7589831 with Pembrolizumab vs Pembrolizumab Alone in Adults with Advanced Colorectal Cancer (MSI‑High or dMMR)

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

Advanced colorectal adenocarcinoma is a cancer that starts in the colon or rectum and has spread beyond the original site. Some of these tumors show genetic features called microsatellite instability and deficient mismatch repair, which can influence how the disease behaves and responds to treatment. The study evaluates a new oral medication identified as VVD-133214 taken together with an existing immunotherapy drug pembrolizumab, which is given by infusion.

The purpose of the study is to compare the effectiveness of the combination therapy with pembrolizumab alone. Participants are assigned by chance (randomized) to receive either the combination or the single drug, and both the doctors and participants know which treatment is being used (open-label). Treatment is given over several months, with regular visits for blood tests, physical exams, and imaging scans to see how the tumor is responding. Scans are evaluated using a standard set of rules known as RECIST v1.1, which helps determine whether the cancer is growing, shrinking, or staying the same.

Throughout the study, safety is closely watched for side effects, and the disease is followed to see if it stays under control for at least six months, which is an early sign of benefit. This trial is a phase 2 investigation, meaning it is designed to gather more information about how well the new drug works when added to standard therapy.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and Assignment

    After joining the study, you will be randomly placed into one of two groups. One group receives the study drug VVD‑133214 together with pembrolizumab. The other group receives only pembrolizumab.

  2. Step 2

    Baseline Assessments

    Before any medication is given, a series of tests will be performed. These may include physical examinations, blood tests, and imaging scans to document the current state of your cancer.

  3. Step 3

    Start of Treatment

    If you are assigned to the combination group, you will begin taking an oral tablet of VVD‑133214. The tablet may be 200 mg, 150 mg, or 25 mg in strength, as specified by the study protocol, and you will take it exactly as instructed.

    In addition, you will receive an infusion of pembrolizumab at a dose of 200 mg. An infusion means the medication is delivered slowly into a vein by a health professional.

    If you are assigned to the pembrolizumab‑only group, you will receive the same 200 mg infusion of pembrolizumab without taking any oral tablet.

  4. Step 4

    Ongoing Treatment Cycles

    You will continue the oral tablet (if applicable) and receive the 200 mg infusion of pembrolizumab at each scheduled visit. The exact timing of each visit follows the study schedule and will be explained to you by the study team.

    Treatment will continue until the study ends, the disease gets worse, or side effects become unacceptable, whichever occurs first.

  5. Step 5

    Regular Monitoring Visits

    During the study, you will attend regular visits for safety checks. These visits include blood tests, physical examinations, and imaging scans to see how the cancer is responding and to monitor any side effects.

    All observations will be recorded using standard criteria, such as the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

  6. Step 6

    End‑of‑Study Assessments

    When treatment stops, a final set of assessments will be performed. This includes imaging to evaluate the disease status and a review of any adverse events that occurred during the trial.

    The results will be used to determine outcomes such as progression‑free survival at six months, overall response rates, and other efficacy measures.

Who can join the trial?

14 criteria

  • Must be at least 18 years old on the day you sign the consent form.
  • If you are a woman who could become pregnant, you need a negative pregnancy blood test before starting treatment.
  • You must have a life expectancy of at least 12 weeks (doctors expect you to live at least three months).
  • Your overall health score must be 0 or 1 on the ECOG performance‑status scale (a simple rating of daily activity ability; 0 = fully active, 1 = limited but able to do light work).
  • Your tumor must be tested and shown to have microsatellite instability (MSI) or deficient mismatch repair (dMMR) – special lab findings that indicate certain genetic changes in the cancer.
  • The cancer must be an advanced (cannot be removed by surgery) or metastatic (spread to other parts of the body) colorectal adenocarcinoma, confirmed by tissue testing.
  • You must not have received any prior systemic treatment (such as chemotherapy) for the metastatic disease, and surgery cannot cure the cancer.
  • Your tumor’s MSI or dMMR status must have been determined in a certified laboratory as part of routine diagnostic work.
  • You need a stored sample of your tumor tissue that is fixed in formaldehyde and embedded in paraffin (FFPE) that can be sent for additional testing, along with a copy of the pathology report if available.
  • Your disease must be measurable according to RECIST v1.1 criteria (a standard method doctors use to measure tumor size on scans).
  • Recent lab tests (within 14 days before the first dose) must show:
    • Sufficient blood cell counts: neutrophils ≥ 1500/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 9.0 g/dL.
    • Good kidney function: creatinine clearance ≥ 50 ml/min.
    • Good liver function: bilirubin ≤ 1.5 × upper normal limit, ALT and AST ≤ 2.5 × upper normal limit (if liver metastases are present, ALT and AST may be up to 5 × upper normal limit).
    • Normal blood clotting tests: PT/INR and aPTT ≤ 1.5 × upper normal limit (if you are on blood thinners, the dose must be stable for at least one week before the first treatment).

Who cannot join the trial?

10 criteria

  • Have already received systemic treatment (medicine that goes throughout the whole body) for advanced colorectal cancer, unless you only had adjuvant chemotherapy (extra treatment after surgery) and the cancer came back at least 12 months after the last dose.
  • Have taken any drug that blocks a protein called WRN helicase (a protein that helps repair DNA).
  • Have had prior immune checkpoint therapy, such as drugs that target PD‑1, PD‑L1, PD‑L2, CTLA‑4, or other medicines that stimulate the immune system, including anti‑tumor vaccines.
  • Have known active or uncontrolled CNS (central nervous system) or brain cancer spread (brain metastases) that are getting worse or need seizure medicines or steroids, or have cancer in the lining of the brain (carcinomatous meningitis).
  • Have an active autoimmune disease (where the body attacks itself) or immune deficiency (weak immune system) that required treatment in the past 2 years (exceptions: thyroid disease treated with hormone replacement and well‑controlled type 1 diabetes mellitus treated with insulin).
  • Have had another malignancy (cancer) within the past 5 years, except for certain low‑risk cancers such as cervical pre‑cancer (carcinoma in situ), non‑melanoma skin cancer, localized prostate cancer with a low Gleason score (< 7), superficial bladder cancer, or ductal carcinoma in situ; people with Lynch syndrome are allowed.
  • Require systemic immunosuppressive medication (such as corticosteroids) within 2 weeks before starting the study, or are expected to need it during the study, except for inhaled steroids or short‑term low‑dose steroids (less than 10 mg prednisone daily).
  • Test positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating an active infection; participants who have completed curative antiviral therapy for hepatitis C and have at least two negative PCR (virus‑detecting) tests may be eligible.
  • Have known Werner Syndrome (WRN), a rare genetic disorder.
  • Still have side effects from previous cancer therapy that are worse than mild (Grade > 1 on the CTCAE scale), except for mild hair loss, mild nerve problems, or minor lab changes that the doctor decides are not important.
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Investigated drugs

  • VVD-133214

    is an experimental oral medication that comes in a small film‑coated tablet. In this study the tablet is taken by mouth and is being tested to see if it can help the immune system fight colorectal cancer that has specific genetic features (microsatellite instability or deficient mismatch repair). The drug is being given together with another therapy to evaluate whether the combination works better than the other therapy alone.

  • Pembrolizumab

    (brand name Keytruda) is a medicine given through an IV infusion. It belongs to a class of drugs called immune checkpoint inhibitors, which help the body’s own immune cells recognize and attack cancer cells. In this trial pembrolizumab is used both by itself (as a standard treatment) and together with the experimental tablet to see if the combination improves outcomes for patients with advanced colorectal cancer.

What is already known about the treatment

  • VVD-133214 (RO7589831)

    It is taken as a film‑coated tablet that is swallowed whole. The drug is still investigational and is being studied in Phase 2 trials for advanced colorectal cancer with microsatellite instability or deficient mismatch repair. It works by blocking a protein that cancer cells need to grow, acting as an oral small‑molecule anticancer agent. It belongs to the experimental oral kinase‑inhibitor class.

  • Pembrolizumab

    It is given as a solution that is infused into a vein by a health professional. Pembrolizumab is an approved cancer medicine that has been studied widely and appears in many treatment guidelines. It works by attaching to the PD‑1 receptor on immune cells, stopping the cancer from turning off the immune response, and is classified as an immune‑checkpoint inhibitor monoclonal antibody. It is used to treat several cancers, including advanced colorectal adenocarcinoma that shows microsatellite instability.

Investigated diseases

Advanced colorectal adenocarcinoma - Advanced colorectal adenocarcinoma is a malignant tumor that originates from the glandular cells lining the colon or rectum. In its advanced stage the cancer has grown through the wall of the bowel and often involves regional lymph nodes. It may also spread to distant organs such as the liver, lungs, or peritoneum. The disease typically progresses from an early localized mass to deeper tissue invasion and then to metastatic spread. Growth is driven by uncontrolled cell division and can lead to the formation of new blood vessels that support tumor expansion.
Trial detailsLast updated 2 Nov 2026
Age18+ yearsPhasePhase IITrial ID2026-525507-26-00Protocol codeVVD-133214-02Estimated enrolment90 patientsSponsorVividion Therapeutics Inc.

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