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Study of ARV-6723 Alone or with Pembrolizumab to Assess Safety and Early Effect in Adults with Advanced Cancer

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

The study focuses on people with Advanced Cancer, which means the cancer has spread beyond its original location and cannot be removed by surgery. It examines a new oral medication called ARV-6723 and an already approved drug named pembrolizumab, which is given as a liquid that is infused into a vein or injected under the skin. The oral medication may be taken alone (called monotherapy) or together with the infused medication (called combination therapy).

The purpose is to determine how safe the treatments are, how well they are tolerated, and to identify the appropriate dose for future studies. Participants will receive the study drug(s) in a series of treatment cycles, with regular doctor visits, simple lab tests, and imaging scans to monitor for any side effects or problems. The study follows each participant for a set period to collect this information.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Assessments

    After you join the study, you will undergo a series of baseline assessments to document your health status before any treatment begins.

    These assessments include a physical examination, blood tests, and imaging studies such as CT or MRI scans to record the size and location of the tumor.

    All results are used as reference points for later comparisons during the trial.

  2. Step 2

    Start of ARV-6723 Monotherapy

    You will begin taking ARV-6723, which is provided as a tablet taken by mouth (oral administration).

    The exact dose, how many tablets you take each time, and how often you take them are specified in the study protocol and will be explained to you by the study staff.

    Treatment is given in repeated cycles; each cycle’s length and total number of cycles are defined by the protocol.

  3. Step 3

    Addition of Pembrolizumab (Combination Therapy)

    If you are assigned to the combination part of the study, you will also receive pembrolizumab.

    Pembrolizumab may be administered either as an intravenous infusion (solution for infusion) or as a subcutaneous injection (solution for injection) under the skin.

    The frequency (for example, every few weeks) and total duration of pembrolizumab treatment are set by the study protocol and will be explained to you before each dose.

    These doses are given by trained medical personnel in a clinical setting.

  4. Step 4

    Ongoing Monitoring and Follow‑up

    During the treatment period you will attend regular study visits for safety monitoring.

    At each visit you will have blood tests and a review of any side effects, known as adverse events, that you may be experiencing.

    The study team will also perform repeat imaging (CT or MRI) at scheduled times to assess changes in tumor size.

    All findings, including laboratory results and any side effects, are recorded to evaluate how well the treatment is tolerated.

  5. Step 5

    End of Study Evaluation

    At the conclusion of the planned treatment period, you will undergo a final assessment that includes imaging, blood tests, and a comprehensive review of any side effects that occurred during the trial.

    These data are used to determine the recommended dose for future studies and to assess any early signs that the treatment may be effective against the tumor.

Who can join the trial?

4 criteria

  • Be at least 18 years old and have advanced solid tumors (cancers that are large or have spread beyond their original site).
  • Have a confirmed histologic or cytologic diagnosis (a lab test of tissue or cells) showing an unresectable (cannot be removed by surgery) or metastatic (has spread to other parts of the body) solid tumor cancer.
  • Have received at least one previous treatment that targets immune‑checkpoint pathways such as PD-1, PD-L1, CTLA-4, LAG-3 or other similar drugs, in any setting including neoadjuvant (treatment given before the main therapy) or adjuvant (treatment given after the main therapy).
  • Have had at least one prior standard of care (SOC) therapy that is appropriate for the type of cancer they have.

Who cannot join the trial?

5 criteria

  • Having cancer that has spread to the brain and is currently active (brain metastasis); this means tumor cells are growing in the brain.
  • Having cancer cells in the protective lining of the brain and spinal cord (carcinomatous meningitis); this is a serious spread of disease to the membranes surrounding the brain.
  • Having any other active cancer within the past two years; this includes any newly diagnosed or untreated malignancy in the last 24 months.
  • Being allergic or possibly allergic (hypersensitivity) to the study drug ARV-6723, the drug pembrolizumab, or any of the ingredients used in these medicines.
  • Having an active autoimmune disease (where the immune system attacks the body) or a past autoimmune disease that could flare up again.
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Investigated drugs

  • Pembrolizumab (Keytruda)

    is a medicine that helps the body’s immune system recognize and fight cancer cells. In this study it is given either as a liquid that is infused into a vein or as an injection under the skin. The goal is to see how well it works together with the other drug and to check its safety in people with advanced solid tumors.

  • ARV-6723

    is an experimental oral tablet being tested for the first time in people with advanced solid tumors. It is taken by mouth and is studied both by itself (as a single treatment) and together with pembrolizumab. The trial aims to find a safe and effective dose and to see if the drug can help shrink or control the tumors.

What is already known about the treatment

  • Pembrolizumab

    This medication is given as a liquid that can be infused into a vein or injected under the skin. It is an approved cancer drug that has been studied in many clinical trials and is listed in medical references worldwide. It is used to treat several types of advanced cancer by blocking a protein called PD‑1, which lets the body’s immune system recognize and attack tumor cells. Pembrolizumab belongs to the class of immune‑checkpoint inhibitors, which are a type of monoclonal antibody therapy.

  • ARV‑6723

    ARV‑6723 is taken as a tablet that is swallowed orally. It is still an experimental drug and is currently being evaluated in early‑stage clinical studies for safety and effectiveness. The drug is being tested for use in patients with advanced solid tumors, where it aims to stop cancer cells from growing by interfering with specific molecular signals inside the cells. ARV‑6723 is classified as an oral investigational anticancer agent, likely a small‑molecule inhibitor.

Investigated diseases

Advanced Cancer - Advanced cancer describes cancer that has grown beyond its original location and involves multiple regions of the body. The disease spreads from the primary site to nearby tissues or distant organs, a process known as metastasis. With progression, the total amount of tumor tissue increases, often affecting the function of the involved organs. Patients may notice new symptoms as the disease involves additional body systems. The condition continues to evolve as cancer cells multiply and invade new areas.
Trial detailsLast updated 25 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2026-525614-57-00Protocol codeARV-6723-101Estimated enrolment409 patientsSponsorArvinas Operations Inc.

sourced from the EU Clinical Trials Register and site verification

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