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Phase 2 Study of Trastuzumab Deruxtecan plus Bevacizumab versus Standard Chemotherapy in Patients with Recurrent Ovarian Cancer after PARP Inhibitor Therapy

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 involves people with ovarian cancer that has returned after previous treatment with a PARP inhibitor. Participants must have cancer cells that show a protein called HER2 at any level (1+, 2+, or 3+). The investigational drug being tested is trastuzumab deruxtecan, given by intravenous infusion (medicine delivered through a vein), and it may be combined with the drug bevacizumab. The comparison treatment is standard platinum-based chemotherapy, also given by infusion, which may be combined with bevacizumab as well.

The main aim of the trial is to determine whether the new combination can keep the cancer from growing for a longer time, measured as progression‑free survival. Participants are randomly placed into one of the two groups, receive their assigned infusions on a regular schedule, and undergo routine doctor visits and imaging scans to check the size of the tumors. The scans are evaluated using a standard system called RECIST, which simply means doctors compare pictures of the tumor over time to see if it is getting bigger, staying the same, or shrinking.

The study continues until the cancer shows signs of getting worse, the participant stops treatment, or the study ends. Throughout the trial, safety is closely monitored with regular checks of vital signs, blood tests, and heart evaluations to ensure any side effects are identified promptly.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    After you have joined the study, you will be assigned by a computer to one of two treatment groups. the assignment is random, meaning it is not based on any personal characteristic.

    The two possible groups are: trastuzumab deruxtecan (sometimes given together with bevacizumab) or standard chemotherapy (which may also include bevacizumab).

  2. Step 2

    Start of treatment

    Once you are assigned, you will begin receiving the medication that belongs to your group.

    If you are in the trastuzumab deruxtecan group, the drug will be given as a powder that is mixed to make a solution for infusion. the dose is 5.4 milligrams per kilogram of body weight.

    If bevacizumab is part of your regimen, it will be given as a solution for infusion at a dose of 15 milligrams per kilogram of body weight.

    If you are assigned to standard chemotherapy, the specific drugs and doses will be chosen by the investigator and given by intravenous infusion.

  3. Step 3

    Infusion visits

    Each dose is administered through an intravenous infusion, which means the medication is delivered into a vein using a needle or catheter.

    The infusion takes place in a clinic or hospital setting. you will be asked to stay for a period of time while the medication is given and while staff monitor you.

    The exact schedule (how often the infusion is repeated) follows the study protocol and will be explained to you by the study team.

  4. Step 4

    Monitoring during infusion

    While the infusion is running, staff will check your vital signs (such as blood pressure, heart rate, and temperature) to ensure you are tolerating the medication.

    Blood samples may be taken to check laboratory values and to look for any early signs of side effects.

  5. Step 5

    Regular assessments

    At scheduled intervals, you will have imaging tests (such as CT or MRI scans) to see whether the cancer is growing, shrinking, or staying the same. these scans are evaluated using RECIST 1.1 criteria, a standard way doctors measure tumor changes.

    You will also have routine blood tests, electrocardiograms (ECG), and heart imaging (ECHO or MUGA) to monitor your overall health and safety.

    The study will record any side effects you experience, using a grading system called CTCAE v5.0.

  6. Step 6

    Continuation of treatment

    You will continue receiving the assigned medication at each infusion visit until one of the following occurs:

    • the disease shows progression (the cancer grows) as defined by the study criteria,

    • you develop side effects that are too severe to continue, or

    • the study ends or you choose to stop.

  7. Step 7

    Post‑treatment follow‑up

    After treatment stops, you will still have follow‑up visits to collect information about survival and any later therapies you may receive.

    These visits may include additional scans, blood tests, and questionnaires about your health status.

Who can join the trial?

13 criteria

  • Be at least 18 years old on the day you sign the consent form.
  • Have adequate organ function, which includes a white‑blood‑cell count (absolute neutrophil count) of 1,500 or higher, platelets of 100,000 or higher, hemoglobin of 9 g/dL or more, kidney function measured by serum creatinine within normal limits or a calculated creatinine clearance of at least 50 mL/min, bilirubin (a liver waste product) within normal limits, liver enzymes (AST and ALT) not more than 2.5 times the normal range (or up to 5 times if liver metastases are present), and normal clotting tests (INR/PT and aPTT) unless you are on blood‑thinning medication that requires a therapeutic range.
  • Provide a negative pregnancy test within 72 hours before the first dose, unless you cannot become pregnant (non‑childbearing potential), which is defined as being 45 years or older with no periods for more than one year, having post‑menopausal hormone levels, or having had a hysterectomy, removal of both ovaries, or tubal ligation confirmed by medical records or imaging.
  • If you can become pregnant, you must use a highly effective method of contraception (or choose abstinence if that is your preferred method) from the time you consent until 7 months after the last study dose.
  • Have less than 2+ protein in a urine dipstick test; if the test shows 2+ or more, a 24‑hour urine collection must show less than 1 gram of protein.
  • Sign the informed consent form and be able to follow all study procedures.
  • Show positive HER2 expression on tumor testing (IHC score of 1+, 2+, or 3+ as defined by local laboratory standards).
  • Provide a sample of tumor tissue for research, either a formalin‑fixed paraffin‑embedded (FFPE) tumor block or at least 20 unstained slides.
  • Have a confirmed diagnosis of recurrent high‑grade serous or high‑grade endometrioid ovarian, primary peritoneal, or fallopian tube cancer.
  • Have an ECOG performance status score of 0 or 1, meaning you are fully active or restricted in physically strenuous activity but able to do light work.
  • Have documented disease progression while receiving a PARP inhibitor maintenance therapy (first‑line or second‑line) within 180 days of the last PARP inhibitor dose; if progression occurred on first‑line maintenance, you may have had up to one additional line of platinum‑based chemotherapy with a treatment‑free interval of more than 6 months before study entry, while progression on second‑line maintenance does not allow any further systemic therapy before entry.
  • Have measurable disease according to RECIST 1.1 criteria, which means the cancer can be measured on imaging studies.
  • Have a left ventricular ejection fraction (LVEF) of 50 % or higher on an echocardiogram or similar test performed within 28 days before randomization.

Who cannot join the trial?

18 criteria

  • Cannot take part if your ovarian cancer got worse while you were on the first round of platinum‑based chemotherapy, or if it got worse within 6 months after finishing platinum chemotherapy in a later line of treatment.
  • Cannot take part if you have ever had (or currently have) non‑infectious interstitial lung disease (ILD) or pneumonitis that needed steroid medicines, or if doctors cannot rule out these lung problems with a scan.
  • Cannot take part if you have serious heart or blood‑vessel problems, such as an abnormal heart rhythm called a long QT interval, a recent heart attack, uncontrolled chest pain, moderate to severe heart failure, very high blood pressure, serious irregular heartbeats, or other uncontrolled cardiovascular conditions.
  • Cannot take part if you are currently in another clinical study or have received any investigational drug or device within 4 weeks before the first dose of this study.
  • Cannot take part if you have a bleeding tendency or a major clotting problem (unless you are on prescribed blood‑thinning medication).
  • Cannot take part if you have a current abdominal or pelvic fistula (an abnormal connection between organs).
  • Cannot take part if you have a serious, uncontrolled medical problem or infection that needs treatment, such as uncontrolled lung inflammation, uncontrolled dangerous heart rhythm, uncontrolled seizures, unstable spinal cord compression, superior vena cava syndrome, or psychiatric or substance‑abuse issues that would prevent you from following the study requirements.
  • Cannot take part if you have previously received other HER2‑targeted medicines or similar experimental drugs that contain an exatecan‑type ingredient (a topoisomerase I inhibitor).
  • Cannot take part if you are pregnant, breastfeeding, or plan to become pregnant from the time of screening until 7 months after the last dose of study treatment.
  • Cannot take part if you have received a live (containing weakened virus) vaccine within 30 days before the first dose or while you are receiving the study drug. Inactivated vaccines (such as the flu shot) are allowed.
  • Cannot take part if you have had another type of cancer within the past 3 years, except for certain skin cancers (squamous or basal cell) or cervical carcinoma in situ, or other cancers that your doctor considers cured with very low risk of coming back.
  • Cannot take part if you received any cancer treatment (chemotherapy, targeted therapy, hormone therapy, or radiation) very recently – typically within 21 days (or less than five half‑lives of the drug) before the study starts. Radiation to the chest needs at least 4 weeks washout, and other radiation needs at least 2 weeks.
  • Cannot take part if you have uncontrolled cancer spread to the brain (brain metastases) or cancer cells in the lining of the brain and spinal cord (carcinomatous meningitis). Treated, stable brain metastases may be allowed if they have not grown for at least 4 weeks and you are off steroids.
  • Cannot take part if you have an active or uncontrolled infection, except if you have well‑controlled HIV, hepatitis B, or hepatitis C that meets specific lab criteria and is being treated as directed.
  • Cannot take part if you have not fully recovered from side effects of previous chemotherapy, except for mild nerve problems, mild hair loss, or mild fatigue (grade 2 or lower).
  • Cannot take part if you have not fully recovered from complications of any major surgery before starting the study treatment.
  • Cannot take part if you are allergic (have a hypersensitivity) to the study drug or any of its ingredients.
  • Cannot take part if you have an active or ongoing bowel obstruction (a blockage in the intestines).
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Investigated drugs

  • Trastuzumab Deruxtecan

    is a special medicine that combines an antibody that finds HER2 proteins on cancer cells with a chemotherapy drug that kills those cells. It is given through an IV line and is designed to deliver the chemotherapy directly to the tumor while sparing healthy tissue.

  • Bevacizumab

    is a medicine that blocks a signal called VEGF, which tumors use to grow new blood vessels. By stopping this signal, the drug helps to slow tumor growth. It is also given by IV infusion and can be used together with other cancer treatments.

  • Platinum‑based chemotherapy

    refers to a group of standard cancer medicines, such as carboplatin or cisplatin, that contain platinum. These drugs work by damaging the DNA of cancer cells, which stops them from multiplying. In the trial, doctors could choose one of these medicines as the comparison treatment, and they are given through an IV.

What is already known about the treatment

  • Trastuzumab deruxtecan

    It is given as a powder that is mixed with liquid and then infused into a vein. The drug is already approved for certain HER2‑positive breast and stomach cancers and is now being tested in ovarian cancer. It works by linking a chemotherapy payload to an antibody that finds HER2 proteins on cancer cells, delivering the poison directly to the tumor. It belongs to the class of antibody‑drug conjugates.

  • Bevacizumab

    It is supplied as a liquid concentrate that is diluted and given by intravenous infusion. This medicine is approved for several solid tumors, including ovarian cancer, and is used together with chemotherapy in the study. It blocks a protein called VEGF that tumors need to grow new blood vessels, which helps slow tumor growth. It is classified as a monoclonal antibody that inhibits angiogenesis.

Investigated diseases

Ovarian cancer - Ovarian cancer is a type of cancer that starts in the ovaries, the organs that produce eggs and hormones. It often begins in the outer layer of the ovary and can spread to nearby pelvic tissues. As it grows, cancer cells may invade the lining of the abdomen (peritoneum) and lymph nodes. The disease can also travel through the bloodstream to distant organs such as the liver or lungs. Over time, the tumor may increase in size and cause the formation of new blood vessels that help it grow further. The pattern of spread varies, but it typically follows a stepwise progression from the ovary outward.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-527010-23-00Protocol codeAPGOT-OV14Estimated enrolment116 patientsSponsorFundacion Grupo Espanol De Investigacion En Cancer Ginecologico

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