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Rinatabart Sesutecan plus Bevacizumab vs standard care as maintenance for recurrent platinum‑sensitive ovarian cancer after second‑line chemotherapy

Fast replyRegistered 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 women who have a return of Platinum-Sensitive Ovarian Cancer after having received a second round of platinum‑based chemotherapy. The experimental medication, Rinatabart Sesutecan (also called Rina‑S), is given by an IV infusion and is tested together with the usual treatment that doctors normally give after chemotherapy. The comparison group receives the usual treatment alone, which in this trial includes the drug bevacizumab.

The purpose of the study is to see whether adding Rinatabart Sesutecan can keep the cancer from growing for a longer time compared with the usual treatment alone. Participants are randomly placed into one of the two groups after completing their second‑line chemotherapy, then they receive the assigned maintenance therapy for several months while doctors monitor their health through regular clinic visits and scans.

Progression‑free survival means the period during which the cancer does not get worse. Doctors use a set of rules called RECIST to measure whether tumors have grown or shrunk on imaging tests. To understand how the treatments affect overall well‑being, participants also complete a questionnaire known as the EORTC QLQ‑C30, which asks about symptoms, daily activities, and overall quality of life.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After joining the study, a written consent form is signed to confirm understanding of the trial procedures.

    Personal health information and eligibility are verified before any study activities begin.

  2. Step 2

    Baseline assessments

    A series of tests are performed to record the current health status, including blood tests, imaging scans, and questionnaires about quality of life.

    The results create a reference point for later comparisons during the trial.

  3. Step 3

    Assignment to treatment group

    Participants are randomly placed into one of two groups: the rinatabart sesutecan plus standard of care group, or the standard of care alone group that may receive bevacizumab as the comparator.

    The assignment is open‑label, meaning the participant knows which treatment is being received.

  4. Step 4

    Start of maintenance therapy

    The first dose of the assigned medication is given by intravenous infusion in a clinical setting.

    For rinatabart sesutecan, the dose is expressed as milligram per square meter (mg/m2) and is prepared as a solution for infusion.

    For bevacizumab, the dose is expressed as milligram per kilogram (mg/kg) and is also administered intravenously.

    The exact amount is calculated by the study team based on body measurements and the protocol specifications.

  5. Step 5

    Repeated infusion visits

    Subsequent infusions are scheduled at regular intervals defined by the study protocol.

    Each visit includes the administration of the same medication, monitoring of vital signs, and assessment for any immediate reactions.

    The infusion duration and any pre‑medication are managed by the clinical staff.

  6. Step 6

    Periodic disease evaluation

    Imaging scans are performed at predefined times to measure tumor size and determine progression‑free survival according to standard criteria.

    The scans are reviewed by an independent central reviewer who is unaware of the treatment assignment.

  7. Step 7

    Quality‑of‑life questionnaires

    Participants complete the eortc qlq‑c30 questionnaire at scheduled intervals to assess overall health status and any changes over time.

  8. Step 8

    Monitoring for side effects

    At each visit, health professionals ask about treatment‑emergent adverse events and record any symptoms.

    Laboratory tests may be repeated to detect changes that could indicate toxicity.

  9. Step 9

    Continuation or discontinuation of therapy

    Treatment continues until disease progression, unacceptable side effects, or the end of the study period as defined by the protocol.

    If discontinuation occurs, a final assessment is performed to document the reason and collect remaining outcome data.

  10. Step 10

    Final study visit

    A concluding visit includes a last set of scans, blood tests, and quality‑of‑life questionnaires.

    The collected information contributes to the overall analysis of the study objectives.

Who can join the trial?

6 criteria

  • You need a confirmed diagnosis (checked under a microscope) of one of the following cancers: high‑grade serous ovarian cancer, endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
  • You must have platinum‑sensitive ovarian cancer (PSOC), which means your cancer got worse at least 6 months (more than 183 days) after the last dose of the first round of platinum‑based chemotherapy.
  • If you have a known BRCA mutation (either inherited or acquired) or your tumor is homologous recombination deficiency (HRD)‑positive, and you achieved a complete response (CR) or partial response (PR) after first‑line platinum chemotherapy, you must have already received a PARP inhibitor (PARPi) maintenance therapy as part of that first‑line treatment.
  • You must have finished a second‑line (2L) platinum‑based chemotherapy regimen for your recurrent cancer.
  • You need to be entered into the study (randomized) no later than 8 weeks after the last dose of the second‑line platinum chemotherapy.
  • After completing the second‑line platinum chemotherapy, you must have had a complete response (CR), no clinical evidence of disease (NED), a partial response (PR), or, if you received bevacizumab together with the chemotherapy, you may have a stable disease (SD) as judged by your doctor.

Who cannot join the trial?

4 criteria

  • Having a tumor type called clear cell, mucinous, sarcomatous, a mix of these types, or a low‑grade/borderline ovarian tumor, which are special forms of ovarian cancer that do not fit the study’s focus.
  • Having received more than two separate courses (lines) of systemic therapy (treatment that goes throughout the whole body, such as chemotherapy) before joining the trial.
  • Having cancer that got worse (progression) while on or right after the second‑line (2L) platinum‑based chemotherapy before being assigned to a study group.
  • Receiving any extra cancer treatment that travels through the whole body (intervening systemic anticancer treatment) after the last dose of the second‑line platinum chemotherapy and before starting the trial, except for the drug bevacizumab.
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Investigated drugs

Rinatabart Sesutecan is an experimental medicine being studied for women whose ovarian cancer has come back after earlier treatment. It is given through an IV infusion and is designed to help keep the cancer from growing again after patients have finished a second round of platinum‑based chemotherapy. This drug is considered an orphan drug, meaning it is intended for a condition that is relatively rare.

Bevacizumab is a medication that is already used in cancer care. It works by blocking signals that tell tumors to grow new blood vessels, which can slow the growth of cancer. In this trial it is used as a comparison treatment and is also given by IV infusion.

The standard of care in this study refers to the usual chemotherapy regimen that doctors give after a second‑line platinum‑based doublet chemotherapy. It includes the typical drugs and schedules that are commonly used to maintain disease control in patients with recurrent platinum‑sensitive ovarian cancer. In the trial, some participants receive this standard treatment alone, while others receive it together with Rinatabart Sesutecan.

What is already known about the treatment

  • BEVACIZUMAB

    This medication is given by slow injection into a vein (intravenous infusion). It is an approved drug that is widely used and described in many medical studies. It is mainly used to treat several cancers, including ovarian cancer, by attaching to a protein called VEGF and stopping new blood vessels from feeding the tumor. It belongs to the class of monoclonal antibodies that work as anti‑angiogenic agents.

  • RINATABART SESUTECAN

    This drug is supplied as a solution for infusion and is administered through an intravenous drip. It is an experimental, orphan‑designated medicine that is currently being studied in clinical trials. It is being tested for patients with recurrent platinum‑sensitive ovarian cancer and works by blocking a specific receptor that helps cancer cells grow and survive. It is classified as a targeted therapy designed to interfere with tumor‑growth signals.

Investigated diseases

Platinum-sensitive ovarian cancer - A type of ovarian cancer that initially responds well to platinum‑based chemotherapy and then returns after a period of remission. After treatment, the cancer may reappear, but it tends to grow more slowly than platinum‑resistant forms. The disease often shows a measurable increase in tumor size or new lesions over time. Symptoms can develop gradually as the tumor expands within the pelvis or abdomen. Monitoring the size and spread of the cancer helps track its progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522167-15-00Protocol codeGCT1184-04Estimated enrolment544 patientsSponsorGenmab A/S

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