Rinatabart Sesutecan with or without bevacizumab versus standard platinum‑based chemotherapy drug combination in patients with recurrent platinum‑sensitive ovarian cancer
The study focuses on Recurrent Platinum-Sensitive Ovarian Cancer, a type of ovarian cancer that returns after initial treatment but still responds to drugs that contain platinum. The aim of the trial is to compare how long patients can live without their cancer getting worse when treated with a new therapy versus standard chemotherapy.
Participants are randomly assigned to receive either the investigational drug Rinatabart Sesutecan together with, or without, the targeted antibody bevacizumab, or to receive the investigator’s choice of platinum‑based chemotherapy such as paclitaxel, carboplatin, gemcitabine or pegylated liposomal doxorubicin, also with or without bevacizumab. All chemotherapy agents are given by intravenous infusion (a drip that puts medicine directly into a vein), while subcutaneous injection (a shot under the skin) is used for the antibody. Treatment cycles are given every few weeks, and patients undergo regular clinic visits, blood tests, and imaging scans to check tumor size using standard criteria called RECIST. The study follows patients for several months after treatment to record the time they remain free of disease progression, known as progression-free survival, as well as overall health and side effects.
1randomization and baseline assessments
after joining the study, you will be randomly assigned to receive either Rina‑S with or without bevacizumab, or the investigator’s choice of standard platinum‑based chemotherapy with or without bevacizumab.
baseline examinations, including imaging scans, blood tests, and quality‑of‑life questionnaires, will be performed to record your condition before treatment starts.
2first treatment administration
on the first day of treatment you will receive the medicines chosen for you by intravenous infusion, unless a different route is specified.
the possible medicines include:
paclitaxel (intravenous infusion),
carboplatin (5 mg given intravenously),
gemcitabine (intravenous infusion),
bevacizumab (intravenous use),
Caelyx (liposomal doxorubicin, given intravenously),
and the investigational drug Rina‑S (intravenous infusion).
3repeated treatment cycles
treatment will be given in repeated cycles according to the study schedule.
each cycle may include one or more of the medicines listed above, administered on the days defined by the protocol.
the exact number of cycles depends on your response and any side effects.
4supportive medication
to help maintain blood cell counts, you may receive pegfilgrastim as a subcutaneous injection (under the skin).
pegfilgrastim is given after chemotherapy to reduce the risk of low white‑blood‑cell levels.
5regular monitoring
during the study you will have periodic visits for safety checks, including blood tests and physical examinations.
imaging scans will be performed to assess tumor size and determine progression‑free survival.
questionnaires will be completed to evaluate quality of life and overall health status.
6completion of treatment
treatment will stop when the disease progresses, when unacceptable side effects occur, or after the planned number of cycles is completed.
your doctor will discuss the reason for stopping treatment and any further care needed.
7post‑treatment follow‑up
after treatment ends, you will continue to be followed for overall survival, further disease progression, and long‑term safety.
follow‑up visits may include additional scans, blood tests, and quality‑of‑life assessments according to the study timeline.
Who Can Join the Study?
Must be a woman with ovarian, fallopian‑tube, or peritoneal cancer that doctors have confirmed by examining a tissue sample under a microscope.
Must have had the cancer come back or get worse after the first round of chemotherapy that included a platinum drug (such as carboplatin) and paclitaxel, and the cancer must be platinum‑sensitive (meaning it did not get worse for at least 6 months after the last platinum treatment).
If you have a BRCA1 or BRCA2 gene change (germline or somatic) or a tumor that is HRD‑positive (has trouble repairing DNA), you must have already taken a PARP inhibitor (PARPi) maintenance therapy, with or without the drug bevacizumab.
Your cancer must be measurable on scans using the standard method called RECIST v1.1, which doctors use to track tumor size.
You must be able to provide a sample of your tumor tissue for testing.
You must have an ECOG performance status of 0 or 1, meaning you are fully active (0) or able to do light work (1).
You must be an adult (generally 18 years of age or older).
Who Cannot Join the Study?
People whose cancer is a type called clear cell, mucinous, or sarcomatous, any mixed tumor that includes these types, or a slower‑growing low‑grade/borderline ovarian tumor cannot join the study. (Clear cell, mucinous, and sarcomatous are specific patterns of tumor cells; low‑grade/borderline means the tumor grows more slowly and is less aggressive.)
People who have already been treated with other anti‑angiogenic agents besides bevacizumab or its biosimilar cannot join. (Anti‑angiogenic agents are medicines that try to stop new blood vessels from feeding the tumor; bevacizumab is a particular drug of this type; a biosimilar is a medication made to be very similar to an existing biologic drug.)
People who have previously received an antibody‑drug conjugate (ADC) that contains a topoisomerase‑1 inhibitor cannot join. (Antibody‑drug conjugate is a lab‑made molecule that links an antibody, which finds cancer cells, to a chemotherapy drug; a topoisomerase‑1 inhibitor is a chemotherapy agent that blocks an enzyme needed for cancer cells to copy their DNA.)
People who have previously received an ADC that targets the folate receptor alpha (FRα) cannot join. (Folate receptor alpha is a protein on some ovarian cancer cells that helps them take in folate, a vitamin; targeting it means the drug is designed to attach specifically to those cells.)
Rinatabart Sesutecan is an experimental medicine being tested in this study. It is given by an IV infusion and is meant to treat ovarian cancer that has come back after earlier platinum‑based treatment. In the trial it is used alone or together with another drug that blocks blood vessel growth.
Bevacizumab is a targeted therapy that stops new blood vessels from forming, which can help slow tumor growth. In this study it is given together with the experimental drug or with standard chemotherapy, depending on the treatment arm.
Paclitaxel is a chemotherapy drug that interferes with the ability of cancer cells to divide. It is one of the standard options that doctors may choose for patients in the control group of the study.
Carboplatin is another chemotherapy medicine that damages the DNA of cancer cells, making it harder for them to grow. It can be used alone or in combination with other drugs as part of the standard treatment choices.
Gemcitabine is a chemotherapy agent that blocks the building of DNA in cancer cells, helping to stop their spread. It is also an option that investigators may select for the control treatment.
Caelyx (pegylated liposomal doxorubicin) is a specially formulated form of the chemotherapy drug doxorubicin. The drug is packed in tiny fat‑like particles that stay in the bloodstream longer and cause fewer side effects. It can be chosen as part of the standard chemotherapy regimen.
Pegfilgrastim is a medication that stimulates the bone marrow to make more white blood cells. It is given as a sub‑cutaneous injection to help protect patients from infections after they receive chemotherapy.
Recurrent platinum-sensitive ovarian cancer – This disease is ovarian cancer that has returned after previous therapy and still responds to platinum‑based chemotherapy. It begins in the ovaries and can spread to nearby pelvic organs and the abdominal lining. After an initial period of remission, cancer cells can reappear, often months to a few years later. The returning tumor may grow and form new visible lesions that can be seen on imaging studies. The course of the disease is marked by cycles of remission followed by recurrence.
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