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Evaluation of Raludotatug Deruxtecan With Carboplatin, Paclitaxel, or Bevacizumab in Relapsed High-grade Serous Ovarian, Peritoneal, or Fallopian Tube Cancer

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What is this trial about?

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

This clinical trial is focused on studying a type of cancer known as high-grade serous epithelial ovarian cancer, as well as similar cancers that affect the lining of the abdomen, called primary peritoneal cancer, and the tubes connecting the ovaries to the uterus, known as fallopian tube cancer. These cancers have returned after previous treatment with platinum-based chemotherapy. The study aims to evaluate the safety and effectiveness of a new treatment called Raludotatug Deruxtecan, also known by its code name MK-5909. This treatment will be tested alone and in combination with other cancer-fighting drugs, including Carboplatin, Paclitaxel, and Bevacizumab.

The study is designed to understand how well these treatments work together and how safe they are for patients. Participants will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will be conducted in different groups, with some participants receiving Raludotatug Deruxtecan with Carboplatin, others with Paclitaxel, and another group with Bevacizumab. The goal is to find the best combination that offers the most benefit with the least side effects.

Throughout the study, researchers will closely monitor participants for any side effects and how their cancer responds to the treatment. The study will help determine the most effective and safe way to use these medications for treating these specific types of cancer. The trial is expected to continue for several years to gather enough information to make informed conclusions about the treatments being tested.

The research process

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

Step 1
Initial visit and baseline assessments
After joining the study, you attend an initial visit where eligibility is confirmed and baseline information is collected.
Baseline assessments include medical history, physical examination, laboratory tests, and imaging studies to document the current status of the cancer.
Step 2
First treatment infusion
The first infusion combines raludotatug deruxtecan (r-dxd) with the investigational partner drug assigned to your cohort.
If assigned to cohort a-1 arm 1, r-dxd is given together with carboplatin at an area‑under‑curve (auc) of 5 mg/ml·min.
If assigned to cohort a-1 arm 2, r-dxd is given together with paclitaxel (dose determined by the protocol).
If assigned to cohort a-1 arm 3, r-dxd is given together with carboplatin at auc 4 mg/ml·min.
If assigned to cohort b-1 or b-2, r-dxd is given together with bevacizumab (dose determined by the protocol).
If assigned to cohort c-1, r-dxd is given together with pembrolizumab (dose determined by the protocol).
All drugs are administered by intravenous infusion according to the study schedule.
Step 3
Subsequent treatment cycles
Treatment is repeated in cycles as defined by the study protocol.
Each cycle includes another infusion of r-dxd together with the same partner drug used in the first cycle.
The number of cycles continues until a stopping rule is reached, such as disease progression, unacceptable toxicity, or completion of the planned treatment period.
Step 4
Regular safety monitoring
Before each infusion you undergo safety assessments that include laboratory tests and a physical examination.
Any adverse events, including dose‑limiting toxicity, are recorded and evaluated.
The study team may adjust the dose or interrupt treatment based on these safety findings.
Step 5
Tumor response evaluations
Imaging studies are performed at scheduled intervals to assess the tumor’s response to treatment.
Responses are measured using the RECIST 1.1 criteria, which compare the size of target lesions over time.
Step 6
Study completion or discontinuation
Treatment continues until one of the following occurs: disease progression, occurrence of unacceptable side effects, withdrawal from the study, or completion of the protocol‑defined treatment period.
If treatment is stopped, you will have a final safety assessment and a final imaging evaluation.

Who can join the trial?

12 criteria

Must have a confirmed diagnosis (by tissue testing) of high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Must be a woman (female patient).
Must have measurable tumor that can be seen on scans, as defined by RECIST 1.1 (a set of rules for measuring tumor size).
Must have provided a sample of tumor tissue from a biopsy that has not been treated with radiation before.
Must have an ECOG performance status of 0 or 1 (fully active or able to do light work) measured within 7 days before joining the study.
If you have a history of hepatitis C virus (HCV), the virus must not be detectable in your blood at screening.
If you are positive for hepatitis B surface antigen, you must have taken hepatitis B antiviral medicine for at least 4 weeks and have an undetectable HBV viral load before joining.
If you are HIV‑positive, your HIV must be well‑controlled with anti‑retroviral therapy.
For participants in Cohort C‑1 or Cohort D: must have disease that came back after exactly one prior line of therapy, with scan‑shown progression at least 6 months (180 days) after the last platinum‑based chemotherapy (called platinum‑sensitive disease), and you must have progressed while taking a PARP inhibitor (PARPi) in the first‑line setting.
For participants in Cohort A‑1 Arm 2 or Arm 3: must have disease that came back after 1 to 3 prior lines of therapy, with scan‑shown progression at least 6 months (180 days) after the last platinum‑based chemotherapy (platinum‑sensitive disease).
For participants in Cohort B‑1 or Cohort B‑2: must have disease that came back after 1 to 3 prior lines of therapy, with scan‑shown progression less than 6 months (180 days) after the last platinum‑based chemotherapy (platinum‑resistant disease), and you must be a candidate for treatment with bevacizumab (a drug that blocks blood‑vessel growth to tumors).
Must have radiographic (scan) evidence of disease progression according to the time frames described above (≥6 months for platinum‑sensitive, <6 months for platinum‑resistant).

Who cannot join the trial?

12 criteria

Had a stroke, mini‑stroke (also called a transient ischemic attack), or another serious blood clot in an artery (arterial thromboembolic event) within the last 6 months.
Has a past or current history of non‑infectious lung inflammation (pneumonitis or interstitial lung disease) that required treatment with steroids, or still has this lung problem.
Has an active infection that needs medicines given to the whole body (systemic therapy).
Is infected with HIV and has ever had Kaposi’s sarcoma (a type of skin cancer) or Multicentric Castleman’s Disease (a rare disorder of the lymph nodes).
Has uncontrolled or serious heart disease.
Has severe lung problems caused by other lung illnesses, autoimmune diseases (where the body attacks itself), connective‑tissue or inflammatory disorders, or has had a lung removed (pneumonectomy).
Has nerve damage in the arms or legs (peripheral neuropathy) that is Grade 2 or higher (moderate to severe).
Has already received any systemic anticancer therapy before joining the study.
Has had radiation therapy within 2 weeks before starting the study drug, or has radiation‑related side effects that need steroid treatment.
Is taking chronic steroid medication (long‑term steroids).
Has another cancer that is getting worse or needed active treatment within the past 3 years.
Has cancer that has spread to the brain or spinal cord (active CNS metastases) or cancer cells in the lining of the brain and spinal cord (carcinomatous meningitis).

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital General Universitario De Valencia
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Valencia, Spain
Hospital Universitario 12 De Octubre
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Madrid, Spain
Hospital Universitario De Navarra
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Pamplona, Spain

Trial locations

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Investigated drugs

Raludotatug deruxtecan
is an experimental medicine that attaches an antibody, which seeks out cancer cells, to a chemotherapy payload. When the antibody finds a cancer cell, the attached chemotherapy is released inside the cell, helping to kill it. The trial is testing whether this drug can shrink ovarian and related cancers, either by itself or when combined with other treatments.
Carboplatin
is a chemotherapy drug that contains platinum. It works by damaging the DNA inside cancer cells, which stops them from growing and leads to their death. In this study it is given together with the experimental drug to see if the combination is safe and effective.
Paclitaxel
is a chemotherapy medicine from the taxane family. It blocks cancer cells from dividing by interfering with the structures (microtubules) they need to split. The trial uses it together with the experimental drug to evaluate safety and how well the two work together.
Bevacizumab
is a monoclonal antibody that blocks a protein called VEGF, which tumors use to create new blood vessels. By stopping the formation of these vessels, the drug can slow tumor growth. The study combines it with the experimental drug to test safety and benefit.
Pembrolizumab
is an immunotherapy drug that blocks the PD‑1 protein on immune cells, helping the body’s immune system recognize and attack cancer cells. It is being studied together with the experimental drug in patients whose cancer progressed after earlier treatments.

What is already known about the treatment

Bevacizumab
given as an intravenous infusion of a sterile solution, this drug is a monoclonal antibody that blocks a protein called VEGF which tumors use to grow new blood vessels; it is approved worldwide for several cancers including ovarian cancer and is listed in medical literature as an established angiogenesis inhibitor; its main use is to slow tumor growth and improve the effect of chemotherapy; it belongs to the class of anti‑angiogenic monoclonal antibodies.
Paclitaxel
administered by intravenous infusion, paclitaxel is a chemotherapy drug that stabilizes cell microtubules and stops cancer cells from dividing; it is an approved treatment for ovarian, breast, and lung cancers and is widely described in clinical guidelines; the drug is mainly used to shrink tumors or keep them from growing; it is classified as a taxane antineoplastic agent.
Pembrolizumab
delivered as an intravenous infusion, pembrolizumab is a monoclonal antibody that blocks the PD‑1 receptor on immune cells, allowing the body’s immune system to attack cancer; it has received regulatory approval for many tumor types and is recognized in the literature as a checkpoint inhibitor; it is used to treat cancers that express PD‑L1, including in trials for ovarian cancer; it belongs to the class of immune checkpoint inhibitors.
Carboplatin
given by intravenous infusion, carboplatin is a platinum‑based chemotherapy that creates cross‑links in DNA, preventing cancer cells from copying their genetic material; it is an approved drug for ovarian, lung, and other cancers and is a standard part of many treatment regimens; its main indication is to kill or stop the growth of tumor cells; it is classified as a platinum compound antineoplastic agent.
Raludotatug deruxtecan
administered as an intravenous infusion of a sterile solution, this investigational medication is an antibody‑drug conjugate that delivers a potent topoisomerase‑I inhibitor directly to cancer cells that express a specific target; it is currently in Phase 1b/2 clinical trials and is not yet approved for routine use; its purpose is to treat high‑grade serous ovarian and related cancers that have relapsed after platinum therapy; it belongs to the class of targeted antibody‑drug conjugates.

Investigated diseases

High-grade serous ovarian carcinoma - High-grade serous ovarian carcinoma is a fast‑growing cancer that originates in the cells lining the ovary, fallopian tube, or the lining of the abdomen. It often spreads to the peritoneal cavity and nearby organs early in its course. The tumor can form solid masses and produce fluid in the abdomen. As it advances, cancer cells may implant on the surfaces of the abdomen and pelvis. Recurrent disease may appear after initial chemotherapy, showing new growths in the same or new locations.