Ovarian cancer combo shows promise in maintenance therapy
NCT ID NCT06121401
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase IV trial tests whether the drugs olaparib and bevacizumab, taken together after initial chemotherapy, can help prevent ovarian cancer from coming back in women with a specific genetic marker (HRD-positive). About 190 participants who have already responded to first-line treatment will receive the combination as maintenance therapy. The study aims to confirm how well this approach works in everyday medical practice.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- olaparib (Lynparza) and bevacizumab
- What this could lead to
- If successful, this could confirm that combining olaparib with bevacizumab helps keep advanced ovarian cancer from coming back longer after initial treatment.
- What could go wrong
- This is a phase IV trial confirming real-world use, not a new breakthrough. Results may show limited benefit or side effects like fatigue, nausea, or high blood pressure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 190 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patient who has completed first line platinum-taxane chemotherapy 2. Patient on treatment with bevacizumab (patient must have received at least 1 cycle of bevacizumab in combination with chemotherapy). Bevacizumab treatment should have been administered at a dose of 15mg/kg q3 weeks. 3. Patient must be without evidence of disease (NED) or in complete response (CR) or partial response (PR) from her first line treatment. 4. Patients with histologically confirmed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer and HRD-positive tumor according to the Myriad Mychoice CDx Plus evaluation. 5. Patients must have normal organ and bone marrow function values measured within 28 days before administration of olaparib 6. Normal blood pressure (BP) or adequately treated and controlled hypertension (systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg 8\. Patients must have a life expectancy ≥ 16 weeks. 9. Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of olaparib administration and confirmed the day of treatment start. Exclusion Criteria: 1. Persistent toxicities (Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia 2. Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML. 3. Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required 4. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. 5. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication. 6. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV). 7. Patients with known active hepatitis (i.e. Hepatitis B or C). 8. Any previous treatment with PARP inhibitor, including Olaparib. 9. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to olaparib. 10. Major surgery within 2 weeks of starting olaparib and patients must have recovered from any effects of any major surgery 11. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted as are steroidal antiemetics). 12. Concomitant use of known strong CYP3A inhibitors 13. Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers 14. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT). 15. Patients with a known hypersensitivity to olaparib or any of the excipients of the product. 16. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of olaparib or puts the patient at high risk for treatment-related complications. 17. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements. 18. Breast feeding and pregnant women
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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A.O. Ordine Mauriziano
Torino, Italy
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A.O.U. Citta della Salute e della Scienza
Torino, Italy
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AOU Parma
Parma, Italy
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Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
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Azienda Socio Sanitaria Territoriale (ASST) Lariana
San Fermo della Battaglia, Como, 22042, Italy
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Istituto Europeo di Oncologia
Milan, Italy
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Istituto Nazionale dei Tumori
Milan, Italy
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Istituto Oncologico Veneto IRCCS
Padova, 35128, Italy
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Ospedale Manzoni
Lecco, Italy
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Ospedale San Luca
Lucca, Italy
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Ospedale Santa Chiara
Pisa, Italy
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Ospedale Umberto I
Roma, Italy
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Policlinico Careggi
Florence, Italy
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Spedali Civili
Brescia, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Patient's own immune cells fight ovarian cancer?
- Ovarian Cancer's spread: scientists probe abdominal fluid for clues
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Can a new drug combo keep ovarian cancer from coming back?
- New drug takes aim at ovarian cancers that resist platinum chemotherapy
- Can engineered immune cells outsmart Drug-Resistant ovarian cancer?