Old malaria and HIV drugs repurposed to fight ovarian cancer
NCT ID NCT06971744
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tests whether combining two drugs that affect cell cleanup (hydroxychloroquine and nelfinavir) with standard maintenance therapy (bevacizumab) can help keep ovarian cancer from growing back. About 38 women with recurrent high-grade serous ovarian cancer will take these pills plus an IV infusion every three weeks. The study will check safety and how long the cancer stays under control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hydroxychloroquine, nelfinavir, and bevacizumab
- What this could lead to
- If it works, this could offer a new maintenance option to delay cancer progression in patients with recurrent ovarian cancer.
- What could go wrong
- This is a small, early-phase trial (38 participants) with no control group, so results may not be conclusive. The drugs can cause side effects like nausea or vision changes.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 38 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jun 2029
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 years and older
- Sex
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Anyone
- 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: * Participants must have platinum-sensitive first recurrent high-grade serous or high-grade predominantly serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Patients must have had a 6-month disease-free progression since last platinum chemotherapy to be considered platinum sensitive. * All participants must agree to have previously undergone genetic testing with germline panel testing with at least BRCA 1/2 mutation status known and/or somatic tumor next generation sequencing with homologous recombination deficiency (HRD) testing and/or loss of heterozygosity (LOH) known. * Participants must be enrolled within 3-8 weeks of the first day of the last cycle of platinum-based chemotherapy for their first cancer recurrence. - Participants must have received at least 3-courses of bevacizumab during chemotherapy and have a plan to continue maintenance bevacizumab therapy. * Evidence of platinum-sensitive response to current platinum-based chemotherapy with a partial or complete response based on imaging or CA-125 trend * Participants of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin \[hCG\]) within 7 days before receiving the first dose of study treatment. * Voluntary, signed, and dated, Institutional Review Board (IRB) approved consent form per regulatory and institutional guidelines. * 18 years of age or older. * ECOG performance status of 0-2 * Bilirubin ≤ 1.5 times the upper limit of normal (ULN) and AST / ALT ≤ 3 times ULN. Subjects with Gilbert's syndrome may be included if the total bilirubin is \< 3 times ULN and the direct bilirubin is within normal limits. * CrCl ≥35 mL/min, according to the Cockgroft-Gault formula. * Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3. * Platelet count ≥ 75,000 cells / mm3 * Hemoglobin ≥ 9 g/ dL, recent transfusion is allowed, though must be ≥ 7 days C1D1 of investigational agents * Adequately controlled blood pressure (\<160 mm Hg/100 mm Hg) as determined by the treating investigator. * Subjects with the potential to produce children must agree to effective contraceptive method use during study participation and at least 6 months after discontinuation of the study. * Patients requiring narcotic analgesics must be on stable doses for at least 2 weeks before study entry. * Patients must discontinue any statin use within 48 hours of beginning study treatment. * Patients must have a QT interval of \<450 ms on screening upon ECG. * Patients who have diabetes mellitus must have it well-controlled (A1c of \<8%). Exclusion Criteria: * New York Heart Association (NYHA) Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or history of ischemia on baseline ECG. * Underlying psychiatric disorder requiring hospitalization within the last two years. * Clinically significant neurological disorder (Parkinson's disease, dementia, multiple sclerosis), as determined by the enrolling investigator. * Platinum resistant or refractory disease * Active, uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy. * Treatment with local or systemic radiation therapy, surgery, or investigational therapy within 28 days before registration with the exception of the platinum doublet and bevacizumab. * Unwillingness or inability to comply with procedures required in this protocol. * Serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator. * Patients who are receiving coumadin * Patients who are currently participating in any other clinical trial of an investigational product. * Any other mental incapacitation or psychiatric illness that would preclude study participation, as determined by the enrolling investigator. * Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled in this study. * Female patients who are of child-bearing potential (WOCBP) who are pregnant or planning to become pregnant during the study or within 6 months of the last dose of study drugs. A urine pregnancy test for WOCBP will be collected during the screening period. Females will be determined not to be of child-bearing potential with a history of hysterectomy, tubal ligation, dual salpingo-oophorectomy, or age 45 or older with postmenopausal status \> 12 months. * Patients unable to stop taking strong inhibitors and inducers of CYP2C8, CYP3A4, CYP2C19, CYP2D6, FMO-1, and MAO-A. * Patients unable to stop taking substrates of CYP2D6, CYP3A4, P-gp, MATE1K, and MATE2K. * Patients diagnosed with myasthenia gravis * Patients with G6PD Deficiency * Patients with porphyria * Platinum-sensitive patients that are candidates for PARP inhibitor maintenance, patients will be allowed if previously did not tolerate PARP and opt against PARP maintenance * Patients that have contraindications to bevacizumab, as per approved product labeling * Patients that have a high ASCVD score based on the American College of Cardiology ASCVD Risk Estimator Plus calculator and who should not stop their statin due to cardiovascular risk
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Medical University of South Carolina
RECRUITINGCharleston, South Carolina, 29425, United States
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Other studies related to the condition(s) this trial covers.
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- Mapping the DNA test that decides who gets PARP inhibitors
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- Can inhaled manganese make ovarian cancer immunotherapy hit harder?