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Ovarian CancerPhase 2NCT06971744

Autophagy Maintenance (AUTOMAIN)

A Phase 2 study testing Hydroxychloroquine, Nelfinavir and Bevacizumab in people with Ovarian Cancer, run by Medical University of South Carolina at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a single-institution, single-arm study with a safety lead-in to determine if previously established safe doses of autophagy drugs, hydroxychloroquine (HCQ) and nelfinavir mesylate (NFV) will benefit ovarian cancer patients in a maintenance setting. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ovarian Cancer
What is being tested?
Hydroxychloroquine, Nelfinavir and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
18 Dec 2025to 18 Jun 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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%).

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brian Orr contact

843-792-9300

orrb@musc.edu

United States1 site, 1 recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Casey Charlton

    charltoc@musc.edu

    Recruiting

Other trials in United States

About this study

Official title: Autophagy Maintenance (AUTOMAIN) Therapy in High-Grade Serous Ovarian Cancer: A Phase II Trial

This is a single-institution, single-arm study with a safety lead-in to determine if previously established safe doses of autophagy drugs, hydroxychloroquine (HCQ) and nelfinavir mesylate (NFV) will benefit ovarian cancer patients in a maintenance setting. Patients will receive the two study drugs HCQ and NFV in combination with maintenance bevacizumab.

Conditions
Ovarian Cancer
Being tested
Hydroxychloroquine, Nelfinavir, Bevacizumab
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HydroxychloroquineDrug

    3 x 200 milligram tablets twice daily

  • NelfinavirDrug

    2x 625 milligram tablets twice daily

  • BevacizumabDrug

    IV 15 milligram/kilogram every 3 weeks

Study groups in NCT06971744
Study groupRoleWhat they receive
Hydroxychloroquine+Nelfinavir+BevacizumabExperimentalSubjects will take Hydroxychloroquine 3x 200 milligram tablets twice daily Subjects will take Nelfinavir 2x 625 milligram tablets twice daily Subjects will be administered Bevacizumab IV 15 milligram/kilogram every 3 weeks. DLT Period 21 Days (1 Cycle)
Receives: Drug: Hydroxychloroquine; Drug: Nelfinavir; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of combination of study drugs

    To measure the safety of HCQ + NFV in combination with standard-of-care maintenance bevacizumab in patients with high-grade serous ovarian cancer. DLT (dose limiting toxicity) is the standard endpoint in evaluating safety at this study phase. Will monitor adverse events per CTCAE v5.0.

    Measured: 6 months

  2. Evaluation of Anti Tumor Activity

    Evaluate the anti-tumor activity of HCQ + NFV in combination with standard-of-care maintenance bevacizumab in patients with high-grade serous ovarian cancer. Measured by 6-month progression-free survival rate, a composite metric based on CA 125 and radiographic imaging.

    Measured: 6 months

Secondary outcomes (2)

  1. Changes in CA125

    changes in CA125 in patients treated with HCQ + NFV in combination with standard-of-care maintenance bevacizumab

    Measured: 6 months

  2. Changes in Quality of Life

    To document the change in QOL (via disease-specific FACT questionnaire, composite score) in patients treated with HCQ + NFV in combination with standard-of-care maintenance bevacizumab

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2025
  2. Study start18 Dec 2025
  3. Primary completion18 Jun 2028 (estimated)
  4. Study completion18 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06971744
Sponsor's protocol ID
103919
Other IDs
Pro00143653
Status last verified
Dec 2025
First submitted
3 Apr 2025
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hydroxychloroquine, Nelfinavir and Bevacizumab in people with Ovarian Cancer, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brian Orr (843-792-9300, orrb@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of combination of study drugs (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06971744.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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