Recruiting
Phase 2

HCQ & NFV

Sponsor:

Medical University of South Carolina

Code:

NCT06971744

Conditions

Ovarian Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hydroxychloroquine

Nelfinavir

Bevacizumab

Study Details

Brief 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. Patients will receive the two study drugs HCQ and NFV in combination with maintenance bevacizumab.

Conditions

Ovarian Cancer

Study ID

NCT06971744

Start date

Dec 18, 2025

Status verified date

Dec, 2025

Completion date

Jun 18, 2029

Anticipated

Primary completion date

Jun 18, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

38 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hydroxychloroquine+Nelfinavir+Bevacizumab

Subjects 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)

Interventions

Hydroxychloroquine

3 x 200 milligram tablets twice daily

Nelfinavir

2x 625 milligram tablets twice daily

Bevacizumab

IV 15 milligram/kilogram every 3 weeks

Primary outcome measure

  • Safety of combination of study drugs [ Time Frame: 6 months ]
  • Evaluation of Anti Tumor Activity [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Brian Orr

843-792-9300orrb@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

charltoc@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2025-12-22.