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OncoMatch/Clinical Trials/NCT06971744

Autophagy Maintenance (AUTOMAIN)

Is NCT06971744 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Hydroxychloroquine and Nelfinavir for ovarian cancer.

Phase 2RecruitingMedical University of South CarolinaNCT06971744Data as of Jun 2026

Treatment: Hydroxychloroquine · Nelfinavir · BevacizumabThis 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.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Bevacizumab

Other

HydroxychloroquineNelfinavir

Cancer type

Ovarian Cancer

Biomarker criteria

Required: BRCA1 mutation status known (germline or somatic)

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

Required: BRCA2 mutation status known (germline or somatic)

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

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: platinum-based chemotherapy — first recurrence

Participants must have had a 6-month disease-free progression since last platinum chemotherapy to be considered platinum sensitive.

Must have received: bevacizumab (bevacizumab) — during chemotherapy for first recurrence

Participants must have received at least 3-courses of bevacizumab during chemotherapy and have a plan to continue maintenance bevacizumab therapy.

Cannot have received: PARP inhibitor maintenance

Exception: patients will be allowed if previously did not tolerate PARP and opt against PARP maintenance

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

Lab requirements

Blood counts

ANC ≥ 1,000 cells/mm3; Platelet count ≥ 75,000 cells/mm3; Hemoglobin ≥ 9 g/dL (recent transfusion allowed, must be ≥ 7 days before C1D1)

Kidney function

CrCl ≥35 mL/min, Cockgroft-Gault formula.

Liver function

Bilirubin ≤ 1.5x ULN and AST/ALT ≤ 3x ULN. Gilbert's syndrome: total bilirubin < 3x ULN and direct bilirubin within normal limits.

Cardiac function

QT interval <450 ms on screening ECG; adequately controlled blood pressure (<160/100 mm Hg)

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. Patients must have a QT interval of <450 ms on screening upon ECG.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Medical University of South Carolina · Charleston, South Carolina

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06971744 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior PARP inhibitor maintenance disqualifies patients from enrollment.

Does this trial require BRCA1?

Yes, BRCA1 mutation status known (germline or somatic) is a required biomarker for enrollment.

Does this trial require BRCA2?

Yes, BRCA2 mutation status known (germline or somatic) is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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