OncoMatch/Clinical Trials/NCT06971744
Autophagy Maintenance (AUTOMAIN)
Is NCT06971744 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Hydroxychloroquine and Nelfinavir for ovarian cancer.
Treatment: Hydroxychloroquine · Nelfinavir · Bevacizumab — 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.
Check if I qualifyExtracted eligibility criteria
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
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