RecruitingPhase 2NCT06971744

Autophagy Maintenance (AUTOMAIN)

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


Sponsor

Medical University of South Carolina

Enrollment

38 participants

Start Date

Dec 18, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding two repurposed drugs — hydroxychloroquine (an anti-malarial) and metformin (a diabetes medication) — to standard bevacizumab maintenance therapy can help prevent ovarian cancer from coming back after chemotherapy. **You may be eligible if...** - You have high-grade serous ovarian, fallopian tube, or primary peritoneal cancer that came back but is still sensitive to platinum-based chemotherapy (meaning your cancer was in remission for at least 6 months after your last platinum chemo) - You completed your most recent platinum-based chemo 3–8 weeks ago - You received at least 3 doses of bevacizumab during chemotherapy and plan to continue it - Your cancer responded (partially or completely) to the most recent chemotherapy - You are 18 or older with acceptable blood counts, liver, and kidney function **You may NOT be eligible if...** - Your cancer did not respond to platinum chemotherapy - You have serious heart disease or poorly controlled blood pressure - You are currently in another clinical trial - You have a condition such as G6PD deficiency, porphyria, or myasthenia gravis - You have a high cardiovascular risk score and cannot safely stop statin medications - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHydroxychloroquine

3 x 200 milligram tablets twice daily

DRUGNelfinavir

2x 625 milligram tablets twice daily

DRUGBevacizumab

IV 15 milligram/kilogram every 3 weeks


Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT06971744


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