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OncoMatch/Clinical Trials/NCT04169763

Nelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by Surgery

Is NCT04169763 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Cisplatin and Nelfinavir for stage ii vulvar cancer ajcc v8.

Phase 1RecruitingM.D. Anderson Cancer CenterNCT04169763Data as of May 2026

Treatment: Cisplatin · NelfinavirThis phase I trial studies the side effects and best dose of nelfinavir when given together with cisplatin and external beam radiation therapy in treating patients with vulvar cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery. Nelfinavir is an antiviral drug normally used to treat human immunodeficiency virus (HIV). Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving nelfinavir, cisplatin, and external beam radiation therapy may work better than giving only cisplatin and external beam radiation therapy in treating patients with vulvar cancer.

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Extracted eligibility criteria

Cancer type

Cervical Cancer

Disease stage

Excluded: Stage T1N0

Performance status

ECOG/GOG 0–2

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: pelvic or abdominal radiation

Patients who have received previous pelvic or abdominal radiation

Cannot have received: cytotoxic chemotherapy

Patients who have received previous...cytotoxic chemotherapy

Cannot have received: any previous therapy for this malignancy

Patients who have received previous...therapy of any kind for this malignancy

Lab requirements

Blood counts

anc >= 1,500/microliter; platelet count >= 100,000/microliter

Kidney function

creatinine < 2.0 mg/dl; egfr >= 30

Liver function

total bilirubin =< 1.5 times normal; sgot =< 3 times normal

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

US trial sites

  • M D Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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