Vulvar cancer is a relatively rare gynecological malignancy, most commonly squamous cell carcinoma, arising from the skin of the external female genitalia. It primarily affects older women and is often preceded by lichen sclerosus or high-grade vulvar intraepithelial neoplasia, though HPV-related cases also occur in younger women.
What's actually going on in research
Surgery remains the primary treatment for localized disease, and platinum-based chemotherapy with radiation is used for locally advanced cases. Immune checkpoint inhibitors are being studied for recurrent and metastatic disease, where prognosis has historically been poor. HPV vaccination programs are expected to reduce the proportion of HPV-related cases over coming decades, and trials are testing whether pembrolizumab and other agents can improve outcomes in both HPV-positive and HPV-negative disease.
Immune checkpoint inhibitors
Pembrolizumab and other PD-1/PD-L1 blocking antibodies are in trials for recurrent and metastatic vulvar cancer, building on their success in cervical and other HPV-related cancers.
Organ-preserving surgery
Trials are studying whether sentinel lymph node biopsy and less extensive local resection can preserve quality of life without compromising cancer control in selected early-stage patients.
HPV-targeted approaches
Therapeutic HPV vaccines and immune-priming strategies designed to clear HPV-related precancerous lesions and early tumors are being studied specifically in younger patients with HPV-driven vulvar cancer.
What to know before you search
Eligibility depends on cancer stage, HPV status of the tumor, prior surgical and radiation treatment, and performance status.
What types of trials are currently open
- Systemic therapy trials — Testing immune checkpoint inhibitors and chemotherapy combinations for recurrent or metastatic disease.
- Organ preservation trials — Evaluating less extensive surgical approaches and sentinel node techniques in early-stage disease.
- Radiation therapy trials — Refining radiation field design and sensitizing drug combinations for locally advanced vulvar cancer.
- Precancerous lesion trials — Testing topical immunomodulators and therapeutic vaccines for high-grade vulvar intraepithelial neoplasia.
- HPV prevention trials — Studying whether HPV vaccination reduces the incidence of HPV-positive vulvar cancer and precursor lesions.
Recently added Vulvar Cancer trials
AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors
This is a first-in-human (FIH), Phase 1 open-label, multicenter dose escalation study investigating AVA6103 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumors that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.
Electrochemotherapy for Recurrent Vulvar Cancer
This phase I/II interventional study evaluates the effectiveness and safety of electrochemotherapy (ECT) as neoadjuvant treatment for local recurrence of vulvar cancer. Electrochemotherapy combines intravenous administration of bleomycin with delivery of electric pulses to the tumor area, increasing drug uptake into cancer cells. The main goal is to assess tumor response and reduce the need for mutilating surgical procedures, thereby improving quality of life in women with recurrent vulvar cancer. Participants will be followed prospectively and treatment outcomes will be evaluated using RECIST criteria and adverse events using CTCAE v5.0.
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