Vulvar cancer is an uncommon malignancy that accounts for 10% of all gynecological cancers, but the incidence is rising. It is commonly treated by surgery, and includes radical resection of the primary vulvar tumour, excision of inguinal lymph nodes and sometimes (chemo)radiotherapy. The treatment is associated with impressive and long-lasting morbidity, sexual and psychological dysfunction and wound healing disorders. Therefore, less radical treatments are urgently needed.

Research from the lab of Oncode Investigator Sjoerd van der Burg and Gynecologic Oncologist Mariette van Poelgeest by Dr.  Kim Kortekaas, who is now also clinically involved in this project, strongly supports a role for the immune system towards a better clinical response to this standard treatment. A sizeable proportion of patients display a specific immune profile that not only is associated with a better response to standard treatment but based on the data of PD-1 checkpoint immunotherapy in other cancers, is also expected to lead to clinical responses in patients with vulvar cancer treated with  anti-PD1 therapy. 

The goal of this study is to investigate if two infusions with a PD-1 blocking antibody have direct clinical and immunological effects in patients with vulvar squamous cell carcinoma (VSCC) before they are treated by surgery. This will be done for the first time in a clinical trial.

The study could lead to a potential new treatment option for this patient group for the first time. It may reduce the tumor load and as consequence lead to less radical surgery and thus reduce its impressive side effects. The added clinical benefit could be a reduction of recurrences or metastases at the long term.