Phase 2 tisotumab vedotin (tissue factor–targeted) MMAE ADC in recurrent/metastatic vulvar SCC.

This open-label, single-arm Phase 2 study sponsored by the GOG Foundation evaluates tisotumab vedotin in recurrent or metastatic vulvar squamous cell carcinoma, with objective response rate as the primary efficacy readout. Tisotumab vedotin (Tivdak; originally developed by Genmab and Seagen, now part of Pfizer) is an antibody-drug conjugate that binds tissue factor (TF) on tumor cells and delivers the microtubule inhibitor payload MMAE to drive cell death. Participants receive 2.0 mg/kg IV every 3 weeks (capped at 200 mg for ≥100 kg) until progression, unacceptable toxicity, or withdrawal. Scientifically, this is an expansion of a validated TF-ADC platform from cervical cancer into a rarer gynecologic SCC where prospective drug data are limited. In this setting today’s care is individualized: surgery and/or radiation when feasible, and for metastatic/recurrent disease systemic therapy is often platinum-based chemotherapy ± immunotherapy (when biomarker-eligible) or clinical trials.