Tisotumab Vedotin Humax-tf-adc

Evidence outlook · lead readout

NCT02001623 · Ovary Cancer, Cervix Cancer, Endometrium Cancer, Bladder Cancer, Prostate Cancer (CRPC), Esophagus Cancer, Lung Cancer(NSCLC), Squamous Cell Carcinoma of the Head and Neck (SCCHN)

The reported results come from study designs that frequently fail to replicate under controlled conditions — see the rationale below.

NCT02001623: This was an open-label, single-arm phase 1/2 safety study: 195 patients with advanced solid tumors all received tisotumab vedotin in dose-escalation cohorts (3–6 patients) and tumor-specific expansion cohorts, with no randomization, blinding, placebo, or active control. The primary endpoints were counts of treatment-emergent adverse events, so the results are descriptive safety/tolerability data only; there was no comparator arm or formal statistical comparison to establish efficacy. Because the design provides no controlled evidence of benefit, the evidence grade is weak.