Patients with pre neoplastic high grade HPV-related vulvar and cervical lesions
Conditions
Brief summary
Proportion of subjects with no evidence of cervical HSIL on histology at surgical treatment.
Detailed description
Proportion of subjects with no evidence of vulvar VIN 2-3 on histology at surgical treatment., Incidence and severity of systemic events for the duration of the study (CTCAE version 5.0)., Proportion of subjects with downstaging of cervical and vulvar pre-neoplastic lesion on histology., Proportion of patients with no evidence of HPV by HPV testing at Week 36 visit., Proportion of subjects with no progression of cervical HSIL and vulvar VIN 2-3 to cervical and vulvar carcinoma respectively from baseline on histology.
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with no evidence of cervical HSIL on histology at surgical treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with no evidence of vulvar VIN 2-3 on histology at surgical treatment., Incidence and severity of systemic events for the duration of the study (CTCAE version 5.0)., Proportion of subjects with downstaging of cervical and vulvar pre-neoplastic lesion on histology., Proportion of patients with no evidence of HPV by HPV testing at Week 36 visit., Proportion of subjects with no progression of cervical HSIL and vulvar VIN 2-3 to cervical and vulvar carcinoma respectively from baseline on histology. | — |
Countries
Italy
Outcome results
None listed