Ensayo aleatorizado, abierto, de fase 3 de tisotumab vedotín versus quimioterapia a elección del investigador en cáncer de cuello uterino recurrente o metastásico en segunda o tercera línea

Criterios de inclusión

• Has recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and:
• Has experienced disease progression during or after treatment with a standard of care systemic chemotherapy doublet, or platinum-based therapy (if eligible), defined as either:
• paclitaxel + cisplatin + bevacizumab + anti-PD-(L)1 agent, or
• paclitaxel + carboplatin + bevacizumab + anti-PD-(L)1 agent, or
• paclitaxel + topotecan/nogitecan + bevacizumab + anti-PD-(L)1 agent
• Note: In cases where bevacizumab and/or anti-PD-(L)1 agent is not a standard of care therapy or the participant was ineligible for such treatment according to local standards, prior treatment with bevacizumab and/or anti-PD-(L)1 agent is not required.
• Has received 1 or 2 prior systemic therapy regimens for recurrent and/or metastatic cervical cancer. Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy, should not be counted as a systemic therapy regimen. Single agent therapy with an anti-PD(L)1 agent for r/mCC cancer should be counted.
• Measurable disease according to RECIST v1.1 as assessed by the investigator.
• Has ECOG performance status of 0 or 1 prior to randomization.
• Has life expectancy of at least 3 months.
• Has clinically significant bleeding issues or risks. This includes known past or current coagulation defects leading to an increased risk of bleeding; diffuse alveolar hemorrhage from vasculitis; known bleeding diathesis; ongoing major bleeding; trauma with increased risk of life-threatening bleeding or history of severe head trauma or intracranial surgery within 8 weeks of trial entry.
• Has any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack \>1 month prior to screening is allowed).
• Active ocular surface disease or a history of cicatricial conjunctivitis or inflammatory conditions that predispose to cicatrizing conjunctivitis (e.g. Wagner syndrome, atopic keratoconjunctivitis, autoimmune disease affecting the eyes), ocular Stevens-Johnson syndrome or toxic epidermal necrolysis, mucus pemphigoid, and participants with penetrating ocular transplants. Cataracts alone is not an exclusion criterion.
• Major surgery within 4 weeks or minor surgery within 7 days prior to the first study treatment administration.
• Peripheral neuropathy ≥grade 2.
• Any prior treatment with monomethyl auristatin E (MMAE)-containing drugs.