A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator's Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer - innovaTV 301

iz Whalley0 个研究点目标入组 50 人开始时间: 2021年8月6日最近更新: 2024年5月27日

适应症

试验速览

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•Age =>18 years, or considered an adult by local regulations, at time of consent.
•- 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: only 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 primary neuroendocrine, lymphoid, sarcomatoid, or other histologies not mentioned as part of the inclusion criteria above.
•- 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.

发起方

iz Whalley