Phase 3 Trial of Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer
- Conditions
- Cervical cancer
- Registration Number
- JPRN-jRCT2011210028
- Lead Sponsor
- iz Whalley
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival (OS)
- Secondary Outcome Measures
Name Time Method - Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator <br>- Confirmed objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator<br>- Time-to-response (TTR) as assessed by the investigator<br>- Duration of response (DOR) as assessed by the investigator <br>- Incidence of adverse events (AEs)<br>- Health-related quality of life as assessed by EQ-5D-5L index <br>- Health-related quality of life as assessed by EQ-5D visual analog scale (VAS) <br>- Health-related quality of life as assessed by EORTC-QLQ-C30<br>- Health-related quality of life as assessed by EORTC-QLQ-CX24