Cervical cancer
Conditions
Interventions
Experimental:
Tisotumab vedotin: 2.0 mg/kg intravenous(IV) every 3 weeks
Active Comparator:
Investigator's choice, one of following chemotherapy treatment
- topotecan: 1 or 1.25 mg/m^2 IV on Days 1
Sponsors
Deutsch Sonia
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator - Confirmed objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator - Time-to-response (TTR) as assessed by the investigator - Duration of response (DOR) as assessed by the investigator - Incidence of adverse events (AEs) - Health-related quality of life as assessed by EQ-5D-5L index - Health-related quality of life as assessed by EQ-5D visual analog scale (VAS) - Health-related quality of life as assessed by EORTC-QLQ-C30 - Health-related quality of life as assessed by EORTC-QLQ-CX24 | — |
Countries
Argentina, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Peru, Poland, Singapore, South Korea, Spain, Sweden, Taiwan, UK, United States
Contacts
Public Contactcontact Clinical
ICON Clinical Research GK
Outcome results
None listed