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

Phase 3

• Conditions: D06 Carcinoma in situ of cervix uteri; Carcinoma in situ of cervix uteri

• Registration Number: PER-056-21
• Lead Sponsor: Seagen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-16
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Without startig enrollment
• Sex: Female
• Target Recruitment: 9

Inclusion Criteria

• Age =18 years (for participants in Japan, age =20 years)
• 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, or
- paclitaxel+carboplatin+bevacizumab, or
- paclitaxel+topotecan/nogitecan+bevacizumab
• NOTE: in cases where bevacizumab is not a standard of care therapy or the participant is ineligible for bevacizumab treatment according to local standards, prior treatment with bevacizumab 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 pembrolizumab 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

• 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 (eg, 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
The difference in OS between the treatment and control arms will be assessed by the stratified log-rank test. The 2-sided p-value corresponding to the test of superiority of tisotumab vedotin over chemotherapy (control) will be presented. The estimated HR and its 95% CI from the stratified Cox model will be presented. The median OS will be estimated using the Kaplan-Meier (KM) method and will be presented along with estimated KM curves and the corresponding 95% CI by treatment arm.<br>In the absence of confirmation of death, survival time will be censored at the last date the participant is known to be alive.<br> NAME OF THE RESULT: Overall survival (OS)<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: During the study (3 years)