Clinical Trials List
Protocol NumberSGNTV-003
NCT Number(ClinicalTrials.gov Identfier)NCT04697628
Completed
2021-05-21 - 2024-06-30
Phase III
Recruiting1
Terminated2
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
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Trial Applicant
Pharmaceutical Research Associates Taiwan Inc.
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Sponsor
PRA Taiwan Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Cervical Cancer
Objectives
Demonstrate improvement in clinical efficacy of tisotumab vedotin compared to chemotherapy in participants with second- or third-line (2L 3L) cervical cancer
Test Drug
Tisotumab Vedotin
Active Ingredient
Tisotumab Vedotin
Dosage Form
Powder for concentrate for solution for infusion
Dosage
40
Endpoints
overall survival，OS
Inclution 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.
• 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
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
The Estimated Number of Participants
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Taiwan
15 participants
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Global
482 participants
