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C5721002 _ 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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503813-31-01
Acronym
C5721002 / SGNTV-003
Enrollment
188
Registered
2023-12-04
Start date
2021-09-17
Completion date
2025-11-18
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Second- or Third-Line Recurrent or Metastatic Cervical Cancer

Brief summary

Overall Survival (OS)

Detailed description

1. Progression-free survival (PFS) based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 as assessed by the investigator, 2. Confirmed overall response rate (ORR) based on RECIST v1.1 as assessed by the investigator, 3. Time-to-response (TTR) as assessed by the investigator, 4. DOR as assessed by the investigator, 5. Incidence of adverse events (AEs), 6. EQ-5D-3L index, 7. EQ-5D visual analog scale (VAS), 8. EORTC-QLQ-C30, 9. EORTC-QLQ-CX24

Interventions

DRUGVINORELBINE
DRUGMAXIDEX 0.1% w/v
DRUGeye drops
DRUGsuspension
DRUGIRINOTECAN
DRUGGEMCITABINE
DRUGPEMETREXED
DRUGTEARS NATURALE II
DRUGsolution.
DRUGHuMax-TF-ADC
DRUGBrimonidine Tartrate 0.2% w/v Eye Drops.
DRUGTOPOTECAN

Sponsors

Seagen Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Overall Survival (OS)—

Secondary

MeasureTime frame
1. Progression-free survival (PFS) based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 as assessed by the investigator, 2. Confirmed overall response rate (ORR) based on RECIST v1.1 as assessed by the investigator, 3. Time-to-response (TTR) as assessed by the investigator, 4. DOR as assessed by the investigator, 5. Incidence of adverse events (AEs), 6. EQ-5D-3L index, 7. EQ-5D visual analog scale (VAS), 8. EORTC-QLQ-C30, 9. EORTC-QLQ-CX24—

Countries

Austria, Belgium, Czechia, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026