Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

Conditions

• Cervical Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• tisotumab vedotin — DRUG
  2.0 mg/kg every 3 weeks (Q3W)
• topotecan — DRUG
  1 or 1.25 mg/m2 intravenous (IV) on Days 1 to 5, every 21 days
• vinorelbine — DRUG
  30 mg/m2 IV on Days 1 and 8, every 21 days
• gemcitabine — DRUG
  1000 mg/m2 IV on Days 1 and 8, every 21 days
• irinotecan — DRUG
  100 or 125 mg/m2 IV weekly for 28 days, every 42 days
• pemetrexed — DRUG
  500 mg/m2 IV on Day 1, every 21 days

Study Details

This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.

Key Dates

Start date

Feb 22, 2021

Status verified

Feb 2026

Primary completion

Jul 24, 2023

Completion

Jan 15, 2026

Study Design

Enrollment

502 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tisotumab vedotin
  Tisotumab vedotin monotherapy
• Active Comparator: Chemotherapy
  Investigator's choice of one chemotherapy treatment (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)

Primary Outcome Measure

Overall Survival [ Time Frame: From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum up to 25 months) ]

Locations (53)

Find similar trials in Glendale, AZ

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