Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

Summary

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.

Conditions

• Cervical Cancer

Interventions

DRUG

tisotumab vedotin

2.0 mg/kg every 3 weeks (Q3W)

DRUG

topotecan

1 or 1.25 mg/m2 intravenous (IV) on Days 1 to 5, every 21 days

DRUG

vinorelbine

30 mg/m2 IV on Days 1 and 8, every 21 days

DRUG

gemcitabine

1000 mg/m2 IV on Days 1 and 8, every 21 days

DRUG

irinotecan

100 or 125 mg/m2 IV weekly for 28 days, every 42 days

DRUG

pemetrexed

500 mg/m2 IV on Day 1, every 21 days

Sponsors & Collaborators

• Genmab

  collaborator INDUSTRY

• Seagen, a wholly owned subsidiary of Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-22

Primary Completion

2023-07-24

Completion

2026-01-15

FDA Drug

Yes

Countries

• United States
• Argentina
• Austria
• Belgium
• Brazil
• Canada
• China
• Czechia
• Finland
• France
• Germany
• Hungary
• Italy
• Japan
• Mexico
• Netherlands
• Norway
• Peru
• Poland
• Singapore
• South Korea
• Spain
• Sweden
• Taiwan
• United Kingdom

Study Locations