Tisotumab Vedotin vs Chemotherapy for Cervical Cancer
(innovaTV 301 Trial)

Recruiting in Palo Alto (17 mi)

+221 other locations

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals with cervical cancer that has returned or spread, who have already tried certain standard treatments without success. They should have had one or two previous treatments for their condition and must be in a relatively good physical state (able to perform daily activities without significant limitations). People with serious eye conditions, bleeding risks, recent major surgery, severe nerve damage, or those who've taken drugs containing MMAE are not eligible.

Inclusion Criteria

My cervical cancer has returned or spread and is of a specific cell type.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

My cancer is not neuroendocrine, lymphoid, sarcomatoid, or any other type not listed in the criteria.

I have never been treated with drugs containing MMAE.

I have not had major surgery in the last 4 weeks or minor surgery in the last 7 days.

I have moderate to severe numbness, tingling, or pain in my hands or feet.

I have a history of severe eye inflammation or specific eye diseases, but not just cataracts.

I have a condition or history that increases my risk of serious bleeding.

Participant Groups

The study compares the effectiveness of tisotumab vedotin against traditional chemotherapy drugs (topotecan, vinorelbine, gemcitabine, irinotecan, pemetrexed) in treating recurrent or metastatic cervical cancer. Participants will be randomly assigned to receive either tisotumab vedotin or their choice of one of the chemotherapy drugs.

2Treatment groups

Experimental Treatment

Active Control

Group I: Tisotumab vedotinExperimental Treatment1 Intervention

Tisotumab vedotin monotherapy

Group II: ChemotherapyActive Control5 Interventions

Investigator's choice of one chemotherapy treatment (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)

Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Gemzar for: