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Tisotumab Vedotin vs Chemotherapy for Cervical Cancer (innovaTV 301 Trial)
innovaTV 301 Trial Summary
This trial is to see if tisotumab vedotin is better than chemotherapy to treat cervical cancer.
innovaTV 301 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowinnovaTV 301 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 102 Patients • NCT03438396innovaTV 301 Trial Design
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Who is running the clinical trial?
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- 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.My cancer progressed after receiving standard chemotherapy or treatments.My cervical cancer has returned or spread and is of a specific cell type.I have moderate to severe numbness, tingling, or pain in my hands or feet.I have had 1 or 2 treatments for my returning or spreading cervical cancer, not including initial chemotherapy with surgery or radiation.I have had a brain aneurysm, stroke, or arteriovenous malformation.I am fully active or restricted in physically strenuous activity but can do light work.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.
- Group 1: Tisotumab vedotin
- Group 2: Chemotherapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
At how many hospitals is this research project being conducted?
"Potential participants of this study can go to University of Alberta / Cross Cancer Institute in Edmonton, British Columbia Cancer Agency - Vancouver Centre in Vancouver, Sunnybrook Health Sciences Centre in Toronto, or any of the other five locations."
Could you please provide a list of similar tisotumab vedotin clinical trials?
"Currently, 985 ongoing clinical trials are investigating tisotumab vedotin. 274 of those active studies are in the third stage of testing. Although many trials for tisotumab vedotin originate from Shanghai, there are a total of 45830 locations running these tests."
Can anyone receive this treatment, or are there specific requirements?
"Yes, the information on clinicaltrials.gov indicates that this clinical trial is actively looking for patients. The study was initially posted on 2/22/2021 and was last updated on 10/28/2022. The study is recruiting for 482 patients at 5 locations"
What are the risks associated with tisotumab vedotin?
"Tisotumab vedotin is in Phase 3 of clinical trials, so there have been multiple rounds of safety testing with some efficacy data supporting its use."
How many patients are being allowed to participate in this clinical trial?
"In total, 482 individuals that meet the set inclusion criteria are required for this clinical trial. Eligible patients can choose to participate at either the University of Alberta / Cross Cancer Institute in Edmonton, Alberta or British Columbia Cancer Agency - Vancouver Centre in Vancouver, British Columbia."
What therapeutic purposes does tisotumab vedotin serve?
"tisotumab vedotin can be used as both a cancer treatment and palliative care medication. It is approved to treat malignant neoplasms, unresectable thymoma, mesotheliomas, and advanced non small cell lung cancer (nsclc)."
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