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Tisotumab Vedotin for Cancer (innovaTV 207 Trial)
innovaTV 207 Trial Summary
This trial will study tisotumab vedotin to find out whether it is an effective treatment for certain solid tumors and what side effects (unwanted effects) may occur. There are four parts to this study.
innovaTV 207 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowinnovaTV 207 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 207 Trial Design
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Who is running the clinical trial?
Media Library
- I have colorectal cancer and have been treated with specific drugs but no more than 3 times for advanced disease.I have taken a tyrosine kinase inhibitor and had no more than 4 treatments for my metastatic condition.I have pancreatic cancer and have had only one treatment for it when it could not be surgically removed.I have squamous cell carcinoma of the head and neck and haven't received systemic therapy for recurrent or metastatic disease.My cancer has a PD-L1 score of 1 or higher, and I can provide a tissue sample.People from outside the European Union do not need to meet a specific requirement called CPS for this part of the study.My cancer has a PD-L1 score of 1 or higher, and I can provide a recent tissue sample.I have lung disease but don't need steroids or long-term oxygen.I have or had another type of cancer besides the one I am seeking treatment for.I have pain from my cancer that isn't relieved by treatment.My condition worsened after my last treatment.My cancer's PD-L1 status is known.I am currently experiencing active bleeding.My cancer has returned or spread and I can't have standard treatment.I have active cancer spread to my brain.I have squamous cell NSCLC and haven't had systemic therapy for metastatic disease or significant lung radiation recently.You have a measurable disease that can be tracked using specific guidelines.I have moderate to severe numbness, tingling, or pain in my hands or feet.I have squamous NSCLC, treated with platinum and CPI, and had no more than 3 treatments for advanced cancer.My cancer is not nasopharynx or salivary gland cancer.I do not have any active eye surface diseases, excluding cataracts.I have previously been treated with specific immune therapy drugs.I have SCCHN and my cancer progressed after platinum or CPI treatment. I've had 3 or fewer treatments for advanced disease.My throat cancer has worsened after treatment, and I've had 1-2 treatments including platinum and PD-(L)1 inhibitors.I am fully active or restricted in physically strenuous activity but can do light work.
- Group 1: Part E: Tisotumab Vedotin - 2Q4W Schedule
- Group 2: Part F: Tisotumab Vedotin Combination Therapy - Q2W Schedule
- Group 3: Part G: Tisotumab Vedotin Combination Therapy - Q2W Schedule
- Group 4: Part A: Tisotumab Vedotin - Q3W Schedule
- Group 5: Part B: Tisotumab Vedotin - 3Q4W Schedule
- Group 6: Part C: Tisotumab Vedotin - 2Q4W Schedule
- Group 7: Part D: Tisotumab Vedotin Combination Therapy - Q3W Schedule
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there any sites conducting this research outside of the United States?
"This trial has many different locations where patients can receive treatment. Some of these sites include University Cancer & Blood Center, LLC in Athens, Joe Arrington Cancer Research and Treatment Center in Lubbock, the University of Virginia in Charlottesville, as well as 21 other centres."
Are we still looking for patients to participate in this research?
"The trial is recruiting for 532 participants across 21 locations."
Does tisotumab vedotin have any dangerous side effects?
"While there is some safety data from Phase 2 clinical trials, tisotumab vedotin did not demonstrate efficacy in any of the studies. For this reason, it receives a score of 2."
Is tisotumab vedotin a new medication?
"tisotumab vedotin was first researched in 2018 at Memorial Sloan Kettering Cancer Center. Since that time, there have been 500 completed studies related to tisotumab vedotin. Now, in the present day, there are 3 medical trials actively recruiting patients with a notable number of these taking place in Athens, Georgia."
What illness does tisotumab vedotin commonly treat?
"Tisotumab vedotin can be used as a form of pharmacotherapy to treat neoplasm metastasis and monotherapy."
Is this a new clinical trial?
"As of now, there are 3 ongoing clinical trials for tisotumab vedotin in 160 cities and 26 countries. The first trial was conducted in 2018 by Genmab. Out of the 532 participants, the Phase 2 drug approval stage was completed successfully. In the two years since 2018, 500 more studies have been completed."
How many people are being signed up for this clinical trial?
"In total, 532 participants who meet the eligibility requirements are necessary for this clinical trial. These individuals can receive treatment at various locations, such as University Cancer & Blood Center, LLC in Athens, Georgia and Joe Arrington Cancer Research and Treatment Center in Lubbock, Texas."
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