Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors
This research study is looking at a new medicine called tisotumab vedotin for people with certain solid tumours, specifically colorectal (bowel), non-small cell lung, exocrine pancreatic, and head and neck cancers. The main goals are to understand how effective the medicine is, either on its own or when given with other cancer drugs like pembrolizumab, carboplatin, or cisplatin. We also want to find out what side effects might occur. The study has several parts, each testing different ways of giving tisotumab vedotin, often combined with other treatments over cycles lasting 3, 4, or 6 weeks. The initial goals of the study have been met, and it is now in a longer-term phase. This means participants who are still benefitting from the treatment can continue receiving it, along with their existing drug combinations.
At a glance
What is this study about?
This study is particularly interested in a new treatment called tisotumab vedotin. It's designed for people who have certain types of solid tumours, which are growths or lumps in the body. The specific cancers involved in this research include some forms of bowel cancer (colorectal), lung cancer (non-small cell), pancreatic cancer, and head and neck cancer. The main aim is to see how well tisotumab vedotin works, both on its own and when given alongside other well-known cancer medications like pembrolizumab, carboplatin, or cisplatin. The study also carefully tracks any side effects people might experience.
Over time, research studies like this help doctors learn more about promising new treatments. This study had several different groups, each trying a slightly different way of giving the medication. For example, some groups received tisotumab vedotin every three weeks, while others received it more frequently over a four or six-week period, often combined with other drugs. These different approaches help researchers find the best and safest ways to use the new treatment.
Good news – the main goals for understanding this treatment have been achieved! Because of this, the study has moved into a 'long-term extension phase'. This means that participants who are still finding the treatment helpful, and whose doctors agree, can continue to receive tisotumab vedotin and their combination medicines. This allows for ongoing observation of the treatment's effects over a longer period, which is very valuable for understanding its long-term benefits and safety.
Key takeaways
- This study is testing a new cancer drug called tisotumab vedotin.
- It's for certain advanced solid tumours where standard treatments haven't worked.
- The drug was tested alone and in combination with other cancer medicines.
- The study goals have been met and it's now in a long-term phase for existing participants.
- Participants in this phase continue to receive treatment if it's still beneficial.
- All participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you would generally need to be an adult (18 years or older) with certain types of advanced cancer that has either come back or spread, and where standard treatments haven’t worked or aren't suitable for you. This includes specific kinds of bowel, lung, pancreatic, or head and neck cancers.
For most parts of the study, you would have already received several other types of cancer treatment, and your cancer would have unfortunately progressed (gotten worse) despite these treatments. There were very specific requirements about what previous treatments you would have had, depending on your type of cancer. For instance, some people with bowel cancer would have needed to have tried specific drugs like fluoropyrimidine, oxaliplatin, or irinotecan.
It's important to know that most of the new patient groups for this study are now closed. However, if you are currently in the study and are still benefiting, you would be able to continue receiving the treatment in the long-term extension phase.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a specific type of advanced bowel, lung, pancreatic, or head and neck cancer?
- Has your cancer continued to grow despite previous treatments?
- Have you already received several types of standard cancer treatments for your condition?
- Have you discussed this study with your doctor to see if you meet the specific detailed criteria?
What does participation involve?
If you were to take part in this study, you would receive treatments in cycles, which means you'd get the medicines at regular intervals. Depending on which part of the study you were in, these cycles could be 3, 4, or 6 weeks long. You would come in for your treatment on specific days within these cycles.
Throughout your participation, you would have regular visits to the clinic. During these visits, doctors and nurses would perform various assessments. This includes checking your general health, monitoring any side effects you might experience, and doing scans or tests to see how the treatment is affecting your cancer. The medications you would receive include tisotumab vedotin, and in many cases, it would be combined with other anti-cancer drugs like pembrolizumab, carboplatin, or cisplatin.
Since the study has moved into a 'long-term extension phase', if you are already a participant and your doctor believes you are still benefiting from the treatment, you can continue receiving it. This continuation would involve ongoing visits and assessments to ensure the treatment remains effective and safe for you. The total duration of your participation would depend on how your body responds to the treatment and the doctor's assessment, but continued benefit allows for longer participation.
Potential risks and benefits
Locations (174)
- UCSD Medical Center - EncinitasVerified postcodeEncinitas, United States
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)Verified postcodeLa Jolla, United States
- UC San Diego Moores Cancer CenterVerified postcodeLa Jolla, United States
- UCSD Koman Family Outpatient PavilionVerified postcodeLa Jolla, United States
- UC San Diego/Moores Cancer CenterVerified postcodeLa Jolla, United States
- UCSD Shiley Eye InstituteVerified postcodeLa Jolla, United States
- University of California Davis Medical CenterVerified postcodeSacramento, United States
- University of California, Davis Comprehensive Cancer CenterVerified postcodeSacramento, United States
- UC San Diego Medical Center- HillcrestVerified postcodeSan Diego, United States
- UC San Diego Health - Rancho BernardoVerified postcodeSan Diego, United States
- Stanford Cancer Center South BayVerified postcodeSan Jose, United States
- UCSD Medical Center - VistaVerified postcodeVista, United States
Common questions
What is tisotumab vedotin?
It's a new medicine being studied for certain types of cancer. It targets specific cancer cells to try and stop them from growing.
Which types of cancer is this study for?
This study included certain advanced bowel, lung, pancreatic, and head and neck cancers.
Is this study still looking for new patients?
Most parts of the study that were open for new participants are now closed. It's currently in a long-term phase for existing participants.
What happens if I'm already in the study?
If you're already in the study and your doctor feels you are still getting a benefit, you can continue to receive the treatment.
Will I get other cancer drugs with tisotumab vedotin?
Yes, in many parts of the study, tisotumab vedotin was given alongside other anti-cancer drugs like pembrolizumab, carboplatin, or cisplatin.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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