Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)
This research is a continuation study designed for people with advanced solid tumours or blood cancers who are already being treated with pembrolizumab, or a combination including pembrolizumab, or lenvatinib, in previous studies. The main goal is to understand the long-term safety and how well these treatments work over a longer period. Depending on where you were in your original study, you might continue receiving treatment, or simply be monitored for your health (survival follow-up). Some participants might also have the option to receive a second course of treatment if they meet certain criteria, especially if their cancer has progressed while on a different treatment arm in a previous study. It aims to provide more information about these important cancer therapies.
At a glance
What is this study about?
This study, known as KEYNOTE-587, is what we call an 'extension study.' This means it's designed for people who have been taking part in other cancer drug studies involving pembrolizumab (which also goes by MK-3475) or lenvatinib. Instead of their treatment or follow-up ending with the original study, this new study allows them to continue so researchers can gather more long-term information.
The main aim is to further investigate how safe these treatments are over many months or even years, and how effective they continue to be in managing advanced cancers. This is really important because understanding long-term effects helps doctors and patients make informed decisions about treatment plans in the future.
Participants will enter the study at different stages. Some will continue receiving their current treatment (first course phase), others will be monitored for their overall health and survival (survival follow-up phase), and a smaller group might be able to start a second round of treatment if their cancer has progressed and they meet specific conditions. This flexible design helps to ensure continuity of care while collecting valuable data.
Key takeaways
- It's an extension study for people already in specific cancer treatment trials.
- The main goal is to understand long-term safety and effectiveness of treatments like pembrolizumab.
- Participation might mean continuing treatment or being monitored.
- It's for people with advanced solid tumours or blood cancers.
- Important for gathering crucial long-term data on cancer therapies.
Who may be eligible?
Generally, to join this study, you must have already been enrolled in a specific Merck study that used pembrolizumab or a related treatment, and either still be receiving that treatment or be in their follow-up period.
If you're looking to start a second course of treatment within this study, you'd need to not have had any other cancer treatment since your first course of pembrolizumab, be generally well, and your body's organs need to be working properly. Also, any side effects from your previous treatment must have mostly cleared up.
There are also specific requirements regarding blood pressure if you might receive lenvatinib, and for both men and women, there are important rules about contraception during the study to ensure safety for everyone involved.
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.
- Have I been part of a previous Merck study involving pembrolizumab or similar drugs?
- Am I currently receiving this treatment or in the follow-up phase of that study?
- Am I generally well, and have any past treatment side effects mostly cleared up?
- If female, am I not pregnant or breastfeeding, and willing to use contraception if needed?
- If male, am I willing to use contraception if needed?
What does participation involve?
If you join this study, what you do will depend on where you were in your original study. You might continue to receive your study treatment, such as pembrolizumab or lenvatinib, given every 3 or 6 weeks, usually through an IV drip. This could go on for up to approximately two years.
Alternatively, you might enter a 'survival follow-up' phase, where you won't receive treatment but will have regular check-ups to monitor your health over time. For those starting a 'second course' of treatment, this would also involve regular infusions for a shorter period. Throughout the study, you'll have regular appointments, blood tests, and scans to check on your health and how the treatment is working. The exact number of visits and assessments will vary based on your individual phase in the study.
Potential risks and benefits
Locations (782)
- Arizona Cancer Center at UMC North ( Site 0018)Verified postcodeTucson, United States· Recruiting
- Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 0054)Verified postcodeBakersfield, United States· Recruiting
- California Cancer Associates for Research & Excellence ( Site 0016)Verified postcodeFresno, United States· Active not recruiting
- Providence Medical Foundation ( Site 0087)Verified postcodeFullerton, United States· Completed
- The Angeles Clinic and Research Institute ( Site 0005)Verified postcodeLos Angeles, United States· Active not recruiting
- UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0009)Verified postcodeLos Angeles, United States· Recruiting
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0076)Verified postcodeOrange, United States· Active not recruiting
- Stanford Cancer Center ( Site 0086)Verified postcodePalo Alto, United States· Recruiting
- UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0004)Verified postcodeSan Francisco, United States· Recruiting
- Providence Saint John's Health Center ( Site 0059)Verified postcodeSanta Monica, United States· Recruiting
- University of Colorado Cancer Center ( Site 0021)Verified postcodeAurora, United States· Recruiting
- Yale Cancer Center ( Site 0014)Verified postcodeNew Haven, United States· Active not recruiting
Common questions
What kind of cancers is this study for?
This study is for people with advanced solid tumours (like lung, breast, or bowel cancer) or blood cancers.
Is this a new treatment study?
No, this is an extension study, meaning it's for people who are already receiving pembrolizumab or related treatments in previous studies and want to continue their treatment or follow-up.
What does 'long-term safety and efficacy' mean?
It means the researchers want to see how safe the treatments are and how well they work over a longer period of time, beyond the original studies.
Will I definitely receive more treatment if I join?
Not necessarily. Depending on your situation when you join, you might continue treatment, be in a follow-up phase where you're monitored, or in some cases, start a second course of treatment.
What is 'Standard of Care (SOC)'?
Standard of Care refers to the widely accepted and currently best medical treatments available for your condition.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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